COMMERCIAL AND CORPORATE LAW

In Actavis Group PTC EHF v ICOS Corp [2019] UKSC 15, the Supreme Court of the United Kingdom considered whether, for the purposes of the Patents Act 1977 (UK), a dosage patent involved an inventive step, or failed because of obviousness.  An earlier patent that disclosed the efficacy of a compound in the treatment of sexual dysfunction, but that patent did not set out any optimal dosage regime.  The patent at issue in the present case purported to do so, in consequence of additional clinical research.  Lord Hodge, who delivered the judgment of the Court, emphasised the fact-specific nature of the obviousness inquiry (at [63]), but highlighted that a dosage regime will almost always be obvious because it is standard practice to investigate the appropriate regime (at [76]).

His Lordship, however, did not shut out patents disclosing no more than an optimal dosage regime completely, but emphasised the necessity that any such patents, akin with all others, satisfy the requirements of the statute.  The critical passage of the Court’s reasons is at [103]:

“[There is no] general proposition that the product of well-established or routine enquiries cannot be inventive. … [T]here is no policy reason why a novel and inventive dosage regime should not be rewarded by a patent. A fortiori, efficacious drugs discovered by research involving standard pre-clinical and clinical tests should be rewarded with a patent if they meet the statutory tests.”