GERMANY LAW AND PRACTICE Contributed by: Dr. Clemens Tobias Steins, Dr. Michael Pfeifer, Dr. Daniel Grohs and Dr. Bianca-Lucia Vos, Hoffmann Eitle
(human or veterinary) medicinal product may be the subject matter of an SPC. Article 3 of Regulation 469/2009 sets out the requirements for obtaining an SPC for a medici - nal product. The product (ie, the active ingredi - ent or combination of active ingredients of the approved medicinal product) must be “protect - ed” by a basic patent in force (Article 3(a)). There is no limitation to certain types of patents; a suit - able basic patent may be a patent protecting the product, a process to obtain the product, or an application of the product. However, to be “pro - tected” by the basic patent, the product must be “specifically identifiable” in the patent based on the disclosure of the patent, the common gen - eral knowledge and the prior art. Furthermore, the product must have received a valid authori - sation to be placed on the market as a medicinal product for human or veterinary use (Article 3(b)). Each patent holder may only obtain a single SPC for a particular product (Article 3(c)) on the basis of the first authorisation for placing the product on the market (Article 3(d)). In other words, the holder of several patents must select one pat - ent of the patent portfolio as the basic patent of the SPC. While it is possible to file several SPC applications, once an SPC is granted, it will pre - vent the granting of a further SPC to the same patent holder and the same product. The SPC application must be filed in the name of the patent holder. It is often the case that the marketing authorisation holder and the patent holder are not identical. The current proposal for an amended SPC Regulation contains a provi - sion according to which the patent holder may not obtain an SPC without the MA holder’s con - sent. If the originator (the MA holder) and a third party both hold separate patents (and provided that
both firms are unrelated entities), SPCs may be granted to both parties. The circumstances under which an SPC for a combination of active ingredients can be obtained after an SPC for a single product has already been granted based on the same patent were the subject of the recent Court of Justice of the European Union (CJEU) decision on joined cases C-119/22 and C-149/22. At present, an SPC for the combination may be granted if there is a separate patent that specifically protects that combination. Regulation (EU) No 2019/933 amends Regula - tion (EC) No 469/2009 and introduces the so- called manufacturing waiver for SPCs. This means that, despite the SPC, companies based in the EU can manufacture a generic or biosimi - lar product either solely for export to a country outside the EU (“third” country) where the prod - uct is not protected by a patent or SPC or during the last six months of the SPC term for placing it on the market in the EU once the SPC has expired (stockpiling). 4.2 Paediatric Extensions The SPC term may be extended by 6 months if clinical studies of an agreed paediatric investiga - tion plan (PIP) have been completed (see Article 13 No 3 of Regulation No 469/2009). The paediatric extension of the SPC term was established as an incentive or reward for phar - maceutical companies for the investment and effort put into clinical studies testing the safety and efficacy of a medicinal product in the pae - diatric population.
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