DCT

1:23-cv-00623

Horizon Therap USA Inc v. DR Reddys Laboratories Ltd

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:23-cv-00623, D. Del., 06/07/2023
  • Venue Allegations: Venue is alleged to be proper based on Defendant Dr. Reddy’s Laboratories, Inc.'s participation in acts of infringement within the district, including the preparation and filing of the at-issue ANDA, and on Defendant Dr. Reddy's Laboratories, Ltd.'s status as a foreign corporation.
  • Core Dispute: Plaintiff alleges that Defendant’s filing of an Abbreviated New Drug Application (ANDA) for a generic version of the rheumatoid arthritis drug RAYOS® constitutes an act of infringement of a patent covering a method of treating rheumatoid disease using a delayed-release formulation.
  • Technical Context: The technology relates to chronotherapy, specifically a delayed-release formulation of the glucocorticoid prednisone designed to be taken at bedtime to counteract the early-morning inflammatory surge characteristic of rheumatoid arthritis.
  • Key Procedural History: The action was initiated under the Hatch-Waxman Act following Defendant’s submission of ANDA No. 218035 to the FDA, which included a Paragraph IV certification alleging that the patent-in-suit will not be infringed by the proposed generic product. The complaint was filed within the 45-day statutory window after Plaintiff received Defendant's notice letter, triggering a potential 30-month stay on FDA approval of the ANDA.

Case Timeline

Date Event
2006-08-03 ’699 Patent Priority Date
2016-11-29 ’699 Patent Issue Date
2023-04-26 Date of Defendant's Notice Letter
2023-06-07 Complaint Filing Date

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

U.S. Patent No. 9,504,699 - "Delayed-release glucocorticoid treatment of rheumatoid disease"

  • Patent Identification: U.S. Patent No. 9,504,699, "Delayed-release glucocorticoid treatment of rheumatoid disease," issued on November 29, 2016 (Compl. ¶22; ’699 Patent, p. 1).

The Invention Explained

  • Problem Addressed: The patent describes that patients with rheumatoid arthritis (RA) suffer from a circadian pattern of symptoms, particularly severe joint stiffness and pain upon waking (Compl. ¶1; ’699 Patent, col. 3:11-21). This corresponds to a nocturnal increase in pro-inflammatory cytokines, such as interleukin-6 (IL-6), that conventional morning-dosed glucocorticoids do not optimally suppress (’699 Patent, col. 3:22-43). Administration of immediate-release drugs in the middle of the night (e.g., 2:00 AM) is effective but impractical for patients (’699 Patent, col. 4:19-23).
  • The Patented Solution: The invention is a method of treatment using a delayed-release dosage form of a glucocorticoid, such as prednisone. This dosage form is administered once daily at bedtime, and its formulation delays the release of the active ingredient for several hours (’699 Patent, Abstract; col. 5:62-65). This timing allows the drug's peak concentration to coincide with and suppress the nocturnal rise in inflammatory cytokines, thereby reducing the severity of morning symptoms without requiring the patient to interrupt their sleep (’699 Patent, col. 4:1-9).
  • Technical Importance: The technology provides a method to synchronize the pharmacokinetic profile of a known drug with the chronobiology of a disease, improving therapeutic outcomes for a key symptom while enhancing patient compliance (’699 Patent, col. 4:1-9, 19-23).

Key Claims at a Glance

  • The complaint asserts infringement of at least independent claim 1 (Compl. ¶¶ 31-32).
  • The essential elements of independent claim 1 are:
    • A method for treating a patient with a rheumatic disease who had previously been treated with an oral immediate release glucocorticoid.
    • The method comprises administering daily, at or before bedtime, for at least about two weeks, an effective amount of prednisone.
    • The prednisone is contained in a delayed-release dosage form.
    • The dosage form is a tablet or a capsule.

III. The Accused Instrumentality

Product Identification

  • The accused instrumentality is Defendants' proposed generic prednisone delayed-release tablets, 5 mg dosage strength, which are the subject of ANDA No. 218035 ("DRL Product") (Compl. ¶¶ 9, 26).

Functionality and Market Context

  • The DRL Product is a generic version of Plaintiff's RAYOS® drug and allegedly relies on the RAYOS® New Drug Application for bioequivalence data (Compl. ¶27). The complaint alleges the DRL Product is intended for the same therapeutic uses as RAYOS®, including as an anti-inflammatory and immunosuppressive agent for rheumatologic conditions (Compl. ¶26). As an ANDA product, its infringement is statutory, arising from the act of filing the application to seek FDA approval for commercial manufacture and sale prior to the expiration of the ’699 Patent (Compl. ¶¶ 1, 30).
  • No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

’699 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A method for the treatment of a patient suffering from signs and symptoms of an underlying rheumatic disease who had previously been treated with an oral immediate release dosage form of a glucocorticoid, The DRL Product's proposed label will allegedly instruct physicians and patients to use the drug to treat rheumatic diseases. The complaint alleges inducement of infringement by health care providers who will prescribe the DRL product to this patient population. ¶¶ 26, 33 col. 14:1-5
which method comprises administering daily, at or before bedtime, for at least about two weeks an effective amount of prednisone contained in a delayed-release dosage form to said patient who had previously been treated with an oral immediate release dosage form of a glucocorticoid, The DRL Product is a delayed-release prednisone tablet. The complaint alleges that upon information and belief, the proposed product labeling will instruct for daily administration consistent with the claimed method, thereby inducing infringement by patients and physicians. ¶¶ 26, 32, 33 col. 7:4-6
wherein the delayed release dosage form is a tablet or a capsule. The DRL Product is a delayed-release tablet. ¶26 col. 7:10-11
  • Identified Points of Contention:
    • Scope Questions: The core of the dispute may center on indirect infringement. A question for the court will be whether the proposed label for the DRL Product specifically encourages, recommends, or promotes use of the drug in a manner that satisfies every limitation of the asserted method claim. This raises the question of whether the defendant possesses the requisite specific intent to induce infringement, particularly for the limitation requiring the patient to have been "previously... treated with an oral immediate release dosage form of a glucocorticoid."
    • Technical Questions: An evidentiary question will be whether the DRL Product, as described in its ANDA, is a "delayed-release dosage form" with a release profile that falls within the scope of the claims as construed by the court. While the complaint alleges bioequivalence, any technical differences in the release mechanism or timing could become a point of contention (Compl. ¶27).

V. Key Claim Terms for Construction

  • The Term: "who had previously been treated with an oral immediate release dosage form of a glucocorticoid"
    • Context and Importance: This term defines the specific patient population for the claimed method. The infringement analysis, particularly for inducement, will depend heavily on whether the DRL Product's proposed label is found to specifically target this group. Practitioners may focus on this term because if the label is directed to a broader population of RA patients, it may be more difficult for the plaintiff to prove the defendant had the specific intent to cause infringement of this precise limitation.
    • Evidence for a Broader Interpretation: The patent’s background section broadly discusses the general clinical practice and history of using glucocorticoids for RA, which a party could argue suggests this phrase is merely descriptive of a typical patient's background rather than a strict, required limitation on the method's applicability (’699 Patent, col. 1:17-34).
    • Evidence for a Narrower Interpretation: The claim language is explicit. Furthermore, the patent’s "Example" section describes a clinical study where patients were required to be on a stable dose of prednisone before entering the study, which could be cited to argue that the invention was specifically contemplated for and tested on this patient population (’699 Patent, col. 14:1-5).
  • The Term: "at or before bedtime"
    • Context and Importance: This limitation is critical to the invention's chronotherapeutic rationale. Its construction will determine the required specificity of the administration instructions on the accused product's label.
    • Evidence for a Broader Interpretation: A party could argue that "bedtime" is a patient-subjective term and that any general instruction for evening dosing would meet this limitation.
    • Evidence for a Narrower Interpretation: The specification provides a more precise window, stating administration is "preferably in the evening, e.g. from about 9:00 pm to about 11:00 pm" (’699 Patent, col. 7:4-6). A party could argue this disclosure should be used to narrow the scope of "at or before bedtime" to a specific time frame, potentially creating a higher bar for induced infringement.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that Defendants will induce infringement by physicians, health care providers, and patients (Compl. ¶31). The factual basis for this allegation is that Defendants' proposed product labeling will, on information and belief, instruct users to administer the DRL Product in a manner that directly infringes at least claim 1 of the ’699 patent (Compl. ¶¶ 32, 33). The complaint alleges Defendants have the requisite knowledge and intent for inducement (Compl. ¶33).
  • Willful Infringement: The complaint does not explicitly allege willful infringement. However, it requests an award of attorneys' fees pursuant to 35 U.S.C. § 285, alleging this is an "exceptional case" (Compl., Prayer for Relief ¶E). The basis for such a finding would likely be the allegation that Defendants proceeded with the ANDA filing with knowledge of the ’699 patent, evidenced by their Paragraph IV certification (Compl. ¶28).

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

  • A central issue will be one of induced infringement: does the specific language of the DRL Product's proposed label, which is not yet public, provide sufficient evidence to establish that Defendant possessed the specific intent to encourage direct infringement of every limitation of the asserted method claim, including the "previously treated" patient population element?
  • The case may also turn on a question of claim construction: can the phrase "who had previously been treated with an oral immediate release dosage form of a glucocorticoid" be interpreted broadly as descriptive of a typical RA patient, or will it be narrowly construed as a mandatory prerequisite for any patient falling within the claim's scope, thereby raising the bar for proving inducement?