DCT

1:25-cv-00970

Sumitomo Pharma Switzerland GmbH v. Sandoz Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: Sumitomo Pharma Switzerland GmbH v. Sandoz Inc., 1:25-cv-00970, D. Del., 08/01/2025
  • Venue Allegations: Venue is alleged to be proper in the District of Delaware because Defendant Sandoz Inc. is incorporated in Delaware.
  • Core Dispute: Plaintiffs allege that Defendant’s submission of an Abbreviated New Drug Application (ANDA) to the FDA for a generic version of the prostate cancer drug Orgovyx® (relugolix) constitutes an act of infringement of five U.S. patents.
  • Technical Context: The technology concerns pharmaceutical compositions of the compound relugolix, a gonadotropin-releasing hormone (GnRH) antagonist, and methods for its use in treating advanced prostate cancer.
  • Key Procedural History: This action was initiated under the Hatch-Waxman Act following Defendant’s June 20, 2025, Paragraph IV certification letter, which notified Plaintiffs of its ANDA filing and asserted that the patents-in-suit are invalid or will not be infringed. The patents are listed in the FDA’s Orange Book for the branded drug Orgovyx®.

Case Timeline

Date Event
2012-09-28 Earliest Priority Date for ’178 and ’714 Patents
2016-09-30 Earliest Priority Date for ’198, ’809, and ’990 Patents
2020-12-18 FDA approves Orgovyx® New Drug Application
2023-10-24 ’178 Patent issues
2024-09-24 ’198 Patent issues
2024-11-19 ’809 Patent issues
2025-06-10 ’714 Patent issues
2025-06-11 ’714 Patent listed in Orange Book
2025-06-20 Sandoz sends Paragraph IV Notice Letter to Plaintiffs
2025-06-24 ’990 Patent issues
2025-06-25 ’990 Patent listed in Orange Book
2025-07-29 Plaintiffs provide Sandoz with copies of ’714 and ’990 Patents
2025-08-01 Complaint filed

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

U.S. Patent No. 11,795,178 - "Compositions of Thienopyrimidine Derivatives" (issued Oct. 24, 2023)

The Invention Explained

  • Problem Addressed: The patent background identifies a demand for a "safe production method" of a thienopyrimidine derivative (a GnRH antagonist) that yields a product with "high quality (e.g., high purity) in high yield" (’178 Patent, col. 2:10-16). This highlights the challenge in pharmaceutical manufacturing of achieving high purity and yield simultaneously in a safe manner.
  • The Patented Solution: The patent describes a multi-step chemical synthesis process for producing the thienopyrimidine derivative known as relugolix (’178 Patent, col. 2:17-36). The invention as claimed is not the process itself, but rather the resulting composition, which is characterized as a mixture of the desired active ingredient and a specific, low-level process impurity. The detailed description provides specific reaction conditions and purification steps intended to control the final product's composition (’178 Patent, col. 11:13-12:4).
  • Technical Importance: By defining a composition with a specific, minimal impurity profile, the invention provides a standard for a high-purity, and therefore potentially safer and more effective, pharmaceutical product suitable for commercial use (’178 Patent, col. 2:22-26).

Key Claims at a Glance

  • The complaint asserts infringement of at least independent claim 1 (Compl. ¶39).
  • The essential elements of Claim 1 are:
    • A mixture comprising 1-{4-[1-(2,6-difluorobenzyl)-5-dimethylaminomethyl-3-(6-methoxypyridazin-3-yl)-2,4-dioxo-1,2,3,4-tetrahydrothieno[2,3-d]pyrimidin-6-yl]phenyl}-3-methoxyurea, or a salt or solvate thereof; and
    • 6-(4-aminophenyl)-1-(2,6-difluorobenzyl)-5-dimethylaminomethyl-3-(6-methoxypyridazin-3-yl)thieno[2,3-d]pyrimidine-2,4(1H,3H)-dione;
    • Wherein the 6-(4-aminophenyl)...dione is present in an amount of from about 4.45% to about 0.20% of the mixture, as determined by HPLC.
  • The complaint reserves the right to assert additional claims (Compl. ¶40).

U.S. Patent No. 12,325,714 - "Compositions of Thienopyrimidine Derivatives" (issued Jun. 10, 2025)

The Invention Explained

  • Problem Addressed: As a continuation of the application leading to the ’178 Patent, this patent addresses the same technical problem: the need for a production method for a GnRH antagonist that results in a high-purity, high-yield product (’714 Patent, col. 2:10-16).
  • The Patented Solution: The patent discloses the same synthesis process for relugolix but claims different resulting compositions (’714 Patent, col. 2:17-36). These compositions are defined as mixtures of the active ingredient and other specific, low-level impurities that can arise during the manufacturing process, thereby patenting distinct purity profiles of the final drug substance (’714 Patent, col. 10:50-59, col. 25:10-26:48).
  • Technical Importance: This approach seeks to protect different high-purity versions of the relugolix drug substance, each defined by the presence of different trace impurities, which can provide distinct patentability over prior art and other manufacturing methods (’714 Patent, col. 2:22-26).

Key Claims at a Glance

  • The complaint asserts infringement of independent claims 1, 11, and 19 (Compl. ¶49).
  • The essential elements of Claim 1 are:
    • A mixture comprising 1-{4-[1-(2,6-difluorobenzyl)...]phenyl}-3-methoxyurea, or a salt or solvate thereof; and
    • 1-{4-[1-(2,6-difluorobenzyl)-5-dimethylaminomethyl-2,4-dioxo-3-(6-oxo-1,6-dihydropyridazin-3-yl)-1,2,3,4-tetrahydrothieno[2,3-d]pyrimidin-6-yl]phenyl}-3-methoxyurea;
    • Wherein the second compound is present in an amount of about 0.1% or less of the mixture.
  • The essential elements of Claim 11 are:
    • A mixture comprising 1-{4-[1-(2,6-difluorobenzyl)...]phenyl}-3-methoxyurea, or a salt or solvate thereof; and
    • N-{4-[1-(2,6-difluorobenzyl)-5-dimethylaminomethyl-3-(6-methoxypyridazin-3-yl)-2,4-dioxo-1,2,3,4-tetrahydrothieno[2,3-d]pyrimidin-6-yl]phenyl}-N,N'-dimethoxydicarbonimidic diamide;
    • Wherein the second compound is present in an amount of about 0.08% or less of the mixture.
  • The essential elements of Claim 19 are:
    • A mixture comprising 1-{4-[1-(2,6-difluorobenzyl)...]phenyl}-3-methoxyurea, or a salt or solvate thereof; and
    • Two specified impurities: 1-(2,6-Difluorobenzyl)-5-dimethylaminomethyl-3-(6-methoxy-pyridazin-3-yl)-6-(4-nitrophenyl)thieno[2,3-d]pyrimidine-2,4(1H,3H)-dione AND ethyl (2,6-difluorobenzyl)-[4-dimethylaminomethyl-3-(6-methoxypyridazin-3-ylcarbamoyl)-5-(4-nitrophenyl)thiophen-2-yl]carbamate.
  • The complaint reserves the right to assert additional claims (Compl. ¶50).

U.S. Patent No. 12,097,198 - "Treatment of Prostate Cancer" (issued Sep. 24, 2024)

  • Technology Synopsis: The patent is directed to methods of treating prostate cancer by administering the GnRH antagonist relugolix (’198 Patent, col. 1:12-19). The claimed methods involve specific dosing regimens, such as administering an initial oral load dose followed by a smaller daily oral maintenance dose to suppress sex hormones like testosterone (’198 Patent, col. 61:25-42).
  • Asserted Claims: At least claims 1-2, 4-6, and 10-12 are asserted (Compl. ¶60).
  • Accused Features: The complaint alleges that Defendant's proposed product labeling will instruct physicians and patients to administer the generic relugolix product according to the patented dosing regimens, thereby inducing infringement of the method claims (Compl. ¶63).

U.S. Patent No. 12,144,809 - "Treatment of Prostate Cancer" (issued Nov. 19, 2024)

  • Technology Synopsis: The patent claims methods of treating prostate cancer with relugolix in patients who also require co-administration of a P-glycoprotein (P-gp) inhibitor, a class of drugs that can affect relugolix exposure (Compl. ¶¶70-71). The claimed method mitigates this drug-drug interaction by requiring a specific time separation between the administration of relugolix and the P-gp inhibitor (Compl. ¶73).
  • Asserted Claims: At least claims 1, 3, 5, 9, 12, 19, and 23-29 are asserted (Compl. ¶79).
  • Accused Features: The complaint alleges that the proposed label for Defendant's ANDA Product will instruct healthcare providers on the claimed dosing regimen for patients in need of co-administration with a P-gp inhibitor, which is alleged to constitute induced infringement (Compl. ¶¶76-77).

U.S. Patent No. 12,336,990 - "Treatment of Prostate Cancer" (issued Jun. 24, 2025)

  • Technology Synopsis: This patent, part of the same family as the ’198 and ’809 patents, is also directed to methods of treating prostate cancer with relugolix (’990 Patent, col. 1:12-19). The claims cover specific therapeutic outcomes and dosing regimens, including an initial load dose followed by a maintenance dose, to achieve and maintain medical castration levels of testosterone (’990 Patent, Claims 1, 15).
  • Asserted Claims: At least claims 1-2, 4-7, and 15-30 are asserted (Compl. ¶87).
  • Accused Features: The complaint alleges that Defendant's marketing of its ANDA Product with its proposed label will induce healthcare providers and patients to practice the claimed methods of treatment, constituting induced infringement (Compl. ¶91).

III. The Accused Instrumentality

  • Product Identification: Defendant Sandoz’s Abbreviated New Drug Application No. 219913 product ("the ANDA Product"), which is a generic version of Orgovyx® (relugolix) 120 mg tablets (Compl. ¶1).
  • Functionality and Market Context: By filing an ANDA, Sandoz represents that its product has the same active ingredient, dosage form, strength, and bioequivalence as the branded drug Orgovyx® (Compl. ¶27). Orgovyx® is a nonpeptide GnRH receptor antagonist approved by the FDA for oral administration for the treatment of adult patients with advanced prostate cancer (Compl. ¶17). The complaint alleges that Sandoz seeks approval to manufacture and sell its generic version prior to the expiration of the patents-in-suit (Compl. ¶1). No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint does not provide a detailed claim chart or specific factual allegations mapping elements of the accused product to the claim limitations of the composition patents ('178 and '714). The infringement allegations are primarily based on the act of submitting the ANDA under 35 U.S.C. § 271(e)(2)(A), which creates a statutory act of infringement for purposes of establishing jurisdiction in a Hatch-Waxman case (Compl. ¶¶39, 49).

The substantive infringement theory for the composition patents rests on the allegation that Sandoz’s ANDA product, upon commercial manufacture, will necessarily contain the specific impurities at the levels recited in the claims (Compl. ¶¶40, 50). For the method of use patents ('198, '809, and '990), the infringement theory is based on inducement, alleging that Sandoz’s proposed product labeling will instruct medical professionals and patients to administer the drug in a manner that directly infringes the patented methods (Compl. ¶¶63, 77, 91).

  • Identified Points of Contention:
    • Evidentiary Questions (Composition Patents): A central dispute will be factual and evidentiary: does the Sandoz ANDA product actually contain the specific impurities recited in the claims of the ’178 and ’714 Patents? If so, are those impurities present within the claimed percentage ranges? The complaint does not present any chemical analysis of the Sandoz product.
    • Infringement Questions (Method Patents): The infringement analysis for the method patents will focus on the language of Sandoz's proposed (and eventually FDA-approved) product label. A key question will be whether the label's instructions to physicians and patients will inevitably lead them to perform all the steps of the asserted method claims.

V. Key Claim Terms for Construction

  • The Term: "a mixture comprising" (’178 Patent, Claim 1; ’714 Patent, Claims 1, 11, 19).

  • Context and Importance: The construction of this term is fundamental. Practitioners may focus on this term because the infringement case for the composition patents depends on proving that the accused product is not just the pure active pharmaceutical ingredient (API), but a "mixture" that includes specific trace impurities. Defendant may argue its product is a single API and that any trace elements are not part of a claimed "mixture," while Plaintiff will likely argue that any final drug substance containing the API and the specified impurity constitutes the claimed mixture.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The specification repeatedly describes the invention in terms of a "production method" that results in a high-purity product, suggesting that the claimed "mixture" is the natural output of such a process, and any product made by a similar process would be covered (’178 Patent, col. 2:17-26).
    • Evidence for a Narrower Interpretation: The patent emphasizes achieving "high quality (e.g., high purity)" (’178 Patent, col. 2:14-16). A defendant may argue that this context limits the term "mixture" to only those compositions created by the patent's specific process and that the claims cannot be used to cover any product that happens to have trace impurities.

  • The Term: "about [X]% or less" (’178 Patent, Claim 1; ’714 Patent, Claims 1, 11).

  • Context and Importance: The scope of the word "about" will be critical for determining the literal infringement boundary. The dispute will center on how much deviation from the stated percentage of impurity is permissible while still falling within the claim.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The use of "about" itself implies a degree of numerical flexibility recognized in patent law to avoid a strict, literal interpretation that would be easy to design around. The patent does not explicitly define the term, leaving it open to its ordinary meaning in the context of pharmaceutical chemistry and measurement techniques like HPLC.
    • Evidence for a Narrower Interpretation: The patent provides specific HPLC analysis results and tables showing precise measurements of impurities in its examples (’178 Patent, Tables 4 & 5). A defendant may argue that these specific examples constrain the meaning of "about" to a very narrow range consistent with the measurement tolerances shown in the patent's own data.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges inducement of infringement for all five patents, based on the assertion that Sandoz’s proposed drug label will instruct and encourage healthcare providers and patients to use the generic product in ways that directly infringe the method claims, and that the product itself infringes the composition claims (Compl. ¶¶42, 53, 63, 81, 91). Contributory infringement is alleged for the ’178, ’714, and ’990 patents on the basis that the ANDA product is not a staple article of commerce and is especially made for use in an infringing manner (Compl. ¶¶43, 54, 92).
  • Willful Infringement: The complaint alleges that Sandoz had pre-suit knowledge of the asserted patents, citing the dates the patents were listed in the FDA's Orange Book, the date of its Paragraph IV notification letter, and the date Plaintiffs provided copies of certain patents (Compl. ¶¶31, 33-34, 51, 89). Based on this alleged knowledge, the complaint asserts that Sandoz acted without a reasonable basis for believing it would not be liable and requests that the case be declared "exceptional" to permit recovery of attorneys' fees (Compl. ¶¶46, 57, 67, 84, 95).

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

  • A primary issue will be one of evidentiary proof: Can Plaintiffs demonstrate through chemical analysis that Sandoz's generic relugolix product is, in fact, the specific "mixture" claimed in the '178 and '714 patents, containing the recited impurities within the narrowly defined percentage ranges?
  • A key question of induced infringement will turn on the final language of the FDA-approved label for Sandoz's product: Will the label's instructions for dosing, administration, and management of drug interactions direct users to perform the patented methods of the '198, '809, and '990 patents?
  • A central legal question will concern claim scope: How will the court construe the term "mixture" in the context of a high-purity pharmaceutical product, and what degree of variability will be permitted by the term "about" when defining the percentage of impurities? The answers will define the boundaries of infringement.