Generics (UK) Ltd (t/a Mylan) & Anor v Yeda Research And Development Company Ltd

Patent claims are construed through the eyes of the skilled person and in the context of the patent’s purpose: describing and claiming an invention. A claim is not construed by importing an unstated efficacy threshold from the specification. For novelty, the relevant question is whether the prior publication discloses subject matter falling within the claim on its proper construction; the doctrine of equivalents does not form part of the novelty inquiry. A dosage regimen may nevertheless be obvious where the skilled person is motivated to investigate it and has a fair expectation of success. Post-priority evidence may confirm, but cannot establish for the first time, a technical effect. An Arrow declaration is discretionary and requires more than pending divisional applications or a general desire for commercial certainty.

Mylan and Synthon sought revocation of a patent owned by Yeda and licensed to Teva. The patent concerned administering glatiramer acetate for relapsing forms of multiple sclerosis by three 40 mg subcutaneous injections every seven days, with at least one day between injections. Claim 3 additionally required increased tolerability through reduced injection-site or immediate post-injection reactions.

The claimants alleged lack of novelty, lack of inventive step and insufficiency, relying principally on Pinchasi and, alternatively, Caon and Flechter. They also sought an Arrow declaration concerning the proposed generic product. The central issues were claim construction, novelty, obviousness, plausibility and the discretionary basis for declaratory relief.

1. Claim construction. Patent claims must be interpreted through the eyes of the skilled person and in context. The context includes the patent’s purpose of describing and claiming an invention. Claim 1 required only that the 40 mg three-times-weekly regimen be suitable for treating relapsing multiple sclerosis; it did not require a 30% reduction in annualised relapse rate or equivalence to the 20 mg daily regimen. Claim 3 expressly required comparison with the 20 mg daily regimen.
2. Novelty. Following Synthon BV v SmithKline Beecham plc [2006] RPC 10, prior disclosure and enablement are required. In light of Actavis UK Ltd v Eli Lilly and Co [2017] UKSC 48, the court concluded that novelty is assessed by proper construction and does not extend to obvious equivalents. Pinchasi’s 40 mg every-other-day regimen was distinct from the claimed long-term three-times-weekly regimen. Claims 1 and 3 were therefore novel over Pinchasi.
3. Obviousness. The skilled person had a clear motivation to reduce injection frequency because of tolerability, adherence and convenience. Pinchasi disclosed 40 mg every other day, and three-times-weekly administration was an obvious alternative. The skilled person would expect efficacy compared with placebo and had a reasonable expectation that efficacy would be comparable to 20 mg daily. The increased adverse reactions associated with 40 mg daily would not dissuade investigation of a less frequent regimen. Claims 1 and 3 were obvious over Pinchasi and therefore invalid.
4. Alternative grounds. Caon and Flechter suggested that 20 mg every other day might be as effective as 20 mg daily, but their small, open-label studies were weak. They did not independently establish obviousness if Pinchasi did not.
5. Plausibility and insufficiency. If the claims had not been obvious, efficacy of 40 mg three-times-weekly treatment compared with placebo would have been credible. The asserted equivalence and improved tolerability compared with 20 mg daily would, however, have been speculative for claim 3. Claim 3 would consequently also have failed for lack of inventive step and insufficiency; claim 1 would not have failed on that basis.
6. Arrow declaration. The proposed regimen would have been obvious, but an Arrow declaration was refused. Pending divisional applications, alleged patent enforcement intentions, foreign spin-off value and commercial uncertainty did not justify the discretionary relief. The judgment itself provided the claimants with the relevant certainty.