The Court of Appeal endorses the conditions for obtaining a SPC following the Royalty Pharma decision

[03/03/2021]

On February 9, 2021, the Paris Court of Appeal upheld the INPI decision to reject the application for a Supplementary Protection Certificate (SPC) for the “osimertinib” product ( used to treat cancer) filed jointly by Wyeth LCC and the General Hospital Corporation (GHC) on the ground that the active ingredient “osimertinib” was not protected by the basic patent within the meaning of Article 3, sub a) of regulation EC no 469/2009.

The judges based their decision on the Royalty Pharma (CJEU C-650/17) and Eli Lilly (C-493/12) rulings in which the Court of Justice of the European Union (CJEU) clarified the interpretation of said article and stated that, in order to satisfy the requirement of the same, the active ingredient must be specifically identifiable by a person skilled in the art on the filing or priority date of the basic patent and the state of the art on that same date.

The Court of Appeal thus considered that osimertinib could not be "specifically identifiable" by a person skilled in the art on the filing date of the basic patent in 2006 insofar as it was specifically identified as an active ingredient only in 2012. 

Furthermore, the Court refused to refer a new question to the CJEU on the ground that an answer had already been given in the Royalty Pharma case. 

As a reminder, a Supplementary Protection Certificate (SPC) is an intellectual property right which allows to extend the term of a patent protecting an invention in the pharmaceutical and phytosanitary field beyond 20 years (for a period up to a maximum of five years).

In view of the economic stakes, SPCs are often the subject of legal battles, in particular, between patent holders and patent offices, and questions are regularly referred to the CJEU in order to clarify the interpretation of EC Regulation No. 469. / 2009.

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