Sandoz Ltd & Anor v G.D. Searle LLC & Anor

For Article 3(a) of the SPC Regulation, a product may be protected by a basic patent even though it is not individually named or depicted in the claims. A Markush formula may sufficiently specify or identify the product where it covers that product, at least without resort to equivalents. The breadth of the claims is not generally to be re-examined during the grant or validity assessment of an SPC. An objection that the claims encompass an excessive number of compounds is ordinarily an objection to the validity or sufficiency of the patent itself. Where patent validity is not put in issue, the patent is presumed valid and the ordinary civil standard of proof applies.

The claimants sought revocation of an SPC for darunavir, an anti-retroviral medicine. The defendants relied on a European patent containing broad Markush claims covering darunavir, although darunavir was neither named nor specifically disclosed in the specification. The claimants argued that Article 3(a) required more specific identification of the product and sought a preliminary reference to the CJEU. The central issue was whether darunavir was protected by the basic patent for the purposes of Article 3(a).

1. Article 3(a). The court held that the broadest tenable interpretation requires only that the product fall within at least one patent claim applying the Extent of Protection Rules. Although the CJEU case law indicated that more may be required, it did not support a requirement that the product be individually named or structurally depicted.
2. Markush claims. Lilly established that a functional description may suffice if the claims relate, implicitly but necessarily and specifically, to the active ingredient. That reasoning indicates that a claim may identify a product through a Markush formula covering it, even where the claim also covers many other compounds.
3. Inventive advance. The judge reaffirmed his preferred alternative test: the product must fall within the claim and do so because it embodies the inventive advance or technical contribution of the patent. Darunavir satisfied that test because the inventive advance of claim 1 lay in identifying the claimed compounds as HIV protease inhibitors.
4. The claimants' objection that the claims covered an enormous number of compounds was in substance an objection to patent validity, including breadth, obviousness on AgrEvo grounds or insufficiency. Patent validity had not been put in issue. A granted patent is presumed valid; the burden lies on the party asserting invalidity, while the standard remains the balance of probabilities.
5. The date on which darunavir was developed or first reported, and whether it was independently developed, did not affect whether it was protected by the patent. The SPC complied with Article 3(a). The claim was dismissed. Further argument was reserved on relief on the counterclaim.