DCT

2:24-cv-06486

Ge Healthcare Ltd v. Jubilant DraxImage Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:24-cv-06486, D.N.J., 05/28/2024
  • Venue Allegations: Venue is alleged to be proper because Defendant is a foreign corporation subject to personal jurisdiction in the District of New Jersey, where it has substantial contacts, conducts business, and has appointed a registered agent for service of process.
  • Core Dispute: Plaintiff alleges that Defendant’s submission of an Abbreviated New Drug Application (ANDA) to market a generic version of the radiopharmaceutical product MYOVIEW™ constitutes an act of infringement of a patent covering a specific formulation of the drug.
  • Technical Context: The technology relates to radiopharmaceutical compositions used for diagnostic medical imaging, specifically for preparing technetium Tc99m tetrofosmin, a key agent in cardiac perfusion imaging to diagnose coronary artery disease.
  • Key Procedural History: This action was triggered by Defendant’s filing of ANDA No. 217224 with the FDA, which included a Paragraph IV certification asserting that U.S. Patent No. 9,549,999 is invalid or will not be infringed by its proposed generic product. The patent is listed in the FDA’s Orange Book as covering Plaintiff's MYOVIEW™ product.

Case Timeline

Date Event
2007-09-21 U.S. Patent No. 9,549,999 Priority Date
2017-01-24 U.S. Patent No. 9,549,999 Issued
2024-04-15 Defendant sends notice letter regarding ANDA filing
2024-05-28 Complaint Filed

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

U.S. Patent No. 9,549,999 - "Radiopharmaceutical Composition" (Issued Jan. 24, 2017)

The Invention Explained

  • Problem Addressed: The patent’s background section describes the problem of radiopharmaceuticals, such as 99mTc-tetrofosmin, adsorbing to the surfaces of disposable plastic syringes during preparation and administration (col. 3:5-9). This adsorption can lead to an incomplete and variable delivery of the radioactive dose to the patient, potentially compromising the diagnostic image quality and necessitating the preparation of higher-activity samples, which increases radiation exposure for healthcare personnel (col. 3:60-65).
  • The Patented Solution: The invention addresses this issue by creating a specific chemical formulation for the radiopharmaceutical. The solution is not a new compound, but a composition with precisely defined parameters: a specific molar ratio of the active agent (tetrofosmin) to a radioprotectant (ascorbic acid), along with defined concentration ranges for both components and a specific pH range for the final solution (Abstract; col. 4:7-17). This specific combination is designed to minimize the drug’s tendency to stick to plastic syringes, ensuring more consistent and accurate dosing (col. 5:37-43).
  • Technical Importance: By providing a formulation with reduced and more predictable syringe adsorption, the invention allows for more reliable dosing of a widely used cardiac imaging agent, improving diagnostic accuracy and safety for both patients and radiopharmacy staff (col. 3:36-46).

Key Claims at a Glance

  • The complaint asserts claims 1-13 (Compl. ¶36). The sole independent claim is Claim 1.
  • The essential elements of independent Claim 1 are:
    • A radiopharmaceutical composition "consisting essentially of":
    • (i) a 99mTc complex of tetrofosmin in a biocompatible carrier;
    • (ii) non-radioactive tetrofosmin; and
    • (iii) a radioprotectant (ascorbic acid or a salt thereof).
    • The composition must have four specific properties:
      1. A molar ratio of total tetrofosmin to radioprotectant in the range of 0.2:1.0 to 1.0:1.0.
      2. A radioprotectant concentration in the range of 0.3-0.6 mM.
      3. A pH in the range of 8.0 to 9.2.
      4. A total tetrofosmin concentration in the range of 0.12-0.40 mM.
  • The complaint reserves the right to assert dependent claims (Compl. ¶36).

III. The Accused Instrumentality

Product Identification

The accused instrumentality is "Jubilant's ANDA Product," a generic version of MYOVIEW™ 30 mL, which is a kit for the preparation of technetium Tc99m tetrofosmin for injection with a strength of 1.38 mg/vial (Compl. ¶24).

Functionality and Market Context

The complaint alleges that by filing its ANDA, Defendant has represented to the FDA that its product has the same active ingredient, dosage form, strength, and is bioequivalent to Plaintiff's MYOVIEW™ product (Compl. ¶27). The product is intended for use as a radioactive diagnostic agent for myocardial perfusion imaging to detect coronary artery disease and to assess left ventricular function (Compl. ¶29). If approved, it would compete directly with Plaintiff's branded product (Compl. ¶28).
No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint alleges infringement of claims 1-13 exclusively under the doctrine of equivalents and does not provide a detailed claim chart (Compl. ¶36). The infringement theory is based on the submission of ANDA No. 217224, which is a statutory act of infringement under 35 U.S.C. § 271(e)(2) (Compl. ¶37). The allegations below are based on the complaint's assertion that Defendant's ANDA Product, when reconstituted according to its proposed label, will contain the elements of the claims.

’999 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A radiopharmaceutical composition consisting essentially of: (i) a 99mTc complex of tetrofosmin in a biocompatible carrier; (ii) non-radioactive tetrofosmin; and, (iii) a radioprotectant chosen from ascorbic acid or a salt thereof... The formulation of Defendant's ANDA Product, which is represented as bioequivalent to MYOVIEW™ and contains tetrofosmin and other components. ¶27, ¶36 col. 4:8-14
wherein the molar ratio of total tetrofosmin (i)+(ii) to radioprotectant (iii) is in the range 0.2:1.0 to 1.0:1.0, The molar ratio of components in Defendant's reconstituted ANDA Product is alleged to be equivalent to the claimed range. ¶36 col. 15:35-37
the concentration of said radioprotectant is in the range 0.3-0.6 mM, The concentration of the radioprotectant in Defendant's reconstituted ANDA Product is alleged to be equivalent to the claimed range. ¶36 col. 15:37-38
the pH of the composition is 8.0 to 9.2, The pH of Defendant's reconstituted ANDA Product is alleged to be equivalent to the claimed range. ¶36 col. 15:39
and the concentration of total tetrofosmin is in the range 0.12-0.40 mM. The concentration of total tetrofosmin in Defendant's reconstituted ANDA Product is alleged to be equivalent to the claimed range. ¶36 col. 15:40-42
  • Identified Points of Contention:
    • Equivalence vs. Literal Scope: The complaint’s exclusive reliance on the doctrine of equivalents suggests that Defendant’s ANDA product formulation may not literally meet one or more of the specific numerical ranges recited in Claim 1 (Compl. ¶36). A central dispute will be whether any such deviations are insubstantial. This raises the question: Does the formulation of Defendant's ANDA product perform substantially the same function (reducing syringe adsorption) in substantially the same way to achieve the same result as the claimed invention, even if a claimed numerical value is not literally met?
    • Formulation Details: A key factual question, discoverable from the ANDA filing, is what are the precise quantitative details of Defendant's formulation? The case will depend on comparing the exact molar ratios, concentrations, and pH of the reconstituted ANDA product against the ranges recited in Claim 1 to assess both literal infringement and equivalence.

V. Key Claim Terms for Construction

  • The Term: "consisting essentially of"

    • Context and Importance: This transitional phrase is critical for chemical composition claims. It is narrower than "comprising" and signifies that the claim is open to unlisted ingredients, but only if they do not "materially affect the basic and novel properties of the invention." Practitioners may focus on this term because the infringement analysis will depend on identifying the "basic and novel" property—presumably the reduced syringe adsorption—and then determining if any excipients in Defendant's ANDA product, not listed in Claim 1, materially alter that property.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The use of the phrase itself, rather than the more restrictive "consisting of," signals the patentee did not intend to exclude all other components.
      • Evidence for a Narrower Interpretation: The specification emphasizes that the invention provides "reduced retained activity to a range of clinical-grade plastic syringes" and "improved radiochemical stability" (’999 Patent, col. 5:40-46). A party could argue that any unlisted ingredient in the accused product that materially impacts these specific, touted advantages would fall outside the claim's scope.

  • The Term: "total tetrofosmin"

    • Context and Importance: The claim defines this term as the sum of the 99mTc-complexed tetrofosmin and the non-radioactive tetrofosmin (’999 Patent, col. 15:35-36). Its construction is vital because it is a component of both a claimed ratio and a claimed concentration range. While the definition appears clear, disputes in pharmaceutical cases can arise over the specific analytical methods required to accurately measure this value in an accused product, which could affect whether the product is found to be within the claimed concentration and ratio ranges.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The patent does not mandate a specific analytical technique for measuring this value, potentially leaving room for different scientifically valid methods.
      • Evidence for a Narrower Interpretation: The detailed description clarifies that "total tetrofosmin means the sum of tetrofosmin complexed to 99mTc, plus uncomplexed tetrofosmin" (’999 Patent, col. 4:20-23). This explicit definition provides a clear, albeit general, standard for what must be measured.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that if the ANDA is approved, Defendant will induce infringement by providing a product with labeling that instructs radiopharmacies, doctors, and other users to reconstitute and administer the product in a manner that infringes the ’999 Patent (Compl. ¶¶ 39-40, 42). It further alleges contributory infringement, stating the ANDA product is especially adapted for an infringing use and is not suitable for a substantial non-infringing use (Compl. ¶43).
  • Willful Infringement: The complaint alleges that Defendant had knowledge of the ’999 Patent at least as of the date it submitted its ANDA containing a Paragraph IV certification (Compl. ¶44). It further alleges that Defendant "acted without a reasonable basis for believing that it would not be liable" for infringement (Compl. ¶45).

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

  • A core issue will be one of numerical equivalence: Given the complaint’s sole reliance on the doctrine of equivalents, the case will likely turn on whether the specific formulation of Defendant's proposed generic product, if it falls outside the literal numerical boundaries of Claim 1, is nonetheless legally equivalent. The central question is whether any differences in the claimed molar ratios, component concentrations, or pH are merely insubstantial.
  • A second key issue will be the interpretation of claim scope: The meaning of the phrase "consisting essentially of" will be critical. The court’s determination of what constitutes the "basic and novel properties" of the invention will define the extent to which Defendant's product can include unlisted ingredients without falling outside the scope of the claims.