Hatch–Waxman This, Wockhardt! —Eli Lilly Maintains Patent Exclusivity for Cymbalta®
The U.S. District Court for the Southern District of Indiana has issued an order prohibiting defendants from selling generic versions of Cymbalta (duloxetine hydrochloride) during the drug’s remaining patent term. The order arises from ongoing litigation in the case Eli Lilly and Co. v. Wockhardt Ltd.
This all started in 2008 when Wockhardt submitted an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval for generic Cymbalta tablets, using Eli Lilly’s data for Cymbalta, before the expiration of the patent term. As a result of the Hatch–Waxman Act, the first company is able to challenge a drug’s patent during the pioneer drug’s patent term. The Act gives this first-filer a 180-day market exclusivity, during which time other generic versions of the drug are precluded from entering the market—a major financial incentive for companies such as Wockhardt.
As a result of Wockhardt’s ANDA application, Eli Lilly filed an infringement lawsuit against Wockhardt, to which Wockhardt responded by claiming invalidity. The challenges to Cymbalta’s patent included a §103 obviousness challenge, as well as the following catch-all: “Failure to comply with one or more of the requirements of 35 U.S.C. §§ 101, 102, 103, and/or 112.”
Notwithstanding these challenges, the district court ordered Wockhardt to refrain from entering the market during Cymbalta’s existing patent term, which should last until at least June 2013. The order also requires that Wockhardt notify the FDA that it no longer seeks approval of their previously submitted ANDA during the patent term.
This is a significant win for Eli Lilly, a major innovation driven company that needs its market exclusivity to fund its research and development efforts for future drugs. Another year of Cymbalta being on the market likely means millions in revenue for Lilly. Robert Armitage, Senior Vice President and General Counsel for Eli Lilly, states, “We are very pleased with the District Court’s order that effectively maintains U.S. exclusivity for Cymbalta throughout its patented life…Protection of intellectual property rights is extremely important to the biopharmaceutical industry and the patients we serve. These rights provide assurances of market exclusivity that help support the development of the next generation of innovative medicine to treat unmet medical needs.”