Teva UK Ltd & Ors v Gilead Sciences Inc

For Article 3(a) of the SPC Regulation, it is insufficient that dealings in a product would infringe a basic patent under national infringement rules. The product must fall within at least one claim applying the rules governing the extent of patent protection. It remains unclear whether that is sufficient. The product must apparently also embody the inventive advance or technical contribution of the patent. For a combination product, the combination itself must embody that advance; it is insufficient that one component does so. The proper question concerns the substance of the invention, not merely the wording of claims capable of being drafted broadly. The issue was referred to the Court of Justice for further guidance.

Gilead held an SPC for a combination of tenofovir disoproxil and emtricitabine, marketed as Truvada. The SPC was based on European Patent No 0 915 894, whose claims covered tenofovir disoproxil and pharmaceutical compositions containing a claimed compound, a carrier and optionally other therapeutic ingredients. Emtricitabine was not mentioned in the patent.

The Comptroller-General had initially refused the SPC, but Kitchin J allowed Gilead’s appeal in [2008] EWHC 1902 (Pat). The claimants challenged the SPC afresh in light of subsequent Court of Justice decisions concerning Article 3(a) of the SPC Regulation. The central issue was the criteria for deciding whether a product is protected by a basic patent in force.

1. Claim construction. Applying the principles in Kirin-Amgen Inc v Hoechst Marion Roussel Ltd and Virgin Atlantic Airways Ltd v Premium Aircraft Interiors UK Ltd, claim 27 permitted, but did not require, other therapeutic ingredients. Its scope therefore extended to a composition containing only a claimed compound and a carrier. The presence or absence of another therapeutic ingredient was irrelevant to infringement. [21]-[22]
2. Article 3(a) minimum requirements. The Court of Justice authorities established that it was insufficient for dealings in the product to infringe the patent under the infringement rules. The product had to fall within at least one claim applying the rules governing the extent of patent protection. The reasoning in Medeva BV v Comptroller-General of Patents, Designs and Trade Marks and its progeny remained difficult to apply and did not make clear whether that minimum requirement was sufficient. [63]-[64], [79]-[81], [91]
3. Suggested further requirement. In the judge’s view, the product had to infringe because it contained an active ingredient, or combination of active ingredients, embodying the inventive advance or technical contribution of the basic patent. Where the product was a combination, the combination itself, rather than merely one component, had to embody that advance. A patent for TD did not therefore protect a TD/emtricitabine combination, whereas a patent for a combination having a surprising synergistic effect could protect that combination. [96]-[98]
4. Disposition. The issue remained unclear in the Court of Justice’s case law. A further reference was necessary. The judge referred again the question: what are the criteria for deciding whether the product is protected by a basic patent in force under Article 3(a)? [91], [95]

The judgment records that the Comptroller-General initially refused the SPC application and that Gilead’s appeal was allowed by the Patents Court in [2008] EWHC 1902 (Pat) . The present court reconsidered the issue afresh and made a further reference to the Court of Justice.