Darunavir – Netherlands

Darunavir – Netherlands

On Jan 08, 2019, Court of The Hague held that there is a real chance that the SPC will be held invalid in main proceedings & therefore dismissed the request for a Preliminary Injunction.

G D Searle is the holder of European patent EP 0810209 B1titled “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 introduced its generic product in the October 2018 version of the G-Standard and announced that it would market its product in November 2018. On Oct 23, 2018 Searle sued Sandoz in before the Court of The Hague requesting a provisional injunction. In an interim decision of Nov 01, 2018, the PI Judge granted Searle’s provisional claim.

Sandoz appealed. Sandoz argued that a preliminary injunction should be denied because there is a real and serious chance that the SPC will be found invalid in main proceedings as it does not meet the requirement of Article 3 (a) of the SPC-regulation. Judge said that Markush claim can in some circumstances amount to a sufficiently precise claim for the purposes of Article 3(a), for example where individual substituents are identified in the specification, or where classes of such substituents are set out, and the skilled person would be able to determine the extent of those classes. Therefore it is at least arguable that that substituent must be amongst those which the skilled person would be able to identify based on his common general knowledge at the priority date.

The question to be answered in the present proceedings is whether darunavir satisfies the requirement of Article 3 (a) of SPC, namely whether it is protected by a basic patent in force (EP 209). The way in which this condition must be fulfilled has been worked out by the CJEU in the Teva-Gilead judgment. In order to assess whether an active substance is eligible for an SPC, the following two step tests – must be completed:

1) Does the product (for which SPC protection is requested) embody the invention?

2) Is this product ‘specifically identifiable’ for the person skilled in the art in light of all the data published by that patent and on the basis of his general professional knowledge on the date of filing / priority date of the basic patent ?

Court held that Darunavir satisfies the requirement of the first test, since in that case the question is whether the product embodies the invention, or, in the words of the judgment, or the average person skilled in the art on the basis of his general professional knowledge and in the light of the description and the drawings of the patent can unequivocally understand that the product referred to in the claims of the basic patent is a characteristic that is necessary for the solution of the technical problem disclosed by that patent.

However, it falls under the second test. Here it is relevant whether the active substance (darunavir) was ‘specifically identifiable‘ on the priority date for the average person skilled in the art, using his general professional knowledge, in the light of all information disclosed by the patent. Here, a Markush formula of the basic patent covers an unimaginably large number of substances. In addition, it is not disputed that darunavir compounds is neither disclosed in the claims nor in the description. It is further established between the parties that darunavir did not exist on the first date and that the substance was developed and synthesized only six years later, in 1998. Thus, darunavir was not ‘specifically identifiable’ for the professional on the priority date in the light of all the information published by the basic patent. In view of the foregoing, it cannot be concluded that conclusion 1 of EP 209 is implicit but necessarily and specifically related to darunavir.

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