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16-Nov-2018

Powell Gilbert Successfully Defends Actavis in Supreme Court Patent Battle with Warner-Lambert over Pregabalin Pain Treatment

Leading specialist IP law firm Powell Gilbert LLP has successfully represented Actavis, a leading manufacturer of generic pharmaceuticals, in its long running battle with Warner-Lambert concerning the blockbuster drug pregabalin (marketed by Warner-Lambert as Lyrica). Warner-Lambert alleged that Actavis infringed its patent for a new use of pregabalin in treating neuropathic pain by marketing a so-called “skinny label” product aimed at the off-patent, non-pain market. 

In today’s judgment, the Supreme Court held that Warner-Lambert’s patent was invalid. In a decision that is of key importance to the life sciences sector, the Supreme Court grappled with issues surrounding the plausibility of patents for new therapeutic uses of known drugs and what information must be provided by a patentee to substantiate a claim to a second medical use.

In addition to finding that Warner Lambert’s claim directed to the use of pregabalin in treating neuropathic pain was invalid, the Supreme Court allowed Actavis’ cross-appeal finding that claims to the use of pregabalin for treating specific sub-types of neuropathic pain were also invalid.

Even if the patent claims had been valid, the Court concluded that they would not have been infringed by Actavis’ “skinny label” product. In reaching this decision the Court gave important guidance on how a generic manufacturer could launch a drug for old uses without falling foul of a patent on a new therapeutic use. This guidance is likely to be influential for years to come.

This is a comprehensive win for Actavis in a very complex area of law. The question of when a  “second medical use” patent would be infringed has been a controversial issue, particularly where the generic manufacturer launches a product aimed at the non-patent market but NHS prescribing practices mean that it may also end up being dispensed for the patented use.

The full Supreme Court judgment may be found here.

Tim Powell, partner at law firm Powell Gilbert, commented:

This decision has major ramifications for the pharmaceutical industry as well as for the NHS, doctors and pharmacists prescribing and dispensing old drugs for new uses. In its comprehensive judgment the Supreme Court has sought to balance the interests of patent holders and those of the NHS seeking sources of cheaper generic drugs.”

Tim Powell and Bethan Hopewell led the team at Powell Gilbert which successfully represented Actavis. Warner Lambert was represented by Allen and Overy LLP. Taylor Wessing LLP represented Generics UK, Actavis’ co-respondents in the appeal.

 

Notes to Editors

Powell Gilbert LLP (www.powellgilbert.com) is one of the UK’s leading law firms specialising in intellectual property (IP) litigation, including patents, trademarks, design rights, copyright and confidential information. It advises a wide variety of clients on major UK and international IP-related issues across a range of sectors including pharmaceuticals, biotechnology and medical devices as well as electronics, telecommunications and consumer goods.

 

Background on the case

Pregabalin is used to treat epilepsy, anxiety disorders and neuropathic pain and has a market in the UK of over £200 million a year. Warner-Lambert’s patent protection over pregabalin itself expired in 2013. The dispute with Actavis centres on Warner-Lambert's patent for the use of pregabalin in treating pain (a so-called “second medical use” patent). 

 

Actavis commenced a claim to invalidate Warner-Lambert’s “second medical use” patent in September 2014 and later informed Warner-Lambert of its intention to launch a generic pregabalin product (with a so-called “skinny label”) aimed at the non-pain market. Warner-Lambert commenced infringement proceedings alleging that Actavis’ product would inevitably be dispensed for treating pain as well as for other non-pain disorders.

 

In January 2015 Warner-Lambert’s application for a preliminary injunction to restrain the sales of Actavis’ “skinny label” product was refused and Actavis launched its product in February 2015.  In addition to Actavis taking a number of steps to prevent use of its “skinny label” product for the treatment of pain, Warner-Lambert applied to the court for an order that NHS England be made to issue guidance to try to ensure that when doctors prescribe pregabalin for pain, they do so by reference to the brand name of Warner-Lambert’s product, Lyrica.  Guidance was issued by the NHS in March 2015.

 

The case went to trial in the High Court in June - July 2015.  Judgment was issued in September 2015, finding that Warner-Lambert’s asserted patent claims were invalid and had not been infringed.  Warner-Lambert was also held liable for making groundless threats of patent infringement proceedings based on communications directed to pharmacists and doctors. After judgment, Warner-Lambert applied to amend the patent so as to rescue it from invalidity.  This application was successfully opposed by Actavis and Mylan as constituting an abuse of the court’s process. 

 

The case was next heard by the Court of Appeal in May 2016 with judgment handed down in October 2016, dismissing all of the appeals.  The Court of Appeal’s judgment gave further guidance on what would amount to infringement of second medical use patents by a generic manufacturer and also upheld the High Court’s finding that the patent claims asserted by Warner-Lambert were invalid.  The court also agreed that Warner-Lambert’s post-trial application to amend the patent amounted to an abuse of process. All of these issues were the subject of the Supreme Court Appeal. 

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Last Updated: 16-Nov-2018