DCT

1:24-cv-04366

Incyte Corp v. Apotex Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:24-cv-04366, D.N.J., 03/28/2024
  • Venue Allegations: Venue is alleged to be proper because the defendant, Apotex, is a foreign corporation organized under the laws of Canada and may be sued in any judicial district.
  • Core Dispute: Plaintiff alleges that Defendant’s submission of an Abbreviated New Drug Application to the FDA for a generic version of the drug Jakafi® (ruxolitinib) constitutes an act of infringement of five patents covering the ruxolitinib compound, its salt forms, compositions, and methods of use.
  • Technical Context: The technology is in the field of small-molecule therapeutics, specifically Janus kinase (JAK) inhibitors, which are used to treat myeloproliferative neoplasms and other diseases by modulating key cell signaling pathways.
  • Key Procedural History: This action was initiated under the Hatch-Waxman Act following Defendant’s submission of Abbreviated New Drug Application (ANDA) No. 208869 to the FDA. The complaint states that Defendant provided a Paragraph IV Certification alleging that the patents-in-suit are invalid and/or will not be infringed by the proposed generic product.

Case Timeline

Date Event
2005-12-13 Earliest Priority Date for ’257 and ’362 Patents
2007-06-13 Earliest Priority Date for ’693, ’481, and ’013 Patents
2009-10-06 ’257 Patent Issued
2013-04-09 ’362 Patent Issued
2014-05-13 ’693 Patent Issued
2014-09-02 ’481 Patent Issued
2014-09-09 ’013 Patent Issued
2024-03-28 Complaint Filing Date

II. Technology and Patent(s)-in-Suit Analysis

No probative visual evidence provided in complaint.

U.S. Patent No. 7,598,257 (the “’257 Patent”) - Heteroaryl substituted pyrrolo[2,3-b]pyridines and pyrrolo[2,3-b]pyrimidines as janus kinase inhibitors, Issued October 6, 2009

The Invention Explained

  • Problem Addressed: The patent describes that dysregulated activity of protein kinases, and specifically the Janus Kinase (JAK) family, is implicated in numerous diseases, including cancer and immune-related disorders (Compl. Ex. A, ’257 Patent, col. 1:18-45). The background notes a need for new therapies that can treat such diseases by modulating the activity of JAKs (’257 Patent, col. 5:24-60).
  • The Patented Solution: The invention provides a genus of chemical compounds, identified as “Formula I,” which are described as heteroaryl-substituted pyrrolo[2,3-b]pyridines and pyrrolo[2,3-b]pyrimidines (’257 Patent, Abstract; col. 6:50-65). These compounds are disclosed as being useful for modulating the activity of JAKs and for treating diseases associated with JAK activity (’257 Patent, col. 6:50-65).
  • Technical Importance: The patent claims a class of compounds that inhibit the JAK signaling pathway, a key therapeutic target for various myeloproliferative neoplasms and inflammatory conditions (’257 Patent, col. 3:1-5:23).

Key Claims at a Glance

  • The complaint does not identify specific asserted claims, alleging infringement of "one or more of the claims" of the patent (Compl. ¶29). Analysis of specific claim elements is therefore not possible based on the complaint alone.

U.S. Patent No. 8,415,362 (the “’362 Patent”) - Pyrazolyl substituted pyrrolo[2,3-b]pyrimidines as Janus kinase inhibitors, Issued April 9, 2013

The Invention Explained

  • Problem Addressed: Similar to the ’257 Patent, this invention is directed to the need for therapeutic compounds that can modulate the activity of the JAK family of protein kinases to treat a range of diseases, including immune disorders and cancers (’362 Patent, col. 1:15-41).
  • The Patented Solution: The patent discloses and claims compounds that are pyrazolyl-substituted pyrrolo[2,3-b]pyrimidines (’362 Patent, Abstract). Notably, claim 19 recites the specific compound 3-cyclopentyl-3-[4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl]propanenitrile, which is known as ruxolitinib, the active ingredient in Jakafi® (’362 Patent, col. 393:13-18; Compl. ¶11).
  • Technical Importance: This patent claims the specific chemical entity ruxolitinib, which became the first FDA-approved JAK inhibitor for treating myelofibrosis, representing a significant development in the treatment of myeloproliferative neoplasms (Compl. ¶10-11).

Key Claims at a Glance

  • The complaint does not identify specific asserted claims, alleging infringement of "one or more of the claims" of the patent (Compl. ¶38).

U.S. Patent No. 8,722,693 (the “’693 Patent”) - Salts of the Janus kinase inhibitor (R)-3-(4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentylpropanenitrile, Issued May 13, 2014

  • Technology Synopsis: The patent states a need for new or improved forms of Janus kinase inhibitors for developing more effective pharmaceutical formulations (Compl. Ex. C, ’693 Patent, col. 2:19-27). The invention provides specific salt forms of ruxolitinib, including the maleic acid, sulfuric acid, and phosphoric acid salts, which are disclosed as having advantageous properties such as crystallinity, stability, and improved solubility that facilitate pharmaceutical formulation (’693 Patent, Abstract; col. 2:28-42; col. 3:3-9).
  • Asserted Claims: The complaint alleges infringement of "one or more claims" (Compl. ¶47).
  • Accused Features: The accused infringement is Apotex's submission of an ANDA to market a generic version of Jakafi® (ruxolitinib) (Compl. ¶47).

U.S. Patent No. 8,822,481 (the “’481 Patent”) - Salts of the janus kinase inhibitor (R)-3-(4-(7H-pyrrolo[2,3-d] pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentylpropanenitrile, Issued September 2, 2014

  • Technology Synopsis: This patent is also directed to specific salt forms of the ruxolitinib compound (Compl. Ex. D, ’481 Patent, Abstract). Like the ’693 Patent, it seeks to address the need for improved forms of the JAK inhibitor suitable for pharmaceutical development. The claims are directed to methods of treating myeloproliferative disorders using the phosphoric acid salt of ruxolitinib (’481 Patent, col. 12:5-14:15).
  • Asserted Claims: The complaint alleges infringement of "one or more claims" (Compl. ¶56).
  • Accused Features: The accused infringement is Apotex's submission of an ANDA to market a generic version of Jakafi® (ruxolitinib) (Compl. ¶56).

U.S. Patent No. 8,829,013 (the “’013 Patent”) - Salts of the Janus kinase inhibitor (R)-3-(4-(7H-pyrrolo[2,3-D]pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentylpropanenitrile, Issued September 9, 2014

  • Technology Synopsis: This patent continues the theme of the ’693 and ’481 patents, focusing on salt forms of ruxolitinib (Compl. Ex. E, ’013 Patent, Abstract). The claims are directed to pharmaceutical compositions comprising the phosphoric acid salt of ruxolitinib and a pharmaceutically acceptable carrier (’013 Patent, col. 12:1-14:14). This suggests an effort to build a portfolio of patents covering the compound, its specific salt forms, methods of use, and final drug product compositions.
  • Asserted Claims: The complaint alleges infringement of "one or more claims" (Compl. ¶65).
  • Accused Features: The accused infringement is Apotex's submission of an ANDA to market a generic version of Jakafi® (ruxolitinib) (Compl. ¶65).

III. The Accused Instrumentality

Product Identification

The accused instrumentality is "Apotex's Proposed Products," which are the generic ruxolitinib tablets for which Apotex seeks FDA approval via ANDA No. 208869 (Compl. ¶19). The proposed products are generic versions of Incyte's Jakafi® tablets in 5 mg, 10 mg, 15 mg, 20 mg, and 25 mg dosages (Compl. ¶1).

Functionality and Market Context

The proposed generic products contain ruxolitinib, a compound intended to function as a Janus kinase inhibitor (Compl. ¶1, 11). As a generic drug, it is intended to be a therapeutic equivalent to the brand-name drug Jakafi®, which is listed in the FDA's "Orange Book" for the treatment of certain myeloproliferative disorders (Compl. ¶12). The act of infringement alleged in the complaint is the submission of the ANDA itself, which seeks approval to market these products before the expiration of the patents-in-suit (Compl. ¶1, 24).

IV. Analysis of Infringement Allegations

The complaint does not assert specific claims or provide claim charts mapping elements of any claim to the accused product. The infringement theory is based on the statutory act of filing Abbreviated New Drug Application (ANDA) No. 208869, which seeks FDA approval to market a generic version of Jakafi® (ruxolitinib) prior to the expiration of the patents-in-suit (Compl. ¶29, 38, 47, 56, 65). This act is defined as infringement under 35 U.S.C. § 271(e)(2)(A).

Identified Points of Contention

  • Scope Questions: The primary dispute will likely center on the defenses of non-infringement and invalidity asserted by Apotex in its Paragraph IV Certification (Compl. ¶27). A key question for the court will be whether the specific composition described in Apotex's confidential ANDA—for example, the salt form, crystalline structure, and excipients—falls within the scope of any valid claim of the patents-in-suit. The dispute over the later salt-form patents (’693, ’481, ’013) may raise the question of whether Apotex's product uses a different, non-infringing salt or polymorphic form of ruxolitinib.
  • Technical Questions: A central technical question, to be resolved through discovery, is the precise nature of Apotex's proposed product. The case will require a comparison between the specific limitations of the asserted patent claims and the chemical and physical characteristics of the generic product as detailed in the ANDA.

V. Key Claim Terms for Construction

The complaint does not identify specific asserted claims, precluding a detailed analysis of terms for construction. However, in disputes involving pharmaceutical compounds and their salt forms, certain types of terms frequently become central to the dispute. One such term from a representative claim in the portfolio is analyzed below.

  • The Term: "pharmaceutically acceptable salt thereof" (from claim 19 of the ’362 Patent)
  • Context and Importance: This term defines the scope of protection beyond the free base form of the ruxolitinib compound. Practitioners may focus on this term because Apotex's defense of non-infringement could rely on an argument that its proposed product utilizes a novel salt form that does not qualify as a "pharmaceutically acceptable salt" as understood within the context of the patent.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specification provides a broad, conventional definition, stating that such salts can be formed with "pharmaceutically acceptable non-toxic acids, including inorganic or organic acids" and provides an extensive list of examples such as hydrochloric, phosphoric, sulfuric, and maleic acids (’362 Patent, col. 35:36-65).
    • Evidence for a Narrower Interpretation: A party seeking a narrower interpretation might argue that the scope should be limited by the specific salt forms synthesized and exemplified in the patent. It could also be argued that a salt form with properties substantially different from those contemplated by the patent falls outside the scope of what is "pharmaceutically acceptable" under the claim.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges induced infringement, stating that upon approval, Apotex will "intentionally encourage acts of direct infringement" with knowledge of the patents (e.g., Compl. ¶32, 41). The basis for this allegation appears to be that Apotex's product labeling will instruct physicians and patients to use the generic drug in a manner covered by method claims in the patents-in-suit, similar to the FDA-approved labeling for Jakafi® (Compl. ¶13). Contributory infringement is also alleged on the basis that Apotex's proposed product is especially adapted for an infringing use and has no substantial non-infringing uses (e.g., Compl. ¶33, 42).
  • Willful Infringement: While not pleaded as a separate count, the complaint alleges that the case is "exceptional" and requests attorneys' fees under 35 U.S.C. § 285 (e.g., Compl. ¶36). The factual basis appears to be Apotex's filing of the ANDA with a Paragraph IV certification, which establishes that Apotex had pre-suit knowledge of the patents-in-suit (Compl. ¶27).

VII. Analyst’s Conclusion: Key Questions for the Case

  • A core issue will be one of infringement and claim scope: Does the specific formulation of ruxolitinib detailed in Apotex's confidential ANDA—particularly its salt form and crystalline structure—fall within the literal scope of a valid claim in the asserted patents, especially the later patents (’693, ’481, and ’013) directed to specific salts and compositions?
  • A second key issue will be one of patent validity: Apotex's Paragraph IV certification raises the question of whether the asserted claims are invalid, likely for obviousness. The court will have to consider whether the specific ruxolitinib compound claimed in the ’362 Patent and its salt forms claimed in subsequent patents would have been obvious improvements over the broad genus of compounds disclosed in the earlier ’257 Patent and other prior art.