The Court of Appeal in London ruled on 13 October 2016 that it has upheld last year’s High Court decision that the patent covering Lyrica for pain relief has not been infringed by generic drug manufacturers Actavis and Mylan.
The drug’s manufacturer, Pfizer, says that it will seek a further appeal on the ruling.
Pfizer developed Lyrica (pregabalin) for the treatment of generalised anxiety disorder (GAD) and epilepsy, but the patent for this indication expired in 2013. When Pfizer discovered that pregabalin could also relieve pain, it took out a second medical use patent for Lyrica to cover this use, which expires in July 2017.
Meanwhile Actavis (now renamed Allergan) and Mylan launched their own generic versions of the drug to treat GAD and epilepsy.
Pfizer then claimed in December 2014 that Lyrica’s second medical use patent was being breached and took Actavis and Mylan to the High Court over patent infringement. Pfizer argued that it was inevitable that the generic version would be used for other conditions, but lost the case in September 2015.
A statement from Pfizer, published on 13 October 2016, says that it “maintains its strong belief in the validity and importance of the second medical use patent for the use of Lyrica in pain and intends to seek permission to appeal the decision to the Supreme Court”.
“Pfizer has always made clear that it has not sought to prevent the use of generic pregabalin to treat generalised anxiety disorder or epilepsy. Following the Court of Appeal’s judgement, and pending the outcome of its appeal to the Supreme Court, Pfizer will now seek to have the NHS England Pregabalin Guidance on prescribing and dispensing by brand name, Lyrica, limited to prescribing and dispensing for the types of pain in those patent claims upheld as valid by the Court of Appeal,” the statement says.