DCT

2:19-cv-20890

Alembic Pharma Ltd v. Novartis Pharma Corp

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:19-cv-20890, D.N.J., 11/27/2019
  • Venue Allegations: Venue is based on Defendant Novartis Pharmaceuticals Corp.'s principal place of business in New Jersey, as well as both Defendants' alleged systematic and continuous contacts with the district and history of litigating patent cases in the forum.
  • Core Dispute: Plaintiff, a generic drug manufacturer, seeks a declaratory judgment that its proposed generic version of the iron chelation drug Jadenu® will not infringe Defendant's patent covering specific tablet formulations.
  • Technical Context: The technology concerns oral pharmaceutical formulations of the drug deferasirox, designed to improve upon earlier versions that had poor solubility and caused gastrointestinal side effects.
  • Key Procedural History: This case arises under the Hatch-Waxman Act. Plaintiff Alembic filed an Abbreviated New Drug Application (ANDA) with a Paragraph IV certification of non-infringement. Defendant Novartis, the patent holder, received notice but declined to file an infringement suit within the statutory 45-day window. Alembic initiated this declaratory judgment action to obtain "patent certainty" and trigger a forfeiture of the 180-day market exclusivity held by an unidentified "first-filer," which currently blocks FDA approval of Alembic's product. The complaint also alleges the patent claims were narrowed during prosecution by changing "comprising" to "consisting of" to overcome prior art, potentially creating prosecution history estoppel.

Case Timeline

Date Event
2013-03-08 U.S. Patent No. 9,283,209 earliest priority date
2015-10-19 First-filer ANDA submission date for 90 mg/360 mg Jadenu® strengths
2016-03-15 U.S. Patent No. 9,283,209 issues
2016-04-21 First-filer ANDA submission date for 180 mg Jadenu® strength
2018-03-28 Alembic submits ANDA No. 211824 for its generic deferasirox tablets
2018-06-04 Alembic sends Paragraph IV Notice Letter to Novartis
2019-11-27 Complaint for Declaratory Judgment filed

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

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

  • Patent Identification: U.S. Patent No. 9,283,209, issued March 15, 2016.

The Invention Explained

  • Problem Addressed: The patent describes the active ingredient deferasirox as having poor solubility, which necessitates a high dose to be effective (’209 Patent, col. 1:20-25). An earlier commercial formulation, Exjade®, required tablets to be dispersed in liquid before administration and was associated with gastrointestinal irritation and other side effects (’209 Patent, col. 1:51-57).
  • The Patented Solution: The invention is a new oral tablet formulation of deferasirox intended to be swallowed directly, rather than dispersed. The formulation claims to have a high drug load (45% to 60% by weight), reduced release in acidic gastric conditions, and fast release at a more neutral pH, thereby improving patient compliance and potentially reducing GI side effects (’209 Patent, col. 2:1-15, 40-44). The manufacturing process, detailed in Figure 1, involves wet granulation to create the coated tablets (’209 Patent, Fig. 1).
  • Technical Importance: The invention provided a potential alternative to dispersible tablets, offering a more convenient solid dosage form that could be taken directly and was designed to mitigate known GI irritation issues associated with the active ingredient (’209 Patent, col. 2:1-5).

Key Claims at a Glance

  • The complaint focuses on independent claims 1, 2, and 3, with particular emphasis on claim 2, which corresponds to the 180 mg strength of Alembic's ANDA product (Compl. ¶¶ 66, 73-108).
  • Independent claim 2 recites:
    • A tablet for oral administration
    • consisting of 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; and
    • 9.72 mg seal-coat.
  • The complaint does not reserve the right to assert dependent claims, as it seeks a declaration of non-infringement of all claims.

III. The Accused Instrumentality

Product Identification

  • Alembic’s proposed generic deferasirox tablets, as described in its ANDA No. 211824, specifically the 180 mg strength tablet (Compl. ¶¶ 1, 63).

Functionality and Market Context

  • Alembic’s product is a generic version of Novartis’s Jadenu® tablets, intended for oral administration to treat chronic iron overload (Compl. ¶1). A redacted table in the complaint provides the specific composition of Alembic's 180 mg tablet (Compl. ¶63, Ex. D at 37). This table is the primary visual evidence for Alembic's non-infringement theory.
  • Alembic alleges it is prepared to market its tablets but is blocked from receiving final FDA approval due to the 180-day marketing exclusivity held by a "first-filer" ANDA applicant for the 180 mg strength (Compl. ¶¶ 44, 49). Alembic argues that a declaratory judgment of non-infringement of the ’209 Patent would trigger forfeiture of that exclusivity, clearing the path for its own product to enter the market (Compl. ¶5).

IV. Analysis of Infringement Allegations

’209 Patent Infringement Allegations

Claim Element (from Independent Claim 2) Alleged Infringing Functionality Complaint Citation Patent Citation
A tablet for oral administration consisting of 180 mg deferasirox, Alembic’s tablet contains 180 mg of deferasirox. ¶74 col. 18:25-26
107.23 mg microcrystalline cellulose; The complaint alleges that Alembic’s 180 mg tablets do not contain 107.23 mg of microcrystalline cellulose. ¶74 col. 18:27
7.29 mg poly vinyl pyrrolidone K-30; The complaint alleges that Alembic’s 180 mg tablets do not contain 7.29 mg of poly vinyl pyrrolidone K-30. ¶78 col. 18:28
22.68 mg crospovidone; The complaint alleges that Alembic’s 180 mg tablets do not contain 22.68 mg of crospovidone. ¶82 col. 18:29
0.32 mg poloxamer; The complaint alleges that Alembic’s 180 mg tablets do not contain 0.32 mg of poloxamer. ¶86 col. 18:30
1.62 mg fumed silica; The complaint alleges that Alembic’s 180 mg tablets do not contain 1.62 mg of fumed silica. ¶90 col. 18:31
4.86 mg magnesium stearate; and The complaint alleges that Alembic’s 180 mg tablets do not contain 4.86 mg of magnesium stearate. ¶94 col. 18:32
9.72 mg seal-coat. The complaint alleges that Alembic’s 180 mg tablets do not contain 9.72 mg of seal-coat. ¶98 col. 18:33

Identified Points of Contention

  • Scope Questions: The central dispute concerns the scope of the term "consisting of." Does this term, which has a strong presumption of being closed to any additional, unrecited elements, permit any deviation from the exact weights of the recited excipients? The complaint alleges that its product contains "unclaimed amounts of each of the claimed components" (Compl. ¶107).
  • Technical Questions: A key factual question will be whether Alembic's product formulation, as detailed in its confidential ANDA, literally contains each and every excipient at the exact weight specified in the asserted claims. The complaint’s repeated assertions that it does not (e.g., ¶¶ 74, 78, 82) frame this as the primary basis for its non-infringement argument.
  • Legal Questions: The complaint raises the doctrine of prosecution history estoppel as a bar to any infringement argument under the doctrine of equivalents. It alleges that the applicant amended the claims from "comprising" to "consisting of" to overcome prior art, thereby surrendering any claim to formulations with different components or amounts (Compl. ¶¶ 102-104, 106). The court will have to determine if this amendment was a narrowing one made for reasons of patentability, which would likely preclude reliance on the doctrine of equivalents.

V. Key Claim Terms for Construction

  • The Term: "consisting of"
  • Context and Importance: This transitional phrase is critical because it defines the scope of the composition claims. Unlike "comprising," which is open-ended, "consisting of" is legally understood to be closed, meaning the claim ordinarily covers only compositions with the listed ingredients and no others. Practitioners may focus on this term because Alembic's entire non-infringement case rests on the argument that its product formulation does not match the claim's exacting recipe, and this term prevents Novartis from arguing that minor differences are irrelevant.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The complaint does not present any evidence from the patent for a broader interpretation. A defendant in this position might argue that minor, inconsequential variations (e.g., due to manufacturing tolerances) do not defeat infringement, though the "consisting of" language makes this a difficult position.
    • Evidence for a Narrower Interpretation: The complaint provides significant prosecution history evidence that supports a narrow, closed interpretation. It cites an Interview Summary where the patent examiner "agreed that changing claims 26, 28, and 30 to ‘consisting of’ type claims to exclude the additional components taught by the prior art would render the claims free of the prior art" (Compl. ¶102, Ex. F). This direct evidence of a narrowing amendment to secure allowance is a powerful indicator that the term was intended to be strictly limiting.

VI. Other Allegations

  • Indirect Infringement: The complaint seeks a declaratory judgment that Alembic’s products do not and will not, if marketed, "infringe or induce or contribute to the infringement of any valid claim of the ’209 Patent" (Compl., Prayer for Relief ¶B). This is a standard component of a DJ non-infringement action and does not allege that Novartis has committed indirect infringement.
  • Willful Infringement: Willful infringement is not alleged in this declaratory judgment action.

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

This case appears to turn on two fundamental and interrelated questions of claim scope:

  • A core issue will be one of literal scope: Given the use of the highly restrictive "consisting of" language and the recitation of exact weights for each component, can Novartis demonstrate that Alembic's generic product formulation, as specified in its ANDA, contains the precise recipe claimed in the '209 Patent? Alembic's complaint is built on the premise that it does not.
  • A key legal question will be one of prosecution history estoppel: Did the patentee, by amending the claims from "comprising" to "consisting of" to overcome prior art during prosecution, surrender all rights to claim any formulation that deviates from the explicitly listed components and amounts? If estoppel applies, it would likely bar Novartis from asserting infringement under the doctrine of equivalents, making the literal infringement analysis dispositive.