A suit was filed Friday in the District of Delaware against defendants Sun Pharmaceutical Industries Inc and OHM Laboratories, Inc (collectively, Sun) by plaintiffs Boehringer Ingelheim Pharmaceuticals Inc., and related entities. The complaint claims that the defendants infringed on patents connected to four drugs used to treat diabetes.
In August, the complaint said, a patent (the ‘323 patent) was issued to four individuals titled “Pharmaceutical composition, methods for treating and uses thereof.” Boehringer is a licensee of the patent. They currently hold four separate new drug applications (NDA’s) with the FDA for Jardiance, Glyxambi, Synjardy XR, and Trijardy XR, all of which are covered by the ‘323 patent.
The defendants have submitted four separate abbreviated new drug applications (ANDAs) with the Food and Drug Administration (FDA) for generic versions of the four aforementioned prescriptions, respectively. Boehringer asserts that Sun is well aware of the fact that each of their proposed new prescriptions would infringe on the ‘323 patent, yet have declared their “intent to manufacture, use, offer to sell, or sell,” each of the drugs regardless of the infringement, pending FDA approval.
The plaintiffs filed suit regarding the perceived infringement after receiving four notice letters informing Boehringer of Sun’s intent to file the ANDAs. Boehringer said that if the FDA is to grant approval to the four applications, Boehringer will be both substantially and irreparably harmed.
The complaint cites four separate counts of infringement for each drug. Boehringer is seeking favorable judgment regarding infringement for each of the four NDA’s, permanent injunctions against the defendants from producing, manufacturing, and selling any drugs protected by the ‘323 patent prior to its expiration date, and monetary relief in the case the Sun’s NDAs are approved.
The plaintiffs are represented by Morris, Nichols, Arsht & Tunnell, LLP.
