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Monday 2 April 2012

The Neurim hearing: an eye-witness account

Francisco Bernardo Noriega (Partner, ABG Patentes, Madrid) is a patent attorney who works mainly in the field of pharmaceuticals. He recently attended the hearing before the Court of Justice of the European Union (CJEU) in the Neurim referral (Case C-130/11; see earlier SPC Blog posts here, here and here) which, in his view, deals with a number of interesting issues of SPC law. The case, he notes, is being closely followed by interested parties, as was evident by the surprisingly high number of members of the public attending in Luxembourg, including people from the pharmaceutical industry, solicitors and attorneys. This is what he writes:
“On 15 March 2012, the CJEU heard parties in connection with the C-130/11 Neurim Pharmaceuticals preliminary reference from the Court of Appeal for England and Wales. The reference concerns the interpretation of Articles 3(d) and 13 of the SPC Regulation (EC Regulation 469/2009) and, more particularly, the circumstances in which these Articles mean that an earlier marketing authorisation (“MA”) precludes an SPC based on a subsequent MA. In making the reference, the Court of Appeal had endorsed Neurim’s arguments in strong terms (“We consider that Neurim’s arguments are not only tenable: in our view they are right”), holding that Articles 3(d) and 13 should not preclude Neurim’s SPC, but that Neurim’s arguments needed endorsement by the CJEU:
“In short, if Neurim are wrong, then the Regulation will not have achieved its key objects for large areas of pharmaceutical research: it will not be fit for purpose. Whether that is so or not is clearly a matter for the EU’s highest court.”
Neurim, the UK Government, the Portuguese Government and the Commission appeared at the hearing in front of five judges (Jean-Claude Bonichot, Konrad Hermann Theodor Schiemann, Camelia Toader, Alexandra Prechal and Egidijus JaraĊĦiunas) with Verica Trstenjak as the Advocate General.

Neurim and the Commission were united in arguing that an earlier MA should be taken into consideration (under Article 3(d) or Article 13) only if its subject-matter is within the scope of the basic patent (with reference to Article 4 which limits the scope of the SPC to being no broader than the basic patent). Both parties referred to the underlying scheme and objectives of the Regulation, highlighting the importance of incentivising the type of research which Neurim had undertaken and the consequences of not providing such incentives. They also drew distinctions over the existing case law (C-31/03 Pharmacia, C-431/04 MIT and C-202/05 Yissum etc.); they also emphasised that Neurim’s proposal for the operation of Articles 3(d) and 13 has never before been the subject of a CJEU judgment, and would allow the SPC regulation to meet its purpose, as defined in the recitals.

Neurim also referred to Recital 14 of Regulation 1610/96 (which is explicitly valid under Recital 17 for interpreting the medicinal product SPC Regulation), pointing out that failure to find in Neurim’s favour would deprive Recital 14 of its effet utile. Recital 14 states that an SPC can be granted for a patented salt even if there is an earlier SPC for the same active substance which would, were it not for Recital 14, block the second SPC (because, in such a case, the two active ingredients (“products”) are the same). In making this argument, Neurim referred to C-392/97 Farmitalia to demonstrate that one salt of a particular active ingredient is considered as having the same active ingredient (“product”) as another salt of the same active ingredient (or indeed the active ingredient in its non-salt form). Thus Neurim argued that Recital 14 could not operate properly if the CJEU rejected Neurim’s arguments because, if Neurim’s arguments were rejected, there would be situations where an earlier MA necessarily precludes an SPC based on a subsequently patented salt.

The UK argued that the CJEU has to find against Neurim because the CJEU’s existing case law constrains it from reaching any other conclusion. The UK referred in particular to C-31/03 Pharmacia, C-431/04 MIT and C-202/05 Yissum in addition to the recent cases of C-195/09 Synthon and C-322/10 Medeva. On Medeva, the UK argued that because the CJEU permitted an SPC to be based on an MA which refers to active ingredients (“A + B”) not specified within the scope of the patent (to “A”), it follows that Neurim is wrong. In reply, Neurim argued that the CJEU’s comments in Medeva (which formed the basis of the C-422/11 Novartis reasoned order) are entirely consistent with Neurim’s position because the CJEU confirmed that an SPC to “A” can be used to oppose “A + B” (i.e. “A + B” is within the protection conferred by an SPC to “A”, in accordance with patent law). On Synthon, the UK relied on the comments in AG Mengozzi’s opinion, and both the Neurim and the Commission put forward counterarguments.

The UK and Portugal also argued that Neurim’s approach could lead to evergreening. Both Neurim and the Commission disagreed, 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. They therefore argued that the second SPC could not prevent the free movement of the earlier-authorised medicinal product within the European Community.

The Portuguese Government also considered that SPC availability in cases like Neurim would be contrary to TRIPS.

Neurim also argued that, if the CJEU answers the first three referred questions against it, then an SPC should nonetheless be allowed in those cases where the subsequent formulation/use requires a full marketing approval dossier (“Initial/Global Marketing Authorisation” according to art. 6(1) Directive 2001/83). Neurim highlighted the distinction between Initial/Global Marketing Authorisations as defined under European Pharmaceutical regulation and other authorisations which merely involve variations (and which, unlike an Initial/Global Marketing Authorisation, do not give rise to data exclusivity periods). This is reflected in the fourth question referred to the CJEU.

The Advocate General’s opinion is expected in May 2012, with the actual judgment of the Court likely to be issued several months later".
Thanks so much for this note, Francisco, which paints a colourful picture of the positions taken in this intriguing reference.


Anonymous said...

Neurim's argument based on recital 14 has to be right otherwise recital 14 would be pointless.

I'm pleased to see someone taking this to the CJEU. Let's now see if the regulation and the court are fit for purpose...

Anonymous said...

If I understand the case correctly, I do not see how the court could decide around its own earlier decisions in Pharmacia/cabergolin (a veterinary authorization has to be regarded as the first authorization under Art. 3d) and calcitriol (another indication does not create a new product under Art. 3b). Taking these bits and pieces it should not be possible to grant an SPC for the "new" human indication. Moreover, recital 14 seems to deal with a very different issue; namely, that new products (salts and esters) deserve another SPC.

Anonymous said...

I also travelled to Luxembourg and understood the Commission/Neurim to be making the argument that the Pharmacia/cabergolin patent covered the compound itself and ALL possible uses (animal and vet). So Pharmacia/cabergolin tells you nothing about what happens in the situation where the patent does not cover the earlier vet use.

On recital 14, I understood the argument as being that recital 14 encompasses situations in which one salt is the SAME product as another salt, and yet still is entitled another SPC. Neurim pointed to Farmitalia to back this up.