The new Infection Protection Act (in force since 27 March 2020) provides, inter alia, that the Federal Ministry of Health is authorised to issue so-called orders – initially limited until 31 March 2021 – for the exploitation of an invention pursuant to Sec. 13 Patent Act, in the event that the Bundestag determines an epidemic situation of national importance (Sec. 5 (2) No. 5), like the current Covid-19 pandemic.
The hitherto barely considered provision of Sec. 13 Patent Act applies to national and European patents (Art. 2 (2), 64 EPC), utility models (Sec. 13 (3) Utility Models Act) and protection certificates (Sec. 16a (2) Patent Act) and corresponds to the requirements of Art. 31 TRIPS. Furthermore, the provision is closely related to the regulation of compulsory licenses under Sec. 24 Patent Act.
According to the wording of Sec. 13 Patent Act, “a patent shall have no effect insofar as the Federal Government orders that the invention shall be exploited in the interest of public welfare”.
The aforementioned orders for the exploitation of an invention may refer to the products mentioned in Sec. 5 (2) No. 4, 5 IfSG n.F. in connection with Sec. 13 (1) PatG, such as pharmaceuticals, medical devices as well as items of personal protective. The wording of Sec. 13 Patent Law and Sec. 5 (2) No. 5 IfSG as amended indicates that process patents are also covered.
A de facto expropriation of a multitude of patents within the meaning of Article 14 (3) of the Basic Law is not to be feared. On the one hand, the effect of the exploitation order is limited to the annulment of the prohibition rights, i.e. the patent holder and other entitled persons (e.g. licensees) retain their rights of use. On the other hand, the right of use granted under Sec. 13 Patent Act exists exclusively for the benefit of the issuing authority but may be transferred to third parties. However, use for own commercial purposes by such authorized third parties would be contrary to the purpose and is thus probably excluded. Furthermore, third parties must also meet the regulatory requirements, for example, for medicinal products and medical devices, i.e. they must carry out approval procedures or conformity assessment procedures. Furthermore, according to Sec. 13 (3) Patent Act, the patent proprietor shall receive “adequate remuneration”. In addition, both the exploitation order and the determination of the amount of compensation may be challenged (cf. Sec. 13 (2), (3), 2nd sentence, Patent Act).
Thus, it remains to be seen whether the Federal Ministry of Health will make use of the option to issue an exploitation order.