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Tradjenta® Patent Infringement Allegations Dismissed for Covering Unpatentable Abstract Ideas

Posted in Drugs, Litigation, Patents

On December 8, 2016, Judge Sheridan of the District of New Jersey dismissed infringement allegations for various claims of U.S. Patent No. 8,853,156 (“the ’156 patent”), because they cover unpatentable abstract ideas.  The ’156 patent is alleged to cover Tradjenta®, which contains the active ingredient linagliptin and is FDA-approved as an adjunct treatment for Type 2 diabetes.  The asserted claims related to DPP-IV inhibitors, a class of compounds which is said to be eliminated via hepatic metabolism or biliary excretion, therefore avoiding side effects associated with renal excretion.

The claims at issue were all directed to “a method of treating and/or preventing metabolic diseases in a patient for whom metformin therapy is inappropriate due to at least one contraindication against metformin comprising orally administering to the patient a DPP-IV inhibitor . . . ” The Court held that “the act of administering the DPP-IV inhibitor tot the targeted patient population” was directed to an abstract idea.  The Court stated that the claims were not directed to a law of nature, because they are directed to “administering” a DPP-IV inhibitor.

Having satisfied the first step of the test set forth in Alice Corp. Pty. Ltd. v. CLS Bank Int’l, the Court went on to find that there was no “inventive concept” that transformed the claims into patent eligible subject matter.  In particular, the Court found that the claimed feature of a patient suffering from renal impairment and other conditions was well known in the art.  Therefore, the Court held, the claim “does not amount to significantly more than an abstract idea of providing an instruction for a medical care professional who is treating the targeted patient population.”  The Court also found that dependent claims related to the metabolic activity of the DPP-4 inhibitor were not transformative, because they further recited features of natural phenomena.