Borenius Secures Victory for Teva and Mylan in SPC Dispute over Blockbuster Drug

We secured a victory for two of the largest generics companies, Teva and Mylan, which stood as claimants against originator company Gilead Sciences, Inc. before the Market Court in a dispute concerning the invalidity of a supplementary protection certificate (“SPC”) covering HIV blockbuster drug Truvada. The Market Court handed down rulings in the two formally separate cases on 25 September 2019 where it declared the SPC invalid. These decisions continue the series of rulings in Europe-wide litigation over the Truvada SPC.

A significant milestone in the case was achieved earlier this year when the Supreme Court handed down a landmark decision cancelling the preliminary injunction against Mylan, followed by the Market Court’s decision to cancel the preliminary injunction against Teva as well. However, this important judgment handed down by the Market Court on 25 September 2019 finally clears the way for generic HIV medicines in the Finnish market, making them more accessible and affordable for patients and PrEP medication users.

To open the door for generic competition, the claimants initiated separate invalidity actions at the Market Court in 2017 where they sought to revoke the SPC covering HIV drug Truvada based on the invalidity of the SPC. Truvada is a combination drug consisting of two active ingredients, i.e. tenofovir disoproxil (“TD”) and emtricitabine, whereas SPCs are intellectual property rights that serve as an extension to patents and apply to specific pharmaceutical products.

The Truvada SPC was based on a European patent whose claims only mentioned one of the active ingredients (TD) but included a general reference to combining TD with ‘other therapeutic ingredients’. The expression ‘other therapeutic ingredients’, however, was not defined in the patent. The question that was brought before the Market Court was whether the combination of TD and emtricitabine was protected by the patent and thus eligible for a SPC.

The case concerned the application of Article 3(a) of the SPC Regulation (469/2009), which provides that a SPC will be granted if the product is protected by a basic patent in force. The interpretation of Article 3(a), namely when is a product protected by a basic patent, has been subject to longstanding debate and several referrals to the CJEU over the past years.

In 2018, as a result of a referral by the High Court of Justice of England & Wales in the UK equivalent of the case, the CJEU handed down a preliminary ruling on the interpretation of Article 3(a) (C-121/17). The CJEU adopted a two-step test for establishing whether a product is protected by a basic patent. According to the CJEU, in order for the combination of active ingredients to be protected by a basic patent under Article 3(a), 1) the combination of active ingredients must necessarily fall under the invention covered by that patent and 2) each of those active ingredients must be specifically identifiable.

Although the CJEU’s preliminary ruling clarified the interpretation of Article 3(a), the parties were at odds over the interpretation of the CJEU’s test. Another challenging task before the Market Court was the assessment of extensive scientific and expert evidence.

Based on application of the CJEU’s test and the interpretation thereof put forward by the claimants, the Market Court ruled that the basic patent does not protect the combination of TD and emtricitabine. As a result, the Market Court declared the SPC invalid.

As regards the first part of the two-step test, the Market Court held that the combination of TD and emtricitabine had to be a specification required for the solution of the technical problem disclosed by the patent. The Market Court concluded that the combination did not meet the criterion established in the first part of the two-step test as the technical solution disclosed by the patent was the administration of nucleotides in a more readily bioavailable form and the combination did not contribute to that solution.

As for the second part of the two-step test, the Market Court ruled that it is not enough that the skilled person is able to identify a group of active ingredients that could fall within the general definition claimed in the patent. Rather, the skilled person must be able to identify the specific active ingredient covered by the SPC. The respondent claimed that the skilled person could have identified a group of active ingredients, so-called NRTIs (nucleoside/nucleotide reverse transcriptase inhibitors), from the patent, of which emtricitabine is one, but did not argue that emtricitabine was individually identifiable. The Market Court held that, although the skilled person could have identified such group, it was not specific enough to meet the criterion established in the second part of the two-step test.

Although the debate over the interpretation of Article 3(a) is far from over as new referrals are already waiting to be resolved by the CJEU, the Market Court’s decision not only confirms the CJEU’s interpretation but also brings important clarifications to the application of the two-step test especially in the context of combination products.

More importantly, as the decision clears the way for more affordable HIV medicines, it has considerable implications for public healthcare costs and PrEP medication users’ access to medicines.