No. 26
September 2012
International Association for the Protection of Intellectual Property
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Neurim judgment of European Court of Justice liberalises SPC system
Edward Oates, Carpmaels & Ransford, London, United Kingdom

Neurim judgment liberalises SPC system

In case C-130/11 Neurim Pharmaceuticals , the Court of Justice of the European Union (the “CJEU”, Europe's highest court) issued an eagerly anticipated judgment concerning the availability of supplementary protection certificates (SPCs). SPCs are European intellectual property rights that provide extended protection to patent holders following regulatory delays for medicinal and plant protection products. The Neurim judgment has a liberalising effect on SPC law and presents new opportunities for extending patents through SPC filings, although the question as to precisely how widely the Neurim ruling should be applied is likely to be explored in future disputes.

Neurim's SPC application was based on a marketing authorisation (MA) for the drug Circadin, Neurim's patented formulation of melatonin for use in treating sleep disorders by oral administration to human patients. Two earlier MAs which related to melatonin formulations were cited against Neurim's SPC application. The first was for an ear implant used to modulate the reproductive activity of ewes. The second was for enhancing fur growth in mink.

Prior to Neurim, a series of earlier CJEU decisions (C-258/99 BASF, C-31/03 Pharmacia, C-431/04 MIT, C-202/05 Yissum, C-195/09 Synthon, and C-427/09 Generics ) had been widely interpreted as precluding SPCs under Article 3(d) of Regulation 469/2009, or at least truncating their term under Article 13(1), in any situation where the MA referred to in the SPC application is not the first MA for the active species. Accordingly, the UK Intellectual Property Office (IPO) felt compelled to refuse Neurim's SPC application as a result of the existence of the two earlier Mas, despite the fact that they related to indications wholly different from Neurim's. The IPO's refusal was initially appealed to the High Court of England and Wales, which agreed with the IPO's view that the existing case law was “fatal” to Neurim's position. A further appeal to the Court of Appeal resulted in a more supportive judgment for Neurim, and a referral of questions to the CJEU.

Against that backdrop, Neurim's primary argument to the CJEU was that an earlier MA should give rise to an objection under Article 3(d) or Article 13(1) only if its subject matter is within the scope of the basic patent relied on for the SPC application (with reference to Article 4 which limits the scope of the SPC to being no broader than the basic patent). Neurim's primary argument, reflected in the first and second questions referred to the CJEU, was not restricted to factual situations identical to those in Neurim. Neurim's secondary argument to the CJEU, reflected in the third question, was tied more closely to the facts of the case because it was dependent on the earlier MA relating to a different indication in a different species (veterinary as opposed to human). Neurim's primary proposition garnered support from the European Commission but was met by stiff opposition from the UK Government and the Portuguese Government, who did not favour the pro-innovator line. Neurim supported its position by referring to the underlying scheme and objectives of the Regulation, highlighting the importance of incentivising research into new uses of previously authorised actives. Neurim encountered counterarguments based on the earlier jurisprudence of the CJEU and an allegation that its suggested approach could lead to evergreening. Both Neurim and the Commission disagreed with the allegation of evergreening, highlighting that any SPC granted under Neurim's approach (which requires the basic patent not to extend to the subject-matter of the earlier MA) could not, by reference to Article 4, cover the subject-matter of the earlier MA – a proposition that the CJEU appears to have confirmed.

The Advocate General's opinion, delivered on 3rd May 2012, clearly endorsed Neurim's primary argument. The CJEU's judgment, delivered on 19th July 2012, makes it apparent that Neurim is to be granted its SPC. Although certain passages in the judgment focus on the facts at issue in “Neurim”, the judgment does not explicitly indicate that it is limited to those facts and other passages of the judgment are written in broad terms, suggesting that the CJEU's reasoning can be applied to factual situations significantly wider than those at issue in “Neurim”. Some passages of the judgment suggest that whether or not an MA falls within the scope of the patent is key to determining whether or not that MA is relevant under Articles 3(d) and 13(1), in line with Neurim's primary argument.

Accordingly, there now seems to be merit in making SPC filings for follow-on products, such as second medical uses, provided the patent designated in the SPC application does not include the subject-matter of the earlier MA within its scope. However, it seems likely that we will see further referrals as the boundaries of the judgment are explored.
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