G2/21 decision – Plausibility
A decision has been made in respect of the G2/21 referral. We consider the referral and what the decision…
The drug Lyrica (Pfizer’s trademarked name for pregabalin) was originally developed for the treatment of epilepsy and generalised anxiety disorder. Subsequently it was found that this drug was also suitable for the treatment of pain. In the UK, last year, Pfizer’s sales of this drug totalled around £250m.
The original patent for the use of pregabalin expired in 2013, but a second medical use patent directed to the treatment of pain, was not due to expire until July 2017.
The expiration of the original patent paved the way for the manufacturers of generic drugs, including Mylan and Actaris, to make and sell their own generic versions of pregabalin for the treatment of epilepsy and general anxiety disorder. Pfizer initiated patent infringement actions against these generic manufacturers, arguing that the generic drugs would be prescribed for the treatment of pain, as well as for the treatment of epilepsy and generalised anxiety disorder.
Mr Justice Arnold’s judgement in the case, issued on 10 September 2015, found that the relevant claims (directed to the treatment of pain) were not obvious. However, these claims were found to be invalid on the ground of insufficiency.
Mr Justice Arnold also found Pfizer liable for making groundless threats in respect of patent infringement.
During the case Mr Justice Arnold highlighted the fact that in relation to the NHS there is a need to develop a national system to ensure that where second medical use patents exist, the appropriately branded product is dispensed to patients and not a generic equivalent of such products.
Following the issue of the decision Pfizer has indicated that it intends to appeal this ruling.
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