DCT

3:19-cv-15437

Actelion Pharma Ltd v. Aurobindo Pharma USA Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 3:19-cv-15437, D.N.J., 07/16/2019
  • Venue Allegations: Venue is alleged to be proper based on Defendant Aurobindo USA having a regular and established place of business in New Jersey, including its principal place of business and a distribution center.
  • Core Dispute: Plaintiff alleges that Defendants’ filing of an Abbreviated New Drug Application (ANDA) for generic macitentan tablets constitutes an act of infringement of a patent covering the active pharmaceutical ingredient.
  • Technical Context: The technology concerns sulfamide-based chemical compounds that function as endothelin receptor antagonists, used in therapies for conditions such as pulmonary arterial hypertension.
  • Key Procedural History: This action is a patent infringement suit filed under the Hatch-Waxman Act. The suit was triggered by Defendants' submission of an ANDA containing a Paragraph IV certification, which asserted that the patent-in-suit is invalid, unenforceable, or will not be infringed by the proposed generic product. Plaintiff alleges it received notice of this certification on June 20, 2019, and filed this complaint within the statutory 45-day window.

Case Timeline

Date Event
2000-12-18 ’781 Patent Priority Date
2006-08-22 ’781 Patent Issue Date
2013-10-18 FDA approval of Plaintiff's OPSUMIT® (macitentan)
2019-06-19 Date of Defendants' Paragraph IV Certification Notice Letter
2019-07-16 Complaint Filing Date

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

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

This patent issued on August 22, 2006.

The Invention Explained

  • Problem Addressed: The patent describes a need for new endothelin receptor antagonists, noting that prior art compounds possessed weaknesses such as "complex synthesis, low solubility, high molecular weight, poor pharmacokinetics, or safety problems (e.g. liver enzyme increases)" (’781 Patent, col. 1:59-62).
  • The Patented Solution: The invention claims to solve this problem by providing a new class of "substituted pyrimidines" that contain a "sulfamide unit" (’781 Patent, col. 2:1-4). The patent asserts that this new class of compounds allows for the "specific tailoring" of physicochemical and pharmacokinetic properties and can exhibit either mixed or selective binding profiles for different endothelin receptors (’781 Patent, Abstract; col. 2:4-8).
  • Technical Importance: By addressing the shortcomings of earlier compounds, the invention sought to provide improved therapeutic agents for treating a range of diseases associated with endothelin, including hypertension, heart failure, and renal failure (’781 Patent, col. 1:46-55).

Key Claims at a Glance

  • The complaint asserts infringement of Claim 11 of the ’781 Patent (Compl. ¶12, 32).
  • Claim 11 is a species claim that recites a list of specific chemical compounds. The compound relevant to this dispute, as identified by its chemical name, is:
    • Propylsulfamic acid [5-(4-bromo-phenyl)-6-[2-(5-bromo-pyrimidin-2-yloxy)-ethoxy]-pyrimidin-4-yl]-amide (’781 Patent, col. 144:60-65).

III. The Accused Instrumentality

Product Identification

The accused instrumentality is "Aurobindo's ANDA Product," for which Defendants filed ANDA No. 211198 with the U.S. Food and Drug Administration (FDA) (Compl. ¶11).

Functionality and Market Context

The ANDA seeks approval to market generic macitentan 10 mg oral tablets (Compl. ¶11). Macitentan is the active ingredient in Plaintiff's branded drug, OPSUMIT®, which is an endothelin receptor antagonist indicated for the treatment of pulmonary arterial hypertension (PAH) (Compl. ¶23, 31). Defendants' product is intended to be a generic equivalent of OPSUMIT® (Compl. ¶11).

IV. Analysis of Infringement Allegations

The complaint does not contain or reference a claim chart. The infringement theory is a statutory one under 35 U.S.C. § 271(e)(2)(A), where the submission of an ANDA to obtain approval for a generic drug before the expiration of a relevant patent is a technical act of infringement. The complaint alleges that Defendants seek approval for a generic drug whose active ingredient is macitentan (Compl. ¶31). It further alleges that this ANDA product "meets or embodies all steps of Claim 11 of the ’781 patent" (Compl. ¶32). The core of the allegation is that the chemical compound in Defendants' proposed product is one of the specific compounds enumerated in the asserted claim. No probative visual evidence provided in complaint.

  • Identified Points of Contention:
    • Identity Question: The primary infringement question will be one of chemical identity: does the macitentan active pharmaceutical ingredient in Aurobindo's ANDA product have the exact chemical structure of the compound recited in Claim 11? The complaint’s infringement allegation is predicated on this structural identity.
    • Technical Questions: The complaint does not provide sufficient detail for analysis of potential technical disputes, such as those related to polymorphism, purity, or metabolites.

V. Key Claim Terms for Construction

Because the asserted claim, Claim 11, is a species claim that recites a specific chemical compound by its formal chemical name, significant claim construction disputes regarding the scope of the claim for infringement purposes are not anticipated. The dispute will likely focus on a direct structural comparison between the accused product's active ingredient and the compound defined by the claim's chemical name, rather than on the interpretation of descriptive terms.

VI. Other Allegations

  • Indirect Infringement: The complaint includes a boilerplate allegation that if Defendants commercially manufacture, use, or sell their ANDA product in the United States, they will induce or contribute to infringement of Claim 11 (Compl. ¶36). The complaint does not allege specific facts to support the elements of knowledge and intent for these claims beyond the filing of the ANDA.

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

  • A core issue will be one of chemical identity: does Aurobindo's proposed generic macitentan product contain an active pharmaceutical ingredient that is structurally identical to the specific compound, "Propylsulfamic acid [5-(4-bromo-phenyl)-6-[2-(5-bromo-pyrimidin-2-yloxy)-ethoxy]-pyrimidin-4-yl]-amide," as recited in Claim 11 of the ’781 patent?
  • A central question for the litigation as a whole, though not raised by the complaint, will be the validity of the patent: can Defendants prove by clear and convincing evidence that Claim 11 is invalid, for instance, on grounds of obviousness in light of prior art compounds and synthetic methodologies known at the time of the invention?