ES – Gilead v. Teva & Mylan /Tenofovir+Emtricitabine/ Interim injunction opposition
Gilead Biopharmaceutics Ireland UC., Gilead Sciences, S.L.U., Gilead Sciences Ireland UC., Gilead Sciences, Inc. v. Teva Pharma, S.L.U, Mylan Pharmaceuticals, S.L., Mylan S.A.S., Barcelona Commercial Court No. 4, 20 October 2017, Docket No. 190/2017 – 197/17
In its decision of20 October 2017,Barcelona Commercial Court No. 4 reversed its previous rulings pursuant to which it had granted interim injunction ex parte against Tevaand Mylan, which were ordered, at the request of Gilead, to temporarily refrain from commercializing in Spain generic drugs with the combination of the active compoundsemtricitabine+tenofovirfor the treatment of HIV sold under the brand name Truvada®. The Court had to decide whether Gilead’s Spanish SPC C20050034, which relies on the marketing authorization for Truvada® and Spanish Patent ES 2198003 (EP0915894) – which expired on July 25, 2017 –was likely to be ruled invalid according to Article 3(a) of SPC Regulation No. 469/2009.
In two decisions dated 20 May and 27 June 2017, Barcelona Commercial Court No. 4 granted ex parte interim injunctions against Teva and Mylan basedon the infringement of Spanish patent ES 2198003 (ES 003) and Gilead’s SPC C20050034(SPC 034). Gilead’s SPC 034 covered a combination of the active compounds tenofovirdisoproxil + emtricitabine and was granted pursuant to claim 27 of the basic patent ES 003, which reads 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”.
The defendants Teva and Mylan filed an opposition against those preliminary injunction rulings. Since the defendants raised arguments concerning the validity of the SPC, the Court had to decide if there was a prima facie case concerning the invalidity of the SPC. Indeed, in the context of preliminary injunction proceedings, the Court had to decide whether Gilead’s SPC was likely to be invalidated, that is, whether there would be a high likelihood that the SPC would be declared invalid in proceedings on the merits.
In order to show that the SPC was likely to be ruled valid, Gilead first argued that the Court should follow a decision rendered in previous contentious-administrative proceedings in which a Spanish contentious-administrative Court had already examined the requirements for the granting of the SPC and stated that the SPC was valid. According to Gilead, the civil Court could not re-examine the validity of the SPC in view of said previous contentious-administrative decision, which would constitute res iudicata. Indeed, according to Gilead, this previous ruling handed down by the Administrative Chamber of the Madrid High Court of Justice on 9 September 2016, which examined the granting of SPC 034 (following a decision from the Spanish PTO which denied the granting of the SPC),should be sufficient to find the SPC valid, thus establishing its prima facie casein accordance with Article 103.5 of the Spanish Patent Act: “The invalidation of a patent may not be sought before the civil jurisdiction on the same nullity grounds as those that have already been the subject of a judgment on the meritsrendered in contentious-administrative proceedings, on the same facts invoked as a ground of invalidity”. However, the Court did not follow this argument. It ruled instead that Article 103.5 of the Spanish Patent Act did not apply to this case, as the Administrative Chamber of the Madrid High Court of Justice did not specifically analyze the invalidity of SPC 034 under any of the invalidity grounds as defined by applicable law, but rather analyzed only a particular administrative act. Thus, its judgment of 9 September 2016 did not acquire the effect of res iudicata.
Because the Court did not rely on this argument to dismiss the likelihood of validity, it proceed to consider, following the defendants’ reasoning, whether or not the SPC (covering tenofovir and emtricitabine) should be deemed valid, in view of the basic patent ES 003 for tenofovir.In this sense, the defendants considered that the basic patent did not protect the combination of tenofovir + emtricitabine within the meaning of Art. 3(a) of the SPC Regulation, but only tenofovir. Teva and Mylan argued that the basic patent could not serve as a basis for the granting of an SPC for the combination of tenofovir + emtricitabine based on the Spanish marketing authorization for Truvada ®.
The defendants argued that the phrase “and optionally other therapeutic agents” of claim 27 of ES 003did not add anything new to the patent’s scope of protection, that is, that the claim would have exactly the same scope with or without said phrase, so that any pharmaceutical composition of tenofovir, with or without other therapeutic agents, would fall within the scope of this claim. They stated that, according to CJEU jurisprudence on the issue, if the basic patent protects an active ingredient but not the specific combination, then an SPCwhich protects a combination would be contrary to Article 3(a) and would therefore be invalid.
On the other side, Gilead claimed that the product constituting the subject-matter of theSPC (a combination of tenofovirdisoproxil + emtricitabine)is a product covered by claim 27 of the basic patent, according to Article 3(a). In this regard, Gilead argued that according to the CJEU’s case law,it is not necessary for the product (the combination of active ingredients) to embody the inventive advance or technical contribution of the basic patent.It would suffice for the product to fall within the scope of the basic patent.
Thus, the Court had to decide whether claim 27 and its phrase “and optionally other therapeutic agents” could be deemed as constituting a functional definition of any compound (according to the most recent ECJ case law regarding the sufficiency of a functional definition,provided that it implicitly but necessarily relates to the product in question), keeping in mind that emtricitabinewas not mentioned in the patent.
In this sense, the Court indicated that to be able to interpret the scope of protection of claim 27, page 55, lines 27-31 of the patent description should be analyzed. According to that description, the Court understood that the patent does not indicate what these "other therapeutic agents" are and that, therefore, on the priority date of the basic patent, askilled person could have reduced the expression "other therapeutic agents"to compounds that treat one or more viral infections, which include a wide variety of active ingredients, since the basic patent is not limited to the treatment of HIV. In addition, the Court concluded that the use of the term "optionally" may be interpreted to mean that claim 27 permits the presence of other therapeutic agents, but does not expressly require them. Thus, the scope of protection of claim 27 ranges from a pharmaceutical composition containing a single ingredient formed by a compound of claims 1 to 25, or it may encompass a compound of claims 21 to 25 together with one, two or more therapeutic agents.
The Court considered that in order to assess whether or not a pharmaceutical composition falls within the scope of protection of claim 27, the presence or absence of that other therapeutic agent would be irrelevant. Therefore, the technical contribution of the basic patent ES 003 would consistofdisclosing the new tenofovirdisoproxil. Claim 27 would not provide an additional technical contribution.
Thus, a drug whose active ingredient is tenofovirdisoproxil would be protected by the basic patent in light of Article 3(a) of the SPC Regulation, since this active ingredient constitutes the core invention of the basic patent. However, a product consisting of a combination of the active ingredients tenofovirdisoporxil + emtricitabine would, in principle, not be protected according tothe terms in which the Court interpreted Article 3(a) because said combination of active ingredientsdoes not constitute the objective of the invention covered by said basic patent.
Consequently, the Court concluded there was a prima facie case regarding the invalidity of the SPC, so the granted precautionary measures could not be maintained. It found that claim 27 of the basic patent did not protect the combination oftenofovir and emtricitabine in the sense of Article 3(a) of the SPC Regulation, given that the active principle emtricitabine lacks functional definition as the subject-matter of the invention. The Court thus held that the SPC was likely to be invalidated.
For this reason, the Court lifted the preliminary injunctions previously granted against Teva and Mylan, in view of the high probability that the SPC would be declared invalid in substantive proceedings on the merits.
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