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(1) Actavis Group PTC EHF (2) Actavis UK Ltd v (1) Sanofi (2) Sanofi Pharma Bristol-Myers Squibb SNC (C-443/12)

Case Summary  |  Judgment  |  12 December 2013

 

Four members of chambers recently appeared in a hearing at the CJEU in the much anticipated preliminary reference hearing regarding the availability of Supplementary Protection Certificates (“SPC”). Richard Meade QC and Isabel Jamal appeared for Actavis. Daniel Alexander QC represented Sanofi and Charlotte May was instructed by the United Kingdom Government as an interested party.

Sanofi’s patent is for the antihypertensive pharmaceutical irbesartan. The patent also claims irbesartan as a medication in combination with a variety of other active ingredients, including with a diuretic. Sanofi obtained an SPC over its Marketing Authorisation (“MA”) for Aprovel (Sanofi’s medicinal product containing only irbesartan as the active ingredient). Subsequently, it had also been granted a second SPC for CoAprovel (irbesartan in combination with the diuretic hyrdochlorothyiazide) on the basis of the same patent but based on a different MA.

In the main proceedings before the High Court, Actavis sought to invalidate the second SPC a) under Article (3)(c) of Regulation 469/2009 arguing that, on the correct interpretation of that provision, Sanofi was precluded from an SPC for the combination product due to its previous SPC for irbesartan alone, and b) under Article 3(a) of the Regulation on the basis that the combination product was not ‘specified in the wording of the claims’ (following the CJEU judgment in Medeva).

Sanofi’s position was that the combination product was a different product within the meaning of Article (3)(c) from irbesartan alone and as such that it was entitled to its second SPC. It also argued that the claim for irbesartan plus a diuretic protected the combination product within the meaning of Article 3(a).

Staying proceedings, Arnold J referred 2 questions to the CJEU [2013] R.P.C. 24. The Court of Justice only provided an answer to the second question*, namely:

“In situation in which multiple product are protected by a basic patent in force, does Regulation 469/2009, and in particular Article 3(c), precludes the proprietor of the patent being issued a certificate for each of the products protected?’

In an important clarification of the law, the CJEU gave the answer that, in circumstances such as those in the main proceedings, the second SPC for the combination product should not have been granted.

It was held that where:
1. A patentee has already obtained an SPC for an innovative active ingredient (obtained on the basis of a patent protecting that active ingredient alone and on the basis of an MA for that active ingredient);
2. That SPC entitles the patentee to oppose the use of that ingredient, either alone or in combination with other active ingredients;
3. A second SPC is sought (based on the same patent but on a different MA) for a combination product which contains the same active ingredient as that of the first SPC in combination with another active ingredient which is not protected by the patent as such;

then Article 3(c) of the Regulation must be interpreted as precluding the patentee from obtaining the second SPC relating to that combination product.

This represents a change to the previous understanding held by the UKIPO regarding the grant of an SPC in such situations. It is envisaged that this CJEU judgment will have far reaching consequences on pharmaceutical patent practice in the United Kingdom.
 

* Although the first question regarding the meaning of Article 3(a) was not answered explicitly in this judgment, the CJEU gave a judgment on the meaning of Article 3(a) in Human Genome Sciences v Lilly (C-493/12) which was heard at the same oral hearing as that of Actavis v Sanofi.