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COVID-19 and the Research- and Bolar Exemption Under German Patent Law

A large number of pharmaceutical companies around the world are currently searching for effective drugs and vaccines against the coronavirus SARS-CoV-2 and, in view of the urgency of the situation, they are mainly relying on already known active ingredients or compositions that were proven to be effective in the past in the treatment of viral diseases or as immunomodulators. The particular focus here is on antiviral drugs for the treatment of HIV, Ebola as well as SARS or MERS, which – according to individual reports – have already been successfully used against COVID-19. A (non-exhaustive) overview of current research projects in the fight against COVID-19 can be found on the website of the researching pharmaceutical companies (https://www.vfa.de/de/arzneimittel-forschung/woran-wir-forschen/therapeutic-medicines-coronavirus-covid-19). 

A very high proportion of current research projects is thus concerned with active substances or (active substance) compositions which are already the subject of technical property rights, in particular patents. In this context, patent protection is not limited to the product itself, but also often extends to  the specific manufacturing process, key work steps or the required laboratory equipment. Against this background, the question arises as to whether the research and bolar exemption, which is standardised in § 11 No. 2 and No. 2 b of the German Patent Act (PatG), offers effective protection against possible claims by the patent proprietor.

According to §11 No. 2 Patent Act, the effect of a patent shall not extend to acts done for experimental purposes relating to the subject matter of the patented invention. The necessary relation to the subject matter of the patented invention is given if the technical teaching of the patent claim is the object of the experimental act. This may include both acts of use for experimental purposes carried out with the subject-matter of the invention, e.g. in order to explore the effects of a substance, and acts of use to find new, previously unknown applications.

In addition, under Sec. 11 No. 2b) PatG, those studies and trials, including the resulting practical requirements, which are necessary to obtain a marketing authorization for a medicinal product in the European Union or regulatory drug approval in the Member States of the European Union or in third countries are also privileged (so-called Roche-Bolar rule). This privilege goes beyond the experimental privilege, as the patented invention itself does not have to be the object of the experiment. Rather, all actions that are objectively necessary in order to obtain a desired approval or marketing authorisation under pharmaceutical law are privileged. It should be noted, however, that the tests must be a requirement in order to obtain a marketing authorisation.

It can be assumed that many of the research projects currently underway will benefit from the research or bolar privilege. However, the decisive factor is always the specific individual case, in consideration of the patent and the action taken. In order to avoid a claim by the patent holder, the limits of the privilege should therefore be examined in advance and   corresponding guidelines should be issued to the staff. In particular, it should be considered that the privilege de lege lata only privileges the company conducting the direct research as (future) applicant in the drug approval process itself. A supplier of active substances cannot, as a rule, successfully invoke the privilege under the current legal situation. The principles above apply unless the Federal Government makes use of its authority to issue an order pursuant to Sec. 13 PatG (limitation of the effect of the patent for public welfare and state security).

Our blog contributions shall provide an overview with regard to legal topics, legislation and case law and are supposed to provide some general information rather than constituting any specific advice. Please do not hesitate to contact Maiwald and in particular the authors of the particular contributions if have any questions on the addressed topics or on other legal issues.

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Authors

Tobias Matschke

Senior Associate

Attorney-at-Law