Allergan Sues Drugmakers Over Linzess Generics
By Allergan USA Inc. hit four generic-drug makers with a suit Wednesday in Delaware federal court accusing them of jumping the gun on producing a generic version of its irritable bowel syndrome treatment Linzess.
In the suit filed on Wednesday, Allergan said Teva Pharmaceuticals USA Inc., Mylan Pharmaceuticals Inc., Sandoz Inc. and Aurobindo Pharma Ltd. rushed to apply to make generic Linzess capsules, which are prescribed to relieve symptoms of irritable bowel syndrome and chronic constipation, before the drug’s patents expire.
“Each of the defendants has participated in the preparation and/or filing of an (abbreviated new drug application) seeking approval to market and sell a generic version of plaintiffs' branded product, Linzess, and has distribution channels and plans to market and sell its generic product throughout the United States,” according to the complaint.
The Linzess makers said the generics developers are seeking ANDA approval that could conflict with the Linzess patents and asked the court to prevent the generics makers from entering the market too early.
Forest Laboratories LLC, Forest Laboratories Holdings Ltd., the exclusive licensees of the drug, and Ironwood Pharmaceuticals Inc. were also named as co-plaintiffs. The suit names nine patents allegedly covering the drug.
The applications specifically seek U.S. Food and Drug Administration approval to market the generic products, and they would infringe Linzess if the applications were approved before all nine of the patents expire, the complaint alleges.
It asks that the effective date of any approved ANDA application filed by the companies be set later than the expiration dates of the nine patents.
The suit also asks for monetary relief if any of the companies manufacture, sell or import generics that could compete with Linzess in the United States before the patents expire.
Counsel for Forest, Allergan and Ironwood could not immediately be reached for comment Wednesday.
Forest, Allergan and Ironwood are represented by Jack B. Blumenfeld and Maryellen Noreika of Morris Nichols Arsht & Tunnell LLP.
Counsel information for Teva, Mylan, Sandoz and Aurobindo was not immediately available.
The patents-in-suit are United States Patent Nos. 7,304,036, 7,371,727, 7,704,947, 7,745,409, 8,080,526, 8,110,553, 8,748,573, 8,802,628 and 8,933,030.
The case is Forest Laboratories, LLC et al v. Teva Pharmaceuticals USA, Inc. et al., case number 1:16-cv-01114-UNA, in U.S. District Court for the District of Delaware.
--Editing by Richard McVay and Kelly Duncan.
By Allergan USA Inc. hit four generic-drug makers with a suit Wednesday in Delaware federal court accusing them of jumping the gun on producing a generic version of its irritable bowel syndrome treatment Linzess.
In the suit filed on Wednesday, Allergan said Teva Pharmaceuticals USA Inc., Mylan Pharmaceuticals Inc., Sandoz Inc. and Aurobindo Pharma Ltd. rushed to apply to make generic Linzess capsules, which are prescribed to relieve symptoms of irritable bowel syndrome and chronic constipation, before the drug’s patents expire.
“Each of the defendants has participated in the preparation and/or filing of an (abbreviated new drug application) seeking approval to market and sell a generic version of plaintiffs' branded product, Linzess, and has distribution channels and plans to market and sell its generic product throughout the United States,” according to the complaint.
The Linzess makers said the generics developers are seeking ANDA approval that could conflict with the Linzess patents and asked the court to prevent the generics makers from entering the market too early.
Forest Laboratories LLC, Forest Laboratories Holdings Ltd., the exclusive licensees of the drug, and Ironwood Pharmaceuticals Inc. were also named as co-plaintiffs. The suit names nine patents allegedly covering the drug.
The applications specifically seek U.S. Food and Drug Administration approval to market the generic products, and they would infringe Linzess if the applications were approved before all nine of the patents expire, the complaint alleges.
It asks that the effective date of any approved ANDA application filed by the companies be set later than the expiration dates of the nine patents.
The suit also asks for monetary relief if any of the companies manufacture, sell or import generics that could compete with Linzess in the United States before the patents expire.
Counsel for Forest, Allergan and Ironwood could not immediately be reached for comment Wednesday.
Forest, Allergan and Ironwood are represented by Jack B. Blumenfeld and Maryellen Noreika of Morris Nichols Arsht & Tunnell LLP.
Counsel information for Teva, Mylan, Sandoz and Aurobindo was not immediately available.
The patents-in-suit are United States Patent Nos. 7,304,036, 7,371,727, 7,704,947, 7,745,409, 8,080,526, 8,110,553, 8,748,573, 8,802,628 and 8,933,030.
The case is Forest Laboratories, LLC et al v. Teva Pharmaceuticals USA, Inc. et al., case number 1:16-cv-01114-UNA, in U.S. District Court for the District of Delaware.
--Editing by Richard McVay and Kelly Duncan.