PRESS RELEASE: AstraZeneca Files Patent Infringement Actions in Response to Crestorâ„¢ ANDAs

AstraZeneca Files Patent Infringement Actions in Response to Crestorâ„¢ ANDAs

AstraZeneca today announced that it has filed patent infringement actions in United States District Court, District of Delaware, against seven generic drug manufacturers, which have submitted Abbreviated New Drug Applications (ANDAs) for Crestorâ„¢
On 1st November 2007, AstraZeneca announced its receipt of a notice-letter from Cobalt Pharmaceuticals, Inc., notifying AstraZeneca that Cobalt had submitted an ANDA to the U.S. Food and Drug Administration (FDA). Cobalt’s ANDA sought approval to market generic versions of Crestor™ tablets prior to the expiration of patents covering Crestor™ tablets. Cobalt’s ANDA contained a Paragraph IV certification alleging that the U.S. patents owned or licensed by AstraZeneca, and listed in the FDA’s Orange Book referencing Crestor™, were not infringed or that the patents were otherwise invalid or unenforceable.

Since receiving Cobalt’s notice-letter, AstraZeneca has received similar Paragraph IV Certification notice-letters from eight additional generic drug manufacturers. AstraZeneca received notice letters from (1) Teva Pharmaceuticals, USA (Teva) on October 31, 2007; (2) Aurobindo Pharma Limited (Aurobindo) on November 5, 2007; (3) Apotex, Inc. (Apotex) on November 6, 2007 and December 5, 2007; (4) Par Pharmaceutical (Par) on November 6, 2007; (5) Sandoz Inc. (Sandoz) on November 12, 2007; (6) Mylan Pharmaceuticals Inc. (Mylan) on November 15, 2007; (7) Glenmark Pharmaceuticals, Inc. USA (Glenmark) on November 15, 2007; and (8) Sun Pharmaceutical Industries Ltd. (Sun) on November 19, 2007.

Each of the eight additional generic drug companies has notified AstraZeneca that it has submitted an ANDA to the FDA seeking approval to market generic versions of Crestor™ tablets before the expiration of the U.S. Patents owned or licensed by AstraZeneca. Each notice-letter contained a Paragraph IV certification notice alleging that one or more of the three Orange Book listed US patents referencing Crestor in the FDA’s Orange Book was not infringed or otherwise invalid or unenforceable.

Based on these various ANDA filings and Paragraph IV certifications, on 11th December 2007 AstraZeneca filed individual patent infringement actions in United States District Court, District of Delaware, against Aurobindo, Apotex, Cobalt, Par, Sandoz, Mylan, and Sun, alleging infringement of U.S. No. RE 37,314 (the ‘314 patent). AstraZeneca licenses the ‘314 patent from Shionogi & Co. Ltd.

Summary details of each notice–letter are as follows:

• Teva stated that its Paragraph IV certification alleges that the ‘460 patent and the ‘618 patent are invalid, unenforceable, and/or not infringed. AstraZeneca did not file patent infringement actions against Teva based on the ‘314 patent. Teva did not notify AstraZeneca that they intended to market generic rosuvastatin calcium tablets prior to the expiration of the ‘314 patent, which covers the active ingredient and expires in 2016.
• Aurobindo stated that its ANDA includes a “Paragraph IV” certification, alleging that the claims of U.S. Patent Nos. 6,316,460 B1 (the ‘460 patent), 6,858,618 (the ‘618 patent), and the ‘314 patent are invalid, unenforceable, and/or not infringed.
• Apotex stated that its Paragraph IV certifications alleges that the ’460 patent and the ‘314 patent are invalid, unenforceable, and/or not infringed.
• Par stated that its Paragraph IV certification alleges that the ‘460 patent and the ‘314 patent are invalid, unenforceable, and/or not infringed.
• Sandoz stated that its Paragraph IV certification alleges that the ‘460 patent, the ‘618 patent, and the ‘314 patent are invalid, unenforceable, and/or not infringed.
• Mylan stated that its Paragraph IV certification alleges that the ‘460 patent and the ‘314 patent are invalid, unenforceable, and/or not infringed.
• Glenmark stated that its Paragraph IV certification alleges that the ‘460 patent is invalid, unenforceable, and/or not infringed. AstraZeneca did not file patent infringement actions against Glenmark based on the ‘314 patent. Glenmark did not notify AstraZeneca that they intended to market generic rosuvastatin calcium tablets prior to the expiration of the ‘314 patent, which covers the active ingredient and expires in 2016.
• Sun stated that its Paragraph IV certification alleges that the ‘460 patent, the ‘618 patent, and the ‘314 patent are invalid, unenforceable, and/or not infringed.