No Clear Pointer In The Right Direction: Validity Issues In Europe Of Patent Term Extensions Covering Fixed-Combination Medicinal Products

Pitfalls loom when applying for patent term extensions covering fixed combination medicinal products. Attention has to be paid during prosecution to the impact of the wording of claims on availability of patent term extensions for combination products. At the same time, those involved in product development should take into account the wording of the claims with a view toward securing patent term extension. This Commentary addresses the validity of European patent term extensions, namely supplementary protection certificates ("SPCs"), covering fixed-combination medicinal products. An SPC provides an extension of the patent term by a maximum of five years in order to compensate patent proprietors for the time consumed by development and the market authorization procedure required for medicinal and plant protection products. SPCs for medicinal products are granted on the basis of the European Community Regulation 469/2009 concerning the supplementary protection certificate for medicinal products ("SPC Regulation"). Article 3 of the SPC Regulation stipulates four basic requirements for obtaining a certificate, the first two being of particular relevance for the validity of SPCs covering fixed-combination medicinal products. Art. 3 (a) requires that the product—the active pharmaceutical ingredient ("API") or a combination of APIs—be protected by a basic patent in force, and Art. 3 (b) requires that a valid authorization to place the product on the market as a medicinal product ("marketing authorization") must have been granted. The question arises whether the requirements of Art. 3 (a) and (b) are fulfilled when the patent claims the API A, but the SPC application is relying on the authorization for a medicinal product containing API A in combination with a further API B. The same question arises when the basic patent claims a combination of two APIs, A and B, whereas the SPC application refers only to API A. Similarly, the SPC application may refer to API(s) that are not identical to those used in the authorized medicinal product. Although the SPC Regulation is based on European Community law, and the Court of Justice of the European Union (Court of Justice, CJ) is the final authority to decide about legal issues relating to SPCs, national authorities such as patent offices are appointed to grant SPCs. Also, appeals from the rejection of SPCs are dealt with by national courts. Thus, there has been a number of important decisions of national courts, in particular the High Court in London, relating to SPCs for fixed-combination medicinal products.

Art. 3 (a) of the SPC Regulation

Regarding the requirement of Art. 3 (a) of the SPC Regulation, it appears that there are two different concepts of how to handle the question of whether the product, i.e., the API, is protected by the basic patent. Some of the national jurisdictions seem to follow the so-called "infringement test," and other jurisdictions appear to apply a test that can be described as the "identification test." The rationale behind the "infringement test" appears familiar: whether a fixed-combination medicinal product containing the APIs A and B, which is the object of an SPC application, would infringe a patent claiming the API A. Applying the basic principles of infringement, it would seem that the product of the SPC infringes the patent because the combination of A and B fulfills all...