InvaGen Agrees To Admit Infringing Diabetes Drug To End Suit

Law360
11 Jun, 2019 ,

Pharmaceutical companies Mitsubishi Tanabe Pharma Corp., Janssen Pharmaceuticals Inc., and Cilag GmbH International have asked a New Jersey federal judge to sign off on their deal to drop a patent infringement lawsuit against InvaGen Pharmaceuticals Inc. over its application for the generic version of Janssen's diabetes treatment Invokamet.

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Pharmaceutical companies Mitsubishi Tanabe Pharma Corp., Janssen Pharmaceuticals Inc., and Cilag GmbH International have asked a New Jersey federal judge to sign off on their deal to drop a patent infringement lawsuit against InvaGen Pharmaceuticals Inc. over its application for the generic version of Janssen's diabetes treatment Invokamet.

The trio agreed to dismiss with prejudice the allegations against InvaGen after it agreed to admit infringing a patent for Invokamet by attempting to get approval to sell a generic version, according to the proposed consent judgment filed Thursday. The judgment would also have InvaGen promise not to make or sell the proposed generic until the patent expired.

"InvaGen and its affiliates are hereby enjoined from manufacturing, using, offering for sale, selling in the United States, or importing into the United States, the InvaGen product until the expiration of the Invokamet patents, including any patent term extensions and/or patent term adjustments and during the period of any associated pediatric exclusivity, other than as authorized by plaintiff," the proposed judgment reads.

According to the complaint, which was filed in August 2017, InvaGen had submitted an abbreviated new drug application to the U.S. Food and Drug Administration seeking the agency's approval to market a generic alternative to Janssen's prescription Type 2 diabetes treatment Invokamet.

But InvaGen in its application to the FDA had inaccurately claimed that the patent for Invokamet, U.S. Patent No. 7,943,788, was invalid, the drug companies said.

The complaint had urged the district court to stop InvaGen from selling the generic version of Invokamet until the patent expired, saying that the ANDA infringed the '788 patent. Mitsubishi had obtained the patent in May 2011, and Janssen and Cilag are licensees of it, the filing said.

"Plaintiffs will be irreparably harmed by InvaGen's infringing activities unless those activities are enjoined by this court," the companies had said.

The case was later consolidated with another suit brought by the companies against Sandoz Inc. over its alleged infringement of the '788 patent. The Thursday filing doesn't cover the claims against Sandoz.