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Pfizer loses UK patent protection for Lyrica in pain Posted 25/09/2015

Pharma giant Pfizer suffered a major blow in the UK on 10 September 2015 when the High Court in London ruled that claims of patent protection for the use of its blockbuster drug Lyrica (pregabalin) as a pain treatment were invalid.

Lyrica was first approved for generalized anxiety disorder (GAD) and epilepsy, for which the patent expired in July 2014. However, the pain indication for Lyrica was disclosed and claimed in a later patent, European patent EP 0 034-061, that does not expire until July 2017. That patent does not cover the use of Lyrica to treat epilepsy or GAD.

Generics makers, including Allergan (previously Actavis) and Mylan launched generics of Lyrica when the first patent expired, but sought approval only for use in GAD and epilepsy. However, Pfizer still sued, saying that it is for the neuropathic pain indication for which the majority of prescriptions are written and that since prescriptions in the UK are written using generic names the generic versions would be dispensed for pain, infringing the company’s patent.

Sales of Lyrica reached US$5.2 billion in 2014, making it Pfizer’s best-selling medicine, thus the pharma giant has been fighting hard to protect against use of Lyrica in the neuropathic pain indication. The company even sent letters warning UK doctors not to prescribe generic pregabalin for pain, as this would be infringing Pfizer’s patent, but to prescribe brand-name Lyrica instead [1]. This action had caused anger among the medical community, as it is against the normal prescribing habits of doctors in the UK, where prescriptions are typically written using generic names.

The UK court, however, decided that generics companies had not infringed Pfizer’s secondary patent and its patent claims directed generally to pain and neuropathic pain were invalid. The judge also accused Pfizer of making ‘groundless threats’ of legal action against UK doctors and pharmacies.

Pfizer said in a statement it was disappointed with the ruling and would appeal.

Editor’s comment
Readers interested to learn more about the generic pregabalin’s current situation and implications for health authorities are invited to visit www.gabi-journal.net to view the following manuscripts published in GaBI Journal:

Generic pregabalin; current situation and implications for health authorities, generics and biosimilars manufacturers in the future

Readers interested in contributing a research or perspective paper to GaBI Journal – an independent, peer reviewed academic journal – please send us your submission here.

Related article
Pfizer wins against generic versions of pain drug Lyrica

1. GaBI Online - Generics and Biosimilars Initiative. Pfizer warns UK doctors not to prescribe generic Lyrica for pain [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Sep 25]. Available from: www.gabionline.net/Generics/General/Pfizer-warns-UK-doctors-not-to-prescribe-generic-Lyrica-for-pain

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Source: Bloomberg, WSJ

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