Pfizer announced that the U.S. District Court for the District of Delaware upheld its basic patent and the L-malate salt patent covering SUTENT® (sunitinib malate) capsules. This decision, which is subject to appeal, affirms Pfizer’s right to exclusively provide sunitinib malate as SUTENT to patients through the term of the patent, which expires in 2021.
“The Court’s decision acknowledges the validity and infringement of our patents and affirms the value of SUTENT, a standard of care in the treatment of advanced renal cell carcinoma,” said Douglas M. Lankler, executive vice president and general counsel for Pfizer. “Defending our intellectual property is crucial to our ability to discover and develop innovative new medicines, which is at the very core of what we do.”
Pfizer filed suit in June 2010 after Mylan Pharmaceuticals Inc. applied to the U.S. Food and Drug Administration (FDA) to market a generic version of SUTENT prior to the expiration of the patents covering sunitinib malate and its uses. After a four-day trial, the Court agreed that Mylan infringed the valid patents covering SUTENT.
The patents at issue are U.S. Patent Nos.6,573,293 and 7,125,905.