DCT

1:25-cv-00311

Sumitomo Pharma Switzerland GmbH v. Apotex Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:25-cv-00311, D. Del., 09/23/2025
  • Venue Allegations: Venue is alleged to be proper in the District of Delaware because the Defendant, Sandoz Inc., is a Delaware corporation.
  • Core Dispute: Plaintiffs allege that Defendant’s Abbreviated New Drug Application (ANDA) to market a generic version of Orgovyx® (relugolix) infringes five U.S. patents covering compositions and methods of use for the drug.
  • Technical Context: The technology concerns relugolix, an orally administered gonadotropin-releasing hormone (GnRH) receptor antagonist approved for treating adult patients with advanced prostate cancer.
  • Key Procedural History: This is a Hatch-Waxman action triggered by Sandoz’s submission of ANDA No. 219913 to the FDA. On June 20, 2025, Sandoz sent Plaintiffs a Paragraph IV notice letter, asserting that the patents-in-suit are invalid or will not be infringed by its proposed generic product.

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® (relugolix) NDA
2023-10-24 U.S. Patent No. 11,795,178 Issues
2024-09-24 U.S. Patent No. 12,097,198 Issues
2024-11-19 U.S. Patent No. 12,144,809 Issues
2025-06-10 U.S. Patent No. 12,325,714 Issues
2025-06-11 ’714 Patent listed in Orange Book
2025-06-20 Sandoz sends Paragraph IV Notice Letter to Plaintiffs
2025-06-24 U.S. Patent No. 12,336,990 Issues
2025-06-25 ’990 Patent listed in Orange Book
2025-07-29 Plaintiffs provide Sandoz with copies of ’714 and ’990 Patents
2025-09-23 Complaint Filed

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

U.S. Patent No. 11,795,178 - "Compositions of Thienopyrimidine Derivatives"

  • Patent Identification: U.S. Patent No. 11,795,178, “Compositions of Thienopyrimidine Derivatives,” issued October 24, 2023 (Compl. ¶19).

The Invention Explained

  • Problem Addressed: The patent background section states a demand for a "safe production method of a thienopyrimidine derivative or a salt thereof which has a gonadotropin releasing hormone antagonistic action with high quality (e.g., high purity) in high yield" (’178 Patent, col. 2:10-16).
  • The Patented Solution: The invention is a pharmaceutical mixture containing the active ingredient relugolix and a specific, known impurity, 6-(4-aminophenyl)-...-dione, where the impurity is controlled to a very low level. The patent describes production methods that can safely achieve this high-purity composition (’178 Patent, col. 2:17-26). Claim 1 defines the invention not by the active ingredient alone, but as a mixture characterized by the maximum allowable amount of this specific impurity (’178 Patent, col. 32:5-13).
  • Technical Importance: Controlling impurity levels in active pharmaceutical ingredients is critical for ensuring drug product safety, stability, and efficacy, and is a key requirement for regulatory approval.

Key Claims at a Glance

  • The complaint asserts infringement of at least independent claim 1 (Compl. ¶39).
  • Claim 1 of the ’178 Patent contains the following essential elements:
    • A mixture comprising 1-{4-[1-(2,6-difluorobenzyl)-5-dimethylaminomethyl-3-(6-methoxypyridazin-3-yl)-2,4-di-oxo-1,2,3,4-tetrahydrothieno[2,3-d]pyrimidin-6-yl]phenyl}-3-methoxyurea (relugolix), 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 (an impurity);
    • wherein the impurity is present in an amount of about 0.16% or less of the mixture, as determined by HPLC.

U.S. Patent No. 12,325,714 - "Compositions of Thienopyrimidine Derivatives"

  • Patent Identification: U.S. Patent No. 12,325,714, “Compositions of Thienopyrimidine Derivatives,” issued June 10, 2025 (Compl. ¶20).

The Invention Explained

  • Problem Addressed: Similar to the ’178 Patent, the specification notes a "demand for the development of a safe production method of a thienopyrimidine derivative" with "high quality (e.g., high purity) in high yield" (’714 Patent, col. 2:13-17).
  • The Patented Solution: This invention claims a solid mixture containing the active ingredient relugolix along with a different, specified impurity known as RS-1 (1-{4-[1-(2,6-difluorobenzyl)-...-3-(6-oxo-1,6-dihydropyridazin-3-yl)...]phenyl}-3-methoxyurea). The claims define the composition by limiting this specific RS-1 impurity to a very low concentration, such as "about 0.1% or less" (’714 Patent, col. 25:57-67). The patent describes production and purification methods to achieve this level of purity (’714 Patent, col. 2:21-27).
  • Technical Importance: This technology provides another way to define the patented drug substance through a high-purity composition, focusing on the control of a different potential process impurity or degradant than the one claimed in the ’178 patent.

Key Claims at a Glance

  • The complaint asserts infringement of at least independent claims 1, 11, and 19 (Compl. ¶49).
  • Claim 1 of the ’714 Patent contains the following essential elements:
    • A solid mixture comprising relugolix, or a salt or solvate thereof;
    • and the RS-1 impurity;
    • wherein the RS-1 impurity is present in an amount of about 0.1% or less of the mixture, as determined by HPLC.
  • Independent claim 11 recites the same mixture, but with the impurity limited to "about 0.07% or less."
  • Independent claim 19 recites a method of treating prostate cancer in a subject by administering the mixture of claim 1.

U.S. Patent No. 12,097,198 - "Treatment of Prostate Cancer"

  • Patent Identification: U.S. Patent No. 12,097,198, "Treatment of Prostate Cancer," issued September 24, 2024 (Compl. ¶21).
  • Technology Synopsis: The ’198 Patent is directed to a method for treating prostate cancer using relugolix. The claims recite a specific oral dosing regimen that includes a higher loading dose for a set number of days followed by a lower maintenance dose, which is designed to achieve and maintain medical castration levels of serum testosterone (’198 Patent, Abstract and Claim 1).
  • Asserted Claims: At least claims 1-2, 4-6, and 10-12 (Compl. ¶60).
  • Accused Features: The complaint alleges that Sandoz's proposed labeling for its ANDA Product will instruct and encourage healthcare providers and patients to practice the claimed dosing methods (Compl. ¶63).

U.S. Patent No. 12,144,809 - "Treatment of Prostate Cancer"

  • Patent Identification: U.S. Patent No. 12,144,809, "Treatment of Prostate Cancer," issued November 19, 2024 (Compl. ¶22).
  • Technology Synopsis: The ’809 Patent is directed to a method of administering relugolix to treat prostate cancer specifically in patients who are also being treated with a P-glycoprotein (P-gp) inhibitor. Because P-gp inhibitors can increase a patient's exposure to relugolix, the claimed method requires separating the administration of the two drugs by at least six hours to manage this drug-drug interaction (Compl. ¶¶70, 73).
  • Asserted Claims: At least claims 1, 3, 5, 9, 12, 19, and 23-29 (Compl. ¶79).
  • Accused Features: The complaint alleges that Sandoz's proposed labeling for its ANDA Product will instruct doctors and patients on the claimed method of co-administration with specified dose separation, thereby inducing infringement (Compl. ¶¶76-77).

U.S. Patent No. 12,336,990 - "Treatment of Prostate Cancer"

  • Patent Identification: U.S. Patent No. 12,336,990, "Treatment of Prostate Cancer," issued June 24, 2025 (Compl. ¶23).
  • Technology Synopsis: The ’990 Patent, similar to the ’198 Patent, claims a method for treating prostate cancer with an oral dosing regimen of relugolix. The claims specify a loading dose followed by a maintenance dose intended to rapidly achieve and sustain medical castration by suppressing serum testosterone levels (’990 Patent, Abstract).
  • Asserted Claims: At least claims 1-2, 4-7, and 15-30 (Compl. ¶87).
  • Accused Features: The complaint alleges that Sandoz, by marketing its ANDA Product with its proposed labeling, will induce healthcare providers and patients to practice the claimed methods (Compl. ¶91).

III. The Accused Instrumentality

Product Identification

  • The accused instrumentality is Sandoz Inc.’s proposed generic version of Orgovyx®, identified as 120 mg tablets of relugolix, which is the subject of Abbreviated New Drug Application No. 219913 (the "ANDA Product") (Compl. ¶1).

Functionality and Market Context

  • As a generic drug product, the Sandoz ANDA Product is represented to the FDA as having the same active ingredient, dosage form, and strength as the branded drug Orgovyx®, and to be bioequivalent to it (Compl. ¶27). The active ingredient, relugolix, is a nonpeptide GnRH receptor antagonist used for the oral treatment of adult patients with advanced prostate cancer (Compl. ¶17). The complaint alleges that Sandoz is seeking FDA approval to manufacture and sell this generic product 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 sufficient detail for a claim chart analysis of the composition claims of the ’178 and ’714 Patents. The infringement counts for these patents are based on the statutory act of infringement under 35 U.S.C. § 271(e)(2)(A), which makes the submission of an ANDA for a patented drug an act of infringement (Compl. ¶39, ¶49). The specific composition of the Sandoz ANDA Product, including its impurity profile, is contained within the confidential ANDA that Plaintiffs state they have not yet received under reasonable terms (Compl. ¶35). The infringement allegation rests on the premise that a bioequivalent generic product will necessarily fall within the patents’ claims covering the high-purity composition of the brand name drug.

  • Identified Points of Contention:
    • Factual/Evidentiary Question: The primary point of contention for the ’178 and ’714 Patents will be factual and must be resolved through discovery of the confidential ANDA. The key question is whether the Sandoz ANDA Product, as manufactured according to its application, will in fact contain the specific impurities recited in the claims at concentrations that fall within the claimed ranges.
    • Scope Question: The use of the term "about" in the claims' numerical limitations for impurity levels (e.g., "about 0.16% or less") raises a question of claim scope. The parties may dispute the range encompassed by this term, which could be dispositive of infringement.

V. Key Claim Terms for Construction

  • The Term: "about [X]% or less" (e.g., "about 0.16% or less" from claim 1 of the ’178 Patent; "about 0.1% or less" from claim 1 of the ’714 Patent).
  • Context and Importance: Practitioners may focus on this term because the infringement analysis for the composition claims of the ’178 and ’714 Patents will depend entirely on whether the impurity level of Sandoz's product falls within the claimed numerical range. The word "about" introduces a degree of flexibility to the numerical limit, and the extent of that flexibility will likely be a central dispute.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The use of the word "about" itself is evidence that the patentee did not intend to be limited to the exact numerical values stated in the claims (’178 Patent, col. 32:12; ’714 Patent, col. 25:65). This suggests the claim should cover values that are approximately, or reasonably close to, the stated percentage.
    • Evidence for a Narrower Interpretation: The patent specifications provide examples with specific, measured impurity levels determined by High-Performance Liquid Chromatography (HPLC) (’178 Patent, col. 25:46-50, Table 5; ’714 Patent, col. 25:46-50, Table 5). A defendant may argue that the term "about" should be interpreted narrowly, limited by the precision of the HPLC measurement technique disclosed or confined to the range of impurity levels demonstrated in the patent's own examples, which are well below the claimed upper limits.

VI. Other Allegations

  • Indirect Infringement: For the method of use patents (’198, ’809, and ’990), the complaint alleges induced infringement under 35 U.S.C. § 271(b). The allegations are based on the assertion that Sandoz's proposed product labeling will instruct and encourage healthcare providers and patients to administer the ANDA Product according to the patented methods, such as the specific loading and maintenance dose regimens or the dose separation required when co-administered with a P-gp inhibitor (Compl. ¶63, ¶77, ¶91). The complaint also alleges contributory infringement, stating the ANDA Product and its proposed labeling are especially made or adapted for use in infringing the patents and are not staple articles of commerce suitable for substantial noninfringing use (Compl. ¶64, ¶92).
  • Willful Infringement: The complaint alleges that Sandoz acted without a reasonable basis for believing it would not be liable for infringement and requests that the case be found exceptional (Compl. ¶46, ¶67, ¶84, ¶95). The basis for knowledge includes Sandoz’s Paragraph IV certification for the ’178, ’198, and ’809 Patents, which demonstrates pre-suit knowledge (Compl. ¶28, ¶31). For the more recently listed ’714 and ’990 Patents, knowledge is alleged based on their listing in the FDA’s Orange Book and on direct notice provided by Plaintiffs to Sandoz via email on July 29, 2025 (Compl. ¶51, ¶89).

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

  • A core issue will be one of evidentiary proof: Will the chemical specifications and batch data contained within Sandoz's confidential ANDA demonstrate that its proposed generic product will meet the specific, low-level impurity profiles claimed in the ’178 and ’714 patents?
  • A key legal question will be one of induced infringement: Does the instructional language in Sandoz's proposed product label, which must be substantially similar to the brand-name label, actively encourage and instruct physicians and patients to perform the specific dosing and administration steps recited in the ’198, ’809, and ’990 method patents, thereby creating liability for indirect infringement?
  • A central claim construction dispute will likely involve definitional scope: How broadly should the term "about," as used to define the numerical impurity limits in the composition patents, be construed in light of the patent's examples and the precision of the analytical methods disclosed?