On 11 March 2019, Commercial Court No. 4 of Barcelona declared the invalidity of the Spanish supplementary protection certificate ("SPC") covering the combination of tenofovir disoproxil + emtricitabine.
Gilead is the proprietor of European patent EP0915894 ("EP'894"), entitled Nucleoside analogues, and of a Spanish SPC based on the same over the combination drug product tenofovir disoproxil + emtricitabine, commercialised as Truvada® for the treatment and prevention of viral infections, including HIV.
Claim 27 of EP'894 served as basis for granting the SPC, despite the fact that emtricitabine is not mentioned in the same nor anywhere throughout the patent's specification. The wording of claim 27 is as follows: A pharmaceutical composition comprising a compound according to any one of claims 1-25 together with a pharmaceutically acceptable carrier and optionally other therapeutic ingredients.
Gilead has been litigating over the infringement and/or validity of its SPCs derived from EP'894 in several countries. Interestingly, the Patents Court of the United Kingdom referred a question to the Court of Justice of the European Union (CJEU). The CJEU, in response, issued a well-awaited judgment on 25 July 2018, establishing a double-step test to determine whether a product is protected by the basic patent under the terms of Art. 3(a) of the SPC Regulation whenever it is not expressly mentioned in the claims of such patent. In short, it posited that: (i) first, from the point of view of the person skilled in the art at the priority/filing date, the product (a combination of active ingredients in the case at stake) must necessarily, in light of the description of the basic patent, fall under the invention covered by that patent; and (ii) second, each one of the active ingredients must be specifically identifiable by the skilled person in light of all the information disclosed by the patent.
The Spanish judgment is aligned with the CJEU's guidance, as explained below.
In May and June 2017 Gilead filed actions against Mylan and Teva, together with preliminary injunction requests, for alleged imminent infringement of its SPC.
The preliminary injunctions were granted ex parte, but subsequently revoked after a hearing, on the grounds that the SPC was prima facie invalid based on Article 15.1(a) of the SPC Regulation, in relation to Article 3(a) and the applicable case law from the CJEU. The ruling, issued in October 2017, was further confirmed by the Barcelona Court of Appeal by means of a decision dated 18 December 2018, which took into account the CJEU judgment of July 2018.
In the main proceedings on the merits, the defendants argued that the basic patent protected tenofovir disoproxil, but not its combination with emtricitabine. In this regard, they emphasized that claim 27 of the patent would have exactly the same scope with or without the wording "and optionally other therapeutic ingredients". Consequently, an SPC for the combination would be invalid.
Gilead alleged that the combination is an independent product and is indeed comprised by claim 27. The patentee further pleaded that the skilled person would understand the invention as addressed mainly to the treatment of HIV, and that this would lead him/her to specifically identify emtricitabine as the "other therapeutic ingredient".
The trial took place in January 2019.
In its judgment of 11 March 2019, Commercial Court No. 4 upheld Mylan and Teva's arguments and revoked the SPC, in a decision deliberated by the three Patent Judges of Barcelona.
The decision concludes that, contrary to what Gilead's experts stated, the basic patent was not directed to HIV treatment only, but to the treatment of viral infections in a broader sense, whereas the expression "other therapeutic ingredients" was not further elaborated within the patent as to necessarily encompass emtricitabine. Hence the combination of tenofovir disproxil + emtricitabine is not part of the technical contribution of the invention.
Also, after reviewing the common general knowledge at the priority date, the decision notes that emtricitabine was subject to preliminary stages of development at the time and that, therefore, it could not be specifically identifiable by the skilled person in light of the information disclosed by the patent, which was silent about any active ingredients other than the claimed compounds, i.e. tenofovir disoproxil.
Consequently, the Court finds that the medicinal product consisting of tenofovir disoproxil + emtricitabine as active ingredients is not protected by the EP'894 patent and, thus, Gilead's SPC is invalid for being contrary to Article 3(a) of the SPC Regulation.
Gilead has filed an appeal against this judgment.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.