ASTRAZENECA SETTLES LITIGATION OVER CRESTOR PATENT


AstraZeneca today announced that it has entered into a settlement agreement in
its US patent infringement litigation against Watson Laboratories, Inc.,
Actavis, Inc. (formerly known as Watson Pharmaceuticals, Inc.), and EGIS
Pharmaceuticals regarding Watson’s proposed rosuvastatin zinc product. Watson, a
successor of Cobalt, also agreed not to further appeal a decision by the U.S.
Court of Appeals for the Federal Circuit that upheld the validity and
enforceability of the CRESTOR® (rosuvastatin calcium) substance patent. Shionogi
is also a party to the settlement agreement.

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.

The settlement agreement permits Watson to begin selling its generic version of
CRESTOR and its rosuvastatin zinc product beginning May 2, 2016, at a fee to
AstraZeneca of 39% of net sales of Watson’s products until the end of pediatric
exclusivity on July 8, 2016. The entry date could be earlier and the fees
eliminated in certain circumstances.

All claims and counterclaims will be dismissed in a consent judgment entered by
the United States District Court for the District of Delaware. All other terms
remain confidential.

The substance patent protecting CRESTOR expires on 8 January 2016, and the
pediatric exclusivity period expires on 8 July 2016.

In compliance with the Medicare Prescription Drug, Improvement, and
Modernization Act of 2003, AstraZeneca will file the settlement agreement with
the United States Federal Trade Commission and United States Department of
Justice.

– ENDS –

NOTES TO EDITORS

About the trial

AstraZeneca brought suit against Watson and EGIS in the United States 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 12 and 19 December 2012.

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