DCT

1:25-cv-00312

Sumitomo Pharma Switzerland GmbH v. Cipla Ltd

Log In

I. Executive Summary and Procedural Information

Case Timeline

Date Event
2012-09-28 Earliest Priority Date for U.S. Patent No. 11,795,178
2016-09-30 Earliest Priority Date for U.S. Patent No. 12,097,198
2016-09-30 Earliest Priority Date for U.S. Patent No. 12,144,809
2020-12-18 FDA approves Orgovyx® (relugolix)
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
2025-01-31 Cipla sends Paragraph IV Notice Letter to Plaintiffs
2025-03-12 Complaint for Patent Infringement filed

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

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

The Invention Explained

  • Problem Addressed: The patent describes a demand for a safe and efficient production method for a thienopyrimidine derivative (relugolix) that yields a high-quality, high-purity product. (’178 Patent, col. 2:9-15).
  • The Patented Solution: The patent claims a specific composition, or mixture, containing the active pharmaceutical ingredient (relugolix) and a particular related substance, 6-(4-aminophenyl)-1-(2,6-difluorobenzyl)-5-dimethylaminomethyl-3-(6-methoxypyridazin-3-yl)thieno[2,3-d]pyrimidine-2,4(1H,3H)-dione, which may be a precursor or impurity from the manufacturing process. (’178 Patent, col. 31:62-32:4). The invention is not for the active ingredient alone, but for a mixture containing it.
  • Technical Importance: By claiming a specific mixture that may result from an improved manufacturing process, the patent seeks to protect not only the final drug product but also a specific state of that product that distinguishes it from others.

Key Claims at a Glance

  • The complaint asserts at least independent claim 1. (Compl. ¶40).
  • Claim 1 requires:
    • 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, 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.
  • The complaint does not explicitly reserve the right to assert dependent claims for this patent.

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

The Invention Explained

  • Problem Addressed: The patent background describes the treatment of prostate cancer using androgen deprivation therapies. It notes that traditional gonadotropin-releasing hormone (GnRH) agonists can cause an initial "clinical flare" of symptoms and must be administered by injection, creating a need for an oral treatment that avoids this effect and allows for more flexible administration. (’198 Patent, col. 1:40-2:24).
  • The Patented Solution: The invention is a method for treating prostate cancer by administering an oral formulation of relugolix once-daily. A key feature described is that if administration is suspended, the patient’s serum testosterone levels increase, which is characteristic of a non-depot, orally administered drug and contrasts with the long-lasting suppression from injectable GnRH agonists. (’198 Patent, col. 2:25-34).
  • Technical Importance: This method provides an oral, non-peptide GnRH antagonist therapy that avoids the initial testosterone surge of agonists and allows for a quicker recovery of testosterone levels if the treatment is stopped, offering greater flexibility for managing patient care.

Key Claims at a Glance

  • The complaint asserts independent claims 1 and 10, as well as dependent claims 2, 4-6, 11, and 12. (Compl. ¶50).
  • Independent Claim 1 requires:
    • A method of treating prostate cancer in a subject in need thereof,
    • comprising administering to the subject once-daily an oral formulation comprising about 80 mg to about 480 mg of relugolix,
    • wherein when the once-daily administration is suspended for a suspension period, the subject experiences an increase of serum testosterone levels.
  • Independent Claim 10 is similar but is directed to a subject in need of an increase in serum testosterone levels to a level above 50 ng/dL.

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

Technology Synopsis

This patent, like the ’198 Patent, is directed to methods of treating prostate cancer. It claims specific oral dosing regimens for relugolix, including an initial oral load dose followed by an oral maintenance dose, to achieve and maintain medical castration levels of testosterone.

Asserted Claims

The complaint asserts independent claims 1, 9, 19, 23, 26, and 29, as well as dependent claims 3, 5, 12, 24, 25, 27, and 28. (Compl. ¶60).

Accused Features

The accused features are the manufacture, use, and sale of Cipla's ANDA Product, which, if approved, would allegedly be used according to its proposed labeling to treat prostate cancer in a manner that infringes the claimed dosing methods. (Compl. ¶63-64).

III. The Accused Instrumentality

Product Identification

The accused instrumentality is Cipla's proposed generic relugolix product, described in ANDA No. 220080 (the "ANDA Product"). (Compl. ¶1).

Functionality and Market Context

  • The complaint alleges that the ANDA Product is a generic version of Orgovyx®, containing 120 mg tablets of the active ingredient relugolix. (Compl. ¶1, ¶32).
  • Cipla has represented to the FDA that its ANDA Product has the same active ingredient, dosage form, and strength as Orgovyx®, and is bioequivalent to Orgovyx®. (Compl. ¶33). Orgovyx® is approved for the treatment of adult patients with advanced prostate cancer. (Compl. ¶25).
  • By filing an ANDA, Cipla seeks approval to manufacture and sell its generic relugolix product for the same indication as the branded drug prior to the expiration of the patents-in-suit. (Compl. ¶34).

IV. Analysis of Infringement Allegations

No probative visual evidence provided in complaint.

U.S. Patent No. 11,795,178 Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
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... The complaint alleges that Cipla’s ANDA product is a generic version of Orgovyx® (relugolix), which contains this active ingredient. ¶33, ¶40 col. 31:62-67
...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. The complaint's theory of infringement under 35 U.S.C. § 271(e)(2) is predicated on the allegation that the proposed ANDA Product, if manufactured and sold, will constitute the claimed mixture. ¶40, ¶42 col. 32:1-4
  • Identified Points of Contention:
    • Evidentiary Question: The central dispute will likely be factual: does the manufacturing process described in Cipla's ANDA inherently and necessarily result in a final drug product that contains the specific two-component mixture required by claim 1? The presence and amount of the second component will be a key factual question for the litigation.
    • Scope Questions: A question for the court may be how to construe "mixture." The parties may dispute whether trace amounts of the second component, if present, are sufficient to meet this limitation as it is defined in the patent.

U.S. Patent No. 12,097,198 Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A method of treating prostate cancer in a subject in need thereof, Cipla's ANDA seeks approval to market its generic relugolix product for the treatment of prostate cancer, the same indication as the branded drug Orgovyx®. ¶25, ¶50 col. 1:40-42
comprising administering to the subject once-daily an oral formulation comprising about 80 mg to about 480 mg of [relugolix], The ANDA Product is a 120 mg oral tablet of relugolix. The proposed labeling will allegedly instruct healthcare providers and patients to administer the product once-daily for treating prostate cancer. ¶32, ¶53 col. 2:28-31
wherein when the once-daily administration is suspended for a suspension period, the subject experiences an increase of serum testosterone levels. The complaint alleges that marketing the ANDA product with its proposed labeling will induce infringement of the claimed methods, but does not specify how this limitation is met. ¶53, ¶54 col. 2:31-34
  • Identified Points of Contention:
    • Scope Questions: A primary issue will be the construction of the "suspending administration" clause. Does infringement require Cipla's proposed label to explicitly instruct a user to suspend administration for a period, or is this limitation met simply because the product is an oral, non-depot formulation, making suspension and subsequent testosterone recovery an inherent characteristic of its use?
    • Technical Questions: What evidence does the complaint provide that Cipla’s proposed product labeling will "encourage" or "induce" the specific steps of the claimed method, particularly the suspension element? (Compl. ¶53). The sufficiency of these allegations to support a claim of induced infringement under § 271(e)(2) may be a point of dispute.

V. Key Claim Terms for Construction

"mixture comprising" (’178 Patent, Claim 1)

  • Context and Importance: The infringement analysis for the ’178 Patent hinges on whether Cipla's ANDA product is a "mixture" containing both the active ingredient and a specified second compound. Practitioners may focus on this term because if Cipla's product can be shown to be pure relugolix or a different mixture, it may not infringe.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The use of the open-ended term "comprising" could support an interpretation where the presence of other components does not defeat the claim, as long as the two recited components are present.
    • Evidence for a Narrower Interpretation: The specification describes specific production methods and resulting purities. Language in the examples section detailing the measured amounts of impurities could be used to argue that the term "mixture" requires the components to be present in certain detectable or meaningful quantities, not merely trace amounts. (’178 Patent, col. 25:15-26:35, Tables 4 and 5).

"suspending administration for a suspension period" (’198 Patent, Claim 1)

  • Context and Importance: This term is critical because it introduces a conditional, behavioral step into the method claim. The dispute will likely center on whether infringement requires an explicit instruction for suspension on the product label. If the term is construed broadly to cover the inherent capability of an oral drug to be suspended by a patient, it could ease the plaintiff's burden of proving induced infringement.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The patent’s background distinguishes the invention from depot injections where suspension is not possible. (’198 Patent, col. 2:13-24). This context may support an argument that the term refers to the inherent quality of an oral drug that allows for treatment interruption and subsequent testosterone recovery, a key advantage over prior art injections.
    • Evidence for a Narrower Interpretation: The detailed description repeatedly discusses the concept of suspending administration for specific reasons, such as intercurrent illness or a desire for restored sexual function. (’198 Patent, col. 4:21-30). This could support an argument that the "suspension period" is a deliberate therapeutic choice, not merely a missed dose, and would require some instruction or suggestion on the label to be induced.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges both induced and contributory infringement for all three patents-in-suit. The basis for inducement is that Cipla's proposed labeling for its ANDA Product will allegedly encourage and instruct healthcare providers and patients to use the generic drug in a manner that directly infringes the method claims of the ’198 and ’809 patents. (Compl. ¶53, ¶63). For the ’178 patent, inducement is alleged based on encouraging use of the infringing mixture. (Compl. ¶43). Contributory infringement is alleged on the basis that the ANDA Product is not a staple article of commerce suitable for substantial noninfringing use and is especially made or adapted for infringing the patents. (Compl. ¶44, ¶54, ¶64).
  • Willful Infringement: The complaint alleges that Cipla acted "without a reasonable basis for believing that it would not be liable for directly and/or indirectly infringing" the patents-in-suit. (Compl. ¶47, ¶57, ¶67). This allegation is based on Cipla's knowledge of the patents, as evidenced by its Paragraph IV certification, and forms the basis for a request that the case be declared "exceptional" to allow for recovery of enhanced damages and attorneys' fees.

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

  • A central evidentiary question will be one of compositional identity: Will discovery demonstrate that Cipla's manufacturing process, as detailed in its confidential ANDA, necessarily and inherently produces the specific two-component "mixture" recited in claim 1 of the ’178 patent, or will the ANDA product be shown to be materially different?
  • A core issue will be one of inducement and claim scope: For the method claims of the ’198 and ’809 patents, can infringement under 35 U.S.C. § 271(e)(2) be established based on a proposed label that instructs an infringing dosing schedule (e.g., once-daily for prostate cancer), even if it omits instructions for ancillary steps like "suspending administration"?
  • A key legal question will be the sufficiency of allegations: Given that the lawsuit is based on the artificial act of filing an ANDA rather than on an existing commercial product, the court will need to determine whether the complaint's allegations regarding the contents of the ANDA and the proposed labeling are sufficient to plausibly allege direct, induced, and contributory infringement for each asserted patent.