Open mobile menu
Gilead loses High Court battle to defend Truvada® SPC

Gilead loses High Court battle to defend Truvada® SPC

Industry news 18/10/2018

The English High Court yesterday published its decision relating to the validity of a Supplementary Protection Certificate (SPC) (SPC/GB05/041). The SPC is owned by Gilead and covers a composition containing two active ingredients, tenofovir disoproxil in the form of the fumerate and emtricitabine, which are both reverse transcriptase inhibitors.

The composition is marketed by Gilead under the trade mark Truvada and is an anti-retroviral medication for the treatment of HIV. The validity of the SPC, which was based on European (UK) Patent NO. 0915894 which expired in 2017, had been challenged by Teva UK Limited, Accord Healthcare, Lupin and Mylan (“the Claimants”).

The High Court decision follows a previous referral to the Court of Justice of the EU (CJEU) by Justice Arnold of the following question:

“What are the criteria for deciding whether the product is protected by a basic patent in force in Article 3(a) of the SPC Regulation?”

The CJEU judgement ( C-121/17 ) confirmed that for a product to be protected by a basic patent in force within the meaning of Article 3(a) of the SPC Regulation, it is necessary but not sufficient that the product falls within the scope of the basic patent. The CJEU went on to say that Article 3(a) does not in principle preclude an active ingredient being given a functional definition in the claims but that it is necessary for the claims, as interpreted under Article 69 EPC, to relate implicitly but necessarily and specifically to the active ingredient in question.

Therefore, for a product to be considered protected by a basic patent in force within the meaning of Article 3(a) of the SPC Regulation, the product must be either expressly mentioned in the claims or that the claims relate to the product necessarily and specifically. When determining whether the claims cover the product necessarily and specifically, two tests had to be met. The first test was whether the skilled person would understand, given their understanding of the common general knowledge and in light of the teaching of the patent, whether the product to which the claims of the basic patent relate is “a specification required for the solution of the technical problem disclosed by that patent”.

Justice Arnold construed the term “specification required for the solution of the technical problem disclosed by the patent” to mean that the product was one considered by the skilled person to embody the technical contribution made by the Patent, given the teaching of the Patent and the skilled person’s common general knowledge.

The second test was whether the product was specifically identifiable by a skilled person in light of the description and drawings and their common general knowledge at the priority or filing date and not in light of information available later.

In the present case, the product was not mentioned expressly in the claims and therefore Justice Arnold had to determine whether the claims related to the product “necessarily and specifically” following the tests set out in the CJEU decision. In this regard, the focus was on claim 27 of the basic patent since it recited a composition comprising tenofovir disoproxil and optionally other therapeutic ingredients.

Gilead sought to add further evidence in the form of an expert report from a new expert witness, arguing that the CJEU decision set a new test which could not have been anticipated. However, Justice Arnold ruled that Gilead’s application to add evidence amounted to an abuse of procedure and it would not be appropriate to give the parties permission to adduce further evidence at this stage because it would necessitate a second trial. Furthermore, he did not consider the CJEU decision to represent a new departure in the case law. Rather, the CJEU decision represented an elaboration of the test previously set out by the CJEU in Eli Lilly.

In coming to the decision to revoke Gilead’s SPC, Justice Arnold agreed with the Claimants that neither of the tests laid down by the CJEU were satisfied, thus meaning that the SPC did not comply with Article 3(a) of the SPC Regulation. Particularly, with respect to the first test, the Patent did not say anything about the possibility of combining tenofovir and emtricitabine and there was no basis for the skilled person to consider the combination to embody the technical contribution of the Patent.

With respect to the second test, Justice Arnold considered that whilst emtricitabine was known at the priority date, it was not mentioned in the Patent as a possible additional therapeutic agent and indeed was not known as an effective treatment for HIV at the priority date. As such the skilled person would not have considered it to be specifically identifiable. The SPC thus failed both tests and was revoked.

The full decision can be found here: Decision . If you would like any further information please contact Charlotte Watkins