Pfizer’s Lyrica patents for pain are ruled to be invalid by UK Supreme Court. Credit: Acdx.

The UK Supreme Court has ruled against Pfizer in a long running legal case involving a second medical use patent for its Lyrica (pregabalin) drug.

Lyrica was initially developed for the treatment of epilepsy, but the associated patent expired in May 2013, which allowed other pharmaceutical companies to launch generic versions of the drug at lower prices.

Pfizer obtained a secondary patent for the use of Lyrica as a treatment for pain, inflammatory pain and neuropathic pain. This patent was valid until July last year.

The pharmaceutical giant, through its subsidiary Warner-Lambert, argued that generic formulations by Allergan (Actavis), Mylan and others were also used to treat pain  before the expiry of the pain-related patent, thereby infringing it.

However, in October 2016 the Court of Appeal ruled that the Lyrica patent for pain was not infringed by the generics.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

The Supreme Court upheld the ruling that patent claims relevant to the pain and neuropathic pain indications are invalid. It further removed patent protection for the manufacture of the drug for treating both peripheral and central neuropathic pain.

“The court holds, by a majority that the disclosure in the specification supports the claims in relation to inflammatory pain, but not neuropathic pain, whether peripheral or central.”

The Court added that the claims related to inflammatory pain are valid, however this lacks marketing authorisation.

In its press statement, the court said: “The court holds, by a majority that the disclosure in the specification supports the claims in relation to inflammatory pain, but not neuropathic pain, whether peripheral or central. Thus, the appeal is dismissed and the cross-appeal allowed.”

“The majority’s approach requires the patentee to demonstrate that the specification discloses some scientific reason why the implied assertion of efficacy in the patent claim may well be true.”

Pfizer responded to the judgement in a statement sent to PharmaPhorum, by saying: “[the ruling] has significant impact on innovation in public health. The period that a medicine is under patent is a critical phase in its lifecycle that fuels innovation – as science evolves and knowledge grows, patients increasingly benefit from ongoing research into new uses for existing medicines.

“As situations such as these are expected to become more common, it’s important for patients that pharmaceutical companies are able to protect patents, including second medical use patents.”