Generics (UK) Ltd (t/a Mylan) v Warner-Lambert Company LLC

A Swiss-form second medical use claim is a process claim directed to the manufacturer. The word “for” requires a mental link between manufacture and intentional administration for the patented indication. Applying the persuasive approach in Warner-Lambert CA, foreseeability of intentional use may suffice; mere foreseeability that the product will be used for pain does not.

For insufficiency, the specification and common general knowledge must make efficacy across the whole claim scope plausible without undue burden. Evidence making peripheral neuropathic pain plausible did not support claims extending to central neuropathic pain, idiopathic pain, fibromyalgia or all pain. The claims were therefore partly invalid, while the obviousness case failed.

The proceedings comprised revocation claims brought by Generics (UK) Ltd trading as Mylan and Actavis Group PTC EHF, infringement proceedings brought by Warner-Lambert against Actavis entities, and a threats counterclaim. They concerned European Patent (UK) No 0 934 061, covering pregabalin for treating pain in Swiss form.

The court considered obviousness, insufficiency, construction, direct and indirect infringement, declarations concerning doctors, pharmacists and patients, and alleged threats. The central questions were whether the claims were valid, what mental element the word “for” imported, and whether a skinny-label generic product was intended or foreseeably intended to be used for the patented indication.

1. Validity. None of the claims was obvious over the prior art. The skilled team would regard Mellick as worth investigating, and would pursue gabapentin in an animal model, but would not have a reasonable expectation of success with pregabalin. Taylor II, Gee and Radulovic did not bridge that evidential and logical gap.
2. Construction. “Pain” in claim 1 was not restricted to pain involving central sensitisation. “Neuropathic pain” in claim 3 included both peripheral and central neuropathic pain. “Treating” was a functional technical feature, and the animal-model data were the relevant evidence of efficacy for construction purposes.
3. Insufficiency. Claims 1, 3, 4, 6, 13 and 14 were insufficient. The patent made efficacy for peripheral neuropathic pain just plausible, but did not make efficacy for central neuropathic pain, idiopathic pain or fibromyalgia plausible across the relevant claim scope. Claims 2, 5, 7, 8, 9, 10, 11 and 12 remained valid.
4. Infringement. The Court of Appeal’s reasoning in Warner-Lambert CA was highly persuasive but not binding because it was unnecessary to the interim-relief disposition. The court followed it despite considerable doubts. The relevant intention was principally that of the prescribing doctor, with the pharmacist’s intention also capable of being relevant where the pharmacist knowingly dispensed the generic product for pain. Actavis did not intend Lecaent to be used for pain, and it was not foreseeable that more than a de minimis proportion would be intentionally so administered. There was no infringement under section 60(1)(c) or section 60(2).
5. Threats and declarations. Several communications were groundless threats, including communications to the PSNC, superintendent pharmacists, CCGs and the BMA. Declarations were made that Actavis, wholesalers, doctors, pharmacists and patients had not infringed.

The judgment records earlier interlocutory decisions in the same litigation, including [2015] EWHC 72 (Pat), [2015] EWHC 223 (Pat), [2015] EWHC 249 (Pat) and [2015] EWHC 485 (Pat). The Court of Appeal later dismissed an appeal from the interim-injunction decision and allowed an appeal concerning the section 60(2) strike-out, in [2015] EWCA Civ 556. Those decisions formed part of the same litigation and are not treated as cited target cases.