DCT

3:19-cv-12984

Actelion Pharma Ltd v. Natco Pharma Ltd

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 3:19-cv-12984, D.N.J., 05/28/2019
  • Venue Allegations: Venue is alleged to be proper in the District of New Jersey based on Defendants' consent to jurisdiction and, for Syneos Health, its regular and established place of business within the district. For Natco Pharma, a foreign entity, venue is asserted to be proper in any district where personal jurisdiction exists.
  • Core Dispute: Plaintiff alleges that Defendants' submission of an Abbreviated New Drug Application (ANDA) to the FDA for a generic version of Plaintiff's TRACLEER® (bosentan) product constitutes an act of infringement of a patent covering a dispersible tablet formulation.
  • Technical Context: The technology concerns pharmaceutical formulations, specifically tablets designed to disperse in liquid, which is particularly useful for administering medication to pediatric patients or others who have difficulty swallowing solid pills.
  • Key Procedural History: This action was initiated under the Hatch-Waxman Act following Plaintiff's receipt of a "Natco Notice Letter" on April 17, 2019. This letter contained a Paragraph IV certification, in which Defendants assert that the patent-in-suit is invalid, unenforceable, and/or will not be infringed by their proposed generic product. The filing of this complaint within 45 days of receiving that notice triggers a statutory 30-month stay on FDA approval of the Defendants' ANDA.

Case Timeline

Date Event
2005-05-17 U.S. Patent No. 8,309,126 Priority Date
2012-11-13 U.S. Patent No. 8,309,126 Issued
2019-04-16 Date of Natco Notice Letter to Plaintiffs
2019-04-17 Date Plaintiffs received Natco Notice Letter (approx.)
2019-05-28 Complaint Filing Date

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

U.S. Patent No. 8,309,126 - Dispersible Bosentan Tablet, issued November 13, 2012

The Invention Explained

  • Problem Addressed: The patent addresses the difficulty of administering medication to children, who often struggle to take conventional tablets (’126 Patent, col. 2:1-3). The currently marketed tablet formulation of bosentan (the active ingredient) was considered "not convenient for administration to children" (’126 Patent, col. 2:3-4).
  • The Patented Solution: The invention is a "dispersible tablet" containing the drug bosentan. This tablet is designed to be mixed with water to form a suspension, making it more "children-friendly" and allowing for individualized dosing based on body weight (’126 Patent, col. 2:4-6, col. 2:18-21). The patent also describes that adding an acidifying agent can decrease the solubility of the bitter-tasting active ingredient, thereby improving taste and compliance when the tablet is dispersed before administration (’126 Patent, col. 5:38-43).
  • Technical Importance: The formulation provides a method for administering a treatment for pulmonary arterial hypertension (PAH), a serious condition, to pediatric patients in a manner that improves compliance and allows for more precise, weight-based dosing (’126 Patent, col. 2:16-21).

Key Claims at a Glance

  • The complaint asserts dependent Claims 4, 6, 7, 8, and 9, all of which depend from independent Claim 1 (Compl. ¶59).
  • Independent Claim 1: The essential elements are:
    • A dispersible tablet composition
    • comprising an active ingredient consisting of compound I (bosentan) or a pharmaceutically acceptable salt or solvate thereof
    • and pharmaceutically acceptable excipients.
  • The complaint does not explicitly reserve the right to assert other claims, but lists claims 4, 6, 7, 8, and 9 as being infringed (Compl. ¶59).

III. The Accused Instrumentality

Product Identification

The accused instrumentality is "Natco's Bostenan Tablets for Oral Suspension, 32 mg," which is the subject of Defendants' Abbreviated New Drug Application (ANDA) No. 213154 (the "Natco ANDA Product") (Compl. ¶16).

Functionality and Market Context

The complaint alleges that the Natco ANDA Product is a generic version of Plaintiffs' TRACLEER® (bosentan) 32 mg dispersible tablets for oral suspension (Compl. ¶¶ 1, 16). The product is intended for the treatment of pulmonary arterial hypertension, similarly to Plaintiffs' branded product (Compl. ¶14). The complaint characterizes the ANDA submission itself as the act of infringement under 35 U.S.C. § 271(e)(2) (Compl. ¶60). The complaint does not provide specific details about the excipients or manufacturing process of the Natco ANDA Product. No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint does not contain a claim chart. The infringement allegations are based on Defendants' submission of ANDA No. 213154, which seeks approval to market a generic version of Plaintiffs' TRACLEER® product (Compl. ¶16).

'126 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A dispersible tablet composition The accused product is identified as "Bostenan Tablets for Oral Suspension, 32 mg." ¶16 col. 4:56-58
comprising an active ingredient consisting of compound I ... or a pharmaceutically acceptable salt or solvate thereof The accused product is alleged to be a generic version of Plaintiffs' TRACLEER® (bosentan) product, containing the same active pharmaceutical ingredient. ¶¶ 1, 16 col. 1:11-14
and pharmaceutically acceptable excipients. The accused product is a tablet formulation, which inherently contains pharmaceutically acceptable excipients. ¶16 col. 2:25-27

Identified Points of Contention

  • Scope Questions: A primary question will be whether the Defendants' formulation meets the specific limitations of the asserted dependent claims (4, 6, 7, 8, and 9). For example, does the Natco ANDA product utilize the specific agents recited in Claim 4, is it in the monohydrate form required by Claim 6, and is it manufactured via "direct compression" as required by Claim 9? (Compl. ¶59; ’126 Patent, col. 8:9-12, 8:31-32, 8:41-44).
  • Technical Questions: Since this is an ANDA action, the central dispute is often not infringement but validity. Defendants have asserted that the ’126 patent is invalid and/or not infringed (Compl. ¶18). The technical question for infringement will be whether Defendants have successfully "designed around" any of the limitations in the asserted dependent claims, for instance by using a different manufacturing process than the claimed "direct compression" or by omitting a claimed excipient.

V. Key Claim Terms for Construction

"dispersible tablet"

  • Context and Importance: This term is at the heart of the invention. Its construction will determine the required performance characteristics of an infringing tablet, such as how quickly it must break apart in liquid. This is critical because the core purpose of the invention is to provide a tablet that can be easily suspended in water for administration (’126 Patent, col. 2:4-6).
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: Claim 1 itself does not recite a specific disintegration time, which could support an argument that any tablet capable of dispersing is covered.
    • Evidence for a Narrower Interpretation: The specification provides an explicit definition: "By 'dispersible tablet' is meant a tablet, which disintegrates completely in water at 15-22° C. in not more than 5 minutes or preferably less than 4 minutes" (’126 Patent, col. 4:56-60). Further, dependent claim 11 recites this exact 5-minute limitation, suggesting that the patentee knew how to explicitly claim it when desired (’126 Patent, col. 8:48-50).

"direct compression"

  • Context and Importance: This term appears in asserted process claim 9 and is referenced in composition claim 7. Practitioners may focus on this term because manufacturing processes are a common way for generic companies to design around formulation patents. Infringement of this claim will depend entirely on the process used to manufacture the Natco ANDA Product.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The patent does not provide a formal definition, which may allow for arguments about the scope of processes that qualify.
    • Evidence for a Narrower Interpretation: The specification contrasts the claimed invention with prior art processes, noting that "it was a surprise that despite the general knowledge that direct compression (i.e. compression without previous wet granulation) does not enhance the dissolution of compounds with low solubility, compound I exhibits good dissolution..." (’126 Patent, col. 5:65-col. 6:4). This language suggests that "direct compression" should be construed as a process that excludes a wet granulation step.

VI. Other Allegations

Indirect Infringement

The complaint alleges that Defendants will induce infringement through the proposed labeling for the Natco ANDA Product, which will instruct users on how to use the product in an infringing manner (e.g., dispersing the tablet in liquid before administration) (Compl. ¶¶ 62, 64). It also alleges contributory infringement, asserting that the product is "especially made or adapted for use in infringing the '126 patent" and is "not suitable for any substantial noninfringing use" (Compl. ¶65).

Willful Infringement

The complaint alleges that Defendants had knowledge of the ’126 patent at the time they submitted the ANDA and will be "knowingly and willfully infringing" the patent (Compl. ¶¶ 20, 68). The allegation of knowledge is supported by the fact that Defendants filed a Paragraph IV certification specifically addressing the ’126 patent (Compl. ¶18).

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

  1. A central issue will be patent validity. As this case was triggered by a Paragraph IV certification, the primary defense will likely be that the claims of the ’126 patent are invalid for reasons such as obviousness or lack of novelty, an assertion already made by Defendants to the Plaintiff (Compl. ¶18).
  2. The infringement analysis will likely focus on compliance with dependent claims. While the accused generic product may fall within the broad scope of Claim 1, the key evidentiary question will be whether it also incorporates the specific limitations of the asserted dependent claims, such as the use of "direct compression" (Claim 9) or the inclusion of specific "acidifying," "flavouring," or "sweetening" agents (Claim 4).
  3. A critical legal question will be the construction of "dispersible tablet." The court must determine whether the time-based definition from the specification ("disintegrates... in not more than 5 minutes") should be read into Claim 1, or if that limitation applies only to claims where it is expressly recited, like Claim 11. The outcome of this construction could significantly impact the scope of the patent.