DCT

2:24-cv-09483

Ultragenyx Pharmaceutical Inc v. Navinta LLC

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:24-cv-09483, D.N.J., 09/26/2024
  • Venue Allegations: Venue is alleged based on Defendants' incorporation, principal places of business, established places of business, and systematic business contacts within New Jersey.
  • Core Dispute: Plaintiffs allege that Defendants' submission of Abbreviated New Drug Applications (ANDAs) to the FDA, seeking to market generic versions of Plaintiffs' drug DOJOLVI® (triheptanoin), constitutes an act of infringement of a patent covering the drug's composition.
  • Technical Context: The technology involves compositions of triheptanoin, a synthetic odd-carbon fatty acid, used as a medical food to treat rare, inherited metabolic disorders by providing an alternative energy source for patients.
  • Key Procedural History: The lawsuit was triggered by Defendants sending Paragraph IV certification notice letters to Plaintiffs, stating their belief that U.S. Patent No. 8,697,748 is invalid, unenforceable, or will not be infringed by their proposed generic products. This action initiates litigation under the Hatch-Waxman Act, which imposes a statutory stay on FDA approval of the generic applications.

Case Timeline

Date Event
2004-07-02 U.S. Patent No. 8,697,748 Priority Date
2014-04-15 U.S. Patent No. 8,697,748 Issued
2024-08-14 Navinta sends Paragraph IV Notice Letter to Plaintiffs
2024-08-22 Aurobindo sends Paragraph IV Notice Letter to Plaintiffs
2024-08-27 Esjay sends first Paragraph IV Notice Letter to Plaintiffs
2024-09-23 Esjay sends second Paragraph IV Notice Letter to Plaintiffs
2024-09-26 Complaint Filed

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

  • Patent Identification: U.S. Patent No. 8,697,748, "Glycogen or polysaccharide storage disease treatment method", issued April 15, 2014.

The Invention Explained

  • Problem Addressed: The patent addresses glycogen-storage disease type II (GSD II or "Pompe's disease"), a genetic disorder caused by a deficiency of the enzyme acid alpha-glucosidase. This deficiency leads to the abnormal accumulation of glycogen in cellular lysosomes, which in turn causes cellular injury, organ dysfunction, progressive muscle weakness, and is often fatal ('748 Patent, col. 1:21-48).
  • The Patented Solution: The invention provides an alternative energy source to bypass the defective metabolic pathway. It uses odd-carbon fatty acids, such as triheptanoin, which are metabolized into 5-carbon ketone bodies. These ketones can be used by the body's cells to produce energy via the citric acid cycle (CAC), thereby reducing the reliance on glycogen and sparing muscle protein from being broken down for energy ('748 Patent, col. 19:8-21; Fig. 4). Figure 4 of the patent illustrates how "Odd-Carbon Therapy" using heptanoate (derived from triheptanoin) circumvents the various enzymatic defects associated with glycogen storage disorders. ('748 Patent, Fig. 4).
  • Technical Importance: This therapy offered a novel metabolic approach to manage a severe genetic disease where treatment options were limited and often focused only on supportive care or complex enzyme replacement therapies ('748 Patent, col. 2:4-11).

Key Claims at a Glance

  • The complaint asserts infringement of at least independent claim 1 (Compl. ¶93).
  • The essential elements of independent claim 1 are:
    • A composition comprising an active agent, wherein the active agent consists essentially of a triheptanoin.
    • The composition has an acid value of 0.1 or less mg KOH/gr.
    • The composition has a hydroxyl value of 2.8 or less mg KOH/gr.
  • The complaint alleges infringement of "one or more claims" of the '748 patent, reserving the right to assert additional claims (Compl. ¶93).

III. The Accused Instrumentality

Product Identification

  • The accused instrumentalities are the proposed generic triheptanoin oral liquid, 100% w/w, products described in three separate ANDAs filed by the Defendants: Navinta's ANDA No. 219480, Aurobindo's ANDA No. 219711, and Esjay's ANDA No. 219512 (Compl. ¶1).

Functionality and Market Context

  • The accused products are intended to be generic equivalents of Plaintiffs' FDA-approved drug, DOJOLVI® (Compl. ¶1). DOJOLVI® is used for the treatment of long-chain fatty acid oxidation disorders (LC-FAOD) (Compl. ¶15). The complaint alleges that the Defendants' products are specifically identified as "a triheptanoin oral liquid" (Compl. ¶¶ 69, 78, 87).
  • The complaint highlights the market position of Defendant Aurobindo as the "#1 largest generic pharma company in the US by Rx dispensed," suggesting the potential for significant market disruption upon entry of its generic product (Compl. ¶33).

IV. Analysis of Infringement Allegations

'748 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A composition comprising an active agent, wherein the active agent consists essentially of a triheptanoin... The complaint alleges that Defendants have filed ANDAs for purported generic versions of "triheptanoin oral liquid, 100% w/w," which is the active ingredient identified in the claim. The complaint references the notice letters in which Defendants state their product is a triheptanoin oral liquid. ¶1, ¶69, ¶78, ¶87 col. 37:2-3
...and wherein the composition has an acid value of 0.1 or less mg KOH/gr, a hydroxyl value of 2.8 or less mg KOH/gr. The complaint alleges that the Defendants' products are purported generic versions of DOJOLVI®. Infringement is predicated on the basis that to be a generic equivalent approved under an ANDA, the product must necessarily possess the same characteristics, including the purity levels defined by the claimed acid and hydroxyl values. ¶1, ¶66, ¶75, ¶84 col. 37:4-6

Identified Points of Contention

  • Evidentiary Question: The complaint does not and, at this stage, cannot provide direct evidence of the acid and hydroxyl values of the Defendants' proposed products. A central factual dispute will be whether discovery reveals that the Defendants' manufacturing processes and FDA submissions specify a product that meets these precise purity limitations.
  • Scope Question: The claim uses the transitional phrase "consists essentially of." The interpretation of this term will be critical. It raises the question of whether the Defendants' formulations, which may contain various excipients, "materially affect the basic and novel properties" of the claimed triheptanoin composition, potentially allowing Defendants to argue their products fall outside the scope of the claim.

V. Key Claim Terms for Construction

  • The Term: "consists essentially of"
  • Context and Importance: This term is a legal term of art that is narrower than "comprising" but broader than "consisting of." Its construction will define the patent's boundary. The infringement analysis for the Defendants' ANDA products, which are finished drug formulations and not just pure triheptanoin, will turn on whether any unlisted ingredients they contain are permissible under this standard. Practitioners may focus on this term because it is a common point of dispute in chemical composition claims, especially in the pharmaceutical context where excipients are ubiquitous.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specification describes numerous formulations that include additional components like emulsifiers (e.g., Imwitor 375), vitamins, minerals, and amino acids, suggesting that the inventor contemplated the presence of other ingredients ('748 Patent, col. 2:60-62; col. 4:30-34). Plaintiffs may argue these examples show that such additions do not materially alter the invention's fundamental therapeutic character.
    • Evidence for a Narrower Interpretation: Defendants may argue that the "basic and novel" properties of the invention are tied directly to the high purity of the triheptanoin, as explicitly defined by the low acid and hydroxyl values in the claim itself ('748 Patent, col. 37:4-6). From this perspective, any additional substance that affects these purity parameters or introduces another therapeutically active agent would be a material alteration, placing the composition outside the claim's scope.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that upon FDA approval, Defendants will induce infringement by marketing their products with labels that instruct physicians and patients to use the generic triheptanoin for the patented treatment methods, with knowledge of the '748 patent (Compl. ¶¶ 94, 103, 112).
  • Willful Infringement: The complaint requests a judgment of willful infringement. This allegation is supported by the fact that Defendants filed their ANDAs with Paragraph IV certifications, an act which demonstrates knowledge of the '748 patent, and continued pursuit of their applications post-filing could be alleged to be willful conduct (Compl. ¶¶ 24, 31, 50; Prayer for Relief, a(g)).

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

  • A central issue will be evidentiary and factual: Can Plaintiffs prove, through discovery of Defendants' confidential ANDA submissions and manufacturing data, that the proposed generic products actually meet the specific and restrictive purity limitations (acid and hydroxyl values) recited in Claim 1 of the '748 patent?
  • The case will also turn on a question of claim scope: How will the court construe the term "consists essentially of"? The outcome of this legal determination will dictate whether the presence of standard pharmaceutical excipients in the Defendants' formulations is sufficient to place them outside the bounds of the patent claim.
  • Finally, underlying the entire dispute is the question of patent validity, raised by the Defendants' Paragraph IV certifications: Will the '748 patent's claims to a specific, high-purity form of triheptanoin withstand a challenge based on prior art, and is the patent otherwise valid and enforceable?