AstraZeneca Pharmaceuticals LP has filed another patent infringement suit against Mylan Pharmaceuticals Inc. alleging infringement of a patent for its cholesterol drug Crestor, just two weeks after filing off similar suits against Mylan and six other generics makers.
On Friday, AstraZeneca filed suit against West Virginia-based Mylan in the U.S. District Court for the Northern District of West Virginia, claiming Mylan’s recent ANDA infringes on U.S. Patent Number RE37,314 of Astrazeneca
Mylan filed its ANDA with the U.S. Food and Drug Administration earlier this year, seeking approval to market a generic version of Crestor, rosuvastatin calcium tablets, in 5 mg, 10 mg, 20 mg and 40 mg dosages. AstraZeneca learned of the ANDA by a letter from Mylan dated Nov. 13, the complaint said.
The suit is not much different from another one filed by AstraZeneca in the U.S. District Court for the District of Delaware on Dec. 11. Both complaints claim two counts of infringement of the ‘314 patent and are asking the district court to push the approval date of Mylan’s generic drug back until the patent expires.
In addition to Mylan, AstraZeneca also filed parallel suits against generic makers Apotex Inc., Sandoz Inc., Sun Pharmaceutical Industries Ltd., Par Pharmaceutical Inc., Aurobindo Pharma Ltd. and Cobalt Pharmaceuticals Inc. on Dec. 11 in Delaware District Court.
Since then, AstraZeneca has filed similar suits against Cobalt in the U.S. District Court for the Middle District of Florida on Dec. 13, and against Aurobindo in the U.S. District Court for the District of New Jersey on Dec. 18.
AstraZeneca received the first ANDA notice from Cobalt, alerting AstraZeneca that the company had filed an ANDA with the FDA seeking approval to market generic Crestor tablets before the patents covering Crestor expire, AstraZeneca said last month.
AstraZeneca added that Cobalt's ANDA contained a Paragraph IV certification claiming that the Crestor patents owned or licensed by AstraZeneca were either not infringed, invalid or unenforceable.
After Cobalt's letter, which AstraZeneca announced on Nov. 1, the company received eight similar Paragraph IV certification notice-letters from Teva Pharmaceuticals USA, Aurobindo, Apotex, Par, Sandoz, Mylan, Glenmark Pharmaceuticals Inc. USA and Sun Pharmaceutical, according to AstraZeneca.
When these eight companies notified AstraZeneca that they were seeking approval to market generic Crestor, they also alleged that one or more of the three Orange Book-listed patents referencing Crestor were invalid, unenforceable or not infringed.
AstraZeneca has not sued Glenmark or Teva because neither company told AstraZeneca that it wanted to market its proposed generic before the expiration of the patent asserted in those seven suits, an AstraZeneca spokesperson said last month.
AstraZeneca licenses the '314 patent, which covers Crestor's active ingredient, rosuvastatin calcium, from Shionogi & Co. Ltd. Glenmark's Paragraph IV certification challenged U.S. Patent Number 6,316,460 B1, which covers Crestor's formulation, while Teva's Paragraph IV certification said that the '460 patent and U.S. Patent Number 6,858,618 were invalid, unenforceable and/or not infringed. The '618 patent covers medical methods of use, AstraZeneca said.
AstraZeneca said in December that it was still weighing its options with respect to the '460 and '618 patents. However, no suit has yet been filed asserting those patents.
Crestor generated almost $2 billion in worldwide sales in the first nine months of 2007, and a little over $1 billion in U.S. sales during the same period.
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