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Current information on patent law.

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Patent law reform - Biotechnological inventions

  

Chronology

25.06.2008The Federal Council decides to put the amendments to the Plant Variety Protection Act into force as of 1 September 2008. Within the framework of this Plant Variety Protection Act, provisions for a farmer’s privilege (new Art. 35a and 35b) as well as compulsory licences for dependent plant variety protection rights (new Art. 36a) will be introduced in the Patent Act. 
21.05.2008The Federal Council decides to put the amendment of the Patent Act into force as of 1 July 2008. The Patent Cooperation Treaty of 1 June 2000 will also go into effect for Switzerland at this time. See press release (in German, French, Italian).
22.06.2007Parliament accepts the changes to the Patent Act in the final vote. For parliamentary debates, see the database of parliamentary proceedings (issue 05.082 in German or French).
23.11.2005The Federal Council approves the dispatch regarding the revision of the Patent Act. See press release (in German, French, Italian).
11.03.2005The Federal Council commissions the Federal Department of Justice and Police to draw up a submission to parliament. See press release (in German, French, Italian).
07.06.2004The Federal Council commissions the Federal Department of Justice and Police to carry out a second consultation on the draft of the revision of the Patent Act. The consultation starts on 1 July 2004 and lasts until 31 October 2004 . See press release (in German, French, Italian)
2003The Swiss Federal Institute of Intellectual Property carries out a survey of the Swiss biotechnological industry. The report “Research and Patenting in Biotechnology – A survey in Switzerland” presents the results. The Institute also commissions a legal opinion. The expert opinion by Prof. Dr. Joseph Straus, “Options for implementing Directive 98/44/EC on the legal protection of biotechnological inventions” demonstrates the legislator’s room for manoeuvre and answers open questions.
29.11.2002The Federal Council acknowledges the Federal Department of Justice and Police’s report on the results of the consultation on the draft of the revision of the Patent Act.  The main conclusion of the report shows that the consultations – which focus on the patentability of biotechnological inventions – need more time to be fruitful. The Federal Council, therefore, requests the Federal Department of Justice and Police to analyse certain issues more thoroughly before finalising the final legislative dispatch. See press release (in German, French, Italian).
07.12.2001The Federal Council commissions the Federal Department of Justice and Police to carry out a broad consultation on the draft of the revision of the Patent Act. The consultation lasts until 30 April 2002. See press release (in German, French, Italian)
20.04.1999Parliament submits the Leumann motion, which requests the Federal Council to harmonise Swiss patent law in accordance with the European Parliament’s guidelines 98/44/EC and advice of 6 July 1998 concerning the legal protection of biotechnological inventions.
  

Formalities in patent law

On 1 June 2000, the Patent Law Treaty (PLT) was negotiated and signed by Switzerland. This agreement harmonises certain patent law formalities and therefore contributes to better legal security for patent system users in an increasing global environment. The approval and implementation of this treaty was also the goal of the reform process.

  

Intellectual property piracy

This infringement has increased substantially in the last few years all over the world. The economic damage is enormous. Innovative Swiss companies have been heavily affected. In addition to losses to the Swiss economy, consumers are also hurt. The civil and criminal instruments available up until now have not stopped piracy. The revised law reinforces legal remedies as well as modernising them. As well as importing and exporting, transiting is also now included. Penalties for commercial counterfeiting and piracy have considerably increased. Finally, under the new law, counterfeit goods found in the luggage of individuals can be seized at the border.

  

Compulsory export licences

The provision of medical supplies is often precarious in developing countries. These lands often have very few pharmaceutical manufacturers and the building of infrastructure for it is mostly out of the question. Developing countries are therefore dependent on foreign manufacturers. Recourse to production capacity abroad can fail if the patent protection in that country does not allow the manufacture of the medicine without the permission of the rights holder. According to the law of the World Trade Organisation (WTO), compulsory licenses are only allowed for the supply of the domestic market. Following the changes made to international law, the revised Patent Act makes use of the newly created possibility to also authorise compulsory licenses for export. In cases of serious public health epidemics, developing countries therefore have access to production capacities in Switzerland under the conditions defined by the World Trade Organisation.

  

Biotechnology

Biotechnological inventions are to do with biological material that multiplies itself and demonstrates great complexity.  With a series of modifications, the revised Patent Act allows for these particularities. It guarantees effective and appropriate protection for biotechnological inventions and creates a reliable legal framework. In detail, it concerns the following modifications:

  • Articles 1a and 1b define the limits of patentability relating to the human body and its gene sequences. They clarify when an invention exists in terms of patent law. In addition to prohibiting the patenting of human beings as such in Article 1a, the general reservation regarding public order and morality (Article 2, para. 1) allows the ethical limits in the area of living nature to be defined. The non-exhaustive list of ethical prohibitions should serve as a guideline when applying the reservation of public order (“ordre public”).
  • Exceptions concerning the effect of a patent are now regulated by law (Article 9). In particular, the experimental use privilege is now embodied in the law. It allows scientific research on the object of an invention independent of the patent holder’s permission. The research can also be commercially orientated but must be aimed at gaining knowledge about the invention. In addition, the new law authorises all actions necessary for the approval of a pharmaceutical product in Switzerland or abroad. This facilitates easier market access for generics as the licensing procedure can be carried out even within the patent protection period.  If a biotechnological invention serves as a research tool or aid, then Article 40b requires a license to use it. A further exception is that a patent holder can no longer refuse permission for the use of a patented invention for teaching purposes. Patented biological matter that is, within the domain of agriculture, unintentionally reproduced or produced because it is technically unavoidable, is now also excluded from the effects of the patent. This will protect farmers from excessive claims.
  • In accordance with the revised law, the patent applicant is obliged to give information regarding the source of a genetic resource and traditional knowledge in the patent application. These measures lead to greater transparency and simplify getting permission to access these resources and knowledge necessary for retrospective verification, as well as enforcing the distribution of any economic advantages resulting from their exploitation.
  • With the publication of patent applications and the introduction of a limited opposition procedure as well as an optional prior art search, the new law introduces substantial changes and improvements to the national patent system, which increases transparency, assures the  early dissemination of knowledge and improves the position of third parties. These changes are particularly important for the sensitive area of biotechnological inventions and strengthen the national patent system in general.
  

Contents

  

Background

The first formal step towards a reform of the Patent Act was given by a motion by Council of State Member Helen Leumann-Würsch on 10 June 1998 (98.3243 – Revision of the Swiss Patents for Inventions, in German or French). She requested the Federal Council to adapt the Patent Act in accordance with the European Parliament’s guidelines 98/44/EC and advice of 6 July 1998 concerning the legal protection of biotechnological inventions (AB1. EG No. L 213 of 30 July 1998, p.13). Further points concerning the reform were also added, which allowed the thematically-limited partial revision to grow into a broad reform of patent law.  Following the conclusion of the second consultation, the Federal Council decided to phase in the various individual aspects of the reform under the following schedule by taking into consideration the various priorities and implications:

  • Stage one: Approval of the revised European Patent Convention and the London Agreement
  • Stage two: Revision of the Patent Act (with emphasis on protection of biotechnological inventions) and approval of the Patent Law Treaty
  • Stage three: Patent Attorney Act and Patent Court Act
  
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