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23 September 2015Americas

BioMarin and Dr Reddy’s settle Kuvan row

US biotechnology company BioMarin Pharmaceutical has agreed to settle its patent infringement lawsuit against Dr Reddy’s Laboratories centring on its Kuvan (sapropterin dihydrochloride) drug.

Under the settlement, which BioMarin announced on Friday, September 18, Dr Reddy’s will be given a non-exclusive licence to market Kuvan-related patents.

The India-based company will also be given approval to market a generic version of 100mg sapropterin dihydrochloride tablets in the US. The generic drug, according to the settlement, will not be approved until more than five years from the date of the settlement, or earlier under certain circumstances.

BioMarin sued Dr Reddy’s in January this year at the US District Court for the Southern District of New York.

Kuvan is used to treat people with a certain type of phenylketonuria, a condition where the body is unable to break down a substance called phenylalanine, which builds up in the blood and brain.

High levels of phenylalanine can damage the brain.

Jeff Ajer, executive vice president and chief commercial officer of BioMarin, said: “This settlement agreement recognises the strength of the intellectual property related to Kuvan and helps to ensure that patients who depend on Kuvan will continue to receive the medication and the range of support services offered to patients for years to come.”

Additional details of the agreement remain confidential.

BioMarin added that, as required by law, the two companies will submit details of the agreement to the US Federal Trade Commission and Department of Justice.

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