Indianapolis, Indiana – Patent attorneys for Eli Lilly and Company of Indianapolis, IN, and its subsidiary ICOS Corporation of Indianapolis, IN, initiated litigation alleging Synthon Pharmaceuticals, Inc. of Research Triangle Park, NC, have infringed the following two patents, as issued by the US Patent Office: Patent No. 6,821,975, titled BETA-CARBOLINE DRUG PRODUCTS, and Patent No. 7,182,958, titled BETA.-CARBOLINE PHARMACEUTICAL COMPOSITIONS.
This lawsuit arose after the defendant filed an Abbreviated New Drug Application (“ANDA”) with the FDA seeking approval to market a generic version of the Lilly drug ADCIRCA(R) prior to the expiration of the ‘975 and ‘958 patents and despite Lilly holding approved New Drug Application No. 022332 for the same drug in a dosage identical to that in the defendant’s ANDA. The defendant contends that the Lilly patents are invalid, unenforceable, or would not be infringed by its product.
Practice Tip: A generic drug must be identical to a formerly-patented drug in dosage form, safety, strength, route of administration, quality, performance characteristics, and intended use; a company seeking approval to market a generic drug is required to file an ANDA.Complaint – Eli Lilly v. Synthon
Further information about this case is as follows:
Filed: March 15, 2010 as 1:2010cv00310 Updated: June 11, 2010 00:00:19
Plaintiffs: ELI LILLY AND COMPANY and ICOS CORPORATION
Defendant: SYNTHON PHARMACEUTICALS, INC.
Presiding Judge: Judge Sarah Evans Barker
Referring Judge: Judge Jane Magnus-Stinson
Cause Of Action: Patent Infringement