The Court of Appeal issued an interesting judgement on March 23rd, 2017, on the requirements for the granting of a supplementary protection certificate (SPC). The decision was published in the Industrial Property Bulletin on 19 June.
The facts
Alcon Laboratories Inc. had applied for SPC No. 576 for “nepafenac”, a non-steroidal anti-inflammatory drug contained in the medicinal product NEVANAC (a collyrium), invoking the European Patent No. 999825, regarding “ophthalmic compositions containing galactomannan polymers and borate” as the basic patent.
The Portuguese Patent Office (INPI) refused the SPC on the grounds that it did not meet all the requirements of Regulation (EC) 469/2009, namely that the product for which the applicant sought protection was not covered by a basic patent in force. In fact, from the INPI’s perspective, the core of the invention protected by the patent consisted of a composition comprising only the adjuvants - which cannot be protected by means of SPC -, being the addition of active principle(s) only an embodiment of the invention. The INPI further noted that neither in the description nor in the claims (interpreted inter alia in the light of the description of the invention, as required by Article 69 of the Convention and the Protocol) there was any reference to “nepafenac”.
Against that latter argument, the claimant invoked the guidance given by decision of the Court of Justice of the European Union in case C-493/12 (Eli-Lilly vs. HGS). The Office however, considered that contrary to what happened with the product that based the decision invoked (of the biotechnological type), nepafenac could be perfectly defined in a structural way. Furthermore, the Office added that even if the active principle were to be defined by a functional formula, it would always had to be concluded, in the light of the Eli Lily case, that the claims relate, implicitly but necessarily and specifically , to the active ingredient in question, which was not the case.
On appeal, the first instance court – the Intellectual Property Court – upheld the INPI's decision, basically reaffirming the examiner’s argumentation. The Court of Appeal would also do so with a more detailed reasoning.
Conclusion
The ensemble of the three decisions form an interesting reading for legal experts and are important for those who deal with SPCs, mainly because it involves a fundamental SPC topic and the application of the jurisprudence of the European Court of Justice. The core question is about whether a product is contained in the basic patent or not and more specifically when it is considered that the product’s definition (be it structural or functional) made in the claims specifically addresses, in an implicit but necessary way, the active principle to be protected. In this case the Courts made clear that the definition cannot be too generic, for example, made by reference to a too broad category (such as that of “anti-inflammatories”). The IP Court and Court of Appeal decisions follow another judgment of the IP Court published on November 2016, on a SPC for agalsidase beta where the Eli Lilly case was also relevant for the IP Court’s findings. Again, the IP Court confirmed refusal of protection to the SPC because it was considered that the active principle was not covered by the basic patent invoked.
Sandra Martins Pinto - This email address is being protected from spambots. You need JavaScript enabled to view it.