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Pfizer apologises ‘for causing GPs concern’ over pregabalin patent enforcement

Drugs giant Pfizer has written an open letter apologising for ‘causing GPs concern’, after its legal action led to practices being forced to re-issue prescriptions for pregabalin with the branded form Lyrica.

Pfizer said it recognised that ‘discussion and media reporting’ about the policy had caused some clinicians concern, adding that ‘we apologise if this has been the case’.

And the company said it had been working hard with the Government and NHS policy makers for the past 12 months to ‘find the best way of supporting healthcare professionals’.

Pfizer is in the process of taking Actavis and other generics manufacturers of pregabalin to court, to prevent infringement of a ‘second medical use’ patent it claims to hold for the drug’s use specifically in neuropathic pain.

As a result, a recent interim High Court judgment ruled that GPs should be told they must now only prescribe pregabalin by its brand name – Lyrica – when giving it to patients for neuropathic pain, although they may continue to prescribe by the generic name for anxiety or epilepsy.

However GPs have reacted angrily to the directive, which they say encroaches on their fundamental prescribing rights and principles, and LMCs recently voted to push the Government to stop companies from enforcing second medical patents in the future.

The letter from Dr Berkely Phillips, medical director at Pfizer UK, and Seema Patel, established pharma medical director at the company, states: ‘There has been some discussion and media reporting about our patent for the use of Lyrica (pregabalin) in pain over recent months. We recognise this has been the cause of concern for some of you; and we apologise if this has been the case.

‘We hope this letter will help to bring further clarity and reassurances to all concerned.’

The letter adds that Pfizer has done over 50 clinical studies of pregabalin specifically for the treatment of neuropathic pain and that ‘it is only as a result of our investment in this additional research programme that millions of patients have had access to this important treatment’.

It goes on to acknowledge that ‘the evolving R&D model and the forging of new ways are not without challenges for the NHS or industry’, adding that ‘we have been working with senior Government officials and NHS policymakers in England and the devolved administrations for almost 12 months to identify the best way of supporting healthcare professionals and communicating this relatively unusual and complex patent situation’.

And it concludes that Pfizer is ‘committed to doing the right thing for patients and the NHS, and we will continue to work with policymakers to find ways of supporting implementation at a local level’ and that ‘we hope that any framework that is put in place as a result of this work makes things easier for all and, ultimately, ensures that patients have access to life-saving and life-changing medical innovations of the future’.

LMCs recently dismissed the case for manufacturers to enforce such second patents at the LMCs Conference last month.

Dr Andrew Green, chair of the GPC’s clinical and prescribing committee, said: ‘At the LMC conference there was a debate about patent protection at which I took care to ensure the position of the drug companies as outlined in this extraordinary letter were aired; having heard this GPs were clear in their opposition to this behaviour.

‘GPs are experts at reading between the lines of what is said and drawing their own conclusions as to the true motives behind peoples’ actions, and I leave it up to my colleagues to decide whether Pfizer is demonstrating by its actions as well as this letter that it is committed to doing the right thing for patients and the NHS.’

Liverpool GP Dr Andrew Mimnagh said it was ‘gratifying that Pfizer acknowledges the additional workload from the company’s action, leaving the Department of Health starkly isolated from reality in maintaining that it had no significant detrimental impact on GPs.’

The full High Court hearing into Pfizer’s action to uphold the patent on neuropathic pain will take place on 29 June.

Readers' comments (7)

  • I think Pfizer has a right to protest and take matters to Court if they feel their patent rights are being encroached upon. One must remember that introducing a new drug into the market from producing the initial ingredient and going through clinical trials from phase 1-3 before actual registration takes years and can cost anything up to 500 million USD to launch.
    The question here is whether the High Court has not been excessive in its judgment depriving GPs the right to decide what they prescribe. Apologies of Pfizer are welcome and hope this confusion and distress caused to GPs will not be repeated in future by other Companies and Courts. Inform us and let us make our own decisions please.

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  • There is a fine balance between aiming to recoup the costs of investing in developing new drugs and milking an existing patent for most benefits at expense of others
    Pfizer should have rather directed the the efforts to develop a local solution with the GP Soc providers to help switch same easily-and to pay CCG`s a nominal amount to help their pharmacists support practices to switch the same easily- eg. MIQUEST search on indications for initial issue of the same and also search for read codes for pain/anxiety etc and then GP just Ok`s or veto the search result which should batch convert the same to Lyrica. This would have meant the profession wouldn't have felt isolated and also (pfizer) can maintain its profit .
    When faced with an option to buy Pfizer product which is same quality and cost as a competitor, I will go for the competitor as the brand is slightly toxic to me now. Also as per NICE guidelines for Neuropathic pain which include TCA, Gabapentin , Duloxetine and then Lyrica, I will try other three first always!!!

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  • pfizer should perhaps realise that when you're in a hole you should stop digging.

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  • We were grateful to pfizer for rationalising our prescribing to Gabapentin...are they only now responding to the after-effects of their own goal?!

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  • Sympathy for pfizer? oh please, they have obviously just realized their stunt has led to reduced levels of prescribing.

    A vast percentage of what they spend 'developing' new drugs actually goes on PR and marketing anyway.

    They are making billions and abuse the patent system (evergreening , etc) to make even more.

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  • Stop prescribing the drug - end of.

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  • As a patient with MS and some neuropathic pain.

    Pfizer's aggressive stance on this drug (which may help me) has caused me to become very anxious.

    Did they realise this when they made the announcement ?

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