German Federal Court of Justice invalidates Truvada SPC

Gilead’s German SPC covering its HIV drug Truvada was finally invalidated on 22 September 2020 (case no. X ZR 172/18). The German Federal Court of Justice (“FCJ”)’s judgment upholds the German Federal Patent Court’s 2018-decision, which had rendered invalid the SPC at first instance. It is also in line with the Court of Justice of the European Union (“CJEU”)’s 2018-judgment passed on a referral question in parallel proceedings relating to the counterpart SPC granted for the UK (case no. C-121/17, judgment of 25 July 2018 – Teva UK Ltd and Others v Gilead Sciences Inc.). The recent outcome of the German proceedings is hardly surprising, as the CJEU’s 2018-judgment had already been taken into consideration by the Federal Patent Court. The FCJ’s judgment is also in line with the final decision of the UK Court of Appeal, which once again proves that the application of different European patent laws – despite arguable differences in the national laws – finally achieves similar results. The litigation and the judgment in detail:

SPC at issue

Truvada is a drug approved for the treatment and prevention of HIV infection in adults and children. The underlying substance combination contains two active ingredients with a combined effect for that treatment, namely tenofovir disoproxil and emtricitabine. It was granted market authorization in 2005. In Germany, it was covered by an SPC filed by Gilead in 2005 (file no. DE 12 2005 000 041; “the SPC”)). The SPC’s validity was challenged by a number of generic manufacturers on the basis that the – underlying – basic patent EP 9 158 940 expressly only claimed one of the active ingredients, namely tenofovir disoproxil (claims 27 and 25 of the patent), but did not mention the second ingredient emtricitabine. Rather, the claim referred to “other therapeutic ingredients”. The validity attack therefore argued that the basic patent did not protect the SPC-covered product pursuant to Article 3 (a) of Regulation No. 469/2009 (“SPC Reg.”). Consequently, it was contended that the SPC failed to meet this condition for granting. 

Legal issue

Lacking an express reference to emtricitabine in the basic patent, e.g. by a structural formula, the case turned on the issue whether the wording “other therapeutic ingredients” of the basic patent was nevertheless a sufficient functional formula for covering the second active ingredient emtricitabine. 
Principally, even if the specific combination is not explicitly mentioned in the basic patent, the requirement of SPC Reg. Article 3 (a) could also be met if the patent provides for a functional formula covering the active ingredient emtricitabine. This would however further require that the claims relate, implicitly but necessarily and specifically, to the active ingredient in question (CJEU (Third Chamber), judgment of 12 December 2013, case no. C-493/12 – Eli Lilly and Company). 

The legal issue was under which circumstances the relevant patent claims actually provided for the required relation to the specific combination in question.

The Federal Patent Court’s decision

At first instance, the Federal Patent Court held that a necessary and specific relation to emtricitabine would only exist if the preamble or functional description ruled out that other active ingredients, which do not share the specific medicinal properties or effects, could be read under the functional description. 

Applying this test, it concluded that this was not the case with regard to the basic patent underlying the SPC, and therefore invalidated it. The Federal Patent Court’s decision remarks that the court saw its legal opinion validated by the CJEU’s judgment, which was handed down after the first instance hearing, but prior to the announcement of the Federal Patent Court’s decision. 

Based on the preliminary opinion of the Federal Patent Court, the Munich District Court had already rejected seven requests for preliminary injunctions by Gilead against a number of generic manufacturers in August 2017 (case nos. 7 O 11152/17 through 7 O 11158/17). 

The CJEU’s judgment

The CJEU has jurisdiction to give preliminary rulings concerning the interpretation of the SPC Regulation. With SPCs being an economically relevant and highly litigated intellectual property right, questions relating to the interpretation of the SPC Regulation are frequently referred to the CJEU.  
In 2018, the CJEU ruled on a referral from the High Court of Justice of England & Wales regarding the parallel UK SPC on the criteria of the product’s protection by a basic patent in force (SPC Reg. Article 3(a)), seeking clarification due to divergent decisions in a number of Member States. The validity of the SPC’s UK-counterpart had been attacked in this regard. For the purpose of legal unity and in order to marry the aim of an additional period of exclusivity upon expiry of the basic patent and the constraint of the extent of protection conferred by same patent, the CJEU had to clarify the relevant standard. 

Addressing abovementioned legal issue, the CJEU held that protection by the basic patent exists if one of its claims related necessarily and specifically to that combination. 

It established a two-pronged test, according to which there is a necessary and specific relation by the claims if:

(1) the combination of those active ingredients necessarily, in the light of the description and drawings of that patent, falls under the invention covered by that patent, and

(2) each of those active ingredients is specifically identifiable, in the light of all the information disclosed by that patent.

Both prongs are to be assessed from the point of view of a person skilled in the art and on the basis of the prior art at the filing date or priority date of the basic patent.

On the basis of the guidance provided by the CJEU, it is up to the Member States to determine whether the two-pronged test for SPC Reg. Article 3(a) is met. The CJEU does not have jurisdiction over the patent laws of the Member States and Article 1 of the Protocol on the Interpretation of Article 69 of the EPC. However, the CJEU commented that it did not find the first prong to be met in the case of Truvada. The basic patent, having a 1996-priority date, lacked any information on the combined use of the two active ingredients for the relevant HIV treatment. The CJEU clarified that the test was to be applied by the referring court, i.e. the High Court of Justice of England & Wales. The latter came to the conclusion that the two-pronged test had not been met (judgment of 18 September 2018, case no. [2018] EWHC 2416 (Pat)). This was confirmed by the UK Court of Appeal (judgment of 19 December 2019, case no. [2019] EWCA Civ 2272).

The FCJ’s judgment

Now, the FCJ has equally invalidated the SPC relying on the CJEU’s judgment, while simultaneously confirming the Federal Patent Court’s decision. The specifics of the FCJ’s judgment remain subject to the written grounds, which are due to be published in the following weeks.

It can be expected that the court applied the two-pronged test established by the CJEU’s 2018-judgment for determining when “the product is protected by a basic patent in force” according to SPC Reg. Article 3(a) and concluded that the prongs had not been met. The SPC’s term of protection expired in August 2020. The FCJ’s decision finally affirms the invalidation of the SPC ex tunc.

TW comments

In applying the CJEU’s two-pronged test, German and UK courts came to similar results. Despite the differences of the national patent laws, it is good to note that the main European patent jurisdictions reached similar conclusions. This gives guidance and clarity to pharmaceutical companies throughout Europe, which is essential for applying the SPC Regulation in practice.