- Although the primary patent on Pfizer's Lyrica (pregabalin) for epilepsy and generalized anxiety disorder (GAD) has already lapsed, the secondary patent for neuropathic pain does not expire until 2017.
- Generic manufacturers have launched generic pregabalin for the primary indications. But many patients are using it for the neuropathic pain indication.
- Pfizer is claiming patent infringement because of the widespread use of pregabalin for neuropathic pain.
Pfizer has attempted to address patent infringement of pregabalin through various channels in the U.K., including not only the legal system, but also by going directly to prescribing physicians with a letter to the Royal College of Physicians, as well as the National Health Serivce (NHS). Nonetheles, Pfizer cites statistics showing that 80% of the pregabalin prescribed is used to treat neuropathic pain.
Currently, Pfizer has a court order against Allergan (which it filed while the company was still called Actavis), which is preparing to launch generic pregabalin, making it first to market with a generic version of Lyrica.
Next week, High Court Justice Richard David Arnold will hear the case in full.