Indianapolis, Indiana – Patent lawyers for Eli Lilly and Company of Indianapolis, IN, have initiated litigation alleging Fresenius Kabi Oncology PLC of London, United Kingdom, has infringed and will infringe the following two patents, as issued by the U.S. Patent Office: Patent No. 4,808,614, titled DIFLUORO ANTIVIRALS AND INTERMEDIATE THEREFOR, and Patent No. 5,464,826, 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 notes 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.
Maintaining that the ‘614 and ‘826 patents are invalid or at least would not be infringed, the defendant allegedly filed an Abbreviated New Drug Application (“ANDA”) with the FDA in the hopes of marketing a generic version of the Lilly drugs before the expiration of the respective patents. Accordingly, in this case, Lilly requests that the court declare the two asserted patents are valid and enforceable, that the ANDA filing infringes them, and that the defendant’s threatened acts would infringe the patents.
Practice Tip: Under U.S. law, willful, or knowing, infringement of a patent will result in increased damages owed to the patent holder, but a defendant’s mere ANDA filing by itself is not enough to establish that an infringement was willful.Complaint – Eli Lilly v. Fresenius
Further information about this case is as follows:
Filed: February 4, 2010 as 1:2010cv00147 Updated: April 2, 2010 00:03:06
Referring Judge:Magistrate Judge Debra McVicker Lynch
Cause Of Action: Patent Infringement