Indianapolis, Indiana – Patent lawyers for Eli Lilly and Company of Indianapolis, IN, have filed a lawsuit alleging Dr. Reddy’s Laboratories, Ltd. of Hyderabad, India, and Dr. Reddy’s Laboratories, Inc. of Bridgewater, NJ, will infringe Patent No. 5,464,826, titled METHOD OF TREATING TUMORS IN MAMMALS WITH 2′,2′-DIFLUORONUCLEOSIDES, as issued by the U.S. Patent Office.
The ‘826 patent covers the drug marketed under the name GEMZAR(R) for the treatment of abnormal masses of tissue known as neoplasms. The complaint states that, in a separate lawsuit, the ‘826 patent was found invalid on grounds of obviousness-type double patenting, but that Lilly has appealed to the Federal Circuit and believes the ruling will be reversed. Assuming validity, the ‘826 patent is set to expire in late 2012, and a six-month period of FDA-granted market exclusivity follows. Lilly also holds approved New Drug Application No. 20-509 for the use of GEMZAR(R) as a treatment for certain types of cancer.
The defendants allegedly plan on offering a generic version of the drug, have filed an Abbreviated New Drug Application (“ANDA”) to allow early marketing of the generic version, and taken the position that Lilly’s patent is invalid under the doctrine of obvious-type double patenting. Accordingly, in this litigation, Lilly requests that the court declare the ‘826 patent is valid and enforceable and that the defendants’ threatened acts would infringe the patent.
Practice Tip: The term of a utility patent is twenty years from the filing date of the earliest U.S. non-provisional application on which priority is based.
Further information about this case is as follows:
Filed: October 4, 2010 as 1:2010cv01251 Updated: October 4, 2010 21:05:11
Plaintiff: ELI LILLY AND COMPANY
Defendants: DR. REDDY’S LABORATORIES, INC. and DR. REDDY’S LABORATORIES, LTD.
Presiding Judge:Tanya Walton Pratt
Referring Judge:Tim A. Baker
Cause Of Action: Patent Infringement