MSD’s ezetimibe-simvastatin SCP revoked by the Paris Court of Appeal

Thanks to Jean-Baptiste Thiénot & Alexandre Ghanty of CMS Francis Lefebvre Avocats for the recent update from France - reproduced below.

In a case involving Merck Sharp and Dohme (MSD) and TEVA, Paris Court of Appeal issued an interesting decision on 25 September 2020 regarding both articles 3(a) and 3(c) of Regulation EU No.469/2009, widely in line with the ruling adopted by the CJEU in Actavis v. Sanofi (CJEU, C-443/12, 12 Dec. 2013). 

Background

MSD obtained two SPCs on the basis of the same patent (EP 0 720 599) entitled “hydroxy-substituted azetidinone compounds effective as hypocholesterolemic agents”. 

• A first SPC had been granted to MSD on 4 February 2005 on the basis of EP 599 for a drug whose API was ezetimibe (EZETROL®). 
• A second SPC had been granted nearly 2 years later, on 21 December 2006, on the basis of the same patent but this time for a combination product ezetimibe + simvastatin (INEGY®). 

The dispute

TEVA launched a revocation action against the second SPC, arguing – among other things - that the combination product at stake was a mere variation of the invention protected by the patent, and not a distinct “product” from ezetimibe alone, in breach of both articles 3(a) and 3(c). 

TEVA’s claims have been dismissed by Paris First instance Court on 25 October 2018. In parallel, a few months later (on 08 February 2019), MSD obtained preliminary injunctions against other generic companies on the basis of this ezetimibe + simvastatin SPC.

This decision has been reversed. Indeed, on appeal, TEVA obtained from the Court of Appeal the revocation of the ezetimibe + simvastatin SPC in a decision dated 25 September 2020. 

Regarding article 3(a), although the patent at stake specifically mentions the combination ezetimibe-simvastatin, the court considered that such combination cannot be deemed as “protected by a basic patent” within the meaning of the Regulation. In other words, the Court considers that patent EP 599 contains only one invention and that the combination with simvastatin cannot be regarded as another invention. Indeed, it emphasizes that the specification uses the singular when designating the invention, presents the combination as “another aspect of the invention”, and makes no distinction in therapeutic effect between the mono and the combination therapies. Besides, it is noted that the skilled person, who was deemed aware of the possibility of combining two anticholesterolemic drugs having different mechanisms of action and who was familiar with simvastatin, would not consider the ezetimibe-simvastatin combination to constitute an innovative product (towards ezetimibe alone). 

Regarding article 3(c), the court recalled, in application of Actavis v. Sanofi, that where the holder of a patent has already obtained a SPC for an active ingredient entitling him to oppose the use of that active ingredient, either alone or in combination with other active ingredients, such article must be interpreted as precluding that patent holder from obtaining a second SPC relating to that combination. 

To the extent that the ezetimibe-simvastatin combination is not deemed to constitute an innovative product, the Court considered that the first SPC granted for the use of ezetimibe should allow, in itself, MSD to oppose to the marketing of a drug containing ezetimibe in combination with simvastatin. 

This decision was predictable since the Court of Appeal used the same reasoning a few months ago (14 February 2020, cases No. 19/03820 (Sandoz) and No. 19/06114 (Mylan) as reported by the SPC blog here) to revoke the preliminary injunctions granted to MSD on the basis of this ezetimibe + simvastatin SPC.

What next?

The battle is not over: an appeal before the Cour de cassation is pending in the above-mentioned preliminary injunction cases and the same is expected in the Teva v. MSD case.

Although the means are quite different here than in the Santen case (CJEU, C-673/18, 9 July 2020), the trend seems to be the same, leading to a stricter approach in the analysis of the conditions of SPCs where the basic patent has already given rise to a first SPC. As it has been observed in Abraxis Bioscience, “the legislature intended, in establishing the SPC regime, to protect not all pharmaceutical research giving rise to the grant of a patent and the marketing of a new medicinal product, but to protect research leading to the first placing on the market of an active ingredient or a combination of active ingredients as a medicinal product” (CJEU, C-443/17, 21 March 2019, §37).