DCT

2:25-cv-15027

Actelion Pharma Ltd v. Seasons Biotechnology Taizhou Co Ltd

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:25-cv-15027, D.N.J., 08/28/2025
  • Venue Allegations: Plaintiff alleges venue is proper in the District of New Jersey because Defendant Novugen Pharma (USA) LLC maintains its principal place of business in the district, and the foreign defendants are subject to personal jurisdiction in the district through their activities related to filing a drug application and planned distribution in the United States, including New Jersey.
  • Core Dispute: Plaintiff alleges that Defendants’ submission of an Abbreviated New Drug Application (ANDA) to the U.S. Food and Drug Administration for a generic version of Plaintiff's OPSUMIT® tablets constitutes an act of infringement of patents covering the active pharmaceutical ingredient, macitentan, and its pharmaceutical composition.
  • Technical Context: The dispute is in the pharmaceutical sector, concerning a drug used for the treatment of pulmonary arterial hypertension (PAH), a serious condition affecting blood vessels in the lungs.
  • Key Procedural History: This action was initiated under the Hatch-Waxman Act following Defendants' filing of ANDA No. 211026 with a Paragraph IV certification, challenging the patents-in-suit. The complaint was filed within the 45-day statutory period, which typically triggers a 30-month stay of FDA approval for the generic product. The complaint's certification of prior litigation indicates that both patents-in-suit, particularly U.S. Patent No. 7,094,781, have been the subject of numerous previous infringement suits against other generic pharmaceutical manufacturers.

Case Timeline

Date Event
2000-12-18 ’781 Patent Priority Date
2005-09-12 ’015 Patent Priority Date
2006-08-22 U.S. Patent No. 7,094,781 Issues
2013-10-18 FDA grants approval for OPSUMIT® (macitentan)
2021-03-16 U.S. Patent No. 10,946,015 Issues
2025-08-28 Complaint Filed

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

U.S. Patent No. 7,094,781 - "Sulfamides and Their Use as Endothelin Receptor Antagonists"

The Invention Explained

  • Problem Addressed: The patent describes endothelin peptides as potent vasoconstrictors involved in various cardiovascular and inflammatory diseases (’781 Patent, col. 1:14-21). The background notes that while endothelin receptor antagonists were being studied as therapeutic agents, existing molecules presented challenges such as complex synthesis, low solubility, and potential safety issues (’781 Patent, col. 1:56-62).
  • The Patented Solution: The invention provides a new class of pyrimidine-sulfamide compounds that act as endothelin receptor antagonists (’781 Patent, Abstract). These compounds are designed to inhibit the biological effects of endothelin, thereby providing a therapeutic benefit for conditions like pulmonary hypertension (’781 Patent, col. 5:26-34). The patent discloses a broad genus of compounds and provides specific examples, including the compound that would become known as macitentan.
  • Technical Importance: This class of compounds offered a novel chemical structure for antagonizing endothelin receptors, a key therapeutic target for managing vasoconstrictive disorders.

Key Claims at a Glance

  • The complaint asserts infringement of Claims 1-11 (Compl. ¶47).
  • Independent Claim 1 defines a broad genus of pyrimidine-sulfamide compounds according to a Markush structure (General Formula I).
  • Claim 11, a dependent claim, is notable for reciting a specific chemical compound by name: "propylsulfamic acid [5-(4-bromo-phenyl)-6-[2-(5-bromo-pyrimidin-2-yloxy)-ethoxy]-pyrimidin-4-yl]-amide", which is macitentan (Compl. ¶49; ’781 Patent, col. 142:1-6).

U.S. Patent No. 10,946,015 - "Stable Pharmaceutical Compositions Comprising a Pyrimidine-Sulfamide"

The Invention Explained

  • Problem Addressed: The patent addresses the need for a stable pharmaceutical formulation for the compound of formula I (macitentan), which was being evaluated in clinical trials (’015 Patent, col. 1:55-58). Developing a stable, solid oral dosage form is a critical step in making an active pharmaceutical ingredient a viable commercial drug product.
  • The Patented Solution: The invention provides a specific formulation comprising the active compound along with a defined set of excipients: a filler, a disintegrant, a surfactant (specifically a polysorbate), and a lubricant, all within particular weight-percentage ranges (’015 Patent, col. 2:15-18; col. 29:28-32). This combination of ingredients is described as providing a stable composition suitable for pharmaceutical use (’015 Patent, col. 10:50-55). The specification details various manufacturing processes, such as wet granulation and direct compression, for producing tablets with these compositions (’015 Patent, Figs. 5-6).
  • Technical Importance: The invention provided a specific technical solution to the challenge of formulating macitentan into a stable oral tablet, enabling its development and commercialization.

Key Claims at a Glance

  • The complaint asserts infringement of Claims 1-2, 4, 9-10, 12, 14, 17-18, and 22-42 (Compl. ¶50).
  • Independent Claim 1 recites the essential elements of the composition:
    • The compound of formula I (macitentan) in a total amount of 1 to 50% by weight.
    • A filler in an amount of 10 to 95% by weight.
    • A disintegrant in an amount of 1 to 20% by weight.
    • A surfactant in an amount from 0.1 to 1% by weight, wherein the surfactant comprises a polysorbate.
    • A lubricant in an amount from 0.05 to 10% by weight.

III. The Accused Instrumentality

Product Identification

  • The accused instrumentality is the generic drug product described in Defendants' ANDA No. 211026 (the "ANDA Product") (Compl. ¶14).

Functionality and Market Context

  • The complaint alleges the ANDA Product is a "macitentan 10 mg oral tablet" (Compl. ¶48). Macitentan is the active ingredient in Plaintiff's branded drug, OPSUMIT®, which is approved for the treatment of pulmonary arterial hypertension (PAH) to reduce certain risks of disease progression (Compl. ¶36). The ANDA Product is a generic version intended for the same therapeutic use and, if approved, would compete directly with OPSUMIT® in the U.S. market (Compl. ¶¶13-14).

IV. Analysis of Infringement Allegations

No probative visual evidence provided in complaint.

’781 Patent Infringement Allegations

Claim Element (from Independent Claim 1, as narrowed by Claim 11) Alleged Infringing Functionality Complaint Citation Patent Citation
propylsulfamic acid [5-(4-bromo-phenyl)-6-[2-(5-bromo-pyrimidin-2-yloxy)-ethoxy]-pyrimidin-4-yl]-amide The complaint alleges that the active pharmaceutical ingredient in the ANDA Product is macitentan, which is the chemical compound recited in Claim 11. ¶¶48, 49 col. 142:1-6

’015 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
a) the compound of the formula I...in a total amount of 1 to 50% in weight The ANDA Product is alleged to be a 10 mg macitentan tablet, which necessarily contains the compound of formula I as its active ingredient. ¶¶48, 50, 53 col. 1:17-43
b) filler, in an amount of 10 to 95% in weight The ANDA Product, as an oral tablet, is alleged to contain one or more fillers meeting this limitation. ¶¶48, 50, 53 col. 2:48-53
c) disintegrant, in an amount of 1 to 20% in weight The ANDA Product, as an oral tablet, is alleged to contain one or more disintegrants meeting this limitation. ¶¶48, 50, 53 col. 2:53-58
d) surfactant, in an amount from 0.1 to 1% in weight...wherein the surfactant comprises a polysorbate The ANDA Product, as an oral tablet, is alleged to contain a polysorbate surfactant meeting this limitation. ¶¶48, 50, 53 col. 2:58-61
e) lubricant, in an amount from 0.05 to 10% in weight The ANDA Product, as an oral tablet, is alleged to contain one or more lubricants meeting this limitation. ¶¶48, 50, 53 col. 2:61-65

Identified Points of Contention

  • Scope Questions: For the ’781 Patent, the primary question is one of direct identity: is the active pharmaceutical ingredient in the ANDA Product the exact chemical entity recited in Claim 11? The complaint alleges this directly (Compl. ¶49).
  • Technical Questions: For the ’015 Patent, the core dispute will be factual and will depend on information obtained through discovery. A key question is whether the specific excipients and their respective weight percentages in the Defendants' ANDA Product fall within the ranges claimed in the patent. The complaint, as is typical at this stage, does not provide these formulation details.

V. Key Claim Terms for Construction

  • The Term: "stable pharmaceutical composition" (’015 Patent, Preamble of Claim 1)
  • Context and Importance: While found in the preamble, the concept of "stability" is the central purpose of the ’015 Patent. The definition of this term could be critical, as it may inform the scope of the claims and the non-obviousness of the claimed formulation. Practitioners may focus on this term because the Defendants will likely argue that achieving stability was obvious, making the construction of what the patent teaches about "stability" important.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The patent provides a general objective of developing a "stable formulation" without necessarily limiting it to a single quantitative measure in all contexts (’015 Patent, col. 1:57-58).
    • Evidence for a Narrower Interpretation: The specification provides a specific, quantitative definition, stating a composition is "considered 'stable', if during a certain period of time 70%, preferably 80% and most preferably 95% of the initial content of compound of formula I...is maintained" (’015 Patent, col. 10:50-55). It also specifies stability testing conditions, such as storage at 25° C./60% relative humidity or 40° C./75% relative humidity (col. 10:56-64).

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that if Defendants' product is approved and launched, they will infringe under 35 U.S.C. §§ 271(b) and/or (c) by inducing or contributing to infringement by others, such as healthcare providers and patients (Compl. ¶¶56, 58). The basis for this is the allegation that Defendants will "act in concert with each other" to commercialize the product (Compl. ¶20).
  • Willful Infringement: The complaint does not use the word "willful" but lays a foundation for such a claim by alleging that Defendants were "aware" that their submission of the ANDA with Paragraph IV Certifications constituted an act of infringement and that future commercialization would also be infringing (Compl. ¶¶54, 57).

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

  • A core issue for the ’781 patent will be one of chemical identity: does the active ingredient in the Defendants' ANDA product correspond precisely to the compound recited in Claim 11? Based on the complaint's allegations, this appears to be a direct allegation of literal infringement where validity, rather than infringement, may become the central battleground.
  • A key evidentiary question for the ’015 patent will be one of compositional compliance: once the formulation of the ANDA product is disclosed, does it meet every limitation of the asserted claims, including the specific identity of the excipients (e.g., a "polysorbate") and their exact weight percentages?
  • A central legal and factual question will be obviousness: particularly for the ’015 patent, Defendants will likely argue that the claimed formulation is an obvious combination of known pharmaceutical excipients to achieve a stable tablet. The outcome may depend on whether the patent discloses unexpected results or successfully teaches away from prior art approaches to formulating similar compounds.