The patent at issue in this complex and closely watched case was Pfizer’s original patent for Pregablin (sold as Lyrica). The $5.1 billion drug was originally developed for epilepsy. However further research showed that the drug was effective in helping patients that suffer from neuropathic pain. Whilst Pfizer’s original patent for Pregablin expired in 2014, it was awarded a secondary patent covering pain; this is valid until July 2017. The expiry of the original patent paved the way for companies such as Actavis (now known as Allergan) to introduce cheaper generic formulations, carrying a “skinny label” which limited the use of the drug to epilepsy and general anxiety disorder. Now, the drug is prescribed more for pain than for epilepsy.
Pfizer launched legal action to vigorously protect this lucrative monopoly access to patients. The drug giant had argued that the generic alternative introduced by Actavis and others, would inevitably be prescribed for the treatment of pain despite targeting non-protected indications, and thus infringing its patent.
A previous High Court decision in 2015 ruled in favour of Actavis.
Separate to the proceedings, Pfizer battled vigorously to protect Lyrica from competition, by threatening to sue National Health Service doctors for prescribing the generic pregablin to patients for pain and pharmacists for dispensing the drug. High Court judge Richard Arnold criticised Pfizer for the threat of legal action, he called the threats ‘groundless’ and commented that the letters “calculated to have a chilling effect on the willingness of pharmacies to stock and dispense generic pregabalin”. In the end Pfizer were forced to cover the expenses for doctors to switch existing pain scripts to the brand.
The Court of Appeal has now affirmed the earlier High Court decision that ruled that the patent covering pregabalin for pain is not infringed by Actavis.
Pfizer commented “it maintains its strong belief in the validity and importance of the second medical use patent for the use of Lyrica in pain” and advised that it now intends to seek permission to appeal the decision in the Supreme Court.
Tim Powell- a partner at Powell Gilbert- the law firm representing Actavis said in a statement “We welcome the Court of Appeal’s decision to uphold the trial judge’s findings and the guidance it has given on the infringement of second medical use patents”. He continued “The judgment offers a pragmatic way forward to strike a fair balance between the patentees’s right to a return for its investment in innovation and the generic manufactures right to sell into the non-patented market”.