Generic Jardiance Draws Patent Lawsuit

Boehringer Ingelheim Pharmaceuticals Inc., and related entities filed a complaint against Dr. Reddy’s Laboratories Ltd. accusing the defendants of patent infringement under the “Food and Drug Laws and Patent Laws of the United States” due to the defendant’s submission of an Abbreviated Drug Application (ANDA) to the Food and Drug Administration (FDA).

According to the complaint, the defendants filed the ANDA to seek approval to manufacture and sell a generic version of the plaintiffs’ Jardiance (empagliflozin) tablets before the plaintiffs’ patent expired.

The complaint states, “On information and belief, DRL (Dr. Reddy’s Laboratories/ defendants) had knowledge of the ’323 patent and, by its promotional activities and package inserts for its ANDA Products, knows or should know that it will aid and abet another’s direct infringement of at least one  of the claims of the ’323 patent,  either literally or under the doctrine of equivalents. ”

The complaint claims that the plaintiffs will be financially harmed, substantially and irreparably, if the defendants aren’t enjoined from infringing upon their patent.

The plaintiffs seek the following for relief: a judgement the defendants have infringed on one claim of the plaintiffs’ patent, an enjoinment preventing further patent infringement by the defendants, monetary relief in the case the defendants sells product infringing on aforementioned patent, and costs and expenses.

The plaintiff is represented by Kirkland & Ellis LLP and Morris, Nichols, Arsht & Tunnell LLP.