23 Jul 2012, BioSpectrum Bureau , BioSpectrum
Singapore: The US Delaware District Court upheld Pfizer's composition of matter patent, and pain and seizure use patents covering LYRICA (pregabalin) capsules. With this decision, Pfizer will exclusively provide pregabalin as LYRICA to patients through December 30, 2018, in the US, pending generic company appeal and further litigation.
Ms Amy Schulman, executive VP and general counsel, Pfizer, said that, "The court's decision recognizes the infringement and validity of our LYRICA patents and affirms the value of LYRICA as a distinct and important innovation for patients. Protecting our intellectual property is vital to our ability to develop new medicines that save and enhance patient lives."
The court's decision affirms the strength of our patents and prevents the generic manufacturers from marketing their generic versions of LYRICA in the US before the patents expire, pending a possible appeal by the generic companies.
Pfizer and Northwestern University (NWU), which owns the patents covering the active ingredient pregabalin and the use for treating seizure disorders, filed suit in 2009 against the generic companies that applied to the FDA to market a generic version of LYRICA prior to the expiration of the patents covering pregabalin and its use.
Litigation on the same patents remains pending against other generic companies, but no trials have been scheduled in these later cases. Three separate patents are at issue in this case, including a patent covering the active ingredient pregabalin (expiring on December 30, 2018); a patent covering a method for using pregabalin to treat seizure disorders (expiring on October 8, 2013); and a patent covering methods for using pregabalin to treat pain (expiring on December 30, 2018).