Posted: January 17th, 2019
G.D. Searle LLC. v. Sandoz B.V., PI Judge District Court the Hague d.d. 8 January 2019, ECLI:NL:RBDHA:2019:72
Searle was the holder of European patent EP 0 810 209 B1 titled “Alpha – and beta-amino acid hydroxyethylamino sulphonamides useful as retroviral protease inhibitors”, which lapsed on 23 August 2013. The claims of this patent define a group of compounds by reference to a Markush formula. Relying on EP ‘209 as basic patent, Searle obtained Dutch SPC 300283 for “Darunavir, or the pharmaceutically acceptable salt, ester or product thereof”. Darunavir is the active ingredient in the anti-retroviral drug Prezista®, used to treat HIV. The SPC expires on 23 February 2019.
Sandoz introduced a generic version of Prezista® on the Dutch market without warning. Sandoz included its generic product in the October 2018 version of the G-Standaard (The G-Standaard is a database comprising ordering information on products that are available with wholesalers and pharmacists in the Netherlands) which was published on 18 October 2018 and announced that it would market its product as per 1 November 2018. On 23 October 2018 Searle sued Sandoz in preliminary relief proceedings before the Court of The Hague requesting a provisional injunction for the duration of the PI proceedings and a preliminary injunction, accompanied by several ancillary claims.
In an interim decision of 1 November, the PI Judge granted Searle’s provisional claim (for more information see here)
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. According to that provision an SPC can only be obtained for an active ingredient that is protected by a basic patent.
Sandoz relied on the two-step test of the CJEU in Teva/Gilead (C-121/17, ECLI:EU:C:2018:585) which according to Sandoz is not only applicable for combination products but also for Markush formula. According to Sandoz, applying this test results in an invalid SPC. The Teva/Gilead decision was rendered after the CJEU referral by the UK Court of Appeal in the parallel UK Sandoz/Searle case (more information can be found here).
According to Sandoz it was clear that the UK Court’s prejudicial question had already been answered as the CJEU asked the UK Court of Appeal whether they maintained their CJEU referral a day after they handed down the Teva/Gilead ruling. According to Sandoz it is therefore an acte éclairé that Searle’s SPC is invalid and the CJEU decision on the referral from the UK Court of Appeal therefore does not have to be awaited.
According to the PI Judge the question whether a product is protected by a basic patent is determined based on the rules for determining the scope of protection of a patent, like those of Art. 69 EPC and Art, 1 of the Protocol and not the rules for determining infringement. Referring to Eli Lilly/HGS (C-493/12, ECLI:EU:C:2013:835) the Judge finds that Article 3 (a) of the SPC-regulation does not preclude that an active ingredient which is covered by a functional formula that is claimed in a European patent is protected by that basic patent. On the condition that the claim implicitly, but necessarily and specifically, relates to the ingredient.
According to the Court it is not improbable that also an ingredient that is covered by a Markush formula which, like a functional formula, may cover a very large number of compounds, may be protected by that patent. Considering the recent CJEU case law and in particular Eli Lilly/HGS and Teva/Gilead it is however to be expected that the CJEU in the pending referrals from the UK and German courts will rule that this will only be the case if the specific conditions mentioned in Eli Lilly/HGS are met.
How these conditions are to be applied has been explained by the CJEU in Teva/Gilead. The CJEU considered that for a product to be ‘protect by a basic patent’ that product must (1) necessarily fall under the invention covered by that patent, from the point of view of a person skilled in the art and in light of the description and the drawings of that patent and (2) be specifically identifiable for the person skilled in the art, on the basis of the prior art at the filing date or priority date of the patent concerned.
The PI Judge finds that the first requirement has been met, since it is undisputed that the Markush-formulae of claims 1 and 5 of EP ‘209 cover Darunavir and that this compound has HIV-inhibiting effect. In relation to the second requirement, the PI Judge considers that the Markush-formulae claimed in EP ‘209 comprise a huge number of compounds. Unlike the approximately one hundred preferred compounds that are described in the patent, Darunavir is not described nor claimed. Further it was not disputed by Searle that Darunavir was not common general knowledge in the field of HIV-medication on the priority date. It was not in dispute that darunavir was only developed and synthesized six years after that date. The PI Judge therefore finds that darunavir was not specifically identifiable on the priority date in light of the data disclosed in the basic patent.
Searle argued that the ruling in Teva/Gilead is only applicable in cases concerning combination products and thus could not be relevant for the present case which concerned a mono-product. This argument is dismissed by the PI Judge. According to the PI Judge the broad wording of the judgment and the fact that it was given by the Grand Chamber of the CJEU points to the fact that it the CJEU intended to formulate more general rules. The Judge further points to the fact that the CJEU asked the UK and German courts whether they wanted to maintain their already submitted preliminary questions. It was undisputed that this is only done by the CJEU when it considers the referred preliminary questions identical or analogous to the questions that have been answered.
The Judge disagrees with Sandoz’ arguments that it would be an acte éclairé that the Teva/Gilead decision has brought all-embracing clarity. According to the Judge this is evidenced by the fact that the German and UK courts, which are not aligned on the interpretation of Art. 3 (a), have not withdrawn their requests for a preliminary ruling following the Teva/Gilead decision. Nevertheless, the PI Judge finds that there is a real and serious chance that the SPC will be held invalid in main proceedings. The PI Judge therefore dismisses Searle’s request for a PI.
The judgment (in Dutch) can be read here.
Headnote: Mattie de Koning and Nathalie Steurrijs, Simmons & Simmons LLP