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Pfizer loses pregabalin appeal

Supreme court judgement could force £500m NHS payout

November 28th 2018

Tagged: Clinical Zone news

By Ailsa Colquhoun

The UK Supreme Court has unanimously rejected an appeal by Pfizer subsidiary’s Warner-Lambert to repeal the cancellation of its patent for the use of pregabalin in the treatment of neuropathic pain.

According to legal analysts, the judgment leaves the Pfizer subsidiary facing a possible pay-out of up to £500 million to the National Health Service (NHS) and will also potentially make life sciences patents harder to obtain and easier to invalidate in the UK by upholding a higher threshold of plausibility

Warner-Lambert had asked the court to overturn a 2015 High Court decision – and subsequent Court of Appeal affirmation – which invalidated its patent for central neuropathic pain.  The appeal centred on the specified effectiveness of the drug for this condition.

The Supreme Court went further, also granting Actavis’ cross-appeal, which claimed that the patent application insufficiently disclosed pregabalin’s efficacy in treating peripheral neuropathic pain.

Although the patent in question expired in July 2017, the decision will come as a major blow to Warner-Lambert, which has fought hard to reverse the previous rulings. Estimates suggest that Pfizer could now have to repay the NHS as much as £502 million, to cover the extra amount spent on the drug between September 2015 and July 2017 when Warner-Lambert was challenging the invalidity ruling.

The ruling may also bad news for pharmaceutical inventors in general, potentially making patents harder to obtain and easier to invalidate.

Further legal analysis is available online.

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