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Switzerland

European Bolar Provisions in Switzerland

Table of contents
  1.  How is Bolar implemented?
  2.  How does the Bolar provision work?
  3.  Is Bolar restricted to exempting studies for generic marketing authorisations?
  4.  Has Bolar been litigated in your jurisdiction?
  5.  Are exempted activities covered by a local exemption regardless of where regulatory approval is ultimately sought? 
  6.  Does Bolar extend to a third party who assists the MAH in carrying out the activities? 
Switzerland
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1. How is Bolar implemented?

Strictly speaking, there are no specific provisions under Swiss law which explicitly implement or refer to Bolar, however there are similar specific exemptions under the Swiss Federal Act on Patents for Inventions (“SFAP”).

2. How does the Bolar provision work?

SFAP does contain specific provisions exempting clinical trials done for purposes of research and/or regulatory marketing approval from patent infringement. 
The relevant exemption/s is/are contained in Article 9(1)(b) and (c) of the SFAP and currently read as follows:
“The effects of the patent do not extend to”

  1. “acts undertaken for research or experimental purposes in order to obtain knowledge about the subject-matter of the invention including its uses; in particular, any scientific research concerning the subject-matter of the invention is permitted”;
  2. “acts necessary for obtaining marketing authorisation for a medicinal product in Switzerland or in countries with equivalent medicinal product control”.

3. Is Bolar restricted to exempting studies for generic marketing authorisations?

Not only to generics, but also to genuinely new drugs, in other words, any other form of research or experimental use (see lit. b) and any acts necessary for obtaining marketing authorisations (see lit. c). Nevertheless, generics will play an important role in the regular practice of this provision.

4. Has Bolar been litigated in your jurisdiction?

No, the Bolar decision was a case disputed in the United States (see https://law.justia.com/cases/federal/appellate-courts/F2/733/858/459501/). The decision had no direct bearing/impact on Swiss territory. Nevertheless, in 2005, the high court of the canton of Thurgau issued a decision on April 7, 2005 in preliminary injunction proceedings where the exemption of infringement of patents due to drug marketing authorisations were discussed. At that time, Art. 9 Paragraph 1 lit. (c) of the SFAP was not yet enacted. Nonetheless, the court granted an exception to the patent infringement doctrine based on equity notions and with a view on the pending revision of the SFAP at that time.

5. Are exempted activities covered by a local exemption regardless of where regulatory approval is ultimately sought? 

Yes, actions on Swiss territory purported for regulatory approvals abroad are also covered, provided that the regulatory approval process abroad is comparable/similar. There is a list of SWISSMEDIC available with countries considered equivalent.

6. Does Bolar extend to a third party who assists the MAH in carrying out the activities? 

Patent infringement activities can be pursued against the primary infringer and the secondary infringer. The exception granted under Art. 9 Paragraph 1 lit. (c) applies to patent infringement in general and therefore, third parties who assist the MAH should benefit from this provision, provided that they were instructed and did not act on their own behalf (for own interests). However, it is pertinent to mention that the exception only applies for actions, which are necessary for market approval (e.g. clinical trials, production of samples or validation charges or bioequivalence studies). This provides for a limitation of the exception rule.