Zydus infringed Takeda's patent, rules US court

Zydus Pharmaceutical USA, a subsidiary of Ahmedabad-based Cadila Healthcare, has lost a patent infringement suit in the US. Recently, a New Jersey district court ruled in favour of Japan’s Takeda Pharmaceutical Company, which had appealed to the court, saying Zydus’ proposed generic gastric relief drug would unfairly compete with its Prevacid SoluTab.

“The court finds Zydus infringed claim 1 of the 994 patent. The court further finds defendants have not established by clear and convincing evidence that claim 1 of the 994 patent is invalid. Consequently, the judgment shall be entered in favor of the plaintiffs,” the verdict said. US district judge Joel A Pisano barred Zydus from manufacturing or selling its proposed drug for the treatment of gastric ulcers until Takeda’s patent number 63,28,994 expired in 2019. Zydus could not be reached for comment.

Takeda had filed a case of patent infringement in response to Zydus’ abbreviated new drug application (ANDA) with the US Food and Drug Administration (US FDA), seeking approval to market and sell a generic version of Takeda’s

product Prevacid SoluTab.

The court further said, “If Zydus were to launch its ANDA product, Takeda would suffer the same, permanent harm it suffered as a result of Teva’s generic---immediate cannibalisation of market shares and sales.

Similar to the impact of Teva’s generic, Takeda would likely not be able to fully recover from the damage caused by the entry of Zydus’ generic prior to the expiration of the 994 patent.

The plaintiff would be irreparably harmed in that they would lose research and development opportunities that could have been funded by Prevacid SoluTab revenues if Zydus’ ANDA product is allowed to enter the market.”

In June last year, Arizona-based Medicis Pharmaceutical Corporation (MPC) had accused Zydus USA of seeking approval from US FDA to commercially manufacture, use and sell a generic version of Solodyn (minocycline hydrochloride) and extended release tablets (a drug for treating acne) before the drug’s patents, which were with MPC, expired.