Tradjenta® (linagliptin)
Case Name: Boehringer Ingelheim Pharms. Inc. v. Apotex Inc., Civ. No. 23-685-CFC, 2025 WL 71979 (D. Del. Jan. 10, 2025) (Connolly, J.)
Drug Product and Patent(s)-in-Suit: Tradjenta® (linagliptin); U.S. Patents Nos. 9,486,526 (“the ’526 patent”) and 10,034,877 (“the ’877 patent”)
Nature of the Case and Issue(s) Presented: Apotex filed its ANDA with the FDA seeking approval to market a generic version of Tradjenta, an orally administered pharmaceutical tablet used to treat patients with type 2 diabetes mellitus. Boehringer Ingelheim (BI) alleged that Apotex’s submission of its linagliptin ANDA constituted infringement of the patents-in-suit. The patents-in-suit claim methods of treating type 2 diabetes mellitus using linagliptin in patients who have severe renal impairment and who, because they suffer from severe renal impairment, are not eligible for being treated with the drug metformin. Pending before the court is Apotex’s Rule 12(c) motion for judgment on the pleadings. The court denied Apotex’s motion insofar as it sought judgment of no induced infringement as a matter of law and granted the motion insofar as it sought judgment of no contributory infringement as a matter of law.
Why Apotex Prevailed (in part): Induced infringement requires that the defendant committed an “affirmative act of some kind” to “cause[ ], or urge[ ], or encourage[ ], or aid[ ] another to infringe a patent.” Apotex argued that it is entitled to a judgment of no induced infringement because its proposed label does not instruct, promote, or otherwise encourage doctors to use its ANDA product to treat patients who are ineligible for being treated with metformin. The court found that there was “much in the label that supports Apotex’s argument, and I would not be surprised if Apotex prevailed on this noninfringement theory at a trial.” The label specifically teaches in its discussion of various clinical trials that Apotex’s ANDA product can be used in combination with metformin—“that is, to use a treatment method that is the very opposite of the method claimed by the asserted patents.” But one sentence in Apotex’s proposed label states, “No dosage adjustment is recommended for patients with renal impairment[.]” Coupled with the fact that it is undisputed that patients who suffer from severe renal impairment are ineligible for metformin, and drawing all reasonable inferences in BI’s favor, a factual dispute therefore existed that precluded entry of judgment of no induced infringement as a matter of law.
Contributory infringement requires that: (i) there is direct infringement; (ii) the accused infringer had knowledge of the patent; (iii) the component has no substantial non-infringing uses; and (iv) the component is a material part of the invention. In a pharmaceutical case, the non-infringing use must be in accordance with the use for which the product is indicated. Apotex argued that because its proposed generic was “suitable for administration to diabetes patients who are eligible for metformin,” BI could not show that Apotex’s ANDA product had no substantial non-infringing use. BI argued that substantial non-infringing use was an intensely factual inquiry not suitable for determination at the pleading stage. The court disagreed, finding “it is undisputed that the use of Apotex’s ANDA product to treat patients with type 2 diabetes mellitus who are eligible for being treated with metformin is in accordance with the use for which it is indicated by Apotex’s proposed label and not unusual, far-fetched, illusory, impractical, occasional, aberrant, or experimental, Apotex is entitled to judgment of no contributory infringement as a matter of law.”
