Pharma cases: No proportionality defence without (expedited) request for compulsory license

In a recent pharmaceutical case, the Dusseldorf District Court did not find merit in a defendant’s proportionality defence based on Sec. 139 (1), 3rd sentence German Patent Act (GPA). The provision was added to the GPA approximately a year ago and codifies previous case law according to which a claim for injunctive relief is barred if it would result in disproportionate and unjustified hardship for the infringer or a third party. In the past, the Dusseldorf courts had quashed disproportionality arguments raised by defendants in pharmaceutical cases if they had not also requested a compulsory license. The same standard has now been applied in assessing the now-codified proportionality defence. In the present case, the defendant (Gilead) had filed a parallel request for a compulsory licence, but not until a year after the infringement action had been filed. Further, it chose not to request a provisional compulsory license, i.e. expedited proceedings. The Dusseldorf District Court did not find this to warrant the defence that an injunction against Gilead would be disproportionate.

Facts of the case

NuCana attacked Gilead’s products Sovaldi, Harvoni, Vosevi and Epclusa, which contain active ingredient sofosbuvir for the treatment of HCV for alleged infringement of NuCana’s patent EP 2 955 190 B1 (“the Patent”).

The Patent is based on an invention relating to nucleotide derivatives, with their use for the treatment of cancer claimed in one of the subclaims. It was upheld during first instance opposition proceedings. An appeal is pending.

NuCana is understood to neither market a product containing the substance for the treatment of cancer nor for the treatment of HCV. By contrast, the products marketed by Gilead – undisputedly – contain a substance within the scope of protection of the Patent.

After the complaint was filed in April, 2021, the parties (unsuccessfully) engaged in license negotiations. A year later, in April, 2022, Gilead filed a request for a compulsory license with the Federal Patent Court. However, it did not file an additional a provisional compulsory license, which would have resulted in expedited proceedings.

In 2022, the Dusseldorf District Court granted injunctive relief to the plaintiff, denying Gilead’s defence based on alleged disproportionality of the injunction.

Too little, too late?

The plaintiff had argued that the (stricter) preconditions of a request for a compulsory license based on public interest (Sec. 24 GPA) should prevail over the disproportionality defence under Sec. 139 GPA. Insofar, NuCana argued that Gilead had initiated compulsory license proceedings only at a very late stage and did not even use the option to file a request for expedited proceedings. NuCana also argued that Gilead had offered inappropriate conditions when engaging in out-of-court license negotiations and had therefore not shown any serious attempts to obtain a license. Finally, NuCana stated that the majority of patients treated with Gilead’s products relevant to the infringement litigation could easily be switched to other available medication.

Or: appropriate response?

The defendant had argued that that its products were not generic versions, but Gilead’s own proprietary development based on extensive research. Thus, particular groups of patients could only be treated with this specific product. With a view to timing, Gilead stated that compulsory license proceedings had not been initiated earlier in order to avoid a negative impact on the negotiations for a voluntary license. Further, Gilead argued that the Patent’s parent EP 1 646 639 A2 had originally focused on the treatment of cancer and that it was only after Gilead’s commercial success that NuCana used the divisional right to enforce broader patent protection.

The judgment

The Dusseldorf District Court did not follow Gilead’s defence based on alleged disproportionality of an injunction. It therefore granted (permanent) injunctive relief to NuCana.

TW comments

As mentioned, the grounds of the judgment have not yet been published. However, this recent ruling concurs with the case law of the Dusseldorf District Court and Court of Appeals prior to the amendment of the German Patent Act, which codified a proportionality defence against the claim for injunctive relief (Dusseldorf Court of Appeals, court order of 5 August 2019, case no. 2 U 35/19; Dusseldorf District Court, judgment of 9 March 2017, case no. 4a O 137/15). In those decisions, the courts held that finding disproportionality of injunctive relief in situations where a compulsory license could have been requested would be a circumvention of the strict requirements for the compulsory license according to Sec. 24 GPA. Apparently, the Dusseldorf District Court did not find the recent codification of the proportionality defence to necessitate deviation from previous judgments. In the present case, it would appear that the late filing of the compulsory license action – one year after the infringement complaint – without a request for expedited proceedings was decisive for the court’s decision to reject the disproportionality defence.