In a blow for the U.S. drugmaker, Pfizer lost a yearslong patent battle for its blockbuster pain drug Lyrica after the U.K. Supreme Court ruled against it Nov. 14, according to Reuters.
Lyrica, a $5 billion per year drug for Pfizer, originally was approved to treat epilepsy but further research revealed it could help patients suffering from neuropathic pain. These patients became the main, lucrative market for the drug
While its basic patent on the drug was set to expire five years ago in Europe, to prevent generic competition from entering, Pfizer secured a secondary patent that extended the exclusivity period for Lyrica. This second patent only applied to the neuropathic pain market.
Once the basic patent expired, generic drugmakers launched cheaper versions of Pfizer's medicine that had a "skinny label," meaning the drug could only be marketed as an epilepsy treatment.
Pfizer sued the generic companies, arguing that those versions would be prescribed to treat pain despite the skinny label. Those companies took the case to the U.K. Supreme Court, and during the legal fight Pfizer's secondary patent expired, making the case more a point of principle for Pfizer.
The Supreme Court ruled Nov. 14, that the secondary patent claims relevant to neuropathic pain were invalid, handing Pfizer a loss.