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| 1 | Hatch-Waxman Act: Overview This Practice Note provides an overview of the Hatch-Waxman Act, formally known as the Drug Price Competition and Patent Term Restoration Act of 1984, P.L. 98-417. This Note also summarizes the relevant regulatory provisions concerning branded and generic drugs, including the drug approval process, exclusivities for both branded and generic drugs, patent term extension and patent litigation under the Hatch-Waxman Act. | Practice Note: Overview | Maintained |
| 2 | Intellectual Property: Overview This Note provides an overview of the principal categories of intellectual property (IP) under US law and related practice considerations. It discusses copyright, patents, trade secrets, trademarks and mask works. For each of these categories of IP, the Note describes the legal authority governing protection, protected subject matter and the scope of protection, the acquisition and maintenance of rights and enforcement considerations. | Practice Note: Overview | Maintained |
| 3 | Leahy-Smith America Invents Act: Overview This Note summarizes the key features of the Patent Reform Act of 2011, known as the Leahy-Smith America Invents Act (AIA). It provides an overview of the AIA's reforms to US patent law, including changing the patent system from a first-to-invent to a first-inventor-to-file system, the scope of prior art used to determine novelty and the procedures for challenging the validity of issued patents. The Note also provides an overview of provisions that expand the prior use defense to patent infringement, eliminate the best mode defense and the need to obtain an opinion of counsel to defend against a willful infringement claim, allow for virtual patent marking and change false patent marking law, create a new supplemental examination procedure to limit potential inequitable conduct claims and change US Patent and Trademark Office and patent litigation procedures. | Practice Note: Overview | Maintained |
| 4 | Patent: Case Tracker A table of key patent cases that PLC Intellectual Property & Technology has reported on since December 2011. The table contains links to the cases and legal updates (and any In Dispute Practice Notes). Cases are sorted by topic, in reverse chronological order. | Practice Note: Overview | Maintained |
| 5 | Patent: Overview This Note provides an overview of US patent law and outlines the legal framework for patent law, the nature of patent protection, ownership of patents, the legal requirements for patents, the process for obtaining a patent, post-grant procedures, enforcement of patent rights and exploitation of a patent portfolio. | Practice Note: Overview | Maintained |
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| 1 | Advertising Injury Insurance Coverage for Patent, Copyright ... A Practice Note discussing potential insurance coverage for patent, trademark and copyright infringement claims as advertising injury claims under commercial general liability (CGL) policies. It addresses the framework for evaluating whether an insurer has a duty to defend or indemnify for a particular claim and common policy exclusions. It also discusses key cases assessing advertising injury coverage for intellectual property (IP) claims. | Practice Notes | Maintained |
| 2 | Antitrust Risks in Standard-Setting Organizations This Practice Note provides an overview of the key antitrust issues raised by participation in an SSO and licensing of standard-essential patents (SEPs). | Practice Notes | Maintained |
| 3 | IP Licenses and Bankruptcy A Practice Note discussing key issues relevant to intellectual property (IP) licensors and licensees affected by bankruptcy. These include issues related to the automatic stay, determining whether an IP license is an executory contract, tests for assignment and assumption of IP licenses and risks and protections for non-debtor licensees of rejected IP licenses. | Practice Notes | Maintained |
| 4 | IP Licenses: Restrictions on Assignment and Change of ... This Note discusses US law relating to the transferability of agreements that contain intellectual property (IP) licenses. It includes guidance on evaluating assignability, dealing with non-assignable licenses in M&A transactions and drafting tips for assignment provisions in favor of a licensor or licensee. It also considers issues relating to the transferability of IP licenses in the context of bankruptcy and secured transactions and change-of-control provisions. | Practice Notes | Maintained |
| 5 | ITC Section 337 Investigations: Patent Infringement Claims A Practice Note describing Section 337 investigations involving intellectual property infringement before the International Trade Commission (ITC), focusing on patent infringement claims. It outlines the basic steps of an ITC Section 337 investigation and the substantive and procedural ways it differs from typical district court patent infringement litigation, including key differences in timing. It also provides an overview of the general steps from pre-filing analysis through post-hearing briefing. | Practice Notes | Maintained |
| 6 | In Dispute: Ass'n for Molecular Pathology v. Myriad Genetics A discussion of the Myriad Genetics litigation where the ACLU, on behalf of medical organizations, researchers, genetic counselors and patients, sued Myriad Genetics, the Directors of the University of Utah Research Foundation and the US Patent and Trademark Office, challenging the patentability of certain composition of matter and method claims relating to human genetics. The main issue was whether isolated DNA molecule claims and diagnostic method claims based on cell growth rates or analyzing certain human gene sequences are eligible for patent protection under Section 101 of the Patent Act. | Practice Notes | Maintained |
| 7 | In Dispute: Bowman v. Monsanto A discussion of the Bowman v. Monsanto Co. litigation where Monsanto sued a 74-year-old Indiana farmer for allegedly infringing Monsanto's patented Roundup Ready® seeds by planting commodity seeds containing the patented technology purchased from a local grain elevator and saving and replanting later generations of those seeds. The key issue is how the patent exhaustion doctrine applies, if at all, to patented replicating technologies. | Practice Notes | Maintained |
| 8 | In Dispute: CLS Bank International v. Alice Corporation A discussion of the CLS Bank Int'l v. Alice Corp. litigation, where CLS Bank International filed suit against Alice Corporation seeking a declaratory judgment that Alice Corporation's patents for a computerized trading platform are invalid and unenforceable. The main issue is whether the alleged computer-related claims cover a particular application of an abstract idea, which is patent-eligible subject matter under Section 101 of the Patent Act, or just the patent-ineligible abstract idea itself. | Practice Notes | Maintained |
| 9 | In Dispute: GlaxoSmithKline v. Classen Immunotherapies A discussion of the GlaxoSmithKline v. Classen Immunotherapies, Inc. litigation. The key litigated issue before the Supreme Court was whether the US Court of Appeals for the Federal Circuit correctly limited the patent infringement safe harbor provided by Section 271(e)(1) of the Patent Act to only potentially infringing drug research activities occurring before FDA approval to market the drug. | Practice Notes | Maintained |
| 10 | In Dispute: Mayo Collaborative Services v. Prometheus ... A discussion of the Mayo Collaborative Services v. Prometheus Laboratories, Inc. litigation where Prometheus sued Mayo for infringing certain claims of two patents covering a method of optimizing the therapeutic efficacy of treating a patient suffering from certain autoimmune diseases. The main issue is whether a method that uses certain individualized drug metabolite measurements based on a law of nature to inform the calibration of the patient's drug dosage is patent-eligible subject matter. | Practice Notes | Maintained |
| 11 | In Dispute: Retractable Technologies v. Becton, Dickinson and ... A discussion of the Retractable Technologies, Inc. (RTI) v. Becton, Dickinson and Co. litigation. The key issue in this case concerns claim construction, specifically, the extent to which a court can use a patent's specification to construe or limit the patent's claims and whether the US Court of Appeals for the Federal Circuit should review a district court's claim construction decision de novo. | Practice Notes | Maintained |
| 12 | In Dispute: Wildtangent v. Ultramercial A discussion of the Wildtangent, Inc. v. Ultramercial, LLC litigation, where Ultramercial, LLC sued Wildtangent, Inc. and Hulu, LLC for infringing its patent covering a method for distributing content over the internet by allowing an internet user to view copyrighted material after viewing an advertisement rather than paying to view it. The main issue is what the level of abstractness is for a computer-related invention when determining whether the invention covers subject matter eligible for patent protection. Specifically, this case focused on whether the claimed computer-related method is a particular application of an abstract idea, which is patent-eligible subject matter under Section 101 of the Patent Act, or is merely a patent-ineligible abstract idea. | Practice Notes | Maintained |
| 13 | Intellectual Property Rights: The Key Issues This Note discusses the main categories of intellectual property (IP) rights in the US and their management, including IP ownership, assignment and licensing. It also examines the issues that arise surrounding business transactions involving IP, including M&A and finance transactions as well as their basic tax treatment under federal law. | Practice Notes | Maintained |
| 14 | Joint Development Agreements This Practice Note discusses the key considerations in an agreement where two unaffiliated entities collaborate on the development of certain technology for commercialization. The agreement may be called a joint development agreement or collaboration, strategic alliance or strategic partnership agreement. This Note provides insight into the scope of the joint development activities, each party's performance obligations, joint development project management, cost allocation, intellectual property provisions, confidentiality, risk allocation, termination and dispute resolution. | Practice Notes | Maintained |
| 15 | PTAB Trial Practice Rules This Note provides an overview of the US Patent and Trademark Office's (USPTO) rules of practice and practice guide for trials before the Patent Trial and Appeal Board (PTAB). On February 9 and 10, 2012, the USPTO published proposed rules to implement the Leahy-Smith America Invents Act's provisions concerning inter partes review, post-grant review, the transitional program for covered business method patents and derivation proceedings. Following the comment period for the proposed rules, the USPTO issued final rules for inter partes review, post-grant review and the transitional program for covered business method patents on August 14, 2012, which are effective as of September 16, 2012. The USPTO issued final rules for derivation proceedings on September 11, 2012, which are effective as of March 16, 2013. | Practice Notes | Maintained |
| 16 | Patent Infringement Claims and Defenses A Practice Note discussing patent infringement claims and defenses in the US federal courts. It provides an overview of direct and indirect infringement claims, claim construction and key defenses under US patent law, as modified by the Leahy-Smith America Invents Act (AIA). It also includes a brief discussion of procedural considerations, remedies and alternative forums for patent dispute resolution, including post-grant and pre-issuance proceedings in the USPTO under the AIA. | Practice Notes | Maintained |
| 17 | Patent License Agreements A Practice Note discussing the key considerations in patent licensing, including the scope of license rights and exclusivity, royalties, sublicensing, representations and warranties, indemnification and licensee estoppel. This Practice Note also provides insight into specific royalty issues, including minimum royalties and best efforts, most favorable licensee provisions, royalty packing, royalty stacking and licensee grantbacks. | Practice Notes | Maintained |
| 18 | Patent Litigation: Mapping a Global Strategy A Note discussing a global approach to patent litigation. It outlines key strategic considerations for patentees seeking to file patent infringement suits against an alleged infringer in more than one jurisdiction, in particular the differences between key jurisdictions in timing, procedure and substantive patent law. | Practice Notes | Maintained |
| 19 | Patent and Technological Tying in the US This Practice Note provides a brief overview of the US antitrust law relating to tying practices, with a particular emphasis on patent and technological tying arrangements and recent developments in these areas. | Practice Notes | Maintained |
| 20 | Road Map to USPTO Leahy-Smith America Invents Act ... This Note tracks the US Patent and Trademark Office (USPTO) rules and other activities that implement various provisions of the Leahy-Smith America Invents Act. It includes links to PLC resources concerning the key areas of patent reform and other topical resources. | Practice Notes | Maintained |
| 21 | Security Interests: Intellectual Property An overview of special issues and considerations with respect to security interests in intellectual property, relevant to both corporate and finance transactions. | Practice Notes | Maintained |
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| 1 | Employee Confidentiality and Proprietary Rights Agreement An agreement between an employer and an employee concerning confidentiality and appropriate handling of the employer's commercially valuable information, compliance with relevant security rules and policies, and protection of the employer's intellectual property assets. Agreements of this type have various titles, which may use the term "non-disclosure" in place of "confidentiality," or "intellectual property" in place of "proprietary rights." This Standard Document is drafted in favor of the employer. It is based on federal law. For information on state law requirements, see the State Q&A Tools under Related Content to the right. This Standard Document has integrated notes with important explanations and drafting tips. | Standard Documents | Maintained |
| 2 | Employee Confidentiality and Proprietary Rights Agreement ... A California-specific agreement between an employer and an employee concerning confidentiality and appropriate handling of the employer's commercially valuable information, compliance with relevant security rules and policies, and protection of the employer's intellectual property assets. Agreements of this type have various titles, which may use the term "non-disclosure" in place of "confidentiality," or "intellectual property" in place of "proprietary rights." This Standard Document is drafted in favor of the employer. It is based on California law. This Standard Document has integrated notes with important explanations and drafting tips. | Standard Documents | Maintained |
| 3 | Evaluation and Option Agreement for a Patent License An agreement granting a prospective licensee a right to evaluate patented technology for a limited time and option to enter into a license agreement for the technology. This Standard Document is drafted in favor of the prospective licensee but aims to be reasonable and includes provisions that are common to negotiated evaluation and option agreements. Each evaluation and option agreement must be tailored to suit the particular circumstances of the transaction. This Standard Document has integrated notes with important explanations and drafting and negotiating tips. | Standard Documents | Maintained |
| 4 | Intellectual Property Assignment Agreement (Short-form) This is a standard short-form intellectual property (IP) assignment agreement for use as an ancillary agreement to a principal asset purchase agreement. This IP assignment agreement can be attached as an exhibit to the prinicpal asset purchase agreement and recorded with the US Patent and Trademark Office (USPTO) and US Copyright Office against scheduled IP applications and registrations. This Standard Document has integrated notes with important explanations and drafting tips. | Standard Documents | Maintained |
| 5 | Intellectual Property Security Agreement (Short-form) This is a standard short-form intellectual property (IP) security agreement to be used with a principal security agreement in a syndicated secured loan transaction. This IP security agreement can be attached as an exhibit to the principal security agreement. In addition, this IP security agreement can be recorded with the US Patent and Trademark Office and US Copyright Office against US IP included in the collateral subject to the security interest. This Standard Document has integrated notes with important explanations and drafting tips. | Standard Documents | Maintained |
| 6 | Joint Development Agreement An agreement between two entities concerning their collaboration on the development of patentable technology for later commercialization. It contains provisions that are common in negotiated joint development agreements, including terms setting out the parties' joint development activity and responsibilities, procedures for project management and dispute resolution, the use and ownership of background and jointly developed intellectual property and patent prosecution and enforcement. This Standard Document has integrated notes with important explanatory drafting and negotiating tips. It aims to be reasonable and is drafted in a balanced manner that does not necessarily favor one joint developer over the other. | Standard Documents | Maintained |
| 7 | Patent Assignment Agreement (Short-form) This is a standard short-form patent assignment agreement for use as an ancillary agreement to a principal asset purchase agreement or other principal transaction agreement. This patent assignment agreement can be attached as an exhibit to the principal asset purchase agreement or other principal transaction agreement and recorded with the US Patent and Trademark Office (USPTO) against scheduled patents and patent applications. This Standard Document has integrated notes with important explanations and drafting tips. | Standard Documents | Maintained |
| 8 | Patent License Agreement (Pro-licensee) An agreement granting a license to use or commercialize products incorporating patented technology. Patent license agreements vary in length and complexity depending on multiple factors (such as the scope of the licensed patents, the complexity and type of patented technology, the relationship among the parties and the value and duration of the licensing arrangement). Each patent license agreement must be tailored to suit the particular circumstances of the transaction. This Standard Document is drafted in favor of the licensee, but includes provisions that are common to negotiated patent license agreements. This Standard Document has integrated notes with important explanations and drafting and negotiating tips. | Standard Documents | Maintained |
| 9 | Patent Litigation: Settlement Agreement and Release (Pro ... A sample agreement between two or more parties settling a pending patent litigation in the US, releasing specific patent infringement claims in existence as of the agreement's effective date. This Standard Document is drafted in favor of the patent owner but aims to be reasonable and includes provisions that are common to negotiated patent settlement agreements. This Standard Document has integrated notes with important explanations and drafting tips. | Standard Documents | Maintained |
| 10 | Patent Security Agreement (Short-form) This is a standard short-form patent security agreement to be used with a principal security agreement in a syndicated secured loan transaction. This patent security agreement can be attached as an exhibit to the principal security agreement. In addition, this patent security agreement can be recorded with the US Patent and Trademark Office against US patents and patent applications included in the collateral subject to the security interest. This Standard Document has integrated notes with important explanations and drafting tips. | Standard Documents | Maintained |
| 11 | Patent and Know-how License Agreement (Pro-licensor) An agreement granting a company a license to commercialize products incorporating the licensor's patented and unpatented technology. This Standard Document is drafted in favor of the licensor, but aims to be reasonable and includes provisions that are common to negotiated patent and know-how license agreements. This Standard Document has integrated notes with important explanations and drafting and negotiating tips. | Standard Documents | Maintained |
| 12 | Release of Intellectual Property Security Interest (Short-form) This Standard Document is a standard short-form agreement to release a security interest in intellectual property (IP) included as collateral in a secured loan transaction. This release can be recorded with the US Patent and Trademark Office (USPTO) and US Copyright Office to terminate and release security interests filed against US IP. This Standard Document has integrated notes with important explanations and drafting tips. | Standard Documents | Maintained |
| 13 | Release of Patent Security Interest (Short-form) This Standard Document is a standard short-form agreement to release a security interest in patents included as collateral in a secured loan transaction. This release can be recorded with the US Patent and Trademark Office (USPTO) to terminate and release security interests filed against US patent applications and issued patents. This Standard Document has integrated notes with important explanations and drafting tips. | Standard Documents | Maintained |
| 14 | Software Assignment and Grant-back License Agreement (Pro ... An agreement for the assignment of intellectual property ownership rights in software and the assignee's grant back to the assignor of a license to use the software. It assumes that the assignment and license agreement is being entered into ancillary to a broader transaction. However, the document contains alternative provisions that allow for its use as at least the starting point for a standalone agreement. While drafted in favor of the assignee, this software assignment and grant-back license agreement aims to be reasonable and includes commonly negotiated provisions. This Standard Document has integrated notes with explanations and drafting tips. | Standard Documents | Maintained |
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| 1 | IP License Clauses: Effect of Licensor Bankruptcy An effect of licensor bankruptcy clause for use in certain types of intellectual property (IP) licenses and related supplementary agreements. This clause is typically included by and for the benefit of the licensee. It describes the subject matter of the agreement as "intellectual property" as defined by section 101(35A) of the Bankruptcy Code and sets out the parties' intent concerning their rights and obligations under section 365(n) of the Bankruptcy Code if the licensor enters into bankruptcy. The Standard Clause has integrated drafting notes with important explanations and drafting tips. | Standard Clauses | Maintained |
| 2 | IP Rights Clauses for Employee Agreements (Long-form) Long-form clauses for the protection of an employer's intellectual property (IP) rights for use in an agreement with a junior or senior employee who is principally involved in a technical or creative role. These clauses include specific language that aims to protect the employer's IP rights in this context, including treatment of pre-existing intellectual property rights. These Standard Clauses have integrated notes with important explanations and drafting tips. | Standard Clauses | Maintained |
| 3 | IP Rights Clauses for Employee Agreements (Short-form) Short-form clauses for the protection of an employer's intellectual property (IP) rights for use in an agreement with a junior or senior employee who is not principally involved in a technical or creative role. These Standard Clauses have integrated notes with important explanations and drafting tips. | Standard Clauses | Maintained |
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| 1 | Joint Development Agreement Checklist A Checklist of common issues to consider when entering into a joint development agreement. This Checklist assumes an arrangement between two companies having expertise in different but complementary technologies seeking to collaborate to develop a new product for commercialization. It addresses preliminary considerations and common joint development agreement provisions, including the scope of the parties' joint development activities and their performance obligations, project management, intellectual property (IP) use and ownership, confidentiality, risk allocation, dispute resolution and termination. | Checklists | Maintained |
| 2 | Leahy-Smith America Invents Act: Key Effective Dates Chart This chart sets out the effective dates for key US patent law reforms under the Leahy-Smith America Invents Act (AIA) enacted on September 16, 2011. It identifies changes that became immediately effective on that date including the changes regarding the prior commercial use defense, the best mode defense, patent marking and litigation procedure. It also identifies other subsequent changes, including the first-inventor-to-file system, changes to the definition of prior art, the creation of derivation proceedings, post-grant and inter partes review, supplemental examination, pre-issuance submissions and changes to the use of advice of counsel in defending a charge of willful infringement. | Checklists | Maintained |
| 3 | Participation in a Standard-Setting Organization Checklist This Checklist provides questions companies should ask before participating in a standard-setting organization and sets out best practices for companies to follow to minimize the antitrust risks of participation. | Checklists | Maintained |
| 4 | Patent License Checklist This Checklist identifies common issues for a patent licensee to consider when entering a patent license agreement for patented technology that supplements its internally developed technology. This Checklist assumes a licensing arrangement where the licensee actively seeks patented technology to license and is not under a patent infringement allegation from the potential licensor. Checklist items include preliminary considerations and common patent license agreement provisions, including the license grant, royalties and other license fees, patent prosecution obligations, litigation proceedings and risk allocation. | Checklists | Maintained |
| 5 | US Patent Application Prosecution Flowcharts These US patent application prosecution flowcharts provide an overview of the basic utility patent application process in the US Patent and Trademark Office (USPTO). The flowcharts assume the invention was invented in the US and the application is a non-provisional patent application. | Checklists | Maintained |
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| 1 | A unified Europe? Unitary patents and the unified patent court The patent system in Europe is set to undergo its biggest overhaul since the 1970s, with the introduction of the Unitary Patent and the Unified Patent Court. After more than 40 years of negotiations, and numerous false starts, the building blocks are in place for a patent with multi-jurisdictional European coverage and a new centralised court system. This article examines the current system, the Unitary Patent, the Unified Patent Court and practical points for life sciences businesses to start considering now. This article is part of the PLC multi-jurisdictional guide to life sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg. | Articles | 01-May-2013 |
| 2 | Concurrent expert evidence in patent cases This article sets out a summary of the giving of concurrent expert evidence in Australian patent cases. In particular, it examines expert evidence, concurrent evidence, legislative support, advantages and disadvantages of concurrent evidence, recent cases involving concurrent evidence and the use of concurrent evidence in patent cases. This article is part of the PLC multi-jurisdictional guide to life sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg. | Articles | 01-May-2013 |
| 3 | Enforcement of competition law in the South Korean ... This article analyses the recent developments in enforcement of competition law in the South Korean pharmaceutical industry. It reviews the enforcement issues involving unreasonable inducement of customers (rebates), collaborative acts (cartels), resale price maintenance, unfair trade practices in the supply of pharmaceutical products and abuse of patent rights. This article is part of the PLC multi-jurisdictional guide to life sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg. | Articles | 01-May-2013 |
| 4 | Indian pharmaceutical patent law: the revocation of two ... The recent revocation of two pathbreaking pharmaceutical patents in India shows interesting developments in Indian patent law. Against this background, this article examines the revocation of Pfizer's Sunitinib patent and the revocation of Roche's patent for a hepatitis C drug (pegasus). This article is part of the PLC multi-jurisdictional guide to life sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg. | Articles | 01-May-2013 |
| 5 | Key aspects of patent enforcement in Ukraine This article examines obtaining and enforcing patents in Ukraine, in particular the legal landscape and recent developments in patent protection at the customs border, obtaining patent protection, patent enforcement including patent licensing strategies, enforcement and defence in the courts and evidence collection for patent enforcement, including general issues and peculiarities for patent infringement proceedings. This article is part of the PLC multi-jurisdictional guide to life sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg. | Articles | 01-May-2013 |
| 6 | Life sciences in Australia: overview A Q&A guide to life sciences law in Australia. The Q&A gives a high level overview of key issues including pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, patents, trade marks, and product liability. To compare answers across multiple jurisdictions, visit the Life Sciences Country Q&A tool. This Q&A is part of the PLC multi-jurisdictional guide to life sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg. | Articles | 01-May-2013 |
| 7 | Life sciences in Brazil: overview A Q&A guide to life sciences law in Brazil. The Q&A gives a high level overview of key issues including pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, patents, trade marks, and product liability. To compare answers across multiple jurisdictions, visit the Life Sciences Country Q&A tool. The Q&A is part of the PLC multi-jurisdictional guide to life sciences law. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg. | Articles | 01-May-2013 |
| 8 | Life sciences in Finland: overview A Q&A guide to life sciences law in Finland. The Q&A gives a high level overview of key issues including pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, patents, trade marks, and product liability. To compare answers across multiple jurisdictions, visit the Life Sciences Country Q&A tool. This Q&A is part of the PLC multi-jurisdictional guide to life sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg. | Articles | 01-May-2013 |
| 9 | Life sciences in France: overview A Q&A guide to life sciences law in France. The Q&A gives a high level overview of key issues including pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, patents, trade marks, and product liability. To compare answers across multiple jurisdictions, visit the Life Sciences Country Q&A tool. The Q&A is part of the PLC multi-jurisdictional guide to life sciences law. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg. | Articles | 01-May-2013 |
| 10 | Life sciences in Germany: overview A Q&A guide to life sciences law in Germany. The Q&A gives a high level overview of key issues including pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, patents, trade marks, and product liability. To compare answers across multiple jurisdictions, visit the Life Sciences Country Q&A tool. This Q&A is part of the PLC multi-jurisdictional guide to life sciences law. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg. | Articles | 01-May-2013 |
| 11 | Life sciences in Hungary: overview A Q&A guide to life sciences law in Hungary. The Q&A gives a high level overview of key issues including pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, patents, trade marks, and product liability. To compare answers across multiple jurisdictions, visit the Life Sciences Country Q&A tool. This Q&A is part of the PLC multi-jurisdictional guide to life sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg. | Articles | 01-May-2013 |
| 12 | Life sciences in India: overview A Q&A guide to life sciences law in India. The Q&A gives a high level overview of key issues including pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, patents, trade marks, and product liability. To compare answers across multiple jurisdictions, visit the Life Sciences Country Q&A tool. The Q&A is part of the PLC multi-jurisdictional guide to life sciences law. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg. | Articles | 01-May-2013 |
| 13 | Life sciences in Ireland: overview A Q&A guide to life sciences law in Ireland. The Q&A gives a high level overview of key issues including pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, patents, trade marks, and product liability. To compare answers across multiple jurisdictions, visit the Life Sciences Country Q&A tool. This Q&A is part of the PLC multi-jurisdictional guide to life sciences law. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg. | Articles | 01-May-2013 |
| 14 | Life sciences in Italy: overview A Q&A guide to life sciences law in Italy. The Q&A gives a high level overview of key issues including pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, patents, trade marks, and product liability. To compare answers across multiple jurisdictions, visit the Life Sciences Country Q&A tool. The Q&A is part of the PLC multi-jurisdictional guide to life sciences law. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg. | Articles | 01-May-2013 |
| 15 | Life sciences in Japan: overview A Q&A guide to life sciences law in Japan. The Q&A gives a high level overview of key issues including pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, patents, trade marks, and product liability. To compare answers across multiple jurisdictions, visit the Life Sciences Country Q&A tool. The Q&A is part of the PLC multi-jurisdictional guide to life sciences law. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg. | Articles | 01-May-2013 |
| 16 | Life sciences in Mexico: overview A Q&A guide to life sciences in Mexico. The Q&A gives a high level overview of key issues including pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, patents, trade marks, and product liability. To compare answers across multiple jurisdictions, visit the Life sciences Country Q&A tool. This Q&A is part of the PLC multi-jurisdictional guide to life sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg. | Articles | 01-May-2013 |
| 17 | Life sciences in South Africa: overview A Q&A guide to life sciences law in South Africa. The Q&A gives a high level overview of key issues including pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, patents, trade marks, and product liability. To compare answers across multiple jurisdictions, visit the Life Sciences Country Q&A tool. The Q&A is part of the PLC multi-jurisdictional guide to life sciences law. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg. | Articles | 01-May-2013 |
| 18 | Life sciences in South Korea: overview A Q&A guide to life sciences in South Korea. The Q&A gives a high level overview of key issues including pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, patents, trade marks, and product liability. To compare answers across multiple jurisdictions, visit the Life Sciences Country Q&A tool. This Q&A is part of the PLC multi-jurisdictional guide to life sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg. | Articles | 01-May-2013 |
| 19 | Life sciences in Spain: overview A Q&A guide to life sciences law in Spain. The Q&A gives a high level overview of key issues including pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, patents, trade marks, and product liability. To compare answers across multiple jurisdictions, visit the Life Sciences Country Q&A tool. The Q&A is part of the PLC multi-jurisdictional guide to life sciences law. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg. | Articles | 01-May-2013 |
| 20 | Life sciences in Sweden: overview A Q&A guide to life sciences law in Sweden. The Q&A gives a high level overview of key issues including pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, patents, trade marks, and product liability. To compare answers across multiple jurisdictions, visit the Life Sciences Country Q&A tool. The Q&A is part of the PLC multi-jurisdictional guide to life sciences law. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg. | Articles | 01-May-2013 |
| 21 | Life sciences in Switzerland: overview A Q&A guide to life sciences law in Switzerland. The Q&A gives a high level overview of key issues including pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, patents, trade marks, and product liability. To compare answers across multiple jurisdictions, visit the Life Sciences Country Q&A tool. The Q&A is part of the PLC multi-jurisdictional guide to life sciences law. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg. | Articles | 01-May-2013 |
| 22 | Life sciences in Turkey: overview A Q&A guide to life sciences law in Turkey. The Q&A gives a high level overview of key issues including pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, patents, trade marks, and product liability. To compare answers across multiple jurisdictions, visit the Life Sciences Country Q&A tool. The Q&A is part of the PLC multi-jurisdictional guide to life sciences law. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg. | Articles | 01-May-2013 |
| 23 | Life sciences in UK (England and Wales): overview A Q&A guide to life sciences law in the UK (England and Wales). The Q&A gives a high level overview of key issues including pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, patents, trade marks, and product liability. To compare answers across multiple jurisdictions, visit the Life Sciences Country Q&A tool. The Q&A is part of the PLC multi-jurisdictional guide to life sciences law. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg. | Articles | 01-May-2013 |
| 24 | Life sciences in the Czech Republic: overview A Q&A guide to life sciences law in the Czech Republic. The Q&A gives a high level overview of key issues including pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, patents, trade marks, and product liability. To compare answers across multiple jurisdictions, visit the Life Sciences Country Q&A tool. This Q&A is part of the PLC multi-jurisdictional guide to life sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg. | Articles | 01-May-2013 |
| 25 | Life sciences in the United States: overview A Q&A guide to life sciences law in the United States. The Q&A gives a high level overview of key issues including pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, patents, trade marks, and product liability. To compare answers across multiple jurisdictions, visit the Life Sciences Country Q&A tool. This Q&A is part of the PLC multi-jurisdictional guide to life sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg. | Articles | 01-May-2013 |
| 26 | Off-label use of medicinal products and product liability This chapter explains the application of the Product Liability Directive in the case of off-label use of medicinal products. In particular, it considers the concept of off-label use, including its background and place in clinical practice, the Product Liability Directive and its main provisions, the liability of the producer under the Product Liability Directive in the case of off-label use, and the liability of the prescribing physician and the pharmacist. This article is part of the PLC multi-jurisdictional guide to life sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg. | Articles | 01-May-2013 |
| 27 | Technology transfer and state aid This article examines notification of research, development and innovation (R&D&I) aid and exemptions, examination of notified state aid and research, technology transfer and prohibited state aid. This article is part of the PLC multi-jurisdictional guide to life sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg. | Articles | 01-May-2013 |
| 28 | Life sciences: Country Q&A tool This tool enables subscribers to search the Life Sciences multi-jurisdictional guide by question and jurisdiction. Simply select the questions and the jurisdictions that you are interested in and click the "submit" button. Please note that the law stated dates for each jurisdiction covered may not be the same. To check the law stated dates for each jurisdiction, please visit the individual article. | Articles | 30-Apr-2013 |
| 29 | Collection of human biospecimens for future unspecified ... This article is part of the PLC multi-jurisdictional guide to life sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg. | Articles | 01-Apr-2013 |
| 30 | Life sciences in Denmark: overview A Q&A guide to life sciences law in Denmark. The Q&A gives a high level overview of key issues including pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, patents, trade marks, and product liability. To compare answers across multiple jurisdictions, visit the Life Sciences Country Q&A tool. This Q&A is part of the PLC multi-jurisdictional guide to life sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg. | Articles | 01-Apr-2013 |
| 31 | Life sciences in Singapore: overview A Q&A guide to life sciences law in Singapore. The Q&A gives a high level overview of key issues including pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, patents, trade marks, and product liability. To compare answers across multiple jurisdictions, visit the Life Sciences Country Q&A tool. This Q&A is part of the PLC multi-jurisdictional guide to life sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg. | Articles | 01-Apr-2013 |
| 32 | Litigation funding: a new landscape for England and Wales Important reforms to the litigation funding regime in England and Wales came into force on 1 April 2013. The claimant lawyer bar has warned that the reforms are likely to seriously impact on the viability of group product liability claims in future, due to the reduction in financial incentive for claimant lawyers to pursue such claims. This article looks at whether this is likely to be the case, or whether the various changes will mean that defendants are in fact more likely to face group claims in the future. This article is part of the PLC multi-jurisdictional guide to life sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg. | Articles | 01-Apr-2013 |
| 33 | Patent protection and data and marketing exclusivity The table summarises patent protection and data and marketing exclusivity in the jurisdictions covered in the PLC multi-jurisdictional guide to life sciences law. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg. | Articles | 01-Mar-2013 |
| 34 | Expert Q&A on Standard-Essential Patents An expert Q&A with Logan Breed of Hogan Lovells US LLP on the antitrust implications of standard-essential patents (SEPs), the DOJ's and FTC's current SEP-related enforcement initatives and best practices for standard-setting organizations. | Articles | 07-Feb-2013 |
| 35 | Life sciences in Thailand: overview A Q&A guide to life sciences law in Thailand. The Q&A gives a high level overview of key issues including pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, patents, trade marks, and product liability. This Q&A is part of the PLC multi-jurisdictional guide to life sciences law. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg. | Articles | 01-Jan-2013 |
| 36 | Life sciences in Vietnam: overview A Q&A guide to life sciences law in Vietnam. The Q&A gives a high level overview of key issues including pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, patents, trade marks, and product liability. To compare answers across multiple jurisdictions, visit the Life Sciences Country Q&A tool. This Q&A is part of the PLC multi-jurisdictional guide to life sciences law. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg. | Articles | 01-Jan-2013 |
| 37 | Patent Litigation Strategy: The Impact of the America Invents ... This Article discusses litigation strategy in view of the new post-grant patent procedures created by the Leahy-Smith America Invents Act (AIA). The AIA provides for post-grant review by the Patent Trial and Appeal Board (PTAB), inter partes review, transitional post-grant review and supplemental examination. These newly created procedures allow third parties to challenge patents and patent owners to strengthen their portfolios. The US Patent and Trademark Office (USPTO) will issue regulations detailing these procedures throughout 2012. | Articles | 27-Jan-2012 |
| 38 | European patent harmonisation: wishful thinking? A look at attempts by EU national courts to harmonise their approach to procedure and substantive law in the field of patent law. | Articles | 01-Dec-2011 |
| 39 | Data protection and life sciences: impact of the proposed EU ... This article sets out the background to the European Commission's proposed new regulation to protect individuals relating to the processing of personal data and the free movement of such data, in relation to clinical trials (including data controllers and data processors and international transfers of clinical data), pharmacovigilance, health data and consent and medical research. This article is part of the PLC multi-jurisdictional guide to life sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg. | Articles | 01-Nov-2011 |
| 40 | EU and US regulation of health information technology ... The emergence of integrated health information systems, mobile apps and software-based medical devices presents significant opportunities in managing healthcare costs and achieving better outcomes. This article analyses the developing EU and US approaches to health information technology (health IT) and mobile medical applications (MMAs), and the emerging rules and compliance issues for companies developing and marketing these products. This article is part of the PLC multi-jurisdictional guide to life sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg. | Articles | 01-Nov-2011 |
| 41 | Generics and biosimilars in Brazil: elements of the industrial ... This chapter provides an overview of the challenges facing the pharmaceutical industry in Brazil, including the regulatory framework for generics, similars and biosimilars, the exponential growth of the market, the problems still existing in the competition with non-interchangeable copies (similars) and the absence of compliance with international standards, to date. The Brazilian government policies to favour domestic pharmaceutical industries and the country's lack of clear rules regarding the purchasing preferences, with its recently enacted government purchasing programme, are also covered. This article is part of the PLC multi-jurisdictional guide to life sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg. | Articles | 01-Nov-2011 |
| 42 | Impact of the South Korea-US Free Trade Agreement on the ... This chapter analyses the provisions of the South Korea-US Free Trade Agreement (FTA), which was signed by South Korea and the US on 30 June 2007 and will take effect on 15 March 2012. It looks at the FTA in terms of the adoption of the independent review process in the pharmaceutical sector, the introduction of the approval-patent linkage system, data exclusivity, customs duties and non-tariff barriers and competition law. This article is part of the PLC multi-jurisdictional guide to life sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg. | Articles | 01-Nov-2011 |
| 43 | Key considerations for European M&A in the life sciences ... This article illustrates how a complex and evolving legal and regulatory environment gives rise to unique challenges for those engaged in European M&A in the life sciences sector, by analysing a hypothetical M&A. In particular, it examines: • A life sciences M&A case study. • Due diligence and its impact. • Intellectual property issues. • Structuring the deal. • European competition laws. • Anti-corruption laws. • Employment issues. • Tax issues. This article is part of the PLC multi-jurisdictional guide to life sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg. | Articles | 01-Nov-2011 |
| 44 | Life sciences in Argentina: overview A Q&A guide to life sciences law in Argentina. The Q&A gives a high level overview of key issues including pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, patents, trade marks, and product liability. To compare answers across multiple jurisdictions, visit the Life Sciences Country Q&A tool. This Q&A is part of the PLC multi-jurisdictional guide to life sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg. | Articles | 01-Nov-2011 |
| 45 | Life sciences in Austria: overview A Q&A guide to life sciences law in Austria. The Q&A gives a high level overview of key issues including pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, patents, trade marks, and product liability. To compare answers across multiple jurisdictions, visit the Life Sciences Country Q&A tool. The Q&A is part of the PLC multi-jurisdictional guide to life sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg. | Articles | 01-Nov-2011 |
| 46 | Life sciences in Belgium: overview A Q&A guide to life sciences law in Belgium. The Q&A gives a high level overview of key issues including pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, patents, trade marks, and product liability. To compare answers across multiple jurisdictions, visit the Life Sciences Country Q&A tool. The Q&A is part of the PLC multi-jurisdictional guide to life sciences law. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg. | Articles | 01-Nov-2011 |
| 47 | Life sciences in Canada: overview A Q&A guide to life sciences law in Canada. The Q&A gives a high level overview of key issues including pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, patents, trade marks, and product liability. To compare answers across multiple jurisdictions, visit the Life Sciences Country Q&A tool. The Q&A is part of the PLC multi-jurisdictional guide to life sciences law. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg. | Articles | 01-Nov-2011 |
| 48 | Life sciences in China: overview A Q&A guide to life sciences in China. The Q&A gives a high level overview of key issues including pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, patents, trade marks, and product liability. To compare answers across multiple jurisdictions, visit the Life Sciences Country Q&A tool. This Q&A is part of the PLC multi-jurisdictional guide to life sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg. | Articles | 01-Nov-2011 |
| 49 | Life sciences in Greece: overview A Q&A guide to life sciences law in Greece. The Q&A gives a high level overview of key issues including pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, patents, trade marks, and product liability. This Q&A is part of the PLC multi-jurisdictional guide to life sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg. | Articles | 01-Nov-2011 |
| 50 | Life sciences in Norway: overview A Q&A guide to life sciences in Norway. The Q&A gives a high level overview of key issues including pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, patents, trade marks, and product liability. To compare answers across multiple jurisdictions, visit the Life Sciences Country Q&A tool. This Q&A is part of the PLC multi-jurisdictional guide to life sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg. | Articles | 01-Nov-2011 |
| 51 | Life sciences in Poland: overview A Q&A guide to life sciences law in Poland. The Q&A gives a high level overview of key issues including pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, patents, trade marks, and product liability. To compare answers across multiple jurisdictions, visit the Life Sciences Country Q&A tool. This Q&A is part of the PLC multi-jurisdictional guide to Life Sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg. | Articles | 01-Nov-2011 |
| 52 | Life sciences in The Netherlands: overview A Q&A guide to life sciences in The Netherlands. The Q&A gives a high level overview of key issues including pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, patents, trade marks, and product liability. To compare answers across multiple jurisdictions, visit the Life Sciences Country Q&A tool. This Q&A is part of the PLC multi-jurisdictional guide to life sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg. | Articles | 01-Nov-2011 |
| 53 | Life sciences in Ukraine: overview A Q&A guide to life sciences law in the Ukraine. The Q&A gives a high level overview of key issues including pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, patents, trade marks, and product liability. To compare answers across multiple jurisdictions, visit the Life Sciences Country Q&A tool. The Q&A is part of the PLC multi-jurisdictional guide to life sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg. | Articles | 01-Nov-2011 |
| 54 | Life sciences in the Russian Federation: overview A Q&A guide to life sciences law in the Russian Federation. The Q&A gives a high level overview of key issues including pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, patents, trade marks, and product liability. To compare answers across multiple jurisdictions, visit the Life Sciences Country Q&A tool. This Q&A is part of the PLC multi-jurisdictional guide to life sciences law. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg. | Articles | 01-Nov-2011 |
| 55 | Out of bounds: CMS proposed rule for AMP under Medicaid This article explores some of the problematic aspects of CMS' proposals to regulate the MDRP, including its questionable exercise of delegated authority. In particular, it examines historical regulation of AMP, expansion of the Medicaid drug rebate programme, determining indirect sales to retail community pharmacies, calculating AMP for 5i drugs, Best Price, new requirements for line extensions, treatment of coupons, vouchers and co-payment assistance, new definition of wholesaler and the authorised generic rule on AMP and changes to CMS' policy on restatements of AMP and Best Price. This article is part of the PLC multi-jurisdictional guide to life sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg. | Articles | 01-Nov-2011 |
| 56 | Parallel trade and pharmaceuticals in the EU: current issues Parallel trade in the European pharmaceutical sector is widespread. To deal with parallel trade, pharmaceutical companies operating in the EU usually respond by adopting dual pricing schemes and allocation systems. To a certain extent, such schemes and systems are supported by European pharmaceuticals regulation. Behaviour such as dual pricing schemes and supply allocation systems have been the subject of legal dispute for some years. Another issue that continues to be the subject of legal dispute concerns the repackaging of pharmaceuticals that have been parallel imported. This chapter considers recent case law on these issues and summarises any conclusions that can be drawn. This article is part of the PLC multi-jurisdictional guide to life sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg. | Articles | 01-Nov-2011 |
| 57 | Patent settlement agreements: the state of play in the EU and ... This chapter describes the extent of anti-trust enforcement in the context of patent settlement agreements in the EU and US, sets out the current positions of the anti-trust authorities and any legislative initiatives taken in this area, and documents significant pending competition investigations or litigation in the EU and US. This article is part of the PLC multi-jurisdictional guide to life sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg. | Articles | 01-Nov-2011 |
| 58 | Patents in Ukraine: where are we now? This article looks at patent regulation in Ukraine, focusing on: The regulatory framework. Patent protection and enforcement. Enforcement and defence of patent rights in Ukrainian courts. Patent infringement on the internet. This article is part of the PLC multi-jurisdictional guide to life sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg. | Articles | 01-Nov-2011 |
| 59 | Recent case law and current issues relating to Supplementary ... This article includes: A general overview of SPCs. A summary of key recent case law from the EU Court of Justice (ECJ) on the conditions for obtaining an SPC. Negative term SPCs and paediatric extensions. An analysis of marketing authorisation in the context of SPCs. This article is part of the PLC multi-jurisdictional guide to life sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg. | Articles | 01-Nov-2011 |
| 60 | Reform of litigation funding and implications for life sciences ... Various reforms have been proposed to the litigation funding regime in England and Wales. This article examines the nature of the reforms and other proposals, conditional fee agreements, after the event insurance, damages based agreements, third party funding/litigation funding, qualified one-way cost shifting, liberalisation of the legal market and the impact on pharmaceutical claims. This article is part of the PLC multi-jurisdictional guide to life sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg. | Articles | 01-Nov-2011 |
| 61 | Regulatory data protection in the EU: an update Under European pharmaceutical law innovator pharmaceutical companies are granted a period of regulatory data exclusivity in which a generic applicant cannot refer to the innovator's data to obtain a marketing authorisation. The European legislation was amended in 2004 and currently contains a period of eight plus two (plus one) years of regulatory data protection (RDP). This article sets out a brief description of RDP under European law, the main changes to the legal system introduced in 2004 and an update of recent developments regarding the interpretation of European RDP law. This article is part of the PLC multi-jurisdictional guide to life sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg. | Articles | 01-Nov-2011 |
| 62 | The 2012 Biotechnology Public Policy and Litigation Agenda ... This chapter looks at recent developments in Canadian public policy and case law that directly or indirectly affect biotechnology. It summarises the 2009 Canadian federal budget and a number of recommendations for improving government programmes, including the 2010 report, "An Action Plan For Prosperity", published by the Coalition for Action on Innovation in Canada. It then outlines the key issues and challenges for the Canadian government to improve business R&D spending, rates of commercialisation and productivity growth. Finally, this chapter looks at the functions of the Patented Medicine Prices Review Board (PMPRB) and recent litigation trends (including class actions). This article is part of the PLC multi-jurisdictional guide to life sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg. | Articles | 01-Nov-2011 |
| 63 | Expert Q&A on the Patent Reform Act of 2011 An expert Q&A with James J. Mullen, III of Morrison & Foerster LLP on the likely implications of the Leahy-Smith America Invents Act (AIA), the most comprehensive and fundamental change to US patent law since the enactment of the Patent Act of 1952. | Articles | 01-Oct-2011 |
| 64 | European patent litigation: the Gordian knot An examination of litigation within the complicated and expensive European patent system. | Articles | 25-Mar-2011 |
| 65 | Financing UK Life Sciences Some are pessimistic about the UK public markets' ability to finance emerging life sciences companies. This chapter considers whether this view is fair, and the range of financing structures available. The statistical data was taken as at 31 December 2010. This article is part of the PLC multi-jurisdictional guide to Life Sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifescienceshandbook. | Articles | 31-Dec-2010 |
| 66 | Biosimilar Regulation: Important Considerations and Global ... This article looks at important considerations and global developments in biosimilar regulation, including scientific and regulatory challenges, patent considerations in the US and considerations for the industry as a whole. This article is part of the PLC multi-jurisdictional guide to Life Sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifescienceshandbook. | Articles | 01-Nov-2010 |
| 67 | Drug and device product recalls: prevention and plan of action A drug or device recall can have enormous impact on a drug or medical device company, and on the future of the concerned product. Careful planning can help to mitigate the risks of a recall and contain liability, while allowing the company to respond quickly to a crisis. This article traces, from a drug and device company's perspective, the steps of a product recall through its various stages as they impact on potential liability and litigation. This article is part of the PLC multi-jurisdictional guide to Life Sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifescienceshandbook. | Articles | 01-Nov-2010 |
| 68 | Generic entry - a challenge to traditional EU competition law Traditionally, the market entry of a generic pharmaceutical brings about a 30% to 40% shift in market share from the innovative pharmaceutical company to the generic firm, along with a 20% (in the first year after generic entry) to 25% (in the second year after generic entry) reduction in the average medicine price. With patent term expiries fully underway, innovative market players increasingly have recourse to a toolbox of strategies. This article is part of the PLC multi-jurisdictional guide to Life Sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifescienceshandbook. | Articles | 01-Nov-2010 |
| 69 | Healthcare and reimbursement of medicines in Germany ... This article looks at the challenges facing the German medical care system and looks at past and future reforms in the German pharmaceutical market, focusing on: • The Act for the restructuring of the drug market (Gesetz zur Neuordnung des Arzneimittelmarktes) (AMNOG). • The early benefit assessment. • The reference price system. • Negotiations between pharmaceutical companies and the statutory health insurance (Gesetzliche Krankenversicherung) (SHI). • Manufacturer's statutory rebates for pharmaceuticals. This article is part of the PLC multi-jurisdictional guide to Life Sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifescienceshandbook. | Articles | 01-Nov-2010 |
| 70 | Legal aspects of REACH and the medical device sector ... This article sets out some of the main features of EU Regulation 1907/2006 on the Registration, Evaluation, Authorisation and Restriction of Chemicals) (REACH) and how it is likely to affect medical device companies. It also provides an overview of the most significant EU regulatory developments as they apply to the medical devices industry sector. This chapter is part of the PLC multi-jurisdictional guide to life sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifescienceshandbook. | Articles | 01-Nov-2010 |
| 71 | Life Sciences: Portugal A Q&A guide to life sciences in Portugal. It provides a high level overview of life sciences funds in Portugal and looks at key issues including pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, patents, trade marks, and product liability. For a full list of recommended life sciences law firms and lawyers in Portugal, please visit PLC Which lawyer? This Q&A is part of the PLC multi-jurisdictional guide to Life Sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifescienceshandbook. | Articles | 01-Nov-2010 |
| 72 | Life Sciences: Romania A Q&A guide to life sciences in Romania. This Q&A is part of the PLC multi-jurisdictional guide to life sciences. It provides a high level overview of life sciences funds in Romania and looks at key issues including pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, patents, trade marks, and product liability. This Q&A is part of the PLC multi-jurisdictional guide to life sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifescienceshandbook. | Articles | 01-Nov-2010 |
| 73 | Recent changes concerning regulatory protections for ... This article examines the following two significant recent changes to the regulatory regime in Japan relating to the business of originator pharmaceutical companies and generic pharmaceutical companies: • The extension of the study period for drugs with new active ingredients. • The new permissibility of partial applications and approvals. These changes directly impact certain legal protections (such as the re-examination system and patent term extensions) in Japan for pharmaceutical companies that produce original drugs. These protections are increasingly important in the light of governmental steps to increase the historically low market share of generic drugs in Japan. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifescienceshandbook. | Articles | 01-Nov-2010 |
| 74 | Recent changes in the anti-corruption landscape for ... In the past 18 months, there have been significant anti-corruption developments for companies and individuals, particularly in the healthcare sector. Against this background, this chapter looks at recent developments in enforcement of anti-corruption laws. This article is part of the PLC multi-jurisdictional guide to Life Sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifescienceshandbook. | Articles | 01-Nov-2010 |
| 75 | Risk management of pharmaceuticals in the EU and US ... This chapter reviews the current regulatory framework concerning risk management of medicinal products in the EU and the US. This article is part of the PLC multi-jurisdictional guide to Life Sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifescienceshandbook. | Articles | 01-Nov-2010 |
| 76 | Supplementary protection certificates for medicinal products ... Pharmaceutical regulatory law and patent law are often seen as separate legal fields governed by distinct laws. However, these fields can be seen to interact in Regulation (EC) 469/2009 concerning the supplementary protection certificate for medicinal products (SPC Regulation). In recent years a number of cases have emerged under the framework of the SPC Regulation, in which the interpretation of certain provisions has led to a discussion of various concepts that have been introduced from patent law or regulatory law. Another, more recent regulatory development that has created an additional interaction between regulatory law and the SPC Regulation is Regulation (EC) 1901/2006 on medicinal products for paediatric use (Paediatric Regulation). The Paediatric Regulation couples the obligation to conduct paediatric clinical research with an extension of an SPC. This means that an additional regulatory factor has been introduced that influences SPCs. This article looks at the: • Legal framework. • Interaction between pharmaceutical regulatory law, patent law and the SPC and the Paediatric Regulation in case law in Europe. This article is part of the PLC multi-jurisdictional guide to Life Sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifescienceshandbook. | Articles | 01-Nov-2010 |
| 77 | Employee's rights to compensation for inventions - a ... Many life science companies rely on their employees' inventiveness to fuel their R&D and generate patents. Employees who create patentable inventions may be entitled to compensation. However, the laws in this area vary significantly across European jurisdictions. A number of substantial compensation awards have been made recently. This chapter considers the legal framework for compensating employees for patented inventions in the UK, France, Germany, The Netherlands and Belgium, whether an employee's rights to compensation can be altered contractually, and provides a checklist of considerations for those considering bringing or defending claims. This article is part of the PLC multi-jurisdictional guide to Life Sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifescienceshandbook. | Articles | 01-Oct-2009 |
| 78 | Interlocutory injunctions in pharmaceutical patent cases The Australian pharmaceutical market is both highly competitive and highly regulated. There are many legal issues which a pharmaceutical company conducting business in Australia must contend with. This article examines general principles governing interlocutory relief, the impact of the Government pharmaceutical pricing regime, recent case law on interlocutory injunctions, and whether there is a trend in the granting of pharmaceutical interlocutory injunctions. This article is part of the PLC multi-jurisdictional guide to Life Sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifescienceshandbook. | Articles | 01-Oct-2009 |
| 79 | Legal aspects of REACH and the medical device sector This article sets out some of the main features of the EU REACH Regulation and how it might affect medical device companies. In particular, the requirement to register, the substance information exchange forum (SIEF), the consortium and data sharing, supply chain interaction and obligations of various members, and commercial relationships affected by REACH. This chapter is part of the PLC multi-jurisdictional guide to life sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifescienceshandbook. | Articles | 01-Oct-2009 |
| 80 | The life sciences industry: trends and predictions The life sciences industry has experienced major changes over the last few years, and will continue to be affected by a number of technological, commercial and legal developments in the coming years. This article examines the changes that have occurred in the key life sciences jurisdictions of Europe, the US and China, and considers lawyers' predictions for the future of these local and international markets. This article is part of the PLC multi-jurisdictional guide to Life Sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifescienceshandbook. | Articles | 01-Oct-2009 |
| 81 | Proposed Unified Patent Litigation System for Europe There have been several attempts to develop a unified patent system for Europe, and a new proposal, termed the Unified Patent Litigation System (UPLS) by the European Commission, is now on the table. This chapter examines problems with the current system, the historical background to patent harmonisation in Europe, the current system and lessons to be learnt from it, and the proposed UPLS for Europe. | Articles | 01-Jan-2009 |
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| 1 | Claim Construction That Differs from Intrinsic Evidence is ... In Aventis Pharmaceuticals Inc. v. Amino Chemicals Ltd., the US Court of Appeals for the Federal Circuit held that a patent claim term should not be construed in accordance with its use in the prosecution history because one of ordinary skill in the art would understand from the term's context that the term should be construed differently in the claim. Specifically, in this pharmaceutical case, the Federal Circuit held that the term "substantially pure" when used in the claim to describe an intermediate should be construed differently from its use in the prosecution history to describe an end product. | Legal Update: archive | 21-May-2013 |
| 2 | Clinical Trial Without Confidentiality Agreement Does Not ... On May 20, 2013, in Dey, LP v. Sunovion Pharmaceuticals, Inc., the US Court of Appeals for the Federal Circuit held that clinical trials of a drug that would anticipate the patented drug were not a public use bar even though the clinical trial participants did not sign confidentiality agreements. The Federal Circuit determined that the circumstances of the clinical trial created an expectation of secrecy that avoided the public use bar under Section 102(b) of the Patent Act. | Legal Update: archive | 21-May-2013 |
| 3 | ITC Issues Final Rule on Discovery in Section 337 ... The International Trade Commission (ITC) has issued a final rule amending its Rules of Practice and Procedure on discovery, including e-discovery, in Section 337 investigations. | Legal Update: archive | 17-May-2013 |
| 4 | Saudi Arabia accedes to Patent Co-operation Treaty An update on Saudi Arabia's accession to the Patent Co-operation Treaty. | Legal Update: archive | 16-May-2013 |
| 5 | CLS Bank v. Alice Corp.: Divided Federal Circuit Affirms ... A majority of the US Court of Appeals for the Federal Circuit sitting en banc affirmed the district court's holding in CLS Bank International v. Alice Corp. that the asserted computer-related method, media and system claims are not directed to patent eligible subject matter under 35 U.S.C. 101. | Legal Update: archive | 13-May-2013 |
| 6 | Supreme Court Affirms Federal Circuit in Bowman v. ... On May 13, 2013, the US Supreme Court issued its decision in Bowman v. Monsanto Co. The court unanimously held that the patent exhaustion doctrine does not allow a farmer to reproduce patented seeds through planting and harvesting without the patent holder's permission. | Legal Update: archive | 13-May-2013 |
| 7 | Response to USPTO Restriction Requirement Can Result in ... In Uship Intellectual Properties, LLC v. US, the US Court of Appeals for the Federal Circuit affirmed the Court of Federal Claims' ruling on summary judgment that the US Postal Service and IBM do not infringe Uship's patents directed to systems and methods of processing packages for shipment. The Federal Circuit held that the patent applicant's response to a USPTO restriction requirement resulted in prosecution history disclaimer, limiting the asserted method claims to performance by an automated machine. | Legal Update: archive | 10-May-2013 |
| 8 | "In the United States" Contract Term is Ambiguous: Delaware ... In Smartmatic International Corp. v. Dominion Voting Systems International Corp., the Delaware Court of Chancery denied cross motions for summary judgment on the meaning of the term "in the United States" in a patent license agreement. | Legal Update: archive | 02-May-2013 |
| 9 | Allocating Patent Ownership in Joint Development ... A discussion of ownership allocation for intellectual property, especially patents, developed during the term of a joint development agreement. This Legal Update includes links to relevant resources that examine this issue. | Legal Update: archive | 30-Apr-2013 |
| 10 | Section 337 Investigations: ITC Issues Final Rule Amending ... The International Trade Commission (ITC) has issued a final rule amending its Rules of Practice and Procedure relating to procedures in Section 337 investigations. | Legal Update: archive | 15-Apr-2013 |
| 11 | USPTO Proposes Changes to Rules of Practice Implementing ... The US Patent and Trademark Office (USPTO) has proposed changes to its rules of practice for consistency with the changes in the Patent Law Treaty and title II of the Patent Law Treaties Implementation Act of 2012. | Legal Update: archive | 11-Apr-2013 |
| 12 | Affidavits or Declarations are not Required to Challenge ... In In re: Morsa, the US Court of Appeals for the Federal Circuit clarified that the holding in In re: Antor Media Corp. does not require a patent applicant to submit affidavits or declarations when challenging the enablement of prior art references. | Legal Update: archive | 08-Apr-2013 |
| 13 | USPTO Seeks to Launch “MyUSPTO” Online Portal The United States Patent and Trademark Office (USPTO) is seeking to launch MyUSPTO, an optional central online customer portal that will allow customers to create a portfolio of information that can be used for USPTO transactions. Pursuant to the Paperwork Reduction Act of 1995, the USPTO is seeking public comment on the proposed collection information in connecction with the MyUSPTO portal. | Legal Update: archive | 04-Apr-2013 |
| 14 | Federal Circuit Clarifies Written Description Requirement for ... In In re Timothy Owens, the US Court of Appeals for the Federal Circuit affirmed the US Patent and Trademark Office Board of Patent Appeals and Interferences's (USPTO BPAI) holding that Owens' continuation design patent application for a mouthwash bottle was not entitled to the benefit of the patent's filing date under 35 U.S.C. § 120 because it failed to satisfy the written description requirement. | Legal Update: archive | 01-Apr-2013 |
| 15 | Federal Circuit: Price Erosion Analysis Starting Point for Post ... In Power Integrations, Inc. v. Fairchild Semiconductor International, Inc., the US Court of Appeals for the Federal Circuit held that the starting point for a price erosion analysis relating to damages arising from post-notice infringement is the date of first infringement. | Legal Update: archive | 01-Apr-2013 |
| 16 | USPTO Issues Interim Final Rule for Patent Term Adjustment ... The USPTO has published an interim final rule revising the rules of practice to implement the changes to the patent term adjustment reduction provisions in Section 1(h) of the AIA Technical Corrections Act. | Legal Update: archive | 01-Apr-2013 |
| 17 | Federal Circuit Finds Patent Documentation Insufficient to ... In Dawson v. Dawson and Bowman, the Court of Appeals for the Federal Circuit affirmed the decision of the USPTO Board of Patent Appeals and Interferences' ruling that the plaintiff failed to prove he was the sole inventor of a process to treat an eye infection. | Legal Update: archive | 26-Mar-2013 |
| 18 | Federal Circuit Reverses Award of Attorneys' Fees to Patent ... In Checkpoint Systems, Inc. v. All-Tag Security S.A., the US Court of Appeals for the Federal Circuit reversed a district court order awarding attorneys' fees to All-Tag Security, an accused patent infringer, ruling that the defendant failed to meet the requirements for establishing an exceptional case under 35 U.S.C. Section 285. | Legal Update: archive | 26-Mar-2013 |
| 19 | USPTO Issues Final Rule of Changes to Implement Technical ... The United States Patent and Trademark Office has issued a final rule revising the rules of practice to implement the changes to the inter partes review process under the Leahy-Smith America Invents Act. | Legal Update: archive | 22-Mar-2013 |
| 20 | The Uncertainty of Patent-eligible Subject Matter ... In computer-implemented and medical-related technologies, the question of the patent-eligibility of certain inventions can be an important and controversial issue. Although the Supreme Court and Court of Appeals for the Federal Circuit have recently issued several opinions on this patent-eligibility question, its resolution remains difficult and uncertain. This Legal Update reviews several of these decisions, which identify key considerations in patent-eligible subject matter determinations. This Legal Update also includes links to relevant resources examining the legal standards concerning computer-implemented and medical-related inventions. | Legal Update: archive | 19-Mar-2013 |
| 21 | USPTO Corrects Final Rules Setting and Adjusting AIA Patent ... The United States Patent and Trademark Office (USPTO) issued a correction of its previously published final rules setting and adjusting patent fees as authorized by the Leahy-Smith America Invents Act (AIA). | Legal Update: archive | 19-Mar-2013 |
| 22 | Federal Circuit Refuses to Create Marking or Royalty Payment ... In Frolow v. Wilson Sporting Goods, Co., the US Court of Appeals for the Federal Circuit refused to create estoppel doctrines based on the licensee's patent marking of certain products or royalty payments for its sales of certain products. The Federal Circuit therefore reversed the US District Court for the District of New Jersey's grant of summary judgment and remanded the case to the district court to weigh the evidence in its determination of whether certain tennis racket models were covered by a patent license agreement. | Legal Update: archive | 18-Mar-2013 |
| 23 | USPTO Corrects Certain Final Rules Implementing the AIA ... The United States Patent and Trademark Office (USPTO) issued a correction of its February 14, 2013 final rules implementing the first-inventor-to-file provisions of the Leahy-Smith America Invents Act (AIA). | Legal Update: archive | 13-Mar-2013 |
| 24 | District Court Applies Wrong Indirect Infringement Standard ... In Move, Inc. v. Real Estate Alliance Ltd., the US Court of Appeals for the Federal Circuit found that the district court did not use the correct standard under Akamai Technologies, Inc. v. Limelight Networks, Inc. for determining indirect infringement. It therefore vacated the district court's decision and remanded the case for a determination under Akamai. | Legal Update: archive | 05-Mar-2013 |
| 25 | USPTO Extends Comment Period for Potential Patent Small ... The United States Patent and Trademark Office (USPTO) is extending the comment period for public comments regarding potential patent small claims proceeding. | Legal Update: archive | 05-Mar-2013 |
| 26 | Delaware Court of Chancery Holds that Reverse Triangular ... The Delaware Court of Chancery held in Meso Scale Diagnostics, LLC v. Roche Diagnostics GMBH that a reverse triangular merger does not trigger an "assignment by operation of law" provision. | Legal Update: archive | 28-Feb-2013 |
| 27 | Federal Circuit Once Again Addresses Vitiation Test Under the ... In Brilliant Instruments, Inc. v. GuideTech, LLC, the US Court of Appeals for the Federal Circuit rejected the alleged infringer's vitiation argument in reversing the district court's summary judgment determination that the accused product did not infringe the asserted patents under the doctrine of equivalents. | Legal Update: archive | 22-Feb-2013 |
| 28 | SCOTUS: Federal Courts Lack Jurisdiction Over Patent Legal ... On February 20, 2013, in Gunn v. Minton, the US Supreme Court reversed a decision by the Supreme Court of Texas that a state law claim alleging legal malpractice in the handling of a patent case must be brought in federal court. The Court held that these legal malpractice claims did not raise a substantial federal issue. | Legal Update: archive | 22-Feb-2013 |
| 29 | Unified Patent Court Agreement signed Twenty-four member states have signed the international agreement for establishing a Unified Patent Court at an EU Council meeting. | Legal Update: archive | 21-Feb-2013 |
| 30 | Fifth Circuit Affirms Breach of Contract Ruling in Patent ... In Tekelec, Inc. v. Verint Systems, Inc., the US Court of Appeals for the Fifth Circuit affirmed the US District Court for the Eastern District of Texas's grant of summary judgment to Tekelec, finding Verint liable for breach of contract for failure to make payments under a patent infringement settlement and license agreement entered into by predecessors of both parties. | Legal Update: archive | 19-Feb-2013 |
| 31 | USPTO Publishes Final AIA First-inventor-to-file Rule and ... The US Patent and Trademark Office (USPTO) has published in the Federal Register its final rule and examination guidelines implementing the first-inventor-to-file provisions of the Leahy-Smith America Invents Act (AIA). | Legal Update: archive | 14-Feb-2013 |
| 32 | Assignor Estoppel Not a Federal Cause of Action: Federal ... In Semiconductor Energy Laboratory Co., Ltd. v. Nagata, the US Court of Appeals for the Federal Circuit affirmed the district court's decision dismissing the plaintiff's complaint for lack of subject matter jurisdiction. The Federal Circuit agreed with the district court's ruling that the doctrine of assignor estoppel does not create a federal cause of action. | Legal Update: archive | 12-Feb-2013 |
| 33 | America Invents Act First-inventor-to-file Transition: Don't Be ... The Leahy-Smith America Invents Act (AIA) will make another significant change to US patent law on March 16, 2013, when the US patent system transitions to a first-inventor-to-file system. This update addresses the key issues concerning the first-inventor-to-file system, including the expanded scope of prior art. | Legal Update: archive | 05-Feb-2013 |
| 34 | District Court Reaches Opposite Conclusion on Same Patent ... In Exelixis, Inc. v. Kappos, the US District Court for the Eastern District of Virginia determined that the US Patent and Trademark Office properly refused to grant Patent Term Adjustment (PTA) for the period after the applicant filed a Request for Continued Examination (RCE) where the RCE was filed more than three years after the original patent application filing date. This decision is directly contrary to the district court's decision in an earlier case involving the same parties. | Legal Update: archive | 01-Feb-2013 |
| 35 | Federal Circuit Clarifies Pleading Standard for Design Patent ... In Hall v. Bed Bath & Beyond, Inc., the US Court of Appeals for the Federal Circuit reversed a district court's decision dismissing the plaintiff's design patent infringement claim. The Federal Circuit found that the district court erred in its interpretation of the pleading standard for design patent infringement claims. | Legal Update: archive | 28-Jan-2013 |
| 36 | FTC Concludes Investigation Into Google's Advertising ... The FTC recently closed its investigation into Google, Inc.'s advertisement management practices and settled with Google as to its licensing of standard-essential patents. | Legal Update: archive | 23-Jan-2013 |
| 37 | Federal Circuit: Arbitrary Contingency Payment in Patent ... The US Court of Appeals for the Federal Circuit issued an opinion in Allflex USA, Inc. v. Avid Identification Systems, Inc., holding that parties cannot manufacture appellate jurisdiction after settlement by stipulating to an arbitrary amount of damages to be paid to the winner on appeal. | Legal Update: archive | 22-Jan-2013 |
| 38 | USPTO Issues Final Rule Setting and Adjusting Patent Fees On January 18, 2013, the USPTO issued a final rule setting and adjusting patent fees.This rulemaking includes a reduction of fees for micro entities under section 10(b) of the Leahy-Smith America Invents Act and extends the existing fee discount for small entities to additional fees. | Legal Update: archive | 17-Jan-2013 |
| 39 | America Invents Act Technical Amendments Enacted into Law President Obama signed H.R. 6621 into law, making certain technical amendments to the Leahy-Smith America Invents Act (AIA). | Legal Update: archive | 15-Jan-2013 |
| 40 | Patent Licensing Satisfies Domestic Industry Requirement for ... In InterDigital Communications, LLC v. International Trade Commission, the US Court of Appeals for the Federal Circuit held that licensing activities alone are sufficient to support a Section 337 action even where no domestic party manufactures the patented products. | Legal Update: archive | 11-Jan-2013 |
| 41 | USPTO and DOJ Issue F/RAND Remedy Guidance The USPTO and the Department of Justice issued a policy statement on appropriate remedies for infringement of standards-essential patents that are encumbered by a RAND or FRAND licensing commitment. | Legal Update: archive | 10-Jan-2013 |
| 42 | EPO and USPTO launch Cooperative Patent Classification The EPO and the USPTO have launched the Cooperative Patent Classification scheme, a global classification system for patent documents. | Legal Update: archive | 07-Jan-2013 |
| 43 | WIPO 2011 statistics reveal China as top patent filer WIPO has published its report World Intellectual Property Indicators 2012 on 2011 intellectual property filing statistics. | Legal Update: archive | 07-Jan-2013 |
| 44 | USPTO Announces Software Partnership The USPTO announced a proposed partnership with the software community to enhance the quality of software-related patents. The USPTO will hold two roundtable events and has requested public comments on this topic. | Legal Update: archive | 02-Jan-2013 |
| 45 | President Obama Signs Patent Law Treaties Implementation ... On December 18, 2012, President Obama signed the Patent Law Treaties Implementation Act of 2012, which amends portions of the Patent Act and implements both the Hague Agreement Concerning International Registration of Industrial Designs and the Patent Law Treaty. | Legal Update: archive | 19-Dec-2012 |
| 46 | USPTO Issues Final Rule Implementing the Micro Entity ... The USPTO has issued a final rule setting out amendments to the rules of practice in patent cases to implement the micro entity provision of the Leahy-Smith America Invents Act. | Legal Update: archive | 18-Dec-2012 |
| 47 | Federal Circuit Addresses Reissue Rules and ANDA ... In Astrazeneca UK Ltd. v. Aurobindo Pharma Ltd., the US Court of Appeals for the Federal Circuit affirmed the US District Court for the District of Delaware's decision finding that Astrazeneca's patent for its Crestor cholesterol-lowering drug was valid, enforceable and infringed by several generic challengers. The decision clarifies the standard for showing error without deceptive intent supporting a reissue patent application and the definition of a FDA approval application submitter who may be subject to infringement liability. | Legal Update: archive | 17-Dec-2012 |
| 48 | USPTO Seeks Public Comment on Potential Creation of ... The US Patent and Trademark Office has requested comments regarding whether it should develop a small claims proceeding for patent enforcement. In particular, the USPTO seeks suggestions for the core characteristics of such a proceeding. | Legal Update: archive | 17-Dec-2012 |
| 49 | Federal Circuit Lets Stand De Novo Review of Exceptional ... The Federal Circuit denied rehearing en banc in Highmark, Inc. v. Allcare Health Management Systems, Inc. and consequently left standing its ruling that exceptional case determinations under 35 U.S.C. Section 285 are subject to de novo review. | Legal Update: archive | 13-Dec-2012 |
| 50 | European Parliament approves Unitary Patent Package The European Parliament has given general approval to the three components of the EU Patent Package. In its meetings on 10 and 11 December 2012, the Competitiveness Council stated that the European Parliament was expected to validate the pending patent package legislation and that, after the vote, the regulations on the Unitary Patent and the translation arrangements should be formally adopted before the end of 2012. | Legal Update: archive | 12-Dec-2012 |
| 51 | Federal Circuit: District Court Abused Discretion in Denying ... In Raylon, LLC v. Complus Data Innovations, Inc., the US Court of Appeals for the Federal Circuit held that the US District Court for the Eastern District of Texas abused its discretion in failing to find the patentee's claim construction frivolous. It remanded to the district court to determine the proper Rule 11 sanctions and whether to award attorneys' fee and costs. | Legal Update: archive | 11-Dec-2012 |
| 52 | Global Patent Litigation Strategy A discussion of key considerations for parties engaged in global patent litigation. | Legal Update: archive | 11-Dec-2012 |
| 53 | Federal Circuit: Terminal Disclaimers Reduce Term of Original ... In In re Yamazaki, the US Court of Appeals for the Federal Circuit affirmed the USPTO Board of Patent Appeals and Interferences' ruling that, under Section 251 of the Patent Act, reissue proceedings cannot be used to withdraw a terminal disclaimer from an issued patent that has already expired. | Legal Update: archive | 10-Dec-2012 |
| 54 | Federal Circuit Addresses Relationship between Vitiation and ... In Deere & Co. v. Bush Hog, LLC, the US Court of Appeals for the Federal Circuit addressed, in dicta, the relationship between the doctrine of claim vitiation and the doctrine of equivalents. It clarified that the vitiation is not an exception to the doctrine of equivalents, but instead a legal determination that no reasonably jury could find equivalence. | Legal Update: archive | 09-Dec-2012 |
| 55 | Federal Circuit Determines Non-enabling Prior Publication ... In its decision in Fox Group, Inc. v. Cree, Inc., the US Court of Appeals for the Federal Circuit held that a non-enabling prior public disclosure may invalidate a claimed invention under Section 102(g) of the Patent Act. The Federal Circuit determined that in this case, prior to the critical date, the alleged infringer publicly disclosed that it made the claimed invention and the patentee failed to prove that the alleged infringer abandoned, suppressed or concealed the invention. | Legal Update: archive | 29-Nov-2012 |
| 56 | Direct Purchasers Have Standing for Walker Process Antitrust ... In Ritz Camera & Image, LLC v. SanDisk Corp, the US Court of Appeals for the Federal Circuit upheld a district court decision finding that a direct purchaser is not categorically excluded from bringing a Walker Process antitrust claim even if the direct purchaser does not have standing for declaratory relief against the patentee under patent law. | Legal Update: archive | 26-Nov-2012 |
| 57 | Federal Circuit Clarifies Patent Infringement Injunction ... In Edwards Lifesciences AG v. CoreValve, Inc., the US Court of Appeals for the Federal Circuit held that changed circumstances should be considered when a district court determines whether to grant or deny an injunction against patent infringement. | Legal Update: archive | 16-Nov-2012 |
| 58 | Laches Period for Correction of Inventorship Claims Begins ... In Hor v. Chu, the US Court of Appeals for the Federal Circuit held that a claim under Section 256 of the Patent Act for correction of inventorship begins when the patent issues for purposes of the laches defense. The court also decided issues of the unclean hands defense and equitable estoppel. | Legal Update: archive | 16-Nov-2012 |
| 59 | Royalty Stacking Provisions in Patent Licenses Negotiating and drafting royalty stacking provisions in patent licenses. | Legal Update: archive | 14-Nov-2012 |
| 60 | AIPPI and EU patent judges comment on Unified Patent Court ... The International Association for the Protection of Intellectual Property and the Intellectual Property Judges Association have both commented adversely on part of the current plans for a Unified Patent Court. | Legal Update: archive | 13-Nov-2012 |
| 61 | District Court Determines that USPTO Improperly Reduces ... In Exelixis, Inc., v. Kappos, the US District Court for the Eastern District of Virginia determined that the US Patent and Trademark Office (USPTO) improperly reduces Patent Term Adjustment (PTA) in patents where the applicant files a Request for Continued Examination (RCE) more than three years after the original patent application filing date. The court held that the USPTO should not deduct any time from an applicant's PTA if the applicant files the RCE more than three years after the patent application was filed. | Legal Update: archive | 09-Nov-2012 |
| 62 | Federal Circuit Clarifies Standards for Assessing Online ... In its decision in Voter Verified, Inc. v. Premier Election Solutions, Inc., the US Court of Appeals for the Federal Circuit clarified the standards for assessing online references as prior art printed publications. | Legal Update: archive | 06-Nov-2012 |
| 63 | DOJ Urges Standard-Setting Organizations to Adopt Clearer ... The Antitrust Division of the Department of Justice (DOJ) recommended that standard-setting organizations (SSOs) adopt clearer policies for the licensing of standard-essential patents (SEPs) to minimize patent hold-up and litigation. The DOJ urged SSOs to consider six policy proposals that would help clarify typical standards commitments. | Legal Update: archive | 19-Oct-2012 |
| 64 | EU Presidency publishes revisions to updated Unified Patent ... The EU Presidency has published a revised version of the new draft of the Unified Patent Court agreement. | Legal Update: archive | 18-Oct-2012 |
| 65 | USPTO Proposes New Rules of Professional Conduct The United States Patent and Trademark Office (USPTO) recently published for public comment a notice of proposed rulemaking to adopt new rules of professional conduct for practitioners appearing before the USPTO. | Legal Update: archive | 18-Oct-2012 |
| 66 | Federal Circuit Reverses Preliminary Injunction Against ... In Apple Inc. v. Samsung Electronics Co., the US Court of Appeals for the Federal Circuit reversed a district court decision that enjoined Samsung from selling allegedly infringing Galaxy Nexus smartphones. The court found that Apple failed to show a causal nexus between its alleged harm and Samsung's alleged infringement. | Legal Update: archive | 12-Oct-2012 |
| 67 | Federal Circuit SanDisk Decision Addresses Appellate ... In SanDisk Corp. v. Kingston Technology Co., Inc., the US Court of Appeals for the Federal Circuit held that the district court erred in applying the disclosure-dedication rule in a patent infringement case concerning flash memory systems. The Federal Circuit also decided issues of jurisdiction and claim construction. | Legal Update: archive | 12-Oct-2012 |
| 68 | USPTO Reopens Comment Period for First-inventor-to-file ... The US Patent and Trademark Office (USPTO) reopened the public comment period for its proposed changes to its patent application rules of practice and new examination guidelines to implement the first-inventor-to-file provisions of the Leahy-Smith America Invents Act (AIA). Comments will be accepted through November 5, 2012. | Legal Update: archive | 11-Oct-2012 |
| 69 | ITC Issues Notice of Proposed Rulemaking on Discovery in ... The International Trade Commission (ITC) has issued proposed amendments to its Rules of Practice and Procedure on discovery, including e-discovery, in Section 337 investigations. | Legal Update: archive | 05-Oct-2012 |
| 70 | Ninth Circuit Affirms Preliminary Injunction Preventing ... In Microsoft Corp. v. Motorola, Inc., the US Court of Appeals for the Ninth Circuit affirmed the district court's grant of a preliminary injunction preventing Motorola from enforcing a patent-related injunction it obtained against Microsoft in a German court. | Legal Update: archive | 02-Oct-2012 |
| 71 | Repeated, Consistent and Exclusive Description Guides ... In In re Abbott Diabetes Care Inc., the US Court of Appeals for the Federal Circuit vacated in part and remanded the Board of Patent Appeals and Interferences' (BPAI) decision rejecting certain patent claims concerning methods and devices for monitoring glucose levels for diabetics. The Federal Circuit held that the BPAI's rejections were based, at least in part, on a claim construction that was contrary to the repeated, consistent and exclusive description of the claimed invention in the patent specification. | Legal Update: archive | 02-Oct-2012 |
| 72 | Numerically Non-equivalent Products Infringe under Doctrine ... In Pozen Inc. v. Par Pharmaceutical, the US Court of Appeals for the Federal Circuit held, among other things, that products having 85% of a relevant drug in a tablet layer infringe, under the doctrine of equivalents, a claim limitation that requires "substantially all" of the relevant drug in that layer even though the limitation was construed to mean "at least 90%, and preferably greater than 95%." | Legal Update: archive | 28-Sep-2012 |
| 73 | Patent Licensee Held to Bear Burden of Proof in Declaratory ... In Medtronic Inc. v. Boston Scientific Corp., the US Court of Appeals for the Federal Circuit held that a patent licensee bears the burden of proving noninfringement when the licensee brings a declaratory judgment action against its licensor seeking a determination that certain of its products do not infringe the licensed patents. | Legal Update: archive | 21-Sep-2012 |
| 74 | USPTO Announces New Online Search Tool for the Manual of ... The United States Patent and Trademark Office (USPTO) has announced a new online search tool for the Manual of Patent Examining Procedure (MPEP). | Legal Update: archive | 18-Sep-2012 |
| 75 | Under Therasense, Suspicious Omission is not Inequitable ... In 1st Media, LLC, v. Electronic Arts, Inc., the US Court of Appeals for the Federal Circuit reversed a district court judgment of inequitable conduct and patent unenforceability because the facts did not support a finding that there was a deliberate decision to withhold a material reference, citing its decision in Therasense, Inc. v. Becton, Dickinson & Co. | Legal Update: archive | 14-Sep-2012 |
| 76 | USPTO Final Rule for New PTAB Derivation Proceeding The US Patent and Trademark Office (USPTO) published a final rule revising the rules of practice to implement the provisions of the Leahy-Smith America Invents Act (AIA) that create a new derivation proceeding to be conducted before the Patent Trial and Appeal Board (PTAB). | Legal Update: archive | 10-Sep-2012 |
| 77 | USPTO Publishes Two New Patent Fee Rules The US Patent and Trademark Office (USPTO) has published two new rules, one proposed and one final, to set and adjust patent fees. | Legal Update: archive | 06-Sep-2012 |
| 78 | Akamai and McKesson: Federal Circuit Rules Divided ... On August 31, 2012, in a sharply divided 6-5 en banc decision, the US Court of Appeals for the Federal Circuit, in Akamai Technologies, Inc. v. Limelight Networks, Inc., overruled its earlier decision in BMC Resources, Inc. v. Paymentech, L.P., 498 F.3d 1373 (Fed. Cir. 2007), which ruled that there can be no liability for inducing the infringement of a patented method without proof that a single entity was induced to carry out all the steps of that method. As a result of the court's significant turnabout in Akamai, it is now possible to prove a claim of induced infringement under Section 271(b) of the Patent Act by showing that a party induced multiple entities to jointly or collectively perform all the steps of a patented method without any one of them practicing all of those steps. | Legal Update: archive | 04-Sep-2012 |
| 79 | Federal Circuit Puts Bite on Entire Market Value Rule The US Court of Appeals for the Federal Circuit affirmed in part, reversed in part and remanded the district court's judgment in LaserDynamics, Inc. v. Quanta Computer, Inc. Addressing a number of damages issues, the court limited the application of the entire market value rule in the damages calculation for the infringement of computer disc drive technology. The court also ruled on, among other issues, whether the infringer had an implied license, the hypothetical negotiation date for reasonable royalty calculations and the admissibility of a settlement agreement as evidence to prove the amount of a reasonable royalty. | Legal Update: archive | 04-Sep-2012 |
| 80 | Lexmark Loses Lanham Act and Induced Patent Infringement ... In Static Control Components, Inc., v. Lexmark International, Inc., the US Court of Appeals for the Sixth Circuit handed Lexmark a loss in its appeal following a patent infringement trial. The Sixth Circuit affirmed the district court's decision denying Lexmark's motions for judgment as a matter of law and a new trial and reversed the district court's ruling that Static Control does not have standing to bring Lanham Act claims against Lexmark. | Legal Update: archive | 31-Aug-2012 |
| 81 | Federal Circuit Clarifies Requirements for Prior Invention ... In Amkor Technology, Inc. v. International Trade Commission, the US Court of Appeals for the Federal Circuit reversed an International Trade Commission (ITC) ruling finding Amkor's patent invalid under Section 102(g)(2) of the Patent Act. | Legal Update: archive | 24-Aug-2012 |
| 82 | Updated Catalogue of Differing Practices published As part of the cooperation between the patent offices of Japan, China, South Korea, the US and the European Patent Office, information has been compiled on the differences in practice between the five offices in the Catalogue of Differing Practices. | Legal Update: archive | 20-Aug-2012 |
| 83 | FTC Proposes Increasing HSR Review of Pharmaceutical ... The FTC recently issued proposed changes to the Hart-Scott-Rodino (HSR) rules regarding tranfers of exclusive rights to pharmaceutical patents. If the amendments are adopted, transfers of all commercially significant pharmaceutical patent rights would be potentially reportable under the HSR Act. | Legal Update: archive | 17-Aug-2012 |
| 84 | Federal Circuit Reaches Same Conclusion in Latest Myriad ... In its August 16, 2012 decision in Association for Molecular Pathology v. Myriad Genetics, Inc., the US Court of Appeals for the Federal Circuit reached the same conclusion as it did in its earlier vacated ruling. The same divided panel concluded that both Myriad's isolated DNA molecule claims and method claims covering the screening of potential cancer therapeutics by changes in certain cell growth rates are eligible for patent protection under Section 101 of the Patent Act. The Federal Circuit noted that the Supreme Court's decision in Mayo Collaborative Services v. Prometheus Laboratories, Inc. does not control the patent-eligibility question of the isolated DNA molecule claims. | Legal Update: archive | 16-Aug-2012 |
| 85 | USPTO Final Rules Implementing the Inventor's Oath or ... On August 14, 2012, the US Patent and Trademark Office (USPTO) issued final rules implementing the inventor's oath or declaration provisions of the Leahy-Smith America Invents Act (AIA). | Legal Update: archive | 14-Aug-2012 |
| 86 | USPTO Final Rules for PTAB Proceedings On August 14, 2012, the US Patent and Trademark Office (USPTO) published extensive final rules under the America Invents Act (AIA) concerning Patent Trial and Appeal Board (PTAB) Rules of Practice, inter partes review and post-grant review proceedings and the transitional program for covered business method patents. | Legal Update: archive | 14-Aug-2012 |
| 87 | USPTO Final Rules on AIA Supplemental Examination ... On August 14, 2012, the US Patent and Trademark Office (USPTO) issued final rules to implement the Leahy-Smith America Invents Act (AIA) provisions regarding supplemental examination proceedings. The final rules take effect on September 16, 2012. | Legal Update: archive | 14-Aug-2012 |
| 88 | USPTO Seeks Input From Potential Users of Patent Review ... The US Patent and Trademark Office (USPTO) is seeking input from potential users to test the Patent Review Processing System (PRPS) electronic filing system. | Legal Update: archive | 14-Aug-2012 |
| 89 | Federal Circuit Expands Hatch-Waxman Safe Harbor to ... In Momenta Pharmaceuticals, Inc. v. Amphastar Pharmaceuticals, Inc., the US Court of Appeals for the Federal Circuit held that a plain reading of the Hatch-Waxman safe harbor statute allows a second generic drug manufacturer to use a first generic drug manufacturer's patented method for manufacturing the approved generic drug, even though the patent owner already obtained FDA approval for the generic drug. | Legal Update: archive | 06-Aug-2012 |
| 90 | USPTO Issues Final Rules for the Prior Art and Written ... On August 6, 2012, the US Patent and Trademark Office (USPTO) issued final rules to implement miscellaneous post-patent provisions of the Leahy-Smith America Invents Act, including the prior art citation and written statement provisions. | Legal Update: archive | 06-Aug-2012 |
| 91 | Federal Circuit Finds Prior Art Printed Publications ... In In Re Antor Media Corporation, the US Court of Appeals for the Federal Circuit affirmed the Board of Patent Appeals and Interferences' (BPAI) decision rejecting Antor Media Corporation's patent as anticipated and obvious over four references. Three of the four references were print publications. The Federal Circuit notably held that a prior art printed publication cited by an examiner is presumptively enabling. | Legal Update: archive | 30-Jul-2012 |
| 92 | Federal Circuit Rejects Bancorp's Patents as Too Abstract to ... In Bancorp Services, LLC v. Sun Life Assurance Co. of Canada (US), the US Court of Appeals for the Federal Circuit affirmed the district court's grant of summary judgment and found that Bancorp's asserted patent claims were invalid under Section 101 of the Patent Act. | Legal Update: archive | 30-Jul-2012 |
| 93 | USPTO Publishes Proposed Rules and Examination ... The US Patent and Trademark Office (USPTO) has proposed changes to its patent application rules of practice and new examination guidelines to implement the first-inventor-to-file provisions of the Leahy-Smith America Invents Act (AIA). It also has proposed to eliminate its rules concerning statutory invention registrations. | Legal Update: archive | 25-Jul-2012 |
| 94 | Section 337 Investigations: ITC Proposes Changes to Rules of ... On July 12, 2012, the International Trade Commission (ITC) issued proposed amendments to its Rules of Practice and Procedure concerning Section 337 Investigations. | Legal Update: archive | 19-Jul-2012 |
| 95 | Third Circuit Finds Generic Drug Reverse Payment ... The US Court of Appeals for the Third Circuit's July 16, 2012 opinion in In re K-Dur Antitrust Litigation held that reverse payment agreements in the pharmaceutical industry are presumptively anti-competitive and should be analyzed under a "quick look" rule of reason test. | Legal Update: archive | 19-Jul-2012 |
| 96 | Federal Circuit Vacates Contempt Sanctions Against Attorneys ... In Wi-LAN, Inc. v. LG Electronics, Inc., the US Court of Appeals for the Federal Circuit vacated and remanded the orders of the US District Court for the Northern District of California directing Wi-LAN, Inc.'s attorneys, Kilpatrick Townsend & Stockton LLP, to produce their pre-litigation communications with Wi-LAN concerning Wi-LAN's V-chip patents and holding counsel in contempt for refusing to do so. The Federal Circuit reasoned that, under the law of the US Court of Appeals for the Ninth Circuit, a district court must weigh considerations of fairness when determining the scope of an express extrajudicial waiver of attorney-client privilege and that the district court's failure to do so required that the case be remanded for this purpose. | Legal Update: archive | 17-Jul-2012 |
| 97 | USPTO Issues Final Rules Implementing Third-party Patent ... The USPTO issued a final rule implementing Section 8 of the Leahy-Smith America Invents Act governing third-party submissions to the Patent Office of patents and other documents relevant to the issuance of pending patents. The final rule sets out the requirements for these third-party preissuance submissions to the USPTO in non-provisional utility, design or plant patent applications and any continuing application. | Legal Update: archive | 17-Jul-2012 |
| 98 | Patent No-challenge Clauses in Pre-litigation Settlements are ... In Rates Technology Inc., v. Speakeasy, Inc., the US Court of Appeals for the Second Circuit affirmed a district court decision that a no-challenge clause in a patent settlement and license agreement entered into without the licensing parties' having sought to litigate the validity of the licensed patents is unenforceable on public policy grounds. | Legal Update: archive | 11-Jul-2012 |
| 99 | Federal Circuit Creates More Uncertainty with Latest Patent ... On July 9, 2012, the US Court of Appeals for the Federal Circuit decided CLS Bank v. Alice Corp. This decision allows district courts to sidestep patent challenges based on patent eligible subject matter in favor of other patent validity challeges. The decision also prevents a computer related invention from being invalidated under Section 101 unless it is manifestly evident that the patent claims are directed to an abstract idea. | Legal Update: archive | 09-Jul-2012 |
| 100 | Federal Circuit Applies Presumption of Validity to Mistakenly ... In Sciele Pharma Inc. v. Lupin Ltd., the US Court of Appeals for the Federal Circuit held that all claims issued by the US Patent and Trademark Office (USPTO) are presumed valid, even claims the USPTO mistakenly issued. Despite this holding, the Federal Circuit vacated the district court's preliminary injunction and remanded the case for futher proceedings. | Legal Update: archive | 05-Jul-2012 |
| 101 | European Parliament postpones vote on unitary EU patent The European Council has agreed the location of the seat for the Unified Patent Court, but Parliament has postponed a vote on the Council’s proposals. | Legal Update: archive | 04-Jul-2012 |
| 102 | Wrigley's Chewing Gum Patent Ruled Invalid: Federal Circuit In WM. Wrigley Jr. Co. v. Cadbury Adams USA LLC, in a split decision, the US Court of Appeals for the Federal Circuit affirmed a district court decision that Wrigley's patent concerning a chewing gum with a cooling composition was anticipated and obvious based on prior art references. The court unanimously affirmed the district court's decision that Wrigley did not infringe a Cadbury patent concerning a chewing gum with a cooling composition. | Legal Update: archive | 25-Jun-2012 |
| 103 | Objective Recklessness for Willful Patent Infringement is a ... In its June 14, 2012 opinion in Bard Peripheral Vascular, Inc. v. W.L. Gore & Associates, Inc., the US Court of Appeals for the Federal Circuit clarified the threshold objectivity prong of its willful patent infringement standard in In re Seagate Technology, LLC. It held that the initial threshold determination of objective recklessness is a matter of law to be decided by the court and subject to de novo review. | Legal Update: archive | 18-Jun-2012 |
| 104 | USPTO Proposes Rules to Implement the Micro Entity ... The USPTO has proposed amendments to the rules of practice in patent cases to implement the micro entity provision of the Leahy-Smith America Invents Act. Among other things, the proposed amendments change the rules of practice for patent applications to allow for applicants to claim micro entity status and pay patent fees at the micro entity rate. | Legal Update: archive | 29-May-2012 |
| 105 | Federal Circuit Affirms USPTO Nullification of Federal Circuit's ... In In re Baxter International, Inc., the US Court of Appeals for the Federal Circuit affirmed the USPTO's nullification of the Federal Circuit's prior ruling that certain claims in Baxter's patent are valid. The Federal Circuit's prior validity ruling came in an appeal from a district court decision in a related patent infringement litigation, while the Federal Circuit's current unpatentability ruling came in an appeal from a BPAI decision in a reexamination proceeding for Baxter's patent. | Legal Update: archive | 18-May-2012 |
| 106 | Federal Circuit Clarifies Patent Recapture Rule Analysis In a May 8, 2012 opinion in In re Youman, the US Court of Appeals for the Federal Circuit, vacated and remanded the USPTO Board of Patent Appeals and Interferences' (BPAI) decision affirming the examiner's rejection of certain reissue patent application claims because the BPAI improperly applied the three-step recapture rule analysis. | Legal Update: archive | 15-May-2012 |
| 107 | Proposed Adjustment of Patent Fees for Fiscal Year 2013 The USPTO proposed a patent fee increase for fiscal year 2013 to reflect fluctuations in the Consumer Price Index (CPI). | Legal Update: archive | 14-May-2012 |
| 108 | Prior Art Clinical Study Protocol Anticipates Treatment Method ... In In re Montgomery, the US Court of Appeals for the Federal Circuit affirmed the Board of Patent Appeals and Interferences' (BPAI) decision rejecting certain patent claims covering administering certain drugs to patients to treat and prevent strokes. The Federal Circuit agreed that a particular prior art clinical study protocol inherently anticipated the claims. | Legal Update: archive | 10-May-2012 |
| 109 | EPO and WIPO sign co-operation agreement The European Patent Office and the World Intellectual Property Organization have agreed on a comprehensive three-year technical co-operation scheme. | Legal Update: archive | 08-May-2012 |
| 110 | Federal Circuit Affirms NJ District Court Decision on ... On May 7, 2012, in Otsuka Pharmaceutical Co. v. Sandoz, Inc., the US Court of Appeals for the Federal Circuit affirmed the US District Court for the District of New Jersey's determination sustaining the validity of asserted claims of US Patent 5,006,528 in the face of the defendants' obviousness and obviousness-type double patenting defenses. | Legal Update: archive | 08-May-2012 |
| 111 | Federal Circuit Jurisdiction for Patent Malpractice Case Recently, the US Court of Appeals for the Federal Circuit asserted jurisdiction over a state law patent attorney malpractice case in Minkin v. Gibbons, P.C., citing Federal Circuit precedent. | Legal Update: archive | 08-May-2012 |
| 112 | AIA Section 299 Does not Prohibit Transfer for Pretrial ... On May 2, 2012 in In re Bear Creek Technologies, Inc., the US Judicial Panel on Multidistrict Litigation (JPML) found that Section 299 of the Leahy-Smith America Invents Act (AIA) does not prohibit it from centralizing multiple related patent infringement claims for pretrial proceedings. | Legal Update: archive | 07-May-2012 |
| 113 | Federal Circuit to Require Electronic Case Filing The US Court of Appeals for the Federal Circuit recently issued notice of a new mandatory electronic case filing (or e-filing) rule that goes into effect on May 17, 2012. Appeals opened or reinstated on March 1, 2012 or later will be assigned to the Federal Circuit's Case Management/Electronic Case Files (CM/ECF) system. | Legal Update: archive | 03-May-2012 |
| 114 | Eleventh Circuit Approves Patent "Pay for Delay" Settlements In FTC v. Watson Pharmaceuticals, Inc., the US Court of Appeals for the Eleventh Circuit rejected the FTC's argument that patent "Pay for Delay" settlements violate antitrust laws when the patent holder is unlikely to prevail in the underlying infringement action that prompted the settlement. | Legal Update: archive | 26-Apr-2012 |
| 115 | Federal Circuit: Failure to File Divisional Patents Not Cured by ... In Landmark Screens LLC, v. Morgan, Lewis, & Bockius, LLP, the US Court of Appeals for the Federal Circuit, asserting subject matter jurisdiction over California state law claims against a patent attorney for legal malpractice, reversed the summary judgment orders of the US District Court for the Northern District of California limiting the plaintiff's claims for damages and dismissing its state law claims. | Legal Update: archive | 24-Apr-2012 |
| 116 | Plaintiff Receives Rule 11 Sanctions for Unreasonable Patent ... In Source Vagabond Systems Ltd. v. Hydrapak, Inc., the US District Court for the Southern District of New York granted the defendant's motion for sanctions against the plaintiff patentee under Rule 11 of the Federal Rules of Civil Procedure. The court ruled that the plaintiff failed to demonstrate that it had an objectively reasonable basis for believing that it had a reasonable chance of proving patent infringement before filing its infringement claim. | Legal Update: archive | 24-Apr-2012 |
| 117 | No Special Limits on New Evidence in Section 145 Patent ... On April 18, 2012, the US Supreme Court, in Kappos v. Hyatt, ruled that there are no limitations on a patent applicant's ability to present new evidence in a Section 145 district court proceeding challenging the Board of Patent Appeals and Interferences's (BPAI) denial of a patent, other than those of general application under the Federal Rules of Evidence and Federal Rules of Civil Procedure. | Legal Update: archive | 19-Apr-2012 |
| 118 | FDA Approved Use Prevents Hatch-Waxman Patent ... In the consolidated appeals of Bayer Schering Pharma v. Lupin Ltd. and Bayer Schering Pharma v. Sandoz, Inc., the US Court of Appeals for the Federal Circuit affirmed a district court's decisions that the defendants' ANDAs for a generic drug did not infringe a method-of-use patent for Bayer's Yasmin drug. Specifically, a divided panel determined that Bayer failed to state a claim for patent infringement because the defendants sought approval to market the generic form of the Yasmin drug for a use approved by the FDA but not covered by Bayer's patent. | Legal Update: archive | 17-Apr-2012 |
| 119 | Generic Drug Manufacturer May Force Correction of ... On April 17, 2012 in Caraco Pharmaceutical Laboratories, Ltd. v. Novo Nordisk A/S, the US Supreme Court held that a generic drug manufacturer may file a counterclaim in a Hatch-Waxman patent litigation seeking an order requiring the branded drug manufacturer to correct Orange Book patent use code information that inaccurately describes the branded drug patent as covering a particular FDA-approved method of using the drug. | Legal Update: archive | 17-Apr-2012 |
| 120 | Second ANDA Filer Has Hatch-Waxman Declaratory ... On April 16, 2012, the US Court of Appeals for the Federal Circuit issued its decision in Dey Pharma, LP v. Sunovion Pharmaceuticals Inc. affirming the district court's exercise of subject-matter jurisdiction to hear a declaratory judgment action brought under the Hatch-Waxman Act by the second Abbreviated New Drug Application (ANDA) filer. | Legal Update: archive | 17-Apr-2012 |
| 121 | Federal Circuit Reverses Obviousness Determination Based ... On April 16, 2012 in In re Cyclobenzaprine Hydrochloride Extended-Release Capsule Patent Litigation and Eurand, Inc. v. Mylan Pharmaceuticals Inc., the US Court of Appeals for the Federal Circuit reversed the US District Court for the District of Delaware's obviousness determination concerning patents relating to extended-release muscle relaxant formulations. The Federal Circuit held that the district court committed multiple errors in its obviousness determination, including failing to consider the lack of a known pharmacokinetic/pharmacodynamic relationship for the claimed drug formulation in its obviousness analysis and determining that the patents-in-suit were obvious before considering the objective considerations of nonobviousness | Legal Update: archive | 16-Apr-2012 |
| 122 | Microsoft TRO Prevents Motorola From Enforcing Potential ... In Microsoft Corporation v. Motorola Inc., the US District Court for the Western District of Washington granted Microsoft a temporary restraining order enjoining Motorola from enforcing any injunction a German court may order that would exclude certain Microsoft products from Germany based on Motorola's patents. | Legal Update: archive | 16-Apr-2012 |
| 123 | Federal Circuit Affirms Inequitable Conduct and ... On April 9, 2012 in Aventis v. Hospira, the Federal Circuit affirmed a District Court determination that two patents are unenforceable due to the inequitable conduct of the inventor. The Federal Circuit affirmed the decision even though the District Court did not have the guidance of the Federal Circuit's decision in Therasense, Inc. v. Becton, Dickinson & Co. | Legal Update: archive | 10-Apr-2012 |
| 124 | Federal Circuit Declines to Adopt Settlement Negotiation ... On April 9, 2012, in In re MSTG, Inc., the US Court of Appeals for the Federal Circuit considered adopting a new privilege in patent cases that would prevent discovery of litigation settlement negotiations related to reasonable royalties and damages. | Legal Update: archive | 10-Apr-2012 |
| 125 | Federal Circuit Clarifies Algorithm Requirements for Means ... In Noah Systems, Inc., v. Intuit Inc., the US Court of Appeals for the Federal Circuit clarified the standard for evaluating computer-implemented means-plus-function claims in a patent having a specification that discloses an algorithm that only accomplishes one of multiple identifiable functions performed by the claimed limitation. | Legal Update: archive | 09-Apr-2012 |
| 126 | USPTO and NIST Announce New IP Awareness Assessment ... The USPTO and National Institute of Standards and Technology (NIST) Manufacturing Extensions Partnership (MEP) announced in a press release the launch of a new web-based IP Awareness Tool designed to help manufacturers, small businesses, entrepreneurs and independent investors evaluate their intellectual property, including copyrights, patents, trademarks and trade secrets. | Legal Update: archive | 30-Mar-2012 |
| 127 | On Therasense Remand, District Court Finds Inequitable ... In Therasense, Inc. v. Becton, Dickinson & Co., the US District Court for the Northern District of California applied the Federal Circuit's new inequitable conduct standard and found that the patent at issue was unenforceable due to inequitable conduct by the pantent holder's attorney and Research and Development Director. | Legal Update: archive | 29-Mar-2012 |
| 128 | Federal Circuit Addresses Computer-implemented Means ... In Ergo Licensing, LLC v. CareFusion 303, Inc., the US Court of Appeals for the Federal Circuit affirmed a district court's decision that certain claims are invalid as being indefinite where the specification failed to disclose sufficient corresponding structure for a computer-implemented means-plus-function term in the claims. | Legal Update: archive | 27-Mar-2012 |
| 129 | Supreme Court Remands Myriad Genetics, Inc. to Federal ... On March 26, 2012, the Supreme Court vacated the US Court of Appeals for the Federal Circuit's decision in Ass'n for Molecular Pathology v. Myriad Genetics, Inc., which upheld Myriad's patents on two isolated human genes (BRCA1 and BRCA2) that account for most inherited forms of breast and ovarian cancers. The Supreme Court remanded the case for further consideration in light of its decision in Mayo Collaborative Services v. Prometheus Laboratories, Inc. | Legal Update: archive | 26-Mar-2012 |
| 130 | Federal Circuit Clarifies Government Contractor Liability for ... In Zoltek Corp. v. United States, the US Court of Appeals for the Federal Circuit issued a partial en banc decision vacating a 2006 Federal Circuit decision that limited government liability for patent infringement under 28 U.S.C. § 1498(a) to acts constituting infringement under 35 U.S.C. § 271(a). The en banc decision clarifies that direct infringement under Section 1498(a) includes acts covered under both 35 U.S.C. § 271(a) and § 271(g). | Legal Update: archive | 20-Mar-2012 |
| 131 | Supreme Court Reverses Federal Circuit in Mayo v. ... On March 20, 2012, the Supreme Court issued its decision in Mayo Collaborative Services v. Prometheus Laboratories, Inc. The court unanimously held that Prometheus's claimed methods using certain individualized drug metabolite measurements to determine the calibration of a patient's drug dosage were not patent-eligible subject matter under Section 101 of the Patent Act because the methods simply recited a law of nature. | Legal Update: archive | 20-Mar-2012 |
| 132 | Federal Circuit Issues En Banc Marine Polymer Decision on ... On March 15, 2012, the Federal Circuit issued its en banc decision in Marine Polymer Technologies, Inc. v. Hemcon, Inc., holding that for ex parte reexaminations, intervening rights only apply to new or amended claims. By a 6-4 majority, the court rejected an earlier Federal Circuit panel decision finding intervening rights were triggered where a patentee made narrowing arguments during reexamination even though the claims were not actually changed. | Legal Update: archive | 19-Mar-2012 |
| 133 | Federal Circuit Tightens Surrendered Patent Claim Scope ... Recently, in Digital-Vending Services International, LLC v. The University of Phoenix, Inc., the Court of Appeals for the Federal Circuit held that a patentee did not disavow the scope of certain claims through limiting language in the patent specification because the specific claims at issue did not recite the contested language of limitation. The dissent argued that the majority erred and that this case presented one of the rare instances where a patentee clearly disavowed claim scope through limiting language in the patent specification. | Legal Update: archive | 13-Mar-2012 |
| 134 | DC District Court Limits Patent Owners' Right to Appeal BPAI ... In Teles v. Kappos, the US District Court for the District of Columbia held that, unlike patent applicants, patent owners cannot take advantage of the de novo review and liberal discovery procedures of a federal civil action to overturn an adverse final decision of the Board of Patent Appeals and Interferences (BPAI) on the reexamination of their patent claims. Rather, patent owners' sole remedy in such cases is to file an appeal to the Federal Circuit seeking limited, appellate review. | Legal Update: archive | 09-Mar-2012 |
| 135 | Eastern District of Texas Adopts Model E-discovery Order for ... On February 27, 2012, the US District Court for the Eastern District of Texas adopted a model order for e-discovery in patent cases. This model order is a variation of the model order for e-discovery in patent cases drafted and adopted by the Advisory Council for the US Court of Appeals for the Federal Circuit in September 2011. | Legal Update: archive | 06-Mar-2012 |
| 136 | Federal Circuit Clarifies Broadening Reissue Patent ... On March 5, 2012, the Court of Appeals for the Federal Circuit reversed a USPTO Board of Patent Appeals and Interferences (BPAI) rejection of reissue patent application claims that were filed after the two-year deadline imposed by Section 251 of the Patent Act for filing broadening reissue patent applications. The claims were submitted in a continuation reissue patent application and were unrelated to the embodiment of the invention claimed in the broadening reissue patent application that was filed within two years of the original patent's issue date. | Legal Update: archive | 06-Mar-2012 |
| 137 | Federal Circuit Sidesteps Section 101 Analysis to Invalidate ... On March 2, 2012, in MySpace v. Graphon, the Court of Appeals for the Federal Circuit upheld a summary judgment ruling invalidating four patents as anticipated and obvious under Sections 102 and 103, respectively, of the Patent Act. Although the patents relate to the manipulation of database records over a computer network, the court did not analyze whether the patents claim patent-eligible subject matter under Section 101. | Legal Update: archive | 05-Mar-2012 |
| 138 | AstraZeneca Loses Generic Drug Infringement Appeal in ... In AstraZeneca Pharmaceuticals LP v. Apotex Corp., the US Court of Appeals for the Federal Circuit affirmed a district court decision dismissing AstraZeneca's method-of-use patent infringement claims based on Abbreviated New Drug Applications (ANDAs) filed by a group of generic drug manufacturers. The Federal Circuit held that AstraZeneca failed to state a valid claim for patent infringement under the Hatch-Waxman Act. | Legal Update: archive | 10-Feb-2012 |
| 139 | USPTO Proposes New Patent Fee Structure Recently, the USPTO released an initial proposal with a new patent fee schedule under the authority granted to it by the Leahy-Smith America Invents Act. Generally, the proposed fee schedule increases most patent fees for both large and small entities. | Legal Update: archive | 09-Feb-2012 |
| 140 | USPTO Publishes Proposed Rules for PTAB Proceedings The USPTO published extensive proposed rules under the America Invents Act (AIA) concerning Patent Trial and Appeal Board (PTAB) practice, inter partes review, post-grant review, the transitional program for covered business method patents and derivation proceedings. The proposed rules will be published in the Federal Register on February 9 and 10, 2012 and have a 60-day public comment period. | Legal Update: archive | 08-Feb-2012 |
| 141 | Federal Circuit Clarifies Use of Post-critical Date Patent ... On February 7, 2012 in Adair v. Carter, the US Court of Appeals for the Federal Circuit clarified the narrow circumstances in which post-critical date patent claims can be used as a basis to declare an interference. | Legal Update: archive | 07-Feb-2012 |
| 142 | Federal Circuit Rules on Joint Inventorship of Chemical ... In Falana v. Kent State University, the US Court of Appeals for the Federal Circuit affirmed a district court decision ordering the USPTO to add a named inventor to a patent claiming a new class of chemical compounds. The Federal Circuit ruled that in certain situations, a researcher who envisioned a novel chemical compound's structure and contributed to the method of making the compound is an inventor of a claim covering that compound. | Legal Update: archive | 24-Jan-2012 |
| 143 | USPTO Proposes Rules on AIA Supplemental Examination ... The USPTO issued a notice of proposed rulemaking, on January 24, 2012, to implement the Leahy-Smith America Invents Act (AIA) provisions regarding supplemental examination proceedings. The USPTO has also proposed adjusting and setting certain fees concerning supplemental examination and ex parte and inter partes reexaminations. | Legal Update: archive | 24-Jan-2012 |
| 144 | Federal Circuit Clarifies When a Business Method Claim is ... On January 20, 2012, in Dealertrack, Inc. v. Huber, the US Court of Appeals for the Federal Circuit affirmed the lower court's finding that certain patent claims are invalid because the claims, concerning a three-step information processing method, are directed to an abstract idea that preempts a fundamental concept. | Legal Update: archive | 23-Jan-2012 |
| 145 | Federal Circuit Applies Pre-KSR Obviousness Analysis to ... In Celsis In Vitro, Inc. v. CellzDirect, Inc., a divided US Court of Appeals for the Federal Circuit affirmed the grant of a motion for a preliminary injunction in favor of Celsis In Vitro, Inc. on January 9, 2012. Notably, Circuit Judge Gajarsa's dissent argued that the majority failed to follow the US Supreme Court's non-obviousness analysis in KSR Int'l Co. v. Teleflex, Inc., 127 S. Ct. 1727 (2007) in evaluating Celsis' patent. | Legal Update: archive | 13-Jan-2012 |
| 146 | USPTO Proposes New Rules to Implement the Inventor's Oath ... On January 6, 2012, the USPTO published proposed rules to implement the inventor's oath or declaration provisions of the Leahy-Smith America Invents Act (AIA). The proposed rules revise and clarify the rules concerning inventor's oaths or declarations, including reissue oaths or declarations, assignments containing oath or declaration statements from inventors and oaths or declarations signed by parties other than the inventors. The proposed rules also revise and clarify other USPTO patent rules of practice. | Legal Update: archive | 10-Jan-2012 |
| 147 | USPTO Proposes Changes to its Rules of Practice to ... The USPTO proposes new rules of patent practice to implement certain post-patent provisions of the Leahy-Smith America Invents Act (AIA). | Legal Update: archive | 09-Jan-2012 |
| 148 | USPTO Proposes New Regulations and Seeks Comment on ... On January 5, 2012, the USPTO published a notice of proposed rulemaking and request for comments on proposed regulations clarifying the commencement date for the one-year statute of limitations for USPTO practitioner misconduct disciplinary proceedings. | Legal Update: archive | 06-Jan-2012 |
| 149 | USPTO Proposes New Rules to Implement the Third Party ... On January 5, 2012, the USPTO proposed new rules to implement the preissuance submission provision under the Leahy-Smith America Invents Act. This provision provides a mechanism for third parties to assist the USPTO with its examination of patent applications. It allows third parties to timely submit any patents, published patent applications and other printed publications of potential relevance to the examination of the application for the USPTO to consider and include in the patent application record. | Legal Update: archive | 05-Jan-2012 |
| 150 | Latest amendments to PCT regulations notified An update on the notification of the most recent amendments to the Regulations under the Patent Co-operation Treaty. | Legal Update: archive | 28-Dec-2011 |
| 151 | USPTO Proposes Revision of Patent Term Adjustment ... The USPTO issued a notice of proposed rulemaking to revise the patent term adjustment provisions concerning appellate review so that appellate review under the patent term adjustment rules begins when jurisdiction over the application passes to the Board of Patent Appeals and Interferences (BPAI) rather than the date when the appeal is filed. The USPTO also proposes to make failure to timely file an appeal brief a failure to engage in reasonable efforts to conclude prosecution of the application. | Legal Update: archive | 28-Dec-2011 |
| 152 | WIPO publishes statistics showing IP filings rebounded in ... WIPO has published a report on the intellectual property filings worldwide in 2010, which suggests that filings rebounded strongly after a decline in 2009. | Legal Update: archive | 22-Dec-2011 |
| 153 | BPAI Refuses to Consider Secondary Considerations of ... The BPAI refuses to consider the secondary considerations of nonobviousness in affirming the examiner's obviousness-type double patenting rejection of certain pending patent claims even though it reversed the patent examiner's obviousness rejection of those claims based on the secondary considerations. | Legal Update: archive | 20-Dec-2011 |
| 154 | USPTO Issues Final Rule to Implement Prioritized ... The USPTO issued a final rule implementing the prioritized examination process for requests for continued examination under the Leahy-Smith America Invents Act (AIA). The rule sets out procedures, goals and conditions for a patent application to qualify for prioritized examination. | Legal Update: archive | 20-Dec-2011 |
| 155 | USPTO and Rospatent Announce Patent Cooperation Treaty ... Under a new agreement between the USPTO and the Russian Federal Service for Intellectual Property (Rospatent), Rospatent will act as an available International Searching Authority (ISA) and International Preliminary Examining Authority (IPEA) for international patent applications filed with USPTO. | Legal Update: archive | 20-Dec-2011 |
| 156 | WIPO provides PCT applicants with ability to indicate ... The World Intellectual Property Organisation has announced that applicants under the Patent Cooperation Treaty interested in licensing the inventions contained in their international patent applications will soon be able to request the International Bureau to make this information available on its PATENTSCOPE website. | Legal Update: archive | 19-Dec-2011 |
| 157 | USPTO Seeks Comment on Potential Changes to Patent ... The USPTO is considering ways to build a more complete record of assigned applications and patents. The proposed changes would increase disclosure requirements at the time of filing the application, but the additional information would benefit the public, financial markets and patenting inventors and manufacturers. | Legal Update: archive | 16-Dec-2011 |
| 158 | Federal Circuit Allows End Run Around Article III Courts ... In In re Construction Equipment Company, the US Court of Appeals for the Federal Circuit affirmed a USPTO ex parte reexamination invalidity finding for the same patent that was upheld as valid by the Federal Circuit in previous litigation. | Legal Update: archive | 13-Dec-2011 |
| 159 | Federal Circuit Confirms Invalidity of Teva Patent Based on ... The US Court of Appeals for the Federal Circuit ruled in Teva Pharmaceuticals v. AstraZeneca Pharmaceuticals that an alleged patent infringer claiming invalidity of the asserted patent based on prior invention by another need only show that the earlier inventor understood the contents of its invention. The earlier inventor does not have to fully appreciate how the invention worked. | Legal Update: archive | 08-Dec-2011 |
| 160 | Federal Circuit Orders Venue Transfer in Patent Infringement ... The US Court of Appeals for the Federal Circuit granted a petition for a writ of mandamus to transfer venue in a patent infringement case from the Delaware District Court to the Northern District of California even though the defendant company is incorporated in Delaware. | Legal Update: archive | 08-Dec-2011 |
| 161 | USPTO Revises Patent Term Adjustment Rule The USPTO has released a final rule revising the patent term adjustment reduction provisions of the patent rules of practice. Specifically, the rule excludes information disclosure statements resulting from the citation of information in a counterpart application that are promptly filed with the USPTO. | Legal Update: archive | 07-Dec-2011 |
| 162 | Recent EU unified patent developments There have been recent further developments in the process of adopting a unified patent for the whole EU and a corresponding unified patent litigation system. | Legal Update: archive | 01-Dec-2011 |
| 163 | Delaware Chancery Court Finds Reverse Triangular Mergers ... An update on the Delaware Court of Chancery's opinion in Meso Scale Diagnostics, LLC v. Roche Diagnostics GMBH holding that a reverse triangular merger may constitute an assignment by operation of law where the plaintiff presents evidence that the defendant converted the target into a shell company immediately following the merger. | Legal Update: archive | 12-Apr-2011 |
| 164 | Federal Circuit Clarifies Burden of Proof for Lack of ... In Cephalon, Inc. v. Watson Pharmaceuticals, Inc., the US Court of Appeals for the Federal Circuit reversed the district court's holding that two patents asserted by Cephalon against Watson in response to Watson's ANDA filing for a generic version of FENTORA were invalid for lack of enablement. | Legal Update: archive | -- |
| 165 | Obviousness-Type Double Patenting Applies Without ... On March 7, 2013, the US Court of Appeals for the Federal Circuit affirmed the USPTO Board of Patent Appeals and Interferences' ruling that pending patent claims may be barred under the doctrine of obviousness-type double patenting, even where there is no common ownership with a patent. | Legal Update: archive | -- |
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| 1 | Federal Circuit upholds denial of request for anti-arbitration ... In Sanofi-Aventis Deutschland v. Genentech, Inc, No. 2012-1454 (Fed. Cir. May 10, 2013), the Federal Circuit considered whether to affirm a denial of a motion for an injunction to prevent related arbitration proceedings. | Legal Update: Case Report | 23-May-2013 |
| 2 | ECJ rejects challenges by Spain and Italy to unitary patent ... The ECJ has rejected all the legal challenges made by Spain and Italy to the enhanced co-operation adopted by all the other member states for a unitary patent and associated translation regime. (Kingdom of Spain and Italian Republic v Council of the European Union, Joined Cases C-274/11 and C-295/11, 16 April 2013.) | Legal Update: Case Report | 18-Apr-2013 |