'Generic Versus Pfizer's' Pregabalin Arguments Hit The Courts

Today's post from pulsetoday.co.uk (see link below) is another peek through the keyhole at how drug companies operate and how expired patents (not patients - but them too!) can throw huge spanners in the works. In this case, it's our old 'friends' Pfizer and their on/off drug Lyrica (pregabalin) which is the case in point. Pfizer is moving mountains to prevent new generic versions of the drug becoming medications of choice for home doctors and neurologists across the world. Irrespective of how dangerous Lyrica may be for certain forms of neuropathy patients, it's a major profit maker and patients' discomfort has never stood in the way of profit as far as big pharma is concerned. It's reached the High Courts but Pfizer may just have to get used to not always getting their own way in a brave new, post-patent world.

Drug giant's pregabalin claim thrown out of court, but GPs still have to switch patients 
14 September 2015 | By Caroline Price

A High Court judge has thrown out Pfizer’s patent claim over use of its drug Lyrica for neuropathic pain, meaning GPs’ efforts to switch patients to the branded version may have been unnecessary.

Despite the ruling, GPs will continue to be tasked with reviewing patients on pregabalin and switching some prescriptions to the branded form Lyrica in order to avoid infringing the patent until further notice.

This is because Pfizer is appealing the High Court judgment, which ruled that the company’s patent claim was invalid in the first place – and that drugs manufacturers supplying generic pregabalin would not have infringed any patent anyway.

The judge ruled ‘none of the claims of the patent is obvious over any of the prior art relied upon’ and that the patent claims for pregabalin’s use in treatment of neuropathic pain, idiopathic pain or fibromyalgia ‘are invalid on the ground of insufficiency’.

Judge Richard Arnold also ruled that ‘even if [the patent claims] are valid’, the generics manufacturers ‘have not infringed those claims’.

In a further blow to Pfizer’s position, the judge found Pfizer had made ‘groundless threats’ in writing to pharmacists to warn them not to dispense the generic drug for neuropathic pain.

Justice Arnold said letters and emails from Pfizer were ‘calculated to have a chilling effect’ on pharmacists stocking and dispensing a generic version of the drug.

But because of the appeal, NHS guidance for GPs to prescribe Lyrica for neuropathic pain and switch existing prescriptions for neuropathic pain over to Lyrica still holds.

Pfizer said in a statement: ‘The central guidance issued by NHS England in March 2015 directing the prescribing of Lyrica by brand name when pregabalin is used for the treatment of neuropathic pain remains unchanged at this time.

‘From the time of issue, it has always been envisaged that the guidance would remain in place until the patent proceedings had ended, following any appeals.’

NHS England told Pulse it was ‘carefully considering’ the ruling before making any decision to update guidance – but confirmed GPs should continue to follow the existing guidance and to switch prescriptions until further notice.

An NHS England spokesperson said: ‘NHS England is carefully considering the judgment handed down yesterday. Once the court order is received we will consider what steps are appropriate to consider in light of pregabalin guidance.’

Dr Nick Bray, the Somerset LMC vice-chair who put forward a motion at the LMCs Conference criticising Pfizer’s actions, said that GPs did not want to be caught in the middle of such a dispute.

He said: ‘GPs are keen to get this situation sorted out, and soon. Whilst the legitimate commercial concerns of the pharmaceutical industry need to be protected, the guidance relating to pregabalin/Lyrica has added considerably to the workload of practices, and probably also to prescribing costs.

‘GPs really don’t want to be caught in the middle of this sort of dispute, just to prescribe the most cost-effective treatment for their patients in the simplest possible way.’

During the court hearing in July, Pfizer had called for even tighter measures to get GPs to carry out the prescription switch-over, claiming the NHS guidance had only had ‘limited impact’ on prescribing.

It has even offered to reimburse GPs via the NHS or other bodies, in order to expedite the process, although the GPC warned practices they should not accept any payment – and it remains unclear whether pharmaceutical industry regulations would allow them.

Dr Andrew Green, chair of the GPC’s clinical and prescribing subcommittee said GPs should continue to follow the NHS guidance on switching patients to Lyrica until the legal proceedings are over.

Dr Green said: ‘While it is true that Pfizer has lost this case the judgement is complex and an appeal is pending, so I would not advise GPs to change their prescribing at the moment.’

http://www.pulsetoday.co.uk/clinical/prescribing/drug-giants-pregabalin-claim-thrown-out-of-court-but-gps-still-have-to-switch-patients/20020085.article#.Vfk1ZPT40u8