Incyte Sues Hetero Over a Generic Jakafi Ruxolitinib ANDA.

The case

The case is Incyte Corp. and Incyte Holdings Corp. v. Hetero USA, Inc., Hetero Labs Limited Unit-V, and Hetero Labs Limited, No. 1:26-cv-13702 (D.N.J.), a 17-page complaint for patent infringement filed October 21, 2026, Document 1. The docket shows the case assigned to Judge Christine P. O'Hearn and referred to Magistrate Judge Matthew J. Skahill. The plaintiffs are Incyte Corporation and Incyte Holdings Corporation, Delaware corporations with a place of business in Wilmington, Delaware. The complaint alleges, on information and belief, that Hetero USA is a Delaware corporation with a principal place of business in Piscataway, New Jersey, and is the U.S. Regulatory Agent for Hetero Unit-V, including for ANDA No. 221679; that Hetero Unit-V is organized under the laws of India and is a division of Hetero Labs; and that Hetero Labs is organized under the laws of India with a principal place of business in Hyderabad, Telangana, India. Subject-matter jurisdiction is pleaded under 28 U.S.C. 1331, 1338(a), 2201, and 2202. A Local Civil Rule 11.2 and 40.1 certification states that the case is related to nine other Jakafi actions by the same plaintiffs, including consolidated Incyte Corp. v. Apotex Inc., No. 24-4366 (D.N.J.), and suits against Hikma, Sun, Granules, Eugia, Dr. Reddy's, Alkem, Alembic, and MSN, because each involves overlapping patents-in-suit and a defendant seeking FDA approval of a generic version of the same drug product.

The drug and the patents

Incyte Corporation holds approved NDA No. 202192 for Jakafi (ruxolitinib). The complaint asserts four patents that it says are listed in the Orange Book with respect to Jakafi: U.S. Patent 8,722,693, issued May 13, 2014; U.S. Patent 8,822,481, issued September 2, 2014; U.S. Patent 8,829,013, issued September 9, 2014; and U.S. Patent 10,016,429, issued July 10, 2018. All four carry the title "Salts of the Janus kinase inhibitor (R)-3-(4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentylpropanenitrile." The complaint says the patents-in-suit are owned by Incyte Corporation and/or Incyte Holdings Corporation. It alleges that the FDA-approved prescribing information for Jakafi instructs and encourages administration according to one or more of the methods claimed in the patents-in-suit.

The ANDA and the notice letter

The complaint alleges that Hetero submitted ANDA No. 221679 seeking approval to manufacture, use, sell, offer for sale, and/or import proposed generic versions of Jakafi 5 mg, 10 mg, 15 mg, 20 mg, and 25 mg tablets before the patents-in-suit expire. On information and belief, in connection with that ANDA Hetero provided Paragraph IV certifications under 21 U.S.C. 355(j)(2)(A)(vii)(IV), alleging that the claims of the patents-in-suit are invalid and/or will not be infringed by the activities described in the ANDA. The complaint says Hetero later sent Incyte written notice of those certifications, conveying that Hetero seeks approval to market its proposed products before the patents-in-suit expire. On information and belief, following FDA approval Hetero will make, use, sell, or offer to sell the proposed products throughout the United States and/or import them, and the proposed labeling will instruct administration according to one or more claimed methods.

The counts

Counts I through IV assert infringement of the '693, '481, '013, and '429 patents, respectively. Each count alleges that Hetero's submission of ANDA No. 221679 with the accompanying Paragraph IV certification and notice constitutes infringement of one or more claims of that patent under 35 U.S.C. 271(e)(2)(A), and that, unless enjoined, commercial manufacture, use, offer for sale, sale, or importation after FDA approval would infringe under 35 U.S.C. 271(a), induce infringement under 271(b), and contributorily infringe under 271(c). Each count also alleges that the case is exceptional and seeks fees under 35 U.S.C. 285.

The relief sought

The prayer asks for judgments that Hetero infringed the patents-in-suit by submitting ANDA No. 221679 with Paragraph IV certifications and notice, and that making, using, selling, offering to sell, and/or importing Hetero's proposed products will infringe one or more claims; an order under 35 U.S.C. 271(e)(4)(A) that the effective date of FDA approval of ANDA No. 221679 be no earlier than the later of the patents' expiration or any later exclusivity to which Incyte is or becomes entitled; preliminary and permanent injunctions, including under 35 U.S.C. 271(e)(4)(B); damages for any acts other than those exempted by 35 U.S.C. 271(e)(1), and damages if commercial launch occurs before patent expiry; a judgment that the patents remain valid and enforceable; a finding that the case is exceptional under 35 U.S.C. 285 with attorneys' fees; costs and expenses; and further relief the court deems just and proper.

What to watch next

Watch for Hetero's answer or Rule 12 motion, any consolidation or coordination with the related Jakafi Hatch-Waxman actions listed in the Local Rule certification, and District of New Jersey Hatch-Waxman scheduling.