Teva Pharmaceutical Industries Ltd. has fired off a suit accusing Amgen Inc. of infringing its patent by making and selling Sensipar®, a drug indicated for the treatment of secondary hyperparathyroidism in patients with chronic disease on dialysis.
Teva has filed patent infringement lawsuit against Innovator Company Amgen for Cinacalcet process patent infringement in District court for Eastern district of Pennsylvania.
Teva got following process patent issued on the date of Nov 11, 2008.US7449603 (Plaintiff: Teva): Which covers process for the synthesis of Cincalcet having independent claims 1, 10, 16, 32, 41 and 42
Earlier, M/s Amgen sued Barr (Now, subsidiary of Teva) for filing Para IV on Cinacalcet (Sensipar) 30, 60 and 90 mg tablets in March, 2008. Subsequently, M/s Amgen sued Teva and Barr in Delaware district court in July, 2008.
(The Brigham and Women’s Hospital, NPS Pharmaceuticals and Amgen filed the lawsuit in the U.S. District Court for the District of Delaware after receiving notices that Teva and Barr planned to make generic versions of Sensipar (cinacalcet HCl). Both firms’ generic Sensipar ANDAs contained Paragraph IV certifications on the ’244, ’146, ’068 and ’003 patents. The ’244 patent expires in October 2015, and the others expire in December 2016.
NPS is the sole owner of the ’244 patent and owns the other patents with the Brigham and Women’s Hospital. Amgen holds exclusive licenses for each of the patents.
The three plaintiffs asked the court to order that the effective date of any FDA approval of generic Sensipar be no earlier than the expiration of the patents or any later date of exclusivity.
Based on IMS data, Sensipar had annual sales of approximately $377 million in the U.S for the 12-month period ending in May, according to Barr. The drug was approved in March 2004 by the FDA after a priority review. )
Now, it will be interesting to monitor counter litigation strategy of Teva against M/s Amgen.
So wait and watch!!!!!!
