27 March 2013Americas

AstraZeneca settles Crestor patent dispute

UK pharmaceutical company AstraZeneca has reached a settlement with Actavis and Egis Pharmaceuticals that delays the release of generic versions of its cholesterol treatment Crestor.

The settlement follows a US Court of Appeals ruling in December 2012 upholding the validity of AstraZeneca’s patent for the drug, which was challenged by companies applying to market competing generics.

Firms including Teva, Sandoz and Mylan claimed AstraZeneca’s patent was obvious and invalid, but the court disagreed and ruled that the patent was enforceable and had been infringed.

Actavis, formerly known as Watson Pharmaceuticals, had been working on producing its own generic version of Creator but has now agreed not to release it until 2016.

According to a statement released on Monday, the agreement allows Actavis to sell generic Crestor tablets from May 2, 2016, provided it pays AstraZeneca 39 percent of net sales until its paediatric exclusivity for the drug expires on July 8.

Actavis and Egis have also agreed not to challenge the US Court of Appeal’s ruling. Further details of the settlement were not disclosed, but AstraZeneca said it will be filed with the US Federal Trade Commission and the Department of Justice.

Crestor is AstraZeneca’s biggest-selling drug—in 2012, it reported sales of $6.6 billion. But the company’s total revenues fell 15 percent in the first half of last year, as its market exclusivity for other blockbuster drugssuch as anti-depressant Seroquel expired.

Agreements delaying the release of generics are facing increasing scrutiny in the US and the Supreme Court began hearing arguments on the legality of so called "pay-for-delay" deals on Monday, March 25.

Paul Bisaro, president and chief executive of Actavis, said in a statement that the deal “will ensure that consumers will benefit from an earlier launch of a rosuvastatin calcium product” and “eliminates ongoing litigation and uncertainty of marketplace acceptance of a non-generically substitutable product, if Actavis had proceeded to launch the alternate product”.

A spokesperson for AstraZeneca said the deal “reaffirms the strength” of the company’s IP, adding: “under the agreement, 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”.

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