Indianapolis, Indiana – Patent attorneys for Eli Lilly and Company of Indianapolis, IN, have initiated litigation alleging Sandoz, Inc. of Princeton, NJ, is infringing Patent No. 5,464,826, as issued by the U.S. Patent Officeand titled METHOD OF TREATING TUMORS IN MAMMALS WITH 2′,2′-DIFLUORONUCLEOSIDES.
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. 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 defendant allegedly filed a New Drug Application in the hopes of marketing a generic version of GEMZAR(R) before the expiration date of the ‘826 patent. Accordingly, in this case, Lilly requests that the court declare the ‘826 patent is valid and enforceable and that the defendant’s threatened acts would infringe the patent.
Practice Tip: In the United States, because an application to protect a pharmaceutical via a utility patent is filed before clinical trials begin, the effective life of a drug patent is often considerably less than the patent term, which is twenty years from the application date. However terms for pharmaceutical patents may be extended to account for delays in obtaining FDA approval.
Further Information about the case is as follows:
Filed: August 23, 2010 as 1:2010cv01057 Updated: August 25, 2010 04:08:13
Plaintiff: ELI LILLY AND COMPANY
Defendant: SANDOZ, INC.
Presiding Judge:Jane Magnus-Stinson
Referring Judge:Tim A. Baker
Cause Of Action: Patent Infringement