BioMarin Announces Kuvan Patent Challenge Settlement

(RTTNews) - BioMarin Pharmaceutical Inc. (BMRN) on Friday said it has entered into a settlement agreement with Dr. Reddy's Laboratories Inc. that resolves patent litigation in the United States related to BioMarin's Kuvan (sapropterin dihydrochloride) 100mg oral tablets.

Under the terms of the settlement, BioMarin will grant Dr. Reddy's a non-exclusive license to its patents related to Kuvan to allow Dr. Reddy to market a generic version of sapropterin dihydrochloride 100mg tablets in the U.S. for the indications approved for Kuvan beginning at a confidential date in the future, but which is more than five years from today, or earlier under certain circumstances. Additional details of the agreement remain confidential.

BioMarin continues to vigorously enforce its intellectual property related to Kuvan. This includes continuing its suit against Par Pharmaceutical, Inc., which is not affected by this settlement.

As required by law, BioMarin and Dr. Reddy will submit the Agreement to the U.S. Federal Trade Commission and the U.S. Department of Justice.