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11 September 2015Big Pharma

UK court: Pfizer issued ‘groundless threats’ over Lyrica patent

The English High Court has ruled that Pfizer’s second medical use patent covering its drug Lyrica (pregabalin) is invalid and that the pharmaceutical company is liable for making “groundless threats” of infringement.

At the centre of the dispute, which the court ruled on yesterday, September 10, is European patent number 0,934,061, called “Isobuytlgaba and its derivatives for the treatment of pain”, owned by Pfizer.

It is a second medical use patent and is used to specifically treat neuropathic pain. The patent is set to expire in 2017.

Pfizer’s original Lyrica patent expired in 2013 and covered the treatment of epilepsy and general anxiety disorder (GAD).

In 2013 sales of Lyrica, which is marketed by Pfizer’s subsidiary Warner-Lambert, amounted to $4.6 billion globally and £310 million ($480 million) in the UK.

According to the NHS, there was a 53% increase in prescriptions for the drug in England between 2011 and 2013.

In December 2014 Pfizer sued Allergan (when it was known as Actavis), accusing it of infringing of the ‘061 patent through its Lecaent drug, a generic version of Lyrica.

Lecaent had been prescribed by NHS medical professionals to treat neuropathic pain as well as epilepsy and GAD.

But Pfizer argued that the prescription of Lacaent for neuropathic pain infringed its second medical use patent covering Lyrica.

Before Pfizer took action both Mylan, in June 2014, and Allergan, in September 2014, filed separate invalidity claims centring on the ‘061 patent at the court.

The invalidity claims, as well as Pfizer’s subsequent infringement claim, were consolidated in yesterday’s ruling, handed down by Mr Justice Arnold.

Arnold concluded that Pfizer’s patent was not obvious, but dealt the pharma company a blow in deeming the patent invalid on the grounds of “insufficiency”.

Furthermore, Arnold said that Pfizer had made “groundless threats” by sending notices to NHS medical professionals which told them that using generic versions of Lyrica to treat neuropathic pain infringed its patent.

In his ruling, Arnold said it should be the responsibility of the patent owner and generic companies to inform the NHS about the legal rights surrounding drugs that are prescribed to patients.

He said: “I consider that it behoves patentees who want their second medical use patents enforced to provide NHS England with all the information and assistance it requires to enable it to issue appropriate guidance as and when required. I also consider that it behoves generic companies who want their interests in obtaining untroubled access to lawful markets protected to cooperate with NHS England as well.

“I recognise that generic companies are always understandably reluctant to disclose their future commercial plans to anyone, but the potential interest of generic companies in a skinny label launch (whether or not pending a challenge to the validity of the patent) to avoid a second medical use patent will usually be obvious. In short, what is needed is a system for dealing with these situations,” he added.

Berkeley Phillips, UK medical director at Pfizer, said: “We know through our experience with the Lyrica situation that the absence of any national policy or framework for second medical use patents in the UK has been a cause of concern and confusion for many, including us.

“This was reflected on by the judge [Arnold] … who has highlighted the need for a national-level solution for second medical use patent situations of this nature that may arise at present and in the future,” he added.

Arty Rajendra, partner at law firm Rouse, said Arnold’s ruling was a carefully considered and clear assessment of the issues and that he was broadly correct to rule that the patent was invalid.

Furthermore, Rajendra said that Arnold’s proposal for a national framework for guiding the NHS on how to use drugs in a non-infringing way was a “sensible solution”.

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