Uncertainties in the SPC field

The Pharmaq v Intervet SPC decision leaves open the question of just how similar to the authorised active ingredient an infringing generic product needs to be. Sam Bailey of Mewburn Ellis reports.

Supplementary protection certificates (SPCs) offer valuable extensions to the protection offered by the patent system for new pharmaceuticals and plant protection products in Europe. They have the potential to provide up to five years of additional protection for the product on the expiry of the basic patent to compensate the innovator for the delay in commercial exploitation due to extended authorisation procedures required to bring these products to market.

When the SPC regulation came into force in 1993, a large portion of new pharmaceutical products were small molecule therapeutics with easily defined chemical structures. However, recent trends towards more complex therapeutic products including antibodies, vaccines, combination therapies, and biologics in general are presenting severe tests to both the wording of the SPC regulation and the legal reasoning of the national and European courts.

A case from the Oslo District Court, Pharmaq v Intervet International (August 2015), has attracted interest in the SPC field not least due to the unusual reference to the European Free Trade Association (EFTA) Court for clarification on interpretation of SPC law, but also due to the broad interpretation of the scope of SPCs for vaccines to encompass the exact product and also therapeutic equivalents. While this decision is clearly in favour of the holders of SPCs for therapeutic biologics, it also presents significant uncertainties about the exact scope of protection of an SPC which will certainly occupy the appeals court in this case and seems likely to arise again in EU court proceedings in the future.