Boehringer Ingelheim Pharms., Inc. v. Mylan Pharms., Inc.

Because a method of treating a specific disease for specific patients using a specific compound at specific doses to achieve a specific outcome qualifies as patentable subject matter, the district court’s judgment finding otherwise was reversed.

March 16, 2020

Robins Kaplan GENERICally Speaking: A Hatch-Waxman Litigation Bulletin

Case Name: Boehringer Ingelheim Pharms., Inc. v. Mylan Pharms., Inc., No. 2019-1172, 2020 U.S. App. LEXIS 8393 (Fed. Cir. Mar. 16, 2020) (Circuit Judges Dyk, Moore, and Hughes presiding; Opinion by Moore, J.) (Appeal from D.N.J., Sheridan, J.)

Drug Product and Patent(s)-in-Suit: Tradjenta® (linagliptin); U.S. Patents Nos. 8,853,156 (“the ’156 patent”), 9,173,859 (“the ’859 patent”), and 8,673,927 (“the ’927 patent”)

Nature of the Case and Issue(s) Presented: The patents-in-suit claimed methods of treating metabolic diseases, such as diabetes, in a specific subset of patients for whom metformin, the traditional and widely used treatment for these diseases, was contraindicated. In particular, those patents claimed the administration of a a DPP-IV inhibitor, such as linagliptin. Defendants moved for partial summary judgment on the pleadings, alleging that claims 10-17, 24, and 25 of the ’156 patent were directed to ineligible subject matter under 35 U.S.C. § 101. The district court granted the motion, finding that the ’156 patent was directed to the “abstract idea” of “administering the DPP-IV inhibitor to the targeted patient population,” which was ineligible subject matter under 35 U.S.C. § 101 and the two-step framework of Alice Corp. v. CLS Bank Int'l, 573 U.S. 208, 217 (2014). A bench trial ensued on the ’859 and ’927 patents. The district court held the asserted claims of those patents invalid for obviousness-type double patenting in light of the claims of U.S. Patent No. 8,178,541, and invalid as obvious in view of U.S. Patent Application Publication No. 2004/0097510. Boehringer appealed. The Federal Circuit reversed the district court’s judgment that the claims of the ’156 patent were directed to ineligible subject matter under 35 U.S.C. § 101 and affirmed the judgment that the asserted claims of the ’859 and ’927 patents were invalid for obviousness and obviousness-type double patenting.

Why Boehringer Prevailed: Boehringer argued that the claims were directed to a “method of treating a specific disease for specific patients (with renal impairment) using a specific compound (linagliptin) at specific doses (same dose in patients with renal impairment as in patients with normal renal function) to achieve a specific outcome.” Mylan argued that the claims were directed to the natural law that “certain DPP-IV inhibitors (including linagliptin) are metabolized by the liver rather than the kidney.” The Federal Circuit held, consistent with its decision in Vanda Pharms. Inc. v. West-Ward Pharms. Int’l Ltd., 887 F.3d 1117 (Fed. Cir. 2018), the claims were directed to a particular method of treatment under step one and were therefore patent eligible. That certain DPP-IV inhibitors (including linagliptin) were metabolized by the liver rather than the kidney did not make the claim directed to that natural ability. Whether those claims were obvious was an issue for a remanded trial.

Regarding the ’859 and ’927 patents, the district court held that the claims at issue were invalid for obviousness-type double patenting in light of the claims of Boehringer’s earlier-expiring ’541 patent. It also held that the claims would have been obvious in light of the ’510 publication, the priority application with the same specification as the ’541 patent. The Federal Circuit found that the parties presented alternative views of the evidence, and that where there were two permissible views of the evidence, the factfinder’s choice between them could not be clearly erroneous. Therefore, it affirmed the district court’s findings on obviousness and obviousness-type double patenting.

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