Under what circumstances are Supplemental Protection Certificates (SPCs) available for combination products? Numerous judgements by the Court of Justice of the EU have failed to provide a clear answer, so a fresh referral has now been made (Teva UK Limited & others v Gilead Sciences Inc).
SPCs are only available for medicinal or plant protection products that are protected by a basic patent. This requirement has proved difficult to assess, particularly in the context of products that contain a combination of two or more active ingredients. Previous decisions from the CJEU that the product must be ‘identified’ or ‘specified’ in the claims of the patent have only been of limited help, raising the question as to how to assess these requirements. The most recent guidance that the claims must relate ‘implicitly but necessarily and specifically’ to the active ingredient has arguably raised more questions than it answered. Against this background, it is no wonder that a new referral has now been made.
TRUVADA® is a combination product consisting of two active ingredients, (i) tenofovir disoproxil (TD) and (ii) emtricitabine. Gilead has an SPC for this product, based on a patent that claims a class of compounds that encompass TD. The patent also claims such a compound together with a pharmaceutically acceptable carrier and optionally other therapeutic ingredients.
Teva challenged the validity of this SPC, alleging that the combination product is not ‘protected’ by the basic patent.
The judge reviewed the available case law in detail and concluded that further clarification from the CJEU is required. He asked a single question:
“What are the criteria for deciding whether ‘the product is protected by a basic patent in force’ in Article 3(a) of the SPC Regulation?”
Sounding exasperated at the CJEU’s failure to provide clear guidance to date, the judge went on to offer his own suggested answer to this question. In his view, the product must contain an active ingredient, or a combination of active ingredients, which embodies the inventive advance or technical contribution of the basic patent. Thus, where the product is a combination of active ingredients, the combination, as distinct from one of them, must embody the inventive advance of the basic patent.
This proposed test would potentially be stricter than the test as to whether a product is ‘identified’ in a claim. It remains to be seen how the CJEU decides to tackle this issue.