13. März 2024 in Zürich
EU: SPC Manufacturing Waiver for Generics and Biosimilars
I. Legal developments in the EU
The new Regulation EU 2019/933 introducing the so-called «SPC Manufacturing Waiver» in the EU entered into force on 1 July 2019. The SPC Manufacturing Waiver is an exception to the principle that a supplementary protection certificate («SPC») should have the same effect as the basic patent. In a nutshell, the SPC Manufacturing Waiver excludes the following acts from the protective effect of the SPC:
- the manufacture of a medicinal product covered by the SPC for export to countries outside the EU.
- the manufacture of a medicinal product covered by the SPC, no earlier than six months before the expiry of the SPC, for the purpose of storing it in the Member State of manufacture, in order to place that product on the EU market after the expiry of the corresponding SPC.
This means that innovators in the EU are no longer able to rely on an SPC to
- prohibit generics/biosimilars producers from manufacturing for export to countries outside the EU;
- prevent the stockpiling of generics/biosimilars in the last six months before the expiry of the SPC term for the purpose of market entry in the EU immediately after the expiry of the SPC term.
Regulation EU 2019/933 imposes a notification obligation on producers of generics/biosimilars. In particular, producers who make use of the SPC Manufacturing Waiver must notify the patent office in the Member State in which manufacture takes place and the SPC holder at the latest three months after commencement of manufacture. In addition, products manufactured for export to countries outside the EU must be marked «EU export», which must be affixed to the outer packaging of the product and, if practicable, also to the primary packaging.
The aim of the SPC Manufacturing Waiver is «to promote the competitiveness of the Union, in a manner that creates a level playing field for makers of generics and biosimilars in relation to their competitors in third-country markets in which protection does not exist or has expired».
II. Legal situation in Switzerland
Under the current Swiss Patent Act (PatA), an SPC grants the same rights as the corresponding basic patent and is subject to the same restrictions (Art. 140d (2) PatA). A SPC thus protects all types of commercial use of the protected medicinal product, including manufacturing, storage, offering, placing on the market, import, export and transit (Art. 8 (2) PatA). Exceptions to the protective effect exist only for the acts mentioned in Art. 9 and 9a PatA. However, these do not include the manufacture of generics or biosimilars for export purposes or the stockpiling of generics or biosimilars for market entry in Switzerland immediately after expiry of the SPC. In other words: Under applicable law, no SPC manufacturing waiver is available to Swiss generic/biosimilars manufacturers.
Initiated by the parliamentary request «SPC-Waiver: Switzerland also needs a solution to maintain the competitiveness of the generics industry» of 12 June 2019 («SPC-Waiver: Auch die Schweiz braucht eine Lösung zum Erhalt der Wettbewerbsfähigkeit der Generika herstellenden Pharmaindustrie»; summer session 2019, no. 19.5334; NR Regazzi), the Federal Council expressed its opinion for the first time on 17 July 2019 on the introduction of an SPC Manufacturing Waiver in Switzerland. The Federal Council announced that it would analyse the advantages and disadvantages of introducing a manufacturing waiver for Switzerland and then decide on the next steps. As the competent authority, the Federal Department of Justice and Police and in particular the Swiss Federal Institute of Intellectual Property are responsible for this matter.
In principle, the Federal Council will endeavour to bring the Swiss regulations on SPC into line with European law. In view of the very controversial discussions in the EU that preceded the introduction of the SPC Manufacturing Waiver, the Federal Council may be inclined to wait for the first experiences with the SPC Manufacturing Waiver in the EU and, based thereon, to decide on its possible implementation. The parliamentary procedure for the legislative amendment required to introduce the SPC Manufacturing Waiver will also take some time. The introduction of an SPC Manufacturing Waiver in Switzerland is therefore not imminent.