The UK Supreme Court handed down its much anticipated judgment in the Warner-Lambert v Mylan and Actavis (Lyrica) case today (https://www.supremecourt.uk/cases/uksc-2017-0078.html), following the hearing in February. The judgment runs to 218 paragraphs over 92 pages and includes different judgments from four of the five Law Lords. It will be the subject of much discussion and learned debate over the next weeks, months and years. In the meantime, this is what you need to know immediately.
Short read for those who know it all: Warner-Lambert’s appeals were rejected, and Mylan and Actavis’ cross-appeal was allowed (see Lord Sumption at ).
Slightly longer read for those who know the facts but are still willing to learn:
- The claims were sufficient to the extent they covered inflammatory pain but insufficient to the extent they covered central or peripheral neuropathic pain (by 3 to 2; for, see Lords Sumption, Reed and Briggs at ; against, see Lords Hodge and Mance at  and  respectively)
- Claim 3 covered all forms of neuropathic pain and not just peripheral neuropathic pain (unanimous; see Lord Briggs at -, but note Lord Mance at ; obiter)
- Warner-Lambert’s attempt to amend the claims after judgment was an abuse of process (unanimous; see Lord Briggs at -; obiter)
- Neither claim would have been infringed if valid (by 4, Lord Mance leaving open; see Lords Sumption and Reed at - (“outward presentation test”), compared to Lords Briggs and Hodge at - and  (“subjective test”) and Lord Mance at -; obiter)
Brief comment for those who haven’t had enough yet: the judgment is obviously a positive one for the generic pharmaceutical industry and a negative one for the innovative pharmaceutical industry. The problem of proper protection for second medical use inventions is well known and has not been solved by the Supreme Court, which leaves it to the legislature. The increased burden of proving sufficiency within the patent itself will delay and increase the cost of filing patents on innovative medicines, and risks the invalidation of existing patents filed before this burden was raised. While this may reduce the cost of some medicines in the short term, the likely outcome is to dampen the incentive to develop innovative new products or expand the range of patients they can be used to treat.
Brief factual background for those new to the case: Warner-Lambert (a company in the Pfizer group) owned European patent EP 0,934,061, which claimed the use of pregabalin for the preparation of a pharmaceutical composition for treating pain (claim 1) and for treating neuropathic pain (claim 3). This is a patent claim to the use of pregabalin (a known compound) for pain, in an old style known as a “Swiss form” claim. “Swiss form” claims were used to cover second medical uses of known compounds until changes to the European Patent Convention allowed a simpler form of patent claim (which here would be pregabalin for use in a method for treating pain/neuropathic pain).
Warner-Lambert sold Lyrica (pregabalin) for use in epilepsy, generalised anxiety disorder (GAD) and pain. Actavis sold Lecaent (also pregabalin) for use in epilepsy and GAD only.
Mylan and Actavis sought to revoke the patent, claiming it lacked an inventive step and was insufficient. At first instance, the inventive step argument was rejected but the patent was found sufficient to the extent the claims covered inflammatory and peripheral neuropathic pain and insufficient to the extent they claimed central neuropathic pain. Warner-Lambert’s subsequent application to limit certain claims was rejected as an abuse of process. This was all upheld by the Court of Appeal.
Warner-Lambert also sought to enforce the patent against Actavis. Normal UK practice is for most prescriptions to be written under the generic name with no reference to the indication, and so it was entirely foreseeable that pharmacies would dispense Actavis' product to patients who had been prescribed it for pain, and they did. At first instance, it was held that the claims would not have been infringed even if they had been valid. The Court of Appeal laid down a different test but confirmed the point was obiter (non-binding) given the relevant claims were invalid.
Disclaimer: the Freshfields UK patent litigation team (in particular Christopher Stothers, Laura Whiting and Paul Abbott) represented EFPIA and ABPI as intervenors in the Supreme Court. However, this comment is strictly their own and should not be taken to represent the views of EFPIA or ABPI (or their members) in any way.