Yeda Research and Development Company Ltd v Comptroller General of Patents

For supplementary protection certificate purposes, a product is identified by what it is, namely its active ingredient or combination of active ingredients, rather than by its therapeutic use. A marketing authorisation referring to the use of one medicinal product with another does not thereby authorise a combination product where the authorised product is identified as the first product alone. The basic patent must protect the product authorised by the marketing authorisation. The relevant test is the narrower test of whether the authorised active ingredient is disclosed and claimed by the patent, not whether its manufacture or supply might amount to infringement. Secondary infringement cannot enlarge the product protected for SPC purposes.

Yeda appealed against the Hearing Officer’s refusal of two applications for supplementary protection certificates based on a patent concerning the combined use of cetuximab and irinotecan. Application 037 claimed the combination, but relied on a European marketing authorisation identifying Erbitux, whose active ingredient was cetuximab, while referring to irinotecan only as concomitant treatment. Application 038 claimed cetuximab alone, although the patent claims required the antibody and an anti-neoplastic agent.

The issues were whether the marketing authorisation authorised the combination and whether cetuximab alone was protected by the basic patent under article 3(a) of Council Regulation No. 1768/92.

1. Appeals dismissed. The Hearing Officer was right to refuse both SPC applications.
2. The concept of “product” under the SPC regime required strict construction. It concerned the active ingredient or combination of active ingredients, not the therapeutic use of an active ingredient. The court adopted the distinction between what the product was and what it did, as reflected in Generics (UK) Ltd v Daiichi Pharmaceutical Co Ltd [2009] EWCA Civ 646, Yissum Research and Development Co v Comptroller-General Case C-202/05 and Takeda Chemical Industries Ltd’s SPC Applications No 3 [2004] RPC 3.
3. The Community marketing authorisation identified “Erbitux – cetuximab” as the medicinal product. Its references to irinotecan described how cetuximab could be used and did not authorise a medicinal product comprising both substances. The 037 application therefore did not correspond with the authorised product.
4. For article 3(a), the narrower test was preferred: the active ingredients of the authorised product had to be disclosed and claimed by the basic patent. The patent claims were directed to the combination of cetuximab and irinotecan. Cetuximab alone was therefore not protected by the patent, so application 038 failed.
5. Even assuming that infringement were the correct test, secondary infringement under section 60(2) of the Patents Act 1977 could not be incorporated into the SPC concept of a protected product. It would impermissibly extend the product beyond the claims. The court also accepted that the claimed therapeutic composition had to exist outside the patient’s body; otherwise the argument would raise the prohibition on methods of treatment in section 4A(1).

The appeal concerning application 037 and the appeal concerning application 038 were each dismissed.

1. High Court (Patents Court): the appeals from the Hearing Officer’s decisions dated 23 February 2010 were dismissed.