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David Reissner: Caught in manufacturers' crossfire

"Some of the burden of protecting Pfizer’s patent rights has been thrown on to pharmacists"

Pharmacists are getting embroiled in pharmaceutical companies' patent battles, says David Reissner

Pharmaceutical manufacturers such as Pfizer have huge amounts of money tied up in their branded products. They use the courts actively to try to protect their patent rights. They are out to make money, not friends. And pharmacies are increasingly being caught in the crossfire between manufacturers of branded products and generics companies.

A few years ago, when the main patent for Lipitor (atorvastatin) was about to expire, Pfizer's UK arm sued not only Teva, which had launched a generic version of the drug, but also pharmacy multiples, including Rowlands and Asda, that had stocked the generic version in readiness for the expiry of the patent.

At the time, it seemed like Pfizer had sued these pharmacies tactically to create tension between Teva and its customers. The case was eventually settled when Teva agreed not to sell generic atorvastatin until the patent for Lipitor expired.

A few weeks ago, Pfizer again took legal action, this time over Lyrica, the company’s pregabalin product. Lyrica can be used to treat epilepsy, anxiety disorders and certain types of pain.

The high court ruled earlier this year that the patent on Lyrica was only valid in relation to the treatment of peripheral neuropathic pain. This led to NHS guidance that Lyrica should be dispensed if a pharmacist has reason to believe that a pregabalin prescription is for the treatment of pain, but otherwise generic pregabalin can be dispensed.

As a result, some of the burden of protecting Pfizer’s patent rights has been thrown on to pharmacists.

Then, in October, Sandoz departed from the practice – common to generics companies – of including only mentions of epilepsy and anxiety, not pain, on pregabalin labels. It sold 100,000 packs to AAH, which were sold on to Lloydspharmacy.

In response, Pfizer rushed to the high court to obtain an emergency interim injunction against Lloydspharmacy, requiring it to send instructions to all its pharmacists and store managers insisting that pregabalin should not be dispensed if the label referred to pain. Mr Justice Birss decided that granting the injunction would preserve the status quo until the court could determine the legal rights of the parties.

There seems to be a constant stream of patent cases going through the courts. The Lyrica case suggests that pharmacy owners and pharmacists will remain at risk of becoming tangled up in the battles between the manufacturers of branded and generic medicines.

David Reissner is senior healthcare partner at law firm Charles Russell Speechlys ([email protected])

More from David Reissner

 

Should pharmacists protect brands' patents or supply the most appropriate medicines? 

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8 Comments

Anonymous Anonymous, Information Technology

You know you're in the wrong profession when professional letter writers a.k.a solicitors earn three times what you do!!

Leon The Apothecary, Student

Guess who is currently studying a BA in Law?

Really? Wow, Superintendent Pharmacist

The significant part of this conundrum has been completely missed. Rx Pregabalin 100mg BD Who holds the responsibility for deciding what product to give? A generic prescription has been written...why not give the generic? Is it now our responsibility to ask every patient why they are taking it? What if they do not know? In reality (IMO), with the current NHS pharmacy system we have, it is the prescribers job to do this. Pharmacy organisations should have been standing up from the beginning of this to publicly remove this responsibility. It is not funded and it is not practical. Also, to those mentioning about loss to the NHS, that is currently not the case....the DT price is still at Lyrica....so inappropriately giving the brand when generic could have been is actually a significant loss to the pharmacy.

Harry Tolly, Pharmacist

Interestingly, Reissner does not even mention once the impact on patients.

London Locum, Locum pharmacist

Because patients are not important. Money is king. As a lwyer he is well aware of this.

Margaret O'doherty, Community pharmacist

No mention of the additional cost to the NHS either.

Ben Merriman, Community pharmacist

As a lawyer, I doubt Mr Reissner is asked to contribute to the C&D for his knowledge of patient experiences. In any case, how will it impact patients? They'll still get the drug(s) they need when they need them. And there isn't an increase in cost to the NHS, there's just no reduction in price.

SP Ph, Community pharmacist

Well no reduction in price itself is a loss to the NHS !!!

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