Pharmaceutical IP and competition law in Sweden: overview

A Q&A guide to pharmaceutical IP and competition law in Sweden.

The Q&A gives a high level overview of key issues including patents, trade marks, competition law, patent licensing, generic entry, abuse of dominance and parallel imports.

For information on pharmaceutical pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, and product recall and liability, visit Medicinal product regulation and product liability in Sweden: overview.

The Q&A is part of the global guide to Life Sciences law. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-guide.

Contents

Patents

1. What are the legal conditions to obtain a patent and which legislation applies? Which products, substances and processes can be protected by patents and what types cannot be patent protected?

Conditions and legislation

For an invention, including a medicinal product to be patentable, it must do all of the following:

  • Be susceptible to industrial application (the invention must, among other things, be capable of being reproduced with the same result).

  • Be novel (the invention must not already be available to the public anywhere in the world).

  • Involve an inventive step (an invention must not, having regard to the state-of-the-art, be obvious to a person skilled in the art).

The Patents Act (SFS 1967:837) and the Patents Regulation (SFS1967:838) apply.

Scope of protection

See above, Conditions and legislation. In addition, certain biotechnical inventions may be patentable.

The following cannot, among other things, be patented:

  • Methods for surgical or therapeutic treatment, or diagnostic methods, practised on humans or animals. However, this does not prevent granting patents for products, including substances and compositions of substances, for use in methods of this type.

  • Inventions, the use of which would be contrary to morality or public order.

 
2. How is a patent obtained?

Application and guidance

On a national level, the Swedish Patent and Registration Office (PRO) (Patent- och registreringsverket) administers patent applications and maintains the official patent register.

The PRO website (www.prv.se) contains information about the requirements and the application process. It also contains application forms and access to an electronic application service.

The applicant must pay a filing fee and supplementary fees for, among other things, each patent claim in addition to the first ten. If the patent is granted, a granting fee and annual fees must be paid. Current fees can be found on the PRO website.

Process and timing

The inventor or its successor-in-title can apply for a patent with the PRO. Since 1 July 2014, the claims, description and abstract can be in English, although a translation into Swedish of the patent claims must be submitted within two months of notice of intention to grant. Additionally, the patent holder can in certain circumstances also be requested to provide translations into Swedish of the description and abstract. The PRO aims to process applications within seven months and render a final decision within two years from the date of filing, although the time period can vary significantly. If a patent application is rejected, the decision can be appealed to the Court of Patent Appeals (Patentbesvärsrätten) within two months. From 1 September 2016 the Court of Patent Appeals will be replaced by the newly established Patents and Market Court.

 
3. How long does patent protection typically last? Can monopoly rights be extended by other means?

Duration and renewal

A patent is effective for 20 years from the day the patent application was filed. An annual fee must be paid after filing of an application for a patent otherwise the application will be dismissed or, following the grant, the patent will lapse.

A patent cannot be renewed.

Extending protection

Supplementary protection can be granted for medicinal products, and for plant protection products, for a period of up to five years under:

  • Regulation (EEC) 1768/92 concerning the creation of a supplementary protection certificate for medicinal products (Medicinal Products Supplementary Protection Certificate Regulation).

  • Regulation (EC) 1610/96 concerning the creation of a supplementary protection certificate for plant protection products.

Medicinal products that have been authorised for the paediatric population and that have been granted supplementary protection can enjoy an additional six months of protection (Regulation (EC) 1901/2006 on medicinal products for paediatric use (Paediatric Medicinal Products Regulation)).

 
4. How can a patent be revoked?

Third parties can give the PRO notice of opposition to a patent within nine months of the grant date. An individual must initiate court proceedings if he wishes to challenge the granted patent after the nine-month period.

The patent can be revoked if one of the following applies:

  • The patent was granted even though the criteria in the Patents Act regarding patentability were not met.

  • The patent relates to an invention the description of which is not sufficiently clear to enable a person skilled in the art to carry out the invention with the guidance of the description.

  • The patent comprises subject matter not appearing in the application as filed.

  • The scope of patent protection has been extended after the grant of the patent.

 
5. How is a patent infringed? How is a claim for patent infringement made and what remedies are available?

Conditions for infringement

A patent is infringed when an individual without the consent of the patent holder, for example, produces, offers for sale or commercially exploits the patented invention. The patent safeguards the exclusive right to commercial exploitation of the patented invention.

Claim and remedies

A patent holder claiming patent infringement can submit an application for a summons to the Stockholm District Court.

The remedies available under the Patents Act are:

  • Penalties (fines or up to two years imprisonment).

  • Injunctions (on penalty of a fine, including preliminary injunctions).

  • Damages.

  • Forfeiture of property relating to a violation, or profits from such a violation, and so on.

  • Corrective measures (such as recalling property from channels of commerce).

  • Liability for costs to publicise information about a judgment in a patent case.

The prosecutor can bring criminal proceedings if the claimant has reported the crime and it is in the public interest. To date, this has never been the case. Therefore, normally the claimant must instigate proceedings on his own.

 
6. Are there non-patent barriers to competition to protect medicinal products?

Directive 2004/27/EC on the Community code relating to medicinal products for human use (Code for Human Medicines Second Amendment Directive) prescribes a data exclusivity period of eight years from the initial authorisation, and another two years of market exclusivity. This ten-year period can be extended by one year, totalling 11 years.

 

Trade marks

7. What are the legal conditions to obtain a trade mark and which legislation applies? What cannot be registered as a trade mark and can a medicinal brand be registered as a trade mark?

Conditions and legislation

To be eligible for registration, a trade mark must fulfil all the following requirements:

  • It must be capable of graphical representation.

  • It must be distinctive.

  • It must not be descriptive.

The requirements to be distinctive and not descriptive do not apply where the mark has become distinctive through use.

The Trade Mark Act (SFS 2010:1877) and the Trade Mark Regulation (SFS 2011:594) apply. The authors note that the new EU trade mark directive (2015/2436) will eliminate the first requirement above. Instead the directive provides that a sign must be capable of "being represented on the register in a manner which enables the competent authorities and the public to determine the clear and precise subject matter of the protection afforded to its proprietor".

Scope of protection

A medicinal product brand can be registered as a trade mark under the Trade Mark Act in the same way as any other brand.

Registration is not allowed if, for example, the mark is intended to mislead the public or is confusingly similar to an earlier trade mark.

The MPA also examines the name of the medicinal product in connection with, for example, the MA approval.

 
8. How is a trade mark registered?

Application and guidance

On a national level, the PRO administers trade mark applications and maintains the official trade mark register (www.prv.se). The applicant must pay a filing fee and a supplementary fee for, among other things, each class in addition to the first. Information, application forms and current fees can be found on the PRO website.

Process and timing

The application must be written in Swedish, unless the PRO in an individual case decides otherwise, and must include:

  • The name and address of the applicant.

  • The name and the address of the counsel (if any).

  • An illustration of the trade mark (for the requirement for graphical representation, see Question 7).

  • Information on the goods and/or services for which the trade mark will be used and the class to which these goods or services belong.

If the formal requirements are fulfilled, the PRO examines whether there are any obstacles to the registration of the mark (for example, if the mark is confusingly similar to an earlier trade mark or business name). If no obstacles are found, it takes about three months to obtain trade mark registration. However, the time period can vary significantly.

The registration is published in the Swedish Trade Mark Gazette (Svensk varumärkestidning). Oppositions can be filed within three months of registration. If an application is rejected, the decision can be appealed to the Court of Patent Appeals within two months. From 1 September 2016 the Court of Patent Appeals will be replaced by the newly established Patents and Market Court.

 
9. How long does trade mark protection typically last?

A trade mark registration is valid for ten years from the date of registration.

The registration can be extended every ten years and can remain in force indefinitely provided the renewal fees are paid. An application for renewal can be made up to one year before expiry and at the latest six months after expiry (in the latter case an increased fee applies).

If an application for renewal is not clear as to which registration it concerns, or if the renewal fee is not paid, a request to cure this will be submitted to the applicant. If the applicant does not comply with the request within the prescribed time, the application will be dismissed. However, the application may still be recovered if the applicant complies with the request within two months and pays a recovery fee.

 
10. How can a trade mark be revoked?

Third parties can give the PRO notice of opposition to a trade mark within three months of the date of publication of the registration. An individual must initiate court proceedings if he wishes to challenge the trade mark after the three-month opposition period. It is also possible to revoke a trade mark by application to the PRO after the three month opposition period, but if the trade mark holder contests the revocation, the matter must be tried in court proceedings.

A trade mark registration can be revoked in any of the following circumstances:

  • The conditions for registration under the Trade Marks Act were not fulfilled at the time of registration and have still not been met. The registration may, however, be upheld if both:

    • any earlier right holder is seen as having consented through passivity to the use; and

    • the application was made in good faith.

  • The trade mark is found to be deceptive, contrary to public order or liable to cause general offence.

  • The trade mark is no longer distinctive.

  • The trade mark has not been in use on the market for an uninterrupted five-year period (unless the trade mark owner can provide an acceptable explanation for non-use).

Proceedings declaring a trade mark invalid can result in the revocation of a trade mark registration for all or some of the goods/services for which it was registered.

 
11. How is a trade mark infringed? How is a claim for trade mark infringement made and what remedies are available?

Conditions

A trade mark is infringed when an individual in the course of trade, without the consent of the trade mark holder, makes use of a mark confusingly similar to the registered trade mark for products identical or similar to the goods and/or services covered by the trade mark registration. In a relatively recent case, the Supreme Court stipulated the additional requirement that the use must further be detrimental to any of the trade mark's functions (if any). If the trade mark is well known and the use of an identical or similar mark would take unfair advantage of, or without due cause be detrimental to, the distinctive character or the repute of the trade mark, there is no requirement for a "likelihood of confusion".

Claim and remedies

A trade mark holder claiming trade mark infringement can submit an application for a summons to a District Court.

The remedies available under the Trade Marks Act are the same as those under the Patents Act.

In addition to the Trade Marks Act, the Market Practices Act and extensive case law from the Market Court offer protection for a trade mark holder against misleading and otherwise unlawful use of its trade marks in marketing. From 1 September 2016 the Market Court will be replaced by the newly established Patents and Market Court.

The prosecutor can bring criminal proceedings if the claimant has reported the crime and it is in the public interest. This happens only very rarely. Therefore, normally the claimant must instigate proceedings on his own.

 
12. Outline the regulatory powers and enforcement action against counterfeiting in the pharmaceutical sector.

The framework on counterfeiting in the pharmaceutical sector has been reformed when Directive 2011/62/EU amending Directive 2001/83/EC as regards the prevention of the entry into the legal supply chain of falsified medicinal products was implemented. Manufacturers and distributors must notify the MPA immediately if there is a suspicion of falsified medicines. Trading with falsified medicines and/or counterfeit products is subject to fines or imprisonment.

Entering falsified medicines and/or counterfeit products into the Swedish market is illegal and subject to fines or imprisonment. The Swedish customs authority can carry out investigations if there is a suspicion of illegal trade.

For information on pharmaceutical pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, and product recall and liability, see Medicinal product regulation and product liability in Sweden: overview ( www.practicallaw.com/1-500-7171) .

IP and competition law issues

 
13. Briefly outline the competition law framework in your jurisdiction and how it impacts on the pharmaceutical sector. In particular, the competition authorities and their regulatory powers, key legislation, whether pharmaceutical investigations are common, key recent activity and case law.

As a general rule, Swedish competition law mirrors EU competition rules and the Swedish Competition Authority/courts must ensure as far as possible that competition law questions are interpreted consistently with EU competition law.

The key legislation is the Competition Act (SFS 2008:579). The Competition Act, as well as the EU competition rules, contain two main provisions:

  • Prohibition against anti-competitive co-operation.

  • Prohibition against abuse of a dominant position.

It also contains rules for:

  • Anti-competitive sales activities by public entities.

  • Control of concentrations between undertakings.

The Competition Authority (Konkurrensverket) is the Swedish regulatory authority responsible for safeguarding and increasing competition and supervising public procurement in Sweden. It can initiate investigations of potential infringements of the Competition Act. If necessary, it can require companies to supply information and relevant persons to appear at a hearing. It can also carry out unannounced inspections (dawn raids).

If the Competition Authority finds that a company is infringing the prohibition against anti-competitive co-operation or the prohibition against abuse of a dominant position it can:

  • Require the company to terminate the infringement.

  • Bring proceedings before the Stockholm District Court, to order the company to pay an administrative fine.

Since the abolition of the state-owned pharmacy's (Apoteket) exclusive right to sell prescriptions and OTC medicinal products to Swedish consumers, new players can enter the Swedish pharmacy market. This has led to companies challenging the traditional way of distributing medicinal products in the Swedish market (primarily to distributors/logistic service providers). In 2013, however, the Competition Authority decided not to investigate a claimed infringement in the market for distribution of prescription medicines, finding that the case was not a priority.

There is no recent Swedish case law on anti-competitive co-operation or abuse of dominance relating specifically to the pharmaceutical sector. There is an ongoing case concerning companies active in healthcare provision but the alleged infringement concerns bidding practices, not behaviour unique to the pharmaceutical industry. In terms of merger activity, the expected consolidation in the pharmacy market has continued, with several transactions securing approval from the Competition Authority in recent years, most recently ICA's purchase of Apotek Hjärtat, cleared in January 2015.

 
14. Briefly outline the competition issues that can arise on the licensing of technology and patents in a pharmaceutical context

Licensing of technology or patenting (technology transfer agreements) can be anti-competitive co-operation if they restrict the parties' freedom in certain ways. Issues in this respect are governed by the Competition Act, particularly the prohibition on anti-competitive co-operation. In addition, Regulation (EC) 316/2014 on the application of Article 101(3) of the TFEU to categories of technology transfer agreements (Technology Transfer Block Exemption Regulation) applies directly in Sweden.

Issues relating to technology transfer agreements in the pharmaceutical sector can arise in particular if one of the parties to the agreement is restricted in relation to, for example:

  • Prices, markets or customers.

  • Output.

  • Exploitation of technology or carrying out research and development.

 
15. Are there competition issues associated with the generic entry of pharmaceuticals in your jurisdiction?

In light of the European Commission's recent attention to patent settlements between originator and generic companies in the pharmaceutical sector (so-called pay-for-delay cases), it is expected that pharmaceutical companies in Sweden will become more observant in this regard. However, there are no current pending cases on this issue in the public domain.

Research and development work carried out in relation to a generic in relation to third-party-patented products is exempted from the patent holder's exclusive right under the Patents Act, if it is done with the object of obtaining a market authorisation.

 
16. Have abuse of dominance issues arisen in the pharmaceutical sector in your jurisdiction?

There have been no recent issues relating to abuse of dominance in the pharmaceutical sector.

 
17. Have parallel imports of pharmaceuticals raised IP and competition law issues in your jurisdiction?

Issues have arisen relating to parallel imports of medicinal products and IP law, especially in relation to repackaging and trade marks. In a decision from 2013, the Stockholm District Court rejected the respondent's claim that repackaging was objectively necessary, and found that the respondent had violated the claimant's trade mark (decision by the Stockholm District Court (T 13704-11)).

In another dispute, the Supreme Court found that alteration of a trade mark by the parallel importer on sticky labels was objectively motivated, and did not violate the trade mark owner's right (decision by the Supreme Court (NJA 2006 s. 380)).

 
18. Does a patent or trade mark licence and payment of royalties under it to a foreign licensor have to be approved or accepted by a government or regulatory body? How is such a licence made enforceable?

There is no requirement for a patent or trade mark licence agreement and payment of royalties under it to a foreign licensor to be approved or accepted by a government or regulatory body. A patent or trade mark licence can be registered with the PRO but this has no effect against third parties. Generally, such agreements are considered enforceable against third parties from the date of the agreement.

For information on pharmaceutical pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, and product recall and liability, see Medicinal product regulation and product liability in Sweden: overview ( www.practicallaw.com/1-500-7171) .

 

Contributor profiles

Helén Waxberg, Partner

Mannheimer Swartling Advokatbyrå

T +46 8 595 064 14
F +46 8 595 060 01
E helen.waxberg@msa.se
W www.mannheimerswartling.se

Professional qualifications. Qualified in Sweden, 1990

Areas of practice. Competition, distribution, marketing and regulatory issues in the pharmaceutical sector; originator pharmaceutical products, medical devices, food, cosmetics and corporate compliance and investigations.

Recent transactions

  • Representing pharmaceutical companies in issues brought before the Information Practices Committee and national authorities.
  • Litigation concerning reimbursement, substitution, regulatory data protection and pharmaceutical advertisement.

Camilla Nortoft, Associate

Mannheimer Swartling Advokatbyrå

T +46 8 595 063 94
F +46 8 595 060 01
E camilla.nortoft@msa.se
W www.mannheimerswartling.se

Areas of practice. Medicinal products, medical devices, food, cosmetics and borderline products.

Recent transactions

  • Representing pharmaceutical companies in issues brought before the Information Practices Committee and national authorities.
  • Litigation concerning reimbursement, substitution, regulatory data protection and pharmaceutical advertisement.

Åsa Edlund, Associate

Mannheimer Swartling Advokatbyrå

T +46 8 595 060 39
F +46 8 595 060 01
E asa.edlund@msa.se
W www.mannheimerswartling.se

Areas of practice. Intellectual property; media and marketing law.

Recent transactions

  • Representing patent holders in litigation.
  • Administrative proceedings relating to trade marks.

Sarah Hoskins, Senior Associate

Mannheimer Swartling Advokatbyrå

T +46 8 595 063 34
F +46 8 595 060 01
E saho@msa.se

W www.mannheimerswartling.se
Professional qualifications. UK-qualified solicitor and EU-advokat.

Areas of practice. EU and competition law, with a particular emphasis on cartel investigations, competition compliance, abuse of dominance and merger control.

Recent transactions

  • Representing a client in an ongoing market manipulation cartel case under investigation by the European Commission.
  • Advising in mergers concerning the pharmaceutical sector.

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