DCT

1:25-cv-15227

Actelion Pharma US Inc v. Vgyaan Pharma LLC

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:25-cv-15227, D.N.J., 09/03/2025
  • Venue Allegations: Venue is alleged to be proper in the District of New Jersey because Defendant VGYAAN is organized and has its principal place of business in New Jersey, and Defendant RK Pharma, Inc. allegedly directs VGYAAN and maintains regular places of business in the state.
  • Core Dispute: Plaintiffs allege that Defendants’ submission of an Abbreviated New Drug Application (ANDA) to the FDA seeking approval to market a generic version of Plaintiffs’ selexipag tablets constitutes an act of infringement of a patent covering the active pharmaceutical ingredient.
  • Technical Context: The technology concerns heterocyclic compound derivatives that act as PGI₂ receptor agonists, used for treating pulmonary arterial hypertension (PAH), a serious condition involving high blood pressure in the arteries of the lungs.
  • Key Procedural History: The complaint alleges that at some time prior to July 24, 2025, Defendants were aware of consent judgments in separate litigations against MSN Pharms. Inc. and Alembic Pharms. Ltd., in which those parties admitted that the claims of the patent-in-suit are valid and enforceable.

Case Timeline

Date Event
2001-04-26 U.S. Patent No. 7,205,302 Priority Date
2007-04-17 U.S. Patent No. 7205302 Issues
2015-12-21 FDA grants approval for UPTRAVI® (selexipag) oral tablets
2025-07-24 Date of Defendants' Notice Letter regarding ANDA filing
2025-08-06 Plaintiffs first request Defendants produce their ANDA
2025-09-03 Complaint Filed

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

U.S. Patent No. 7,205,302 - “Heterocyclic Compound Derivatives and Medicines”

  • Patent Identification: U.S. Patent No. 7,205,302 (“Heterocyclic Compound Derivatives and Medicines”), issued April 17, 2007 (the “’302 Patent”).

The Invention Explained

  • Problem Addressed: The patent describes that Prostaglandin I₂ (PGI₂), a compound produced in the body, has potent therapeutic effects for various vascular diseases. However, PGI₂ is chemically unstable and has a very short biological half-life, making it unsuitable for direct use as a medicine and difficult to administer effectively (’302 Patent, col. 2:27-35).
  • The Patented Solution: The invention provides a new class of non-prostanoid heterocyclic compound derivatives that are chemically stable and act as PGI₂ receptor agonists. These compounds are designed to mimic the therapeutic effects of PGI₂ without its stability and half-life limitations, making them suitable for use in a pharmaceutical composition (’302 Patent, Abstract; col. 2:5-11).
  • Technical Importance: The development of a stable, orally available PGI₂ receptor agonist represented a significant advance in the treatment of conditions like pulmonary arterial hypertension, offering a more convenient and potentially more consistent therapeutic option compared to infused prostanoids (’302 Patent, col. 2:40-46).

Key Claims at a Glance

  • The complaint alleges infringement of claims 1-5 and 10-15 (Compl. ¶38). Independent claims 1 and 10 are asserted.
  • Independent Claim 1 recites:
    • A heterocyclic compound represented by a general chemical formula [1] or a salt thereof, defined by a series of variable chemical groups (R¹, R², Y, Z, A, D, E, G, R³, R⁴, and Q) that form a Markush group covering a genus of related compounds.
  • Independent Claim 10 recites:
    • A method of treating a disease selected from a specified group (including pulmonary hypertension) by administering a pharmaceutical composition comprising the heterocyclic compound of Claim 1.
  • The complaint does not explicitly reserve the right to assert other dependent claims but alleges infringement of claims 1-5 and 10-15 generally (Compl. ¶38).

III. The Accused Instrumentality

Product Identification

  • The accused instrumentalities are generic selexipag tablets in 200, 400, 600, 800, 1000, 1200, 1400, and 1600 mcg dosage strengths, for which Defendant VGYAAN submitted Abbreviated New Drug Application (ANDA) No. 214055 to the FDA (the "ANDA Products") (Compl. ¶14, ¶39).

Functionality and Market Context

  • The ANDA Products contain the active ingredient selexipag, identified by the chemical name 2-{4-[(5,6-diphenylpyrazin-2-yl)(isopropyl)amino]butoxy}-N-(methylsulfonyl) acetamide (Compl. ¶45). The products are generic versions of Plaintiffs' UPTRAVI® brand tablets and are intended for the treatment of pulmonary arterial hypertension (PAH) to delay disease progression and reduce the risk of hospitalization (Compl. ¶27). The submission of the ANDA itself is the statutory act of infringement alleged under 35 U.S.C. § 271(e)(2)(A) (Compl. ¶47).

No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint alleges that the active ingredient in the ANDA Products, selexipag, is a compound claimed by the ’302 Patent (Compl. ¶40, ¶45). The complaint specifically alleges that the chemical name for selexipag is recited in dependent Claim 14 of the patent (Compl. ¶40). Claim 14 depends from independent Claim 10, which in turn incorporates the compound of Claim 1.

’302 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A heterocyclic compound represented by the following general formula [1]: [Formula shown] or a salt thereof The active ingredient of the ANDA Products is selexipag, which is alleged to be a compound falling within the scope of Formula [1] (Compl. ¶45, ¶50). ¶45, ¶50 col. 67:45-68:36
wherein R¹ and R² are the same or different and each represents an optionally substituted aryl The selexipag compound contains a 5,6-diphenylpyrazin-2-yl moiety, where R¹ and R² are both phenyl groups, which is an aryl group (Compl. ¶45). ¶45 col. 1:59-62; col. 2:21
Y represents N... Z represents... CR⁶ The pyrazin-2-yl ring structure of selexipag corresponds to the heterocyclic ring where Y is N and Z is CH (Compl. ¶45). ¶45 col. 2:21; col. 3:17-18
A represents NR⁷... and R⁷ represents... alkyl The selexipag structure includes an N-isopropylamino group, where A is NR⁷ and R⁷ is isopropyl, an alkyl group (Compl. ¶45). ¶45 col. 2:30-32
D represents alkylene The butoxy group in selexipag provides a four-carbon alkylene chain linking the amino group to the rest of the molecule (Compl. ¶45). ¶45 col. 2:32-35
E represents... single bond The linkage in the selexipag structure corresponds to E being a single bond (Compl. ¶45). ¶45 col. 2:45-46
G represents O The butoxy group in selexipag provides an oxygen atom corresponding to G (Compl. ¶45). ¶45 col. 2:58-59
Q represents... a group represented by the following formula (22): -CONH-SO₂-R¹⁰, wherein R¹⁰ represents... alkyl The selexipag structure terminates in an N-(methylsulfonyl)acetamide group, which corresponds to the formula where R¹⁰ is methyl, an alkyl group (Compl. ¶45). ¶45 col. 2:62-65; col. 3:1-5
  • Identified Points of Contention:
    • Scope Questions: A central question is how Defendants will argue for non-infringement when Claim 14 of the ’302 Patent appears to specifically recite the chemical name of selexipag (Compl. ¶40; ’302 Patent, col. 70:25-27). Any non-infringement argument would likely have to rely on a nuanced claim construction theory or on differences between the ANDA product and the claim language (e.g., related to salt form, purity, or polymorph) that are not apparent from the complaint.
    • Technical Questions: The complaint alleges that Defendants' notice letter "does not identify any factual basis for, or any opinion of, noninfringement" (Compl. ¶38). This raises the question of whether the primary dispute will be over infringement at all, or whether it will shift to the validity of the patent, a common strategy in ANDA litigation.

V. Key Claim Terms for Construction

  • The Term: "a pharmaceutically acceptable salt thereof" (Claim 1)
  • Context and Importance: In pharmaceutical patent cases, the specific salt form of an active ingredient can be a point of contention. While Claim 1 covers the base compound, if Defendants' ANDA product uses a novel salt form not contemplated by the patent, they might argue it falls outside the claim scope. The definition of what constitutes a "pharmaceutically acceptable salt" will be critical to resolving such a dispute.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specification provides a non-exhaustive list of examples for salts, including salts of various inorganic and organic acids if the compound is basic, and alkali or alkali earth metal salts if the compound is acidic. The use of "examples" and "such as" suggests the list is illustrative, not limiting (’302 Patent, col. 23:19-31).
    • Evidence for a Narrower Interpretation: A defendant could argue that the provided examples define the universe of acceptable salts, or that a truly novel salt form would not have been considered "pharmaceutically acceptable" by a person of ordinary skill at the time of the invention.

VI. Other Allegations

  • Indirect Infringement: This action is primarily based on the statutory act of infringement under 35 U.S.C. § 271(e)(2) for filing the ANDA (Compl. ¶47). The complaint also seeks a declaration that Defendants will infringe under §§ 271(a), (b), and (c) if they commercially manufacture and sell the ANDA Products post-approval, which would involve claims of inducement based on the product's labeling for the patented indication (Compl. ¶52, ¶55).
  • Willful Infringement: The complaint does not use the term "willful," but it lays a foundation for such a claim by alleging that Defendants had "actual and constructive notice" of the ’302 patent before filing their ANDA (Compl. ¶48). It further alleges that Defendants were aware of prior litigations where other generic manufacturers admitted the validity and enforceability of the patent's claims, which Plaintiffs may argue demonstrates objective recklessness (Compl. ¶36, ¶37). The prayer for relief requests a finding that this is an "exceptional case" for the purpose of awarding attorneys' fees (Compl., Prayer for Relief ¶E).

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

  • A core issue will be one of infringement defense: Given that asserted dependent Claim 14 appears to read directly on the chemical structure of selexipag, what factual or legal basis, if any, will Defendants advance to argue for non-infringement?
  • A second key question will concern patent validity: As infringement appears facially strong based on the complaint's allegations, the case will likely pivot to Defendants' challenge to the validity of the ’302 patent's claims, an issue on which the complaint alleges Defendants have not yet articulated a basis.
  • A final question will be one of culpability: Will Plaintiffs be able to leverage Defendants' alleged pre-suit knowledge of the ’302 patent—and of prior consent judgments affirming its enforceability—to support their request for an "exceptional case" finding and an award of attorneys' fees under 35 U.S.C. § 285?