Pharmaceutical law and patent law must be reformed in a coordinated manner.

UM – 09/2023

On 26 April this year, the European Commission had published the long-awaited package for the revision of European pharmaceutical legislation. The following day, it presented a legislative package to reform the protection of intellectual property. As a result, politicians and officials from the health sector are dealing with the pharmaceutical reform. The patent law amendments, in contrast, are discussed in the civil law working groups and committees. This means that important commonalities may not be considered in a sufficiently coordinated manner and interactions may be overlooked. This especially concerns the exclusivity protection of medicinal products.

Patent protection trumps regulatory market protection

A study commissioned by the European Commission shows that for 61 per cent of the medicinal products considered, the longest effective protection of new medicinal products against generic competition is provided by patent protection or a Supplementary Protection Certificate (SPC). The latter is intended to compensate for the sometimes long procedural period between patent application and market authorisation through additional protection periods of up to a maximum of five years. Consequently, the regulatory market protection of pharmaceutical law only applies in a good third of all cases. This underlines the importance of patent regulations for the position of medicinal products on the market. This must be taken into account in the context of the proposed revision of the European pharmaceutical legislation. This is because the legal design of patent protection has a decisive influence on the balance between incentives for the development of new medicinal products on the one hand and, due to its competitive implications, the long-term financial stability of the healthcare systems on the other.

Shortening of SPC not in sight

If the goals set by the European Commission with the medicinal product package regarding access, availability and affordability of medicines are to be achieved, shortening of exclusivity periods would have to be worked towards in both pharmaceutical law and patent law. This was made clear by the German Social Insurance (DSV) in a statement on the occasion of the consultation on the Commission proposals to amend the draft regulation on the single supplementary certificate for medicinal products and to amend Regulation (EU) 2017/1001, Regulation (EC) No. 1901/2006 and Regulation (EU) No. 608/2013 and to redraft the regulation on the supplementary protection certificate for medicinal products. This is made more difficult by the fact that the dossiers are discussed independently of each other in different panels. Moreover, there already seems to be a consensus among policy makers that the duration of SPCs will not be changed.

Make patent protection transparent

Notwithstanding this, the German Social Insurance (DSV) supports the intended uniform European issuing of SPCs, so that this leads to more competition as well as more transparency, effectiveness and legal certainty, thus contributing to more efficient supply. The new centralised procedure should have priority when applying for SPCs; also in order to exclude specific use of national application procedures by manufacturers in specific cases to protect themselves from competition by generics or biosimilars. Furthermore, the granting of the SPC should be limited to the primary patent (original active ingredient patent independent of references to administration forms, therapeutic indications, etc.). A "patent thicket" of a multitude of secondary patents, which serves to shield a product from competition, must be counteracted.