DCT
2:24-cv-06944
Incyte Corp v. Sun Pharmaceutical Industries Ltd
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Incyte Corporation and Incyte Holdings Corporation (Delaware)
- Defendant: Sun Pharmaceutical Industries Ltd. (India) and Sun Pharmaceutical Industries, Inc. (Delaware)
- Plaintiff’s Counsel: Gibbons P.C.
- Case Identification: 2:24-cv-06944, D.N.J., 06/11/2024
- Venue Allegations: Plaintiff alleges venue is proper because Defendant Sun Inc. maintains its principal place of business and regular, established places of business in New Jersey. Venue over foreign Defendant Sun Ltd. is alleged to be proper in any district where personal jurisdiction exists.
- Core Dispute: Plaintiff seeks a declaratory judgment that Defendant's imminent U.S. launch of its deuruxolitinib product, a treatment for alopecia areata, will infringe a patent covering deuterated forms of the compound ruxolitinib.
- Technical Context: The technology involves Janus Kinase (JAK) inhibitors, a class of small molecule drugs that modulate immune system signaling pathways and are used to treat various cancers and autoimmune disorders.
- Key Procedural History: Defendant's predecessor-in-interest, Concert Pharmaceuticals, previously challenged the validity of the patent-in-suit (U.S. Patent No. 9,662,335) in a Post-Grant Review (PGR) proceeding. The Patent Trial and Appeal Board (PTAB) declined to institute the PGR, finding that Concert had not demonstrated that the challenged claims lacked sufficient support in the patent's specification.
Case Timeline
| Date | Event |
|---|---|
| 2005-12-13 | ’335 Patent Priority Date |
| 2017-05-30 | ’335 Patent Issue Date |
| 2017-06-27 | Concert Pharmaceuticals files PGR petition against ’335 Patent |
| 2018-01-11 | PTAB denies institution of Concert's PGR |
| 2023-03-28 | Sun formalizes merger with Concert Pharmaceuticals |
| 2023-10-06 | FDA accepts Sun's New Drug Application for deuruxolitinib |
| 2024-06-11 | Complaint Filing Date |
| 2024-07-XX | Expected FDA approval (PDUFA date) and product launch |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 9,662,335 - "Heteroaryl Substituted Pyrrolo[2,3-B] Pyridines and Pyrrolo[2,3-B] Pyrimidines as Janus Kinase Inhibitors"
- Issued: May 30, 2017
The Invention Explained
- Problem Addressed: The patent describes how abnormal activity of protein kinases, specifically Janus kinases (JAKs), is implicated in a variety of diseases, including immune system disorders and myeloproliferative disorders (cancers affecting bone marrow) ('335 Patent, col. 1:25-33). The JAK-STAT signaling pathway is a key target for therapeutic intervention in these conditions ('335 Patent, col. 3:34-40).
- The Patented Solution: The invention provides chemical compounds—specifically heteroaryl substituted pyrrolo[2,3-b]pyrimidines—that modulate the activity of JAKs and can be used to treat these diseases ('335 Patent, Abstract). The patent explicitly contemplates and claims compounds where hydrogen atoms are replaced with deuterium, a stable isotope of hydrogen, a process known as deuteration ('335 Patent, col. 32:62-67; col. 366:13-17).
- Technical Importance: The underlying non-deuterated compound, ruxolitinib, was a significant development for treating certain rare cancers (Compl. ¶5). Deuterating an existing drug molecule is a known pharmaceutical strategy that can alter its metabolic profile, potentially leading to improved pharmacokinetic properties such as a longer half-life or reduced toxic metabolites, without changing the drug's primary mechanism of action (Compl. ¶9).
Key Claims at a Glance
- The complaint asserts independent claims 1 and 3 (Compl. ¶54).
- Independent Claim 1:
- A compound, which is 3-cyclopentyl-3-[4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl]propanenitrile,
- wherein one or more hydrogen atoms are replaced by deuterium;
- or a pharmaceutically acceptable salt thereof.
- Independent Claim 3:
- A compound, which is (3R)-3-cyclopentyl-3-[4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl]propanenitrile,
- wherein one or more hydrogen atoms are replaced by deuterium;
- or a pharmaceutically acceptable salt thereof.
III. The Accused Instrumentality
Product Identification
- Defendant's deuruxolitinib product, also referred to as "CTP-543" (Compl. ¶¶2, 10).
Functionality and Market Context
- Deuruxolitinib is described as an investigational oral selective inhibitor of JAK1 and JAK2, developed for the treatment of adults with moderate to severe alopecia areata, an autoimmune hair loss disorder (Compl. ¶14).
- The complaint alleges that the product was created by Defendant's predecessor, Concert Pharmaceuticals, by "modifying the drug ruxolitinib with deuterium atoms at eight key locations" (Compl. ¶¶10, 55).
- Plaintiff alleges that Defendant is engaged in significant pre-launch commercial activities and has publicly stated its plan to launch the product "on approval," which is anticipated in July 2024 (Compl. ¶15). As evidence, the complaint provides a clipping from an economic news article quoting a Sun executive stating that "preparations are in full swing" and involve "priming the market by meeting doctors, meeting payers trying to gain access for customers when the product is available" (Compl. p. 18).
IV. Analysis of Infringement Allegations
'335 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A compound, which is 3-cyclopentyl-3-[4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl]propanenitrile, | The accused product, deuruxolitinib, is alleged to be a modified version of the base compound ruxolitinib, which corresponds to this chemical structure. | ¶55 | col. 106:33-36 |
| wherein one or more hydrogen atoms are replaced by deuterium; | Sun's deuruxolitinib product is alleged to be ruxolitinib "wherein eight hydrogen atoms are replaced with deuterium." | ¶55 | col. 32:62-67 |
| or a pharmaceutically acceptable salt thereof. | The claim covers the compound or its salt form, and the complaint alleges the deuruxolitinib product itself infringes. | ¶54 | col. 33:17-47 |
- Identified Points of Contention:
- Evidentiary Questions: While the complaint alleges that Sun's product is a direct structural match to the claimed invention, a primary question for the court will be an evidentiary one: What is the precise, confirmed chemical structure of the deuruxolitinib product that Sun intends to commercialize? The infringement analysis depends on this factual determination.
- Scope Questions: Claim 3 requires a specific stereoisomer, the (3R) form. The complaint does not specify the stereochemistry of the accused product. This raises the question of whether Sun's product is the specific (3R) enantiomer (implicating claim 3), a racemic mixture of enantiomers (which may still implicate the broader claim 1), or another form entirely.
V. Key Claim Terms for Construction
- The Term: "wherein one or more hydrogen atoms are replaced by deuterium"
- Context and Importance: This phrase is the central point of novelty asserted in the claims over the known compound ruxolitinib. The interpretation of its scope is critical. A broad interpretation covering any deuteration could make the claim more susceptible to a validity challenge based on obviousness, while a narrower interpretation might allow the accused product to escape infringement. Practitioners may focus on this term because the defendant will likely argue that such a broad claim, without specifying the location or benefit of deuteration, is not adequately described or enabled by the patent's disclosure.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The plain language of the claim recites "one or more," which suggests that the replacement of any hydrogen atom with deuterium, at any position, falls within the claim's scope. The patent specification supports this by broadly defining isotopes and including deuterium as an example without tying it to a specific location or function ('335 Patent, col. 32:62-67).
- Evidence for a Narrower Interpretation: A party arguing for a narrower scope might contend that for the claim to be valid (i.e., enabled and possessing adequate written description), its scope must be limited to the specific deuteration patterns disclosed in the patent's examples. While the claim language itself is broad, a defendant could argue that the effective scope of the invention described in the patent is limited to what was actually synthesized and characterized, potentially raising questions about whether the claim is commensurate with the disclosure.
VI. Other Allegations
- Indirect Infringement: The complaint does not provide sufficient detail for analysis of indirect infringement, as its allegations focus on direct infringement by Defendant's own anticipated acts of making, using, offering to sell, selling, and importing the accused product (Compl. ¶¶57-58).
- Willful Infringement: The complaint alleges that Defendant's infringement will be willful (Count II, ¶62). This allegation is based primarily on pre-suit knowledge. It is alleged that Sun's predecessor, Concert, was aware of the '335 Patent no later than June 27, 2017, when it filed a PGR petition to challenge the patent's validity (Compl. ¶62). The complaint further alleges that Defendant continued developing the accused product even after the PTAB denied the PGR petition, and that its predecessor publicly acknowledged Incyte's patent portfolio covering "deuterated analogs of ruxolitinib," suggesting an objectively high and disregarded risk of infringement (Compl. ¶¶10, 12, 64).
VII. Analyst’s Conclusion: Key Questions for the Case
This declaratory judgment action presents several key questions for the court:
- Jurisdiction and Imminence: A threshold issue is whether the plaintiff has demonstrated that the defendant's activities create an "actual case or controversy" sufficient for declaratory judgment jurisdiction. This will turn on whether Sun's stated intent and pre-launch preparations create a dispute of "sufficient immediacy and reality" to warrant judicial intervention before the actual market launch.
- Validity over Infringement: The complaint presents the infringement case as a straightforward matter of an admitted chemical structure. The central dispute will likely pivot to the validity of the '335 Patent's claims. The key question is whether claims to deuterated versions of a known successful drug are nonobvious and meet the written description and enablement requirements, an issue that was raised but not decided on the merits in the prior, uninstituted PGR proceeding.
- Willfulness and Intent: A critical question will be one of objective recklessness: given the history of the PGR and the defendant's predecessor's public statements acknowledging the patent, can the defendant establish that it proceeded with its development and launch plans based on a good-faith belief that the '335 Patent was invalid or not infringed, or do these facts demonstrate the "objectively high likelihood" of infringement required for a finding of willfulness?