DCT

2:19-cv-20810

Cipla Ltd v. Novartis AG

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Key Events
Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:19-cv-20810, D.N.J., 11/26/2019
  • Venue Allegations: Venue is based on Defendant Novartis Pharmaceuticals Corp.'s principal place of business in East Hanover, New Jersey, and both defendants' alleged history of conducting business and litigating patent cases within the district.
  • Core Dispute: Plaintiff, a generic drug manufacturer, seeks a declaratory judgment that its proposed generic deferasirox tablets do not infringe Defendant’s patent, aiming to trigger a statutory forfeiture of a competitor's 180-day market exclusivity that is currently blocking Plaintiff's FDA approval.
  • Technical Context: The technology concerns specific oral tablet formulations of deferasirox, a drug used for treating chronic iron overload in patients.
  • Key Procedural History: This declaratory judgment action arises under the Hatch-Waxman Act. Plaintiff Cipla filed an Abbreviated New Drug Application (ANDA) seeking to market a generic version of Defendant Novartis's drug, JADENU®. Cipla certified that its product would not infringe Novartis's U.S. Patent No. 9,283,209 ('209 Patent). Novartis did not sue Cipla for infringement within the statutory 45-day window. Cipla alleges its final FDA approval is now blocked by a "first-filer" generic applicant's 180-day marketing exclusivity. This lawsuit seeks a court judgment of non-infringement, which could trigger a forfeiture of that exclusivity and clear a path for Cipla's product to enter the market. The complaint notes a prior judicial correction to the '209 patent's Claim 3 in separate litigation.

Case Timeline

Date Event
2013-03-08 '209 Patent Priority Date
2016-03-15 '209 Patent Issue Date
2016-04-21 First ANDA submission date for 180 mg deferasirox tablets
2019-11-26 Complaint Filing Date

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

U.S. Patent No. 9,283,209 - “Oral Formulations of Deferasirox”

  • Issued: March 15, 2016

The Invention Explained

  • Problem Addressed: The patent's background section describes challenges with the then-existing commercial formulation of deferasirox (Exjade™). These challenges included the drug's poor solubility, the need for a high dose, patient non-compliance due to the cumbersome requirement to disperse the tablet in liquid before administration, and significant side effects such as gastrointestinal irritation and ulceration. ('209 Patent, col. 1:12-55).
  • The Patented Solution: The invention claims to solve these problems with a swallowable, non-dispersible tablet formulation containing a high concentration (45% to 60% by weight) of deferasirox. ('209 Patent, col. 2:40-44). The formulation is designed to have reduced drug release in the acidic environment of the stomach but fast release at the neutral pH of the intestine, thereby aiming to minimize gastric irritation, reduce food-related variability in absorption, and improve patient compliance. ('209 Patent, col. 2:1-17; Abstract).
  • Technical Importance: This approach sought to create a more convenient and tolerable once-daily tablet for patients requiring long-term treatment for chronic iron overload, potentially improving safety and therapeutic outcomes compared to the existing dispersible formulation. ('209 Patent, col. 2:1-17).

Key Claims at a Glance

  • The complaint seeks a declaratory judgment of non-infringement of all claims of the '209 patent, with a focus on the 180 mg tablet formulation. The patent contains three independent claims, each directed to a tablet of a specific dosage strength.
  • Independent Claim 1 recites a tablet "consisting of" a specific recipe for a 90 mg dose of deferasirox.
  • Independent Claim 2 recites a tablet "consisting of" a specific recipe for a 180 mg dose of deferasirox with the following elements:
    • 180 mg deferasirox
    • 107.23 mg microcrystalline cellulose
    • 7.29 mg poly vinyl pyrrolidone K-30
    • 22.68 mg crospovidone
    • 0.32 mg poloxamer
    • 1.62 mg fumed silica
    • 4.86 mg magnesium stearate
    • 9.72 mg seal-coat
  • Independent Claim 3 recites a tablet "consisting of" a specific recipe for a 360 mg dose of deferasirox.

III. The Accused Instrumentality

Product Identification

Cipla’s generic deferasirox tablets in 90 mg, 180 mg, and 360 mg strengths, as described in its ANDA No. 211852. (Compl. ¶¶ 2, 85).

Functionality and Market Context

The product is a proposed generic version of Novartis's JADENU®, a drug for treating chronic iron overload. (Compl. ¶¶ 2, 73). Cipla alleges that its ability to receive final FDA approval and enter the market is currently blocked by the 180-day marketing exclusivity held by an unidentified first-to-file ANDA applicant. (Compl. ¶¶ 22, 82). The complaint includes an excerpt from an FDA document showing an applicant is "Eligible" for 180-day exclusivity for 180 mg deferasirox tablets, which forms the basis for Cipla's alleged "blocking injury." (Compl. ¶13). It further provides an excerpt from the FDA's Orange Book to show that while other generic deferasirox tablets have been approved at 90 mg and 360 mg strengths, none have received final approval at the 180 mg strength. (Compl. ¶17). The specific composition of Cipla's proposed product is redacted in the complaint. (Compl. ¶¶99-119).

IV. Analysis of Infringement Allegations

The complaint’s detailed factual basis for non-infringement, which would compare Cipla's formulation to the patent's claims, is redacted (Compl. ¶¶99-119). Therefore, a claim chart cannot be constructed.

The central narrative theory of non-infringement is based on claim construction. Cipla argues that the patent’s claims are "closed" because they use the transitional phrase "consisting of." (Compl. ¶92). According to this theory, a product can only literally infringe if it contains the exact ingredients in the exact amounts recited in the claim, and nothing more. (Compl. ¶¶93-96). The redacted sections of the complaint presumably detail how Cipla's ANDA product formulation differs from the claimed recipes.

Cipla further argues that Novartis is barred from asserting infringement under the doctrine of equivalents due to prosecution history estoppel. (Compl. ¶121). The complaint alleges that during prosecution, the patent applicants narrowed the claims from the open-ended "comprising" to the closed "consisting of" to overcome prior art rejections. (Compl. ¶¶124, 126). Cipla contends this amendment constitutes a "clear and unmistakable surrender" of any formulation that does not match the exact claimed composition. (Compl. ¶122).

  • Identified Points of Contention:
    • Factual Question: Does the formulation of Cipla’s proposed generic product, as defined in its ANDA, differ from the precise list of ingredients and quantities recited in the independent claims of the '209 patent? The complaint asserts that it does, but the evidence is redacted.
    • Claim Scope Question: Will the court interpret the phrase "consisting of" as a strictly closed term that excludes any and all variations from the recited formulation, or does it permit insubstantial variations or the presence of trace impurities?
    • Estoppel Question: Does the amendment from "comprising" to "consisting of" during prosecution estop Novartis from asserting that Cipla's product infringes under the doctrine of equivalents?

V. Key Claim Terms for Construction

  • The Term: "consisting of"
  • Context and Importance: This transitional phrase is the foundation of Cipla's non-infringement argument. A determination that the term is strictly "closed" would mean that any deviation in Cipla's formulation from the patent's recipe would preclude a finding of literal infringement. Practitioners may focus on this term because its construction is dispositive for the literal infringement inquiry.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Narrower Interpretation: The complaint points to prosecution history, alleging the applicants explicitly amended the claims from "comprising" to "consisting of" to "exclude the additional components taught by the prior art" and secure allowance. (Compl. ¶¶126, 128). This history provides strong intrinsic evidence that the patentee intended a narrow, exclusionary meaning.
    • Evidence for a Broader Interpretation: While the patent specification itself offers little support for a broader reading, a defendant could argue under general patent law principles that "consisting of" still permits the presence of impurities or other components that do not materially alter the basic and novel characteristics of the claimed invention.

VI. Other Allegations

  • Indirect Infringement: Cipla seeks a declaration that its product will not infringe the '209 patent either directly or indirectly. (Compl. ¶138). The factual basis for this allegation rests on the same arguments for non-infringement of the formulation itself.
  • Willful Infringement: Not applicable, as this is a declaratory judgment action filed by the accused infringer.

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

  1. A question of justiciability: Can Cipla maintain a declaratory judgment action against a patentee who has chosen not to sue, based on the "blocking injury" caused by a third party's 180-day exclusivity under the Hatch-Waxman Act? The resolution of this issue will determine if the case can proceed.
  2. A question of claim scope: Will the court find that the term "consisting of," as used in the '209 patent claims, creates a strictly closed recipe? The answer will likely decide the question of literal infringement.
  3. A question of prosecution history estoppel: Did the patentee's amendment from "comprising" to "consisting of" during prosecution constitute a clear surrender of subject matter, thereby barring any claim of infringement under the doctrine of equivalents?