Darunavir - France

On Jan 11, 2019, Paris court (Tribunal De Grande Instance) held that Sandoz failed to prove Darunavir SPC invalid & ordered preliminary injunction along with the penalty.

G D Searle is the holder of European patent EP 0810209 B1 titled “Alpha – and beta-amino acid hydroxyethylamino sulphonamides useful as retroviral protease inhibitors”, which generically covers Darunavir. Searle obtained SPC for the product Prezista® based on EP’209 patent which would expire on Feb 23, 2019. Sandoz has applied for marketing authorization several countries, including France. Searle and Janssen discovered early December 2018 that the Darunavir sandoz was effectively put on the market in France. Then they made series of application for prohibition of the Sandoz Darunavir on France market. Sandoz counter argued & said that an injunction should be denied because SPC is invalid as it does not meet the requirement of Article 3 (a) of the SPC-regulation.

Sandoz specifically argued that claims are too vague, even in the light of the description; the person skilled in the art would not understand that such an active ingredient could be the one referred to in the SPC.  Judge said that however, this criticism is irrelevant in that it question of the validity of the basic patent-holder itself, which has not been questioned. It is in fact true that neither the description nor the claims of the basic patent make an explicit reference to Darunavir. Judge further said that it is not always necessary that the active ingredient be mentioned in the claims of this patent by means of a structural formula. When this active ingredient is covered by a functional formula in the claims of a patent issued, this Article 3 (a) does not preclude, in principle, the issue of a SPC for this active ingredient. It should be noted, that in the Eli Lilly decision it was a functional claim, the CJEU therefore insisted on the dual condition of "necessity and specificity". In this case, the claims of the basic patent are structural and thus make it easier for those skilled in the art to apprehend claims if the active ingredient protected by the SPC was covered by the basic patent.

Thus, Darunavir contains the same basic structure as the formulas I and II, and these elements of the "variable" structure are included in the lists of substituents expressly provided in the EP'209 patent. To demonstrate this, the plaintiffs represented the table referred to in the interim prohibition order in the context of the parallel procedure in the United Kingdom whose data are not contested in defense. Therefore, it turns out that Daruvanir is identified by the skilled person implicitly but necessarily and specifically by the patent. The judge thus considered that the defendant did not prove that the SPC was invalid. Accordingly, a preliminary injunction & 50,000 euro-penalty ordered per violation of the injunction.

Interestingly, in another proceeding, Dutch court on Jan 08, 2019 found Darunavir SPC invalid as it did not meet the criteria laid down in Article 3(a) of SPC (reported here on this blog). The said SPC is also the subject matter of litigation in other countries.  On May 03, 2017, Mr Justice Arnod of England and Wales High Court found SPC based on a Markush formula valid (reported here on this blog). Upon appeal the UK Court of appeal has proposed the following question to the CJEU:

“Where the sole active ingredient the subject of [an SPC] issued under [the SPC Regulation] is a member of a class of compounds which fall within a Markush definition in a claim of the patent, all of which class members embody the core inventive technical advance of the patent, is it sufficient for the purposes of Article 3(a) of the SPC Regulation that the compound would, upon examination of its structure, immediately be recognised as one which falls within the class (and therefore would be protected by the patent as a matter of national patent law) or must the specific substituents necessary to form the active ingredient be amongst those which the skilled person could derive, based on their common general knowledge, from a reading of the patent claims”?

So, let’s wait & watch... how CJEU would answer the question & hopefully brings clarity to this issue.