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15 November 2018Big Pharma

Warner-Lambert v Actavis ‘disappointing’ for innovators: lawyers

The UK Supreme Court’s decision in Warner-Lambert v Actavis is disappointing for pharmaceutical innovators, and enforcing second medical use patents may now be more challenging, lawyers have told LSIPR.

Yesterday, the Supreme Court dismissed Warner-Lambert’s (Pfizer’s) appeal in its patent dispute with Actavis, while upholding Actavis and Mylan’s argument that the disputed claims of the patent in question were not sufficient.

As explained by Matthew Royle, partner at Taylor Wessing in London, the case concerned striking the right balance between encouraging innovation in second medical uses and providing a framework in which a patent can be enforced.

However, he said that the decision means that enforcing second medical use patents may now be more difficult.

Yohan Liyanage, partner at Linklaters’ London office, similarly said that yesterday’s judgment “will be disappointing for innovator pharmaceutical companies” as it maintains a threshold plausibility test for therapeutic uses of previously known drugs, while also making it difficult for patent owners to prove that their patents are being infringed.

According to David Fyfield, associate at Charles Russell Speechlys, the court’s test strikes a fair balance by allowing applicants to secure second medical use patents without the need to support their claims with experimental data but by requiring the inclusion of something in the specification that makes the implied claim of efficacy at least plausible.

Warner-Lambert owns an EU patent for Lyrica (pregabalin), covering a second medical use of pregabalin for the treatment of inflammatory pain and neuropathic pain.

Actavis and Generics (trading as Mylan) sought to revoke the patent on the grounds of insufficient disclosure, and in response, Warner-Lambert accused the companies of infringing the patent’s claims.

In 2015, the English High Court held that the patent’s claim for treating neuropathic pain (claim 3)—both peripheral and central—was only partially plausible and concluded that the patent was invalid.

Warner-Lambert applied to amend claim 3, limiting it to peripheral neuropathic pain, but the court found this to be an abuse of process.

On appeal at the Supreme Court, Warner-Lambert argued that all claims of the patent are valid. The pharmaceutical company claimed that plausibility of disclosure is not a requirement for sufficiency under UK law, and all that is required is to show that the invention works.

As explained by Liyanage, the court yesterday looked to case law of the European Patent Office (EPO), before agreeing with the lower courts that plausibility of disclosure is a requirement for sufficiency under UK law.

Gregory Bacon, partner at Bristows in London, said that as the EPO’s stance on plausibility is similar to the approach taken by the court yesterday, this aspect of the judgment should not cause “too much concern” for the life sciences research and development industry, which has been aligned with this approach for years.

The Supreme Court ruled that the patent’s disclosure supports the claims in relation to inflammatory pain, but not neuropathic pain. It concluded that claims 1 (for treating any type of pain) and 3 (for treating neuropathic pain) fail for insufficiency.

Finally, the court found that, even if the claims were valid, Actavis and Mylan had not infringed the Lyrica patent, though the judges disagreed on what was required to establish infringement of a second medical use patent (see LSIPR’s summary of the views here).

Nick Sutcliffe, partner at Mewburn Ellis in Cambridge, said that the decision is potentially bad news for all patentees in the pharmaceutical and biotechnology fields.

“The ruling will make patents easier to avoid and more vulnerable to invalidation and thus weaken patent owners’ rights and ability to innovate with confidence,” he said.

In Sutcliffe’s opinion, in the future, patentees will need to provide a significantly broader range of evidence to justify the scope of their patent protection, which places an “onerous burden” on patent owners and increases the cost and uncertainty of obtaining and enforcing patents.

Bacon, who described his reaction to the decision as “one of frustration”, said that whether second medical use patents provide meaningful protection “has to be seriously doubted following this judgment”.

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More on this story

Big Pharma
14 November 2018   The UK Supreme Court today dismissed Warner-Lambert’s appeal in its pregabalin patent dispute with Actavis, while clarifying the role of plausibility in the sufficiency of patent applications.
Big Pharma
21 February 2018   Infringement and plausibility were the biggest issues on the battleground in the UK Supreme Court’s hearing in a case dealing with second medical use patents, as Claire Phipps-Jones, Katie Cambrook and Rachel Mumby of Bristows report.

More on this story

Big Pharma
14 November 2018   The UK Supreme Court today dismissed Warner-Lambert’s appeal in its pregabalin patent dispute with Actavis, while clarifying the role of plausibility in the sufficiency of patent applications.
Big Pharma
21 February 2018   Infringement and plausibility were the biggest issues on the battleground in the UK Supreme Court’s hearing in a case dealing with second medical use patents, as Claire Phipps-Jones, Katie Cambrook and Rachel Mumby of Bristows report.