NEW YORK — A district court ruled in favor of Pfizer and Northwestern University in a patent infringement case relating to Lyrica (pregabalin).
The U.S. District Court for the District of Delaware upheld the drug maker's composition of matter patent and pain and seizure use patents covering the drug. With this, Pfizer will exclusively provide pregabalin as Lyrica to patients through Dec. 30, 2018 in the United States, pending generic company appeal and further litigation. Pfizer and Northwestern University, 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.
"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," said Amy Schulman, EVP and general counsel for Pfizer. "Protecting our intellectual property is vital to our ability to develop new medicines that save and enhance patient lives."
Three separate patents are at issue in this case: U.S. Patent No. 6,197,819 covers the active ingredient pregabalin and expires Dec. 30, 2018; U.S. Patent No. 5,563,175 covers a method for using pregabalin to treat seizure disorders and expires Oct. 8, 2013; U.S. Patent No. RE 41,920 covers methods for using pregabalin to treat pain and expires Dec. 30, 2018.
As previously reported, the Food and Drug Administration approved Lupin Pharmaceuticals' generic version of a drug earlier this month.