DCT

1:24-cv-01366

Orbicular Pharmaceutical Tech Pvt Ltd v. Shire NPS Pharma Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:24-cv-01366, D. Del., 12/13/2024
  • Venue Allegations: Venue is alleged to be proper in the District of Delaware because both Defendants are incorporated in Delaware and have frequently subjected themselves to the jurisdiction of the court in prior patent litigation.
  • Core Dispute: Plaintiff seeks a declaratory judgment that its generic drug product does not infringe two of Defendants' patents, which, although statutorily disclaimed by Defendants, remain listed in the FDA's Orange Book and block Plaintiff's regulatory approval.
  • Technical Context: The technology involves using teduglutide, a GLP-2 receptor agonist, for the treatment of Short Bowel Syndrome, a malabsorptive condition often requiring parenteral nutrition.
  • Key Procedural History: In July 2022, following litigation brought by a third party (Rigshospitalet) alleging inventorship issues, Defendants filed statutory disclaimers for all claims of the patents-in-suit. However, the patents remain listed in the FDA Orange Book, allegedly because they form the basis for a "First Filer's" 180-day generic drug exclusivity. Plaintiff, a subsequent ANDA filer, brings this action to obtain a judicial declaration of non-infringement, which is a required trigger to resolve the First Filer's exclusivity and clear the path for Plaintiff's own product approval.

Case Timeline

Date Event
2004-11-01 Priority Date for '061 and '992 Patents
2010-12-07 U.S. Patent No. 7,847,061 ('061 Patent) Issue Date
2015-06-23 U.S. Patent No. 9,060,992 ('992 Patent) Issue Date
2016-12-21 A "First Filer" generic challenger files an ANDA for GATTEX®
2017-04-10 Shire files patent infringement litigation against the First Filer
2018-11-26 First Filer litigation is dismissed pursuant to a settlement
2021-09-21 Rigshospitalet files litigation against Shire and Takeda
2022-07-20 Shire disclaims all claims of the '061 and '992 patents
2023-12-05 Plaintiff Orbicular submits its ANDA for a generic version of GATTEX®
2024-01-08 Defendants receive Orbicular's Paragraph IV Notice Letter
2024-02-26 The 45-day statutory period for Defendants to sue Orbicular for infringement expires
2024-12-13 Complaint for Declaratory Judgment filed

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

U.S. Patent No. 7,847,061, “Treatment of Short Bowel Syndrome Patients with Colon-In-Continuity,” Issued Dec. 7, 2010

The Invention Explained

  • Problem Addressed: The patent addresses short bowel syndrome (SBS), a condition resulting from surgical resection of the small intestine that leads to malabsorption, malnutrition, and dehydration, often requiring patients to receive long-term parenteral nutrition (PN) (’061 Patent, col. 1:15-30). While SBS patients with their colon connected to their remaining small intestine ("colon-in-continuity") have an adaptive response, the potential for further improvement with drug therapy was not established (’061 Patent, col. 1:62-67).
  • The Patented Solution: The invention is a method for enhancing intestinal absorption in SBS patients with colon-in-continuity by treating them with a GLP-2 receptor agonist, such as teduglutide (’061 Patent, Abstract; col. 2:5-14). This treatment was shown to increase intestinal wet weight and energy absorption, thereby reducing fecal output and potentially lessening dependence on PN (’061 Patent, col. 4:33-47). Figure 1 of the patent illustrates the measured clinical effect of the treatment on fecal output and intestinal absorption (’061 Patent, Fig. 1).
  • Technical Importance: The invention identified a specific patient sub-population (SBS with colon-in-continuity) that benefits from GLP-2 agonist therapy, despite these patients already having elevated endogenous GLP-2 levels, which previously made the potential for added benefit not obvious (’061 Patent, col. 1:62-col. 2:2).

Key Claims at a Glance

  • The complaint seeks a declaration of non-infringement as to all claims (1-18) of the patent, all of which were disclaimed (Compl. ¶57). Independent claim 1 is representative.
  • Independent Claim 1:
    • A method for enhancing intestinal absorption in a patient with short bowel syndrome presenting with colon in continuity with remnant small intestine,
    • comprising the steps of selecting for treatment such a patient,
    • and treating said patient with a GLP-2 receptor agonist... using a dosing regimen effective to enhance intestinal absorption,
    • wherein the GLP-2 receptor agonist is selected from a group including a GLP-2 peptide, analog, or derivatized versions thereof.

U.S. Patent No. 9,060,992, “Treatment of Short Bowel Syndrome Patients with Colon-In-Continuity,” Issued Jun. 23, 2015

The Invention Explained

  • Problem Addressed: The '992 patent, a divisional of the application that led to the ’061 Patent, addresses the same problem of malabsorption in SBS patients with colon-in-continuity (’992 Patent, col. 1:19-35).
  • The Patented Solution: The solution is also the administration of a GLP-2 receptor agonist. The claims of the ’992 Patent are more specific, defining the patient population by its ability to produce a certain baseline level of endogenous GLP-2, a characteristic of patients with a preserved colon (’992 Patent, col. 6:3-9; Claim 1). The patent provides clinical data showing that treatment with teduglutide provides a therapeutic benefit even in this population, which was a surprising result (’992 Patent, col. 9:30-44).
  • Technical Importance: This patent refines the patient selection criteria for GLP-2 therapy, focusing on a physiological marker (endogenous GLP-2 levels) tied to the presence of a functioning colon, further defining the specific patient group that benefits from the treatment (’992 Patent, col. 6:3-19).

Key Claims at a Glance

  • The complaint seeks a declaration of non-infringement as to all claims (1-26) of the patent, all of which were disclaimed (Compl. ¶58). Independent claims 1 and 2 are representative.
  • Independent Claim 1:
    • A method for enhancing intestinal absorption in a patient with short bowel syndrome with colon-in-continuity,
    • wherein the patient retains colon sufficient to produce at least about 10% of endogenous GLP-2 levels produced by a healthy individual in a fed state,
    • comprising the step of administering to said patient a GLP-2 receptor agonist... effective to enhance intestinal absorption,
    • wherein the GLP-2 receptor agonist is selected from a group including a GLP-2 peptide, analog, or derivatized versions thereof.

III. The Accused Instrumentality

  • Product Identification: The instrumentality at issue is "Orbicular's Teduglutide for Injection product as described in Orbicular's Abbreviated New Drug Application ('Orbicular's ANDA') No. 218582" (Compl. ¶1).
  • Functionality and Market Context: The product is a generic version of Defendants' GATTEX®, which is an injectable pharmaceutical product containing 5mg of teduglutide recombinant per single-use vial (Compl. ¶70). The filing of the ANDA is a technical act of infringement under 35 U.S.C. § 271(e)(2) that gives rise to jurisdiction for patent litigation (Compl. ¶64). The complaint alleges that Orbicular's market entry is currently blocked by the 180-day market exclusivity held by a "First Filer" generic competitor and that a court judgment is necessary to trigger a forfeiture of that exclusivity (Compl. ¶¶ 113, 139, 142).

IV. Analysis of Infringement Allegations

The complaint does not allege infringement but rather seeks a declaratory judgment of non-infringement. The sole basis for this declaration is the legal status of the patents-in-suit. On July 20, 2022, Defendant Shire filed statutory disclaimers for all claims of the '061 and '992 patents (Compl. ¶¶57-58, Exs. D, E). The complaint asserts that, as a matter of law, a disclaimed patent is unenforceable and cannot be infringed (Compl. ¶¶152-153, 167-168). One of the patent's own figures shows the measured increase in intestinal absorption that is a key element of the asserted claims. The patent's Figure 1 shows the measured clinical effect of the treatment on intestinal wet weight absorption in study participants (’992 Patent, Fig. 1; Compl. Ex. B, p. 3).

'061 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Declared Basis for Non-Infringement Complaint Citation Patent Citation
A method for enhancing intestinal absorption in a patient with short bowel syndrome presenting with colon in continuity with remnant small intestine... The '061 patent has been fully disclaimed, is legally unenforceable, and therefore cannot be infringed. ¶¶57, 153, 156 col. 14:50-64
...comprising the steps of selecting for treatment a short bowel syndrome patient presenting with colon in continuity... The '061 patent has been fully disclaimed, is legally unenforceable, and therefore cannot be infringed. ¶¶57, 153, 156 col. 14:53-57
...and treating said patient with a GLP-2 receptor agonist... wherein said GLP-2 receptor agonist is selected from the group consisting of a GLP-2 peptide, a GLP-2 analog, a derivatized GLP-2 peptide or a derivatized GLP-2 analog. The '061 patent has been fully disclaimed, is legally unenforceable, and therefore cannot be infringed. ¶¶57, 153, 156 col. 14:57-64

'992 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Declared Basis for Non-Infringement Complaint Citation Patent Citation
A method for enhancing intestinal absorption in a patient with short bowel syndrome with colon-in-continuity with remnant small intestine... The '992 patent has been fully disclaimed, is legally unenforceable, and therefore cannot be infringed. ¶¶58, 168, 171 col. 14:50-54
...wherein the patient retains colon sufficient to produce at least about 10% of endogenous GLP-2 levels produced by a healthy individual in a fed state... The '992 patent has been fully disclaimed, is legally unenforceable, and therefore cannot be infringed. ¶¶58, 168, 171 col. 14:55-58
...comprising the step of administering to said patient a GLP-2 receptor agonist... The '992 patent has been fully disclaimed, is legally unenforceable, and therefore cannot be infringed. ¶¶58, 168, 171 col. 14:59-61
  • Identified Points of Contention:
    • Legal Question: The primary contention is not technical but legal and procedural: Does a justiciable case or controversy exist for a court to enter a judgment of non-infringement on patents that have been disclaimed and are admittedly unenforceable? The complaint argues it does, because the patents' continued listing in the Orange Book creates a concrete, ongoing barrier to FDA approval (Compl. ¶¶87-88, 143).
    • Procedural Question: The case raises the question of whether a court can or should exercise its declaratory judgment authority solely to resolve a regulatory blockade under the Hatch-Waxman Act, particularly when the patent holder has declined to sue and refuses to provide a consent judgment (Compl. ¶107).

V. Key Claim Terms for Construction

Given that the basis for the requested judgment is a legal disclaimer rather than a technical dispute over claim scope, claim construction is not the central issue. However, had the patents been asserted, the following terms would likely have been focal points of disagreement.

  • The Term: "enhancing intestinal absorption"

  • Context and Importance: This term defines the core utility of the claimed method and is central to infringement. Its construction would determine what type and magnitude of clinical effect is required to meet the limitation. Practitioners may focus on this term because its definition could be outcome-determinative for infringement and validity.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The specification describes the enhancement broadly as an effect that is "revealed particularly as a treatment-mediated, statistically significant increase in absolute wet weight absorption" or a "reduction in fecal wet weight" (’061 Patent, col. 4:36-42). This language could support a construction that does not require a specific numerical threshold.
    • Evidence for a Narrower Interpretation: The patent provides detailed tables and figures from a clinical study, showing specific quantitative results, such as a ~751-788 g/day increase in absolute wet weight absorption and a ~20-26% increase in relative absorption (’061 Patent, Table 2). A defendant could argue these examples implicitly define the required level of "enhancement."

  • The Term: "colon-in-continuity"

  • Context and Importance: This term defines the specific patient population to be treated. Its construction is critical to identifying the subjects of the claimed method.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The patent does not provide an explicit definition but uses the term to distinguish from patients with an "end-jejunostomy and no colon" (’061 Patent, col. 1:46-47). This suggests a broad meaning of any patient whose remaining small intestine is surgically connected to any part of their colon.
    • Evidence for a Narrower Interpretation: The claims and specification repeatedly refer to patients retaining a specific percentage of their colon, such as "at least about 25%" or "at least 50%" (’061 Patent, Claims 2-3). A party could argue that "colon-in-continuity" should be read in light of these more specific embodiments to require a functionally significant portion of the colon, not just any remnant.

VI. Other Allegations

  • Indirect Infringement: The complaint seeks a declaration that its product would not "induce or contribute to the infringement by others" of any claims of the patents-in-suit (Prayer for Relief, B). The basis for this requested declaration is the same as for direct infringement: the patents are disclaimed and unenforceable (Compl. ¶¶156, 171).
  • Willful Infringement: This case presents a reverse allegation of improper conduct. The Plaintiff, Orbicular, requests that the court declare the case "exceptional" and award attorneys' fees under 35 U.S.C. § 285 (Prayer for Relief, D). The basis for this is the allegation that Defendants' conduct—maintaining the Orange Book listing for disclaimed patents and refusing to provide a consent judgment, thereby blocking generic competition—is unreasonable and harms Orbicular (Compl. ¶¶87, 107, 111, 158).

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

The resolution of this case appears to hinge less on traditional patent law questions of infringement and validity, and more on the intersection of patent law with FDA regulatory procedure. The central questions for the court are:

  1. A question of justiciability: Does a declaratory judgment plaintiff have standing to seek a non-infringement judgment on patents that the defendant has statutorily disclaimed, where the continued listing of those patents in the FDA's Orange Book creates a concrete, ongoing regulatory barrier to the plaintiff's market entry?

  2. A question of regulatory mechanics: Can, and should, the court issue a non-infringement judgment based solely on the legal effect of a disclaimer, for the express purpose of triggering the 180-day exclusivity forfeiture provisions under the Hatch-Waxman Act and clearing a regulatory pathway for a subsequent generic applicant?

  3. An equitable question of conduct: Is a patent holder's refusal to either delist a disclaimed patent from the Orange Book or provide a consent judgment of non-infringement—conduct that prolongs a regulatory block on a generic competitor—sufficient to render a case "exceptional" under 35 U.S.C. § 285?