FTSE 100-listed biopharmaceutical business AstraZeneca has entered into a settlement agreement in its US patent infringement litigation against Watson Laboratories, Actavis (formerly known as Watson Pharmaceuticals), and EGIS Pharmaceuticals regarding Watson's proposed rosuvastatin zinc product.
AstraZeneca reported that Watson, a successor of Cobalt, also agreed not to further appeal a decision by the US Court of Appeals for the Federal Circuit that upheld the validity and enforceability of the CRESTOR (rosuvastatin calcium) substance patent.
According to AstraZeneca's website, CRESTOR is prescribed along with diet to lower high cholesterol.
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Shionogi is also a party to the settlement agreement.
Under the agreement, AstraZeneca said that Watson and EGIS concede that the CRESTOR substance patent is valid, enforceable and would be infringed by Watson's rosuvastatin zinc product and its rosuvastatin calcium product.
The settlement agreement permits Watson to begin selling its generic version of CRESTOR and its rosuvastatin zinc product beginning May 2nd 2016, at a fee to AstraZeneca of 39% of net sales of Watson's products until the end of pediatric exclusivity on July 8th 2016.
The entry date could be earlier and the fees eliminated in certain circumstances, the group added.
AstraZeneca reported that all claims and counter-claims would be dismissed in a consent judgement entered by the US District Court for the District of Delaware.
The group said that the substance patent protecting CRESTOR expires on January 8th 2016.
Background: About the trialAstraZeneca brought suit against Watson and EGIS in the US District Court for the District of Delaware, alleging that Watson's rosuvastatin zinc NDA infringed AstraZeneca's substance patent covering CRESTOR.
Watson and EGIS filed counterclaims seeking declaratory judgment of non-infringement and invalidity of the substance patent. The trial took place between December 12th and 19th 2012.MF
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