Prinston Pharmaceutical Sued by Merck Over Generic Diabetes Treatment

A suit was filed on Monday in the District of Delaware by Merck Sharp & Dohme LLC against Prinston Pharmaceutical Inc. The complaint alleges that Prinston’s intent to make a generic version of its diabetes treatment will result in patent infringement.

The complaint explains that defendant Prinston is in the business of “manufacturing and selling generic versions of branded pharmaceutical drugs for the U.S. market.” Prinston, the complaint says, recently submitted an abbreviated new drug application, or ANDA, to the Food and Drug Administration (FDA) seeking approval for the manufacture and market a version of the medication Januvia prior to the expiration of Merck’s patent protecting the drug.

The plaintiff asserts in the complaint that the defendant’s proposed product is simply a generic version of Januvia, a sitagliptin phosphate oral tablet, described on its website as a medication that assists adults with type 2 diabetes in lowering their blood sugar.

The complaint alleges that the defendant’s filing of an ANDA and subsequent intent to produce a generic version of Januvia constitute patent infringement, and believe that after gaining FDA approval, their production of generic Januvia will continue to constitute infringement. Merck contends that their patent is valid, enforceable, and will be infringed upon by the defendant’s actions, stating that “Prinston has acted with full knowledge of the ‘708 patent and without a reasonable basis for believing that it would not be liable for infringement of the ‘708 patent.”

Merck argues that if the patent is further infringed upon, they will be substantially and irreparably harmed. The complaint cites patent infringement and declaratory judgment of infringement of the ‘708 patent. The plaintiff is seeking favorable judgment, that FDA approval of the defendant’s ANDA not come until the expiration of the ‘708 patent, an injunction preventing further infringement, litigation fees, and any other relief deemed just by the Court.

The plaintiff is represented by McCarter & English, LLP.