Metformin hydrochloride extended release tablets: Ivax settle patent dispute with innovator Depomed after licensing agreement

Depomed will receive about $10 million in payment and royalties to settle patent infringement claims aginst Ivax. Depomed announced today that it has reached a settlement with IVAX (Now Teva Pharma), w.r.t the patent infringement lawsuit filed by Depomed against IVAX in January 2006, in which Depomed alleged infringement of Depomed's following patents which covers Extending the duration of drug release within the stomach during the fed mode.
US6340475 (Expiry: Sep 19, 2016)- which covers a controlled-release oral drug dosage form for releasing a drug whose solubility in water is greater than one part by weight of said drug in ten parts by weight of water, said dosage form comprising a solid polymeric matrix with said drug dispersed therein at a weight ratio of drug to polymer of from about 15:85 to about 80:20, said polymeric matrix being one that swells upon imbibition of water thereby attaining a size large enough to promote retention in the stomach during said fed mode, that releases said drug into gastric fluid by the dissolution and diffusion of said drug out of said matrix by said gastric fluid, that upon immersion in gastric fluid retains at least about 40% of said drug one hour after such immersion and releases substantially all of said drug within about eight hours after such immersion, and that remains substantially intact until all of said drug is released.
US6635280- which covers a controlled-release oral drug dosage form for releasing a drug whose solubility in water is greater than one part by weight of said drug in ten parts by weight of water, said dosage form comprising one or more polymers forming a solid polymeric matrix with said drug incorporated therein at a weight ratio of drug to polymer of from 15:85 to 80:20, said dosage form being one that when swollen in a dimensionally unrestricted manner as a result of imbibition of water is of a size exceeding the pyloric diameter in the fed mode to promote retention in the stomach during said fed mode, that releases said drug into gastric fluid by the dissolution and diffusion of said drug out of said matrix by said gastric fluid, that upon immersion in gastric fluid retains at least about 40% of said drug one hour after such immersion and releases substantially all of said drug after such immersion, and that remains substantially intact until substantially all of said drug is released.
The parties have entered into a settlement and license agreement that provides for a one-time payment to Depomed of $7.5 million, and a non-exclusive license to the asserted patents in favor of IVAX and Teva to continue to market their generic Glucophage (metformin hydrochloride extended release tablets) product in the United States under Depomed's patents. Depomed will also receive ongoing royalty payments from Teva on sales by IVAX and Teva of generic Glucophage XR. The royalty is subject to a $2.5 million aggregate cap.
The agreement also provides for the parties to dismiss their pending patent litigation and for a release of all claims associated with the litigation. Michael Plimack of Heller Ehrman LLP represented Depomed.
If innovator has a very strong patent on a particular technology then generic player should device strategy to get license on particular technology. If innovator demands high licensing fees then generic player can face a trial and during the trial in court generic player can settle with innovator with comparatively low licensing fees. Ivax adopted the same strategy on this dispute.
Other generic players on this product
ANDRX PHARMS, SANDOZ, IMPAX LABS, TEVA, RANBAXY, ACTAVIS ELIZABETH, BARR, IVAX PHARMS, MYLAN, APOTEX, NOSTRUM, COBALT, ZYDUS, AUROBINDO, MUTUAL, SUN PHARM and INTERPHARM