Incyte Sues Sandoz Over a Generic Jakafi Ruxolitinib ANDA.

The case

The case is Incyte Corp. and Incyte Holdings Corp. v. Sandoz Inc., No. 1:26-cv-14205 (D.N.J.), a 15-page complaint for patent infringement filed October 30, 2026, Document 1. A docket minute entry that day adds Judge Christine P. O'Hearn and 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 Sandoz Inc. is a Delaware corporation with a principal place of business in Princeton, New Jersey. Subject-matter jurisdiction is pleaded under 28 U.S.C. §§ 1331, 1338(a), 2201, and 2202. The complaint alleges personal jurisdiction because Sandoz maintains its principal place of business in New Jersey, and it alleges venue under 28 U.S.C. §§ 1391 and/or 1400(b). A certification under Local Civil Rules 11.2 and 40.1 states, to the best of its signer's knowledge, that the matter is related to consolidated No. 24-4366 (D.N.J.) and to Nos. 25-1859, 25-13225, 25-13227, 25-17833, 25-17832, 26-2338, 26-7841, 26-7949, and 26-13702, because each involves or involved the same plaintiffs and overlapping patents-in-suit, and because the defendants are seeking FDA approval to sell a generic version of the same drug product. The certification also states, to the best of its signer's knowledge, that the matter in controversy is not the subject of any other action pending in any court, or of any pending arbitration or administrative proceeding.

The drug and the patents

The complaint says Incyte Corporation holds approved NDA No. 202192 for Jakafi (ruxolitinib). It asserts three patents that it says are listed in the Orange Book with respect to Jakafi under 21 U.S.C. § 355(b)(1): U.S. Patent 8,722,693, issued May 13, 2014; U.S. Patent 8,822,481, issued September 2, 2014; and U.S. Patent 8,829,013, issued September 9, 2014. All three are titled "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. Each patent names Incyte Corporation, of Wilmington, Delaware, as assignee. The '481 and '013 patents state that they are subject to a terminal disclaimer, and each is a continuation of application No. 14/097,588, now the '693 patent. The complaint alleges that each patent is presumed valid under 35 U.S.C. § 282, and 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.

What the patents claim

The complaint alleges infringement of one or more claims of each patent. U.S. Patent 8,722,693 has 10 claims. Claim 1 requires a phosphoric acid salt of (R)-3-(4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentylpropanenitrile. Claim 2 requires a drug product comprising that salt and a pharmaceutically acceptable carrier, and claim 4, which depends from claim 2, requires tablet form. Claim 5 requires a crystalline form of that phosphoric acid salt, and claim 7 requires a drug product comprising the crystalline salt and a pharmaceutically acceptable carrier.

U.S. Patent 8,822,481 has 28 claims. Claim 1 requires a method of inhibiting JAK1 and/or JAK2 in a patient in need thereof by administering an effective amount of that phosphoric acid salt. Claim 8 requires a method of inhibiting JAK1 and/or JAK2 by administering an effective amount of a pharmaceutical composition comprising that salt and a pharmaceutically acceptable carrier. Claim 15 requires a method of modulating an activity of JAK1 and/or JAK2 by administering an effective amount of that salt. Claim 22 requires a method of modulating an activity of JAK1 and/or JAK2 by administering an effective amount of a pharmaceutical composition comprising that salt and a pharmaceutically acceptable carrier.

U.S. Patent 8,829,013 has 14 claims. Claim 1 requires a method of treating a myeloproliferative disorder in a patient in need thereof by administering a therapeutically effective amount of that phosphoric acid salt. Claim 2 requires that the disorder is polycythemia vera, claim 3 that it is essential thrombocythemia, and claim 4 that it is myeloid metaplasia with myelofibrosis. Claim 7 requires a method of treating a myeloproliferative disorder by administering a therapeutically effective amount of a pharmaceutical composition comprising that salt and a pharmaceutically acceptable carrier. Claim 11, which depends from claim 7, requires that the composition is suitable for oral administration, and claim 12, which also depends from claim 7, requires that the composition is in tablet form.

The ANDA and the notice

The complaint alleges that Sandoz submitted ANDA No. 221379 seeking approval to engage in the commercial manufacture, use, sale, offer for sale, and/or importation of 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 Sandoz 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 Sandoz later sent Incyte written notice of those certifications, conveying that Sandoz seeks approval to market its proposed products before the patents-in-suit expire. On information and belief, following FDA approval Sandoz will make, use, sell, or offer to sell the proposed products throughout the United States and/or import them, and the proposed products will include prescribing information, similar to that for Jakafi, that instructs and encourages administration according to one or more of the methods claimed in the patents-in-suit.

The counts

Count I is headed Infringement of the '693 Patent, Count II Infringement of the '481 Patent, and Count III Infringement of the '013 Patent. Each count alleges a justiciable controversy as to infringement of that patent, and alleges that Sandoz's submission of ANDA No. 221379, with the accompanying Paragraph IV certification and notice, to engage in commercial manufacture, use, sale, offer for sale, and/or importation of the proposed products before that patent expires, constitutes infringement of one or more claims under 35 U.S.C. § 271(e)(2)(A). Each alleges that, unless enjoined, upon FDA approval Sandoz will infringe one or more claims under § 271(a) by making, using, offering to sell, selling, and/or importing the proposed products, will induce infringement under § 271(b), and will contributorily infringe under § 271(c). The inducement allegations state, on information and belief, that upon FDA approval Sandoz will intentionally encourage acts of direct infringement with knowledge of the patent and knowledge that its acts are encouraging infringement. The contributory allegations state, on information and belief, that Sandoz has had and continues to have knowledge that the proposed products are especially adapted for a use that infringes one or more claims and that there is no substantial non-infringing use for those products. Each count alleges that Incyte will be substantially and irreparably damaged if infringement is not enjoined, that Incyte does not have an adequate remedy at law, and that the case is exceptional and Incyte is entitled to reasonable attorneys' fees under 35 U.S.C. § 285.

The relief sought

The prayer asks for a judgment that Sandoz has infringed the patents-in-suit by submitting ANDA No. 221379 with the Paragraph IV certifications and notice; a judgment that Sandoz has infringed, and that making, using, selling, offering to sell, and/or importing the 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. 221379 be no earlier than the later of the expiration of the patents-in-suit or any later expiration of exclusivity to which Incyte is or becomes entitled; preliminary and permanent injunctions against Sandoz and its officers, agents, attorneys, and employees, and those acting in privity or concert with them, from making, using, offering to sell, selling, and/or importing the proposed products until after that expiration or later exclusivity; a permanent injunction under 35 U.S.C. § 271(e)(4)(B) against practicing any claimed subject matter, or actively inducing or contributing to infringement of any claim, until after that expiration or later exclusivity; a judgment that commercial manufacture, use, offer for sale, sale, and/or importation will directly infringe, induce infringement of, and/or contribute to infringement; damages for any acts with respect to the claimed subject matter other than those expressly exempted by 35 U.S.C. § 271(e)(1); damages and other monetary relief permitted by law, with interest, if commercial manufacture, use, offer for sale, sale, or importation occurs before the patents expire; a judgment declaring that the patents-in-suit remain valid and enforceable; a judgment 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 proof of service of the summons issued November 2, 2026, Sandoz's answer or a Rule 12 motion, and any consolidation or coordination with the actions listed in the Local Rule certification. The docket through November 2, 2026 includes the complaint, a corporate disclosure statement, an AO 120 form filed with the complaint and exhibits, and a summons issued as to Sandoz Inc. Any case can end at any time, including by settlement or voluntary dismissal.