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BOEHRINGER Ingelhein Pharmaceuticals Inc. v. Mylan Pharmaceuticals Inc.

Representative Claim(s)

U.S. 8,853,156 – claims 1 and 10

  1. 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 wherein the contraindication is selected from the group consisting of: renal disease, renal impairment or renal dysfunction, unstable or acute congestive heart failure, acute or chronic metabolic acidosis, and hereditary galactose intolerance.


  1. The method according to claim 1 wherein the metabolic disorder is type 2 diabetes mellitus and wherein the contraindication is renal disease, renal impairment or renal dysfunction, and wherein said DPP-4 inhibitor is used for said patient in the same dose as for a patient with normal renal function.


Appeal from District Court

Exception Category: None

“We hold that, consistent with this court’s decision in Vanda Pharms. Inc. v. West-Ward Pharms. Int’l Ltd., 887 F.3d 1117 (Fed. Cir. 2018), the claims are directed to a particular method of treatment under step one and are therefore patent eligible. The claims in Vanda involved a method of treating patients with schizophrenia that first required performing a genetic test to determine if a patient was a CYP2D6 poor metabolizer. Id. at 1121. Based on the results of that test, a particular dose of iloperidone was selected and internally administered. Id. As a result, the risk of QTc prolongation, a dangerous side effect, was decreased. Id. at 1121 & n.2. We held that the claims were not directed to a natural relationship between iloperidone, CYP2D6 metabolism, and QTc prolongation. Id. at 1134. While we acknowledged that the inventors had recognized the underlying relationships, we explained that those were not what was claimed. Id. at 1135. Instead, the claims were directed to a patent-eligible method of using iloperidone to treat schizophrenia, “a specific method of treatment for specific patients using a specific compound at specific doses to achieve a specific outcome.” Id. at 1136; see also Mayo, 566 U.S. at 87 (distinguishing the Mayo claim from “a typical patent on a new drug or a new way of using an existing drug,” because the Mayo claim did not “confine [its] reach to particular applications” of the natural laws relied upon).

The claims of the ʼ156 patent are likewise directed to a method of treating type 2 diabetes mellitus using a DPPIV inhibitor, such as linagliptin. That “certain DPP-IV inhibitors (including linagliptin) are metabolized by the liver rather than the kidney,” Appellees’ Br. 38, “does not make the claim ‘directed to’ that natural ability.” Rapid Litigation Mgmt. Ltd. v. CellzDirect, Inc., 827 F.3d 1042, 1049 (Fed. Cir. 2016) (stating that the “natural ability of the subject matter to undergo the process does not make the claim ‘directed to’ that natural ability”).

Because we hold that the claims are directed to a method of treatment at step one, we conclude the claims are patent eligible and need not reach step two. We do not, of course, at this stage address the issues of obviousness and obviousness-type double patenting with respect to these claims. Accordingly, we reverse the district court’s grant of judgment on the pleadings and remand to the district court for further proceedings.”

Boehringer Ingelheim Pharms., Inc. v. Mylan Pharms., Inc., 803 Fed. Appx. 397, 400-401, (Fed. Cir. 2020).