The Court of Justice of the European Union (CJEU) rendered a landmark decision extending patent term extensions for certain medicinal products in litigation relating to supplementary protection certificates (SPCs) for the blockbuster anti-HIV drug TRUVAD. Teva UK Ltd., et al. v. Gilead Sciences Inc., Case No. C‑121/17 (CJEU July 25, 2018) (Grand Chamber).

SPCs are special national intellectual property rights in the European Economic Area that extend the term of certain rights associated with patents granted for human or veterinary medicinal and plant protection products. An SPC does not extend the term of protection of a basic patent as such; the protection conferred by an SPC is rather limited to a certain product for which market authorization has been obtained. SPCs were introduced to compensate innovative parties for the significant time necessary to obtain such market authorizations.

The CJEU, sitting as a Grand Chamber comprising 13 judges, answered a request by the UK High Court for a preliminary ruling in proceedings between a group of generics manufacturers (Teva, Accord, Lupin and Mylan) and the US pharmaceutical company Gilead, which holds an SPC for TRUVADA. TRUVADA contains two active ingredients, tenofovir disoproxil and emtricitabine, which have a combined effect for the treatment of HIV. The generics manufacturers argued that Gilead’s TRUVADA SPC was invalid because Gilead’s relevant basic patent did not explicitly mention emtricitabine or a combination of emtricitabine and tenofovir disoproxil (while the patent did comprise a claim directed to tenofovir disoproxil as such). The argument was made because European Regulation No. 469/2009 concerning SPCs for medicinal products requires that the relevant basic patent protect the relevant product in order for an SPC to be granted (Article 3(a)). The generics manufacturers referred to the CJEU decision in Eli Lilly v. Human Genome Sciences (case C-493/12, Dec. 12, 2013), according to which the claims of the basic patent need not expressly mention the product protected by an SPC, but must at least refer to this product “implicitly but necessarily and specifically.” According to the generics manufacturers, this requirement was not fulfilled. Gilead countered that a basic patent protects a product as long as the relevant product falls within the scope of protection conferred by any claim of the basic patent. The UK High Court asked the CJEU what the criteria were for deciding whether a product is protected by a basic patent pursuant to Article 3(a) of Regulation No. 469/2009.

The CJEU ruled that a product comprising a combination of active ingredients is protected by a basic patent pursuant to Article 3(a) of Regulation No. 469/2009, even if the combination is not expressly mentioned in the claims of the basic patent, if the patent claims relate necessarily and specifically to that combination. The CJEU confirmed its decision in Eli Lilly v. Human Genome Sciences, but added that the relevant point in time for such test is the priority or filing date of the basic patent. From the point of view of a person skilled in the art, and on the basis of the prior art at the priority/filing date of the basic patent, two tests must be passed:

  • The combination of the active ingredients must necessarily, in light of the description and drawings of the basic patent, fall under the invention.
  • Each of the active ingredients must be specifically identifiable, in light of all the information disclosed by the basic patent.

Regarding TRUVADA SPC, the CJEU expressed doubt whether the two-part test could be met because, according to the UK High Court, there was no evidence that at the priority date of the relevant basic patent, emtricitabine was an effective agent known to the person skilled in the art for the treatment of HIV in humans. Therefore, a person skilled in the art may not have been able to understand how emtricitabine, in combination with tenofovir disoproxil, necessarily falls under the invention covered by the basic patent. The CJEU referred these factual questions back to the UK High Court.

Practice Note: This CJEU decision gives both innovative and generics companies an incentive to revisit questions of SPC validity. The decision may offer a starting point for generics manufacturers that seek to challenge the validity of an existing SPC and launch a generic product, because evaluation from a priority or filing date perspective may have an effect in favor of invalidity. While the CJEU has brought some long-awaited clarity regarding the new criteria that a basic patent claim must “relate implicitly but necessarily and specifically” to a product that is eligible for SPC protection, this rather factually difficult criteria will remain a part of European SPC law for the foreseeable future.