Patents

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.  

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.

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.

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.

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.

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.

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. 

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.

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. 

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.

An overview of special issues and considerations with respect to security interests in intellectual property, relevant to both corporate and finance transactions.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

A look at attempts by EU national courts to harmonise their approach to procedure and substantive law in the field of patent law.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

An examination of litigation within the complicated and expensive European patent system.

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.

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.

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.

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.

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.

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.

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.  

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.

Cross-border patent litigation in Europe has been controversial over the last 20 years. Relatively recent case law from the European Court of Justice (ECJ) has made cross-border patent injunction claims nearly impossible but certain other cross-border claims are still possible. This chapter examines what a European cross-border patent dispute is, legal arguments against cross-border patent claims, why cross-border patent injunction claims are now nearly impossible, what cross-border claims remain possible and whether "torpedoes" are still possible.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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).

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).

The United States Patent and Trademark Office (USPTO) is extending the comment period for public comments regarding potential patent small claims proceeding.

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.

Twenty-four member states have signed the international agreement for establishing a Unified Patent Court at an EU Council meeting.

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).

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.

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.

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.

President Obama signed H.R. 6621 into law, making certain technical amendments to the Leahy-Smith America Invents Act (AIA).

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.  

WIPO has published its report World Intellectual Property Indicators 2012 on 2011 intellectual property filing statistics.

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.

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.

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.

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.

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.

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.

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.

Negotiating and drafting royalty stacking provisions in patent licenses.

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.

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.

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.

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.

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.

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.

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.

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.

The US Patent and Trademark Office (USPTO) has published two new rules, one proposed and one final, to set and adjust patent fees.

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.

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.  

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. 

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).   

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.

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.

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. 

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.

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. 

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.

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.

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.

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.

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.

The USPTO proposed a patent fee increase for fiscal year 2013 to reflect fluctuations in the Consumer Price Index (CPI).

The European Patent Office and the World Intellectual Property Organization have agreed on a comprehensive three-year technical co-operation scheme.

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.

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.

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.

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.

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.

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

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

The USPTO proposes new rules of patent practice to implement certain post-patent provisions of the Leahy-Smith America Invents Act (AIA).

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.

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.

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.

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.

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.

  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.

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.

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.

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.

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.)