GERMANY Law and Practice Contributed by: Clemens Tobias Steins, Michael Pfeifer, Daniel Grohs and Bianca-Lucia Vos, HOFFMANN EITLE
product, the process for obtaining the product, or the application of the product. However, to be “protected” by the basic patent, the product must be “specifically identifiable” in the patent based on the disclosure of the patent, the common general knowledge and the prior art. Furthermore, the product must have received a valid authorisation 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 patent from the pat ‑ ent portfolio as the basic patent of the SPC. Although a patent holder may file multiple SPC applications for the same product, the grant of one SPC precludes the issuance of any additional SPCs to that same patent holder for the same product. SPC applications must be filed in the patent holder’s name. Frequently, the marketing authorisation holder and patent holder are separate entities – either as dis ‑ tinct legal entities within the same corporate group or through a licensing arrangement. The current proposal for an amended SPC Regulation contains a provision according to which the patent holder may not obtain an SPC without the MA holder’s consent. If the originator (the MA holder) and a third party each 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 combi ‑ nation 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 a recent decision of the Court of Justice of the European Union (CJEU) on joined cases C-119/22 and C-149/22. The CJEU ruled that an SPC may be granted if the com ‑ bination of the two active ingredients necessarily falls within the scope of the same patent. Where a sepa ‑ rate patent specifically protecting the combination of active ingredients exists, the grant of an SPC is gener ‑ ally also possible. Regulation (EU) No 2019/933 amended Regulation (EC) No 469/2009 and introduced the so-called “man ‑
ufacturing waiver” for SPCs. According to this waiver, companies based in the EU are exempt from the legal effects of the SPC if they manufacture a generic or biosimilar product: • either solely for export to a country outside the EU (“third country”) where the product is not protected by a patent or patent term extension (PTE); or • during the last six months of the SPC term for placing it on the market in the EU once the SPC The SPC term may be extended by 6 months if clinical studies of an agreed paediatric investigation plan (PIP) have been completed (see Article 13 No 3 of Regula ‑ tion No 469/2009 and Art. 36 of Regulation (EC) No 1901/2006). The paediatric extension of the SPC term was estab ‑ lished as an incentive and reward for pharmaceutical companies for the investment and effort put into clini ‑ cal studies testing the safety and efficacy of a medici ‑ nal product in the paediatric population. has expired (“stockpiling”). 4.2 Paediatric Extensions 4.3 Paediatric-Use Marketing Authorisations The paediatric-use marketing authorisation (PUMA) is a dedicated marketing authorisation covering the indi ‑ cation (s) and appropriate formulation(s) for medicines developed exclusively for use in the paediatric popu ‑ lation. These authorisations apply to medicines that are already authorised (for adults) and are no longer protected by a patent or an SPC. The development of a PUMA also follows an agreed Paediatric Investiga ‑ tion Plan (PIP). The grant of a PUMA provides the applicant with a new data protection period of eight years, followed by two years of market exclusivity. This type of MA is governed by Regulation (EC) No 1901/2006. 4.4 Orphan Medicines Extensions The “orphan designation” is a status granted by the European Commission, upon the recommendation of the EMA, to a medicine intended for use against a rare condition in accordance with Regulation No 141/2000. Orphan-designated drugs have the advan ‑ tage of a ten-year orphan exclusivity. This period can
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