DCT

2:17-cv-03387

Celgene Corp v. Hetero Labs Ltd

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Key Events
Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:17-cv-03387, D.N.J., 05/11/2017
  • Venue Allegations: Plaintiff alleges venue is proper in the District of New Jersey based on the Defendants, or their U.S. subsidiaries and agents, maintaining principal places of business, registering as drug wholesalers, and conducting systematic business within the district.
  • Core Dispute: Plaintiff alleges that Defendants' filing of Abbreviated New Drug Applications (ANDAs) to market generic versions of Plaintiff's POMALYST® (pomalidomide) drug product constitutes infringement of four U.S. patents covering methods of use and pharmaceutical formulations.
  • Technical Context: The technology relates to the use of pomalidomide, an immunomodulatory drug, for the treatment of multiple myeloma, a type of blood cancer, which represents a significant therapeutic market.
  • Key Procedural History: This action was initiated under the Hatch-Waxman Act following Defendants' submission of ANDAs with Paragraph IV certifications to the FDA, alleging that the patents-in-suit are invalid, unenforceable, or will not be infringed by their proposed generic products.

Case Timeline

Date Event
2002-05-17 Earliest Priority Date for ’262, ’939, and ’428 Patents
2009-05-19 Earliest Priority Date for ’427 Patent
2012-06-12 U.S. Patent No. 8,198,262 Issues
2014-03-18 U.S. Patent No. 8,673,939 Issues
2014-05-27 U.S. Patent No. 8,735,428 Issues
2014-09-09 U.S. Patent No. 8,828,427 Issues
2017-03-29 Earliest Notice Letter Date (Hetero)
2017-03-30 Earliest Notice Letter Date (Apotex)
2017-04-05 Earliest Notice Letter Date (Aurobindo)
2017-04-06 Earliest Notice Letter Date (Mylan)
2017-04-11 Earliest Notice Letter Date (Breckenridge)
2017-05-11 Complaint Filing Date

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

U.S. Patent No. 8,198,262 - "Methods for treating multiple myeloma using 4-(amino)-2-(2,6-dioxo(3-piperidyl))-isoindoline-1,3-dione"

The Invention Explained

  • Problem Addressed: The patent's background describes the significant drawbacks of conventional cancer therapies, including surgery, chemotherapy, and radiation, which can be toxic, cause severe side effects, and are often rendered ineffective by tumor cell resistance (Compl. Ex. A, ’262 Patent, col. 2:19-64).
  • The Patented Solution: The invention provides a specific method for treating multiple myeloma by administering the immunomodulatory compound pomalidomide in combination with the steroid dexamethasone according to a defined cyclic dosing schedule (Compl. Ex. A, ’262 Patent, col. 3:39-44, Abstract). This regimen is designed to treat multiple myeloma, including cases that are refractory to other treatments.
  • Technical Importance: This method provides a specific therapeutic regimen for a difficult-to-treat cancer, offering an alternative for patients who may not respond to or tolerate conventional chemotherapies.

Key Claims at a Glance

  • The complaint asserts infringement of "one or more claims" without specifying them (Compl. ¶107). Independent claim 1 is representative.
  • Claim 1 Elements:
    • A method of treating multiple myeloma
    • Administering to a patient a compound (pomalidomide) or its salt, solvate or stereoisomer
    • At a dose of from about 1 mg to about 5 mg per day
    • For 21 consecutive days followed by seven consecutive days of rest in a 28 day cycle
    • Administering 40 mg of dexamethasone

U.S. Patent No. 8,673,939 - "Methods for treating multiple myeloma with 4-(amino)-2-(2,6-dioxo(3-piperidyl))-isoindoline-1,3-dione"

The Invention Explained

  • Problem Addressed: This patent, part of the same family as the ’262 patent, addresses the same general problem of treating multiple myeloma, with a particular focus on patient populations whose disease has returned (relapsed) or is resistant (refractory) to previous therapies (Compl. Ex. B, ’939 Patent, col. 17:56-59).
  • The Patented Solution: The invention claims methods of treating relapsed or refractory multiple myeloma by administering pomalidomide in specific cyclic dosing regimens (Compl. Ex. B, ’939 Patent, Abstract). The claims are directed specifically to patients who have undergone prior therapy.
  • Technical Importance: This approach provides a defined treatment protocol for a particularly challenging patient population in oncology—those for whom initial treatments have failed.

Key Claims at a Glance

  • The complaint asserts infringement of "one or more claims" (Compl. ¶152). Independent claim 1 is representative.
  • Claim 1 Elements:
    • A method of treating multiple myeloma
    • Administering to a patient who has received previous therapy for multiple myeloma
    • The compound pomalidomide or its salt, solvate or stereoisomer
    • At a dose of from about 1 mg to about 5 mg per day
    • Administered in one or more cycles, each comprising a period of administration followed by a period of rest
    • Wherein the multiple myeloma is relapsed, refractory, or relapsed and refractory

U.S. Patent No. 8,735,428 - "Methods for treating multiple myeloma with 4-(amino)-2-(2,6-dioxo(3-piperidyl))-isoindoline-1,3-dione"

  • Technology Synopsis: Continuing the same technological focus as the ’262 and ’939 patents, the ’428 patent claims methods of treating multiple myeloma with pomalidomide. The claims are specifically directed to patients who have not only received previous therapy but have also demonstrated disease progression on that therapy.
  • Asserted Claims: "one or more claims," with independent claim 1 being representative (Compl. ¶197).
  • Accused Features: The proposed use of Defendants' generic pomalidomide products for the treatment of patients with relapsed/refractory multiple myeloma, as will allegedly be instructed by the product labeling (Compl. ¶¶ 30, 33).

U.S. Patent No. 8,828,427 - "Formulations of 4-amino-2-(2,6-dioxopiperidine-3-YL)isoindoline-1,3-dione"

  • Technology Synopsis: This patent addresses the technical challenge of creating a stable and effective oral dosage form for pomalidomide. It claims specific pharmaceutical compositions for capsules containing pomalidomide, pregelatinized starch, and mannitol, designed to ensure proper delivery and stability of the active ingredient.
  • Asserted Claims: "one or more claims," with independent claim 1 being representative (Compl. ¶242).
  • Accused Features: The physical composition of Defendants' generic pomalidomide capsules, which are alleged to contain the claimed formulation (Compl. ¶¶ 86, 90, 94, 98, 102).

III. The Accused Instrumentality

Product Identification

The accused instrumentalities are the Defendants' proposed generic pomalidomide capsules, in 1 mg, 2 mg, 3 mg, and 4 mg dosage strengths, for which each Defendant filed an ANDA seeking FDA approval (Compl. ¶¶ 86, 90, 94, 98, 102).

Functionality and Market Context

The proposed products are generic versions of Celgene’s POMALYST®, an FDA-approved medication for treating multiple myeloma (Compl. ¶30). The function of the accused products is to deliver a therapeutically effective dose of pomalidomide to patients. The complaint alleges that Defendants seek to commercially manufacture and sell these generic products prior to the expiration of the patents-in-suit, thereby targeting the established market for POMALYST® (Compl. ¶1).
No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint does not provide exhibit-based claim charts. The analysis below summarizes the infringement theory based on the complaint's narrative allegations.

U.S. Patent No. 8,198,262 Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A method of treating multiple myeloma... The proposed labels for Defendants' products will allegedly instruct use for the treatment of multiple myeloma. ¶30 col. 3:39-44
...administering... a compound having the formula [pomalidomide]... Defendants' ANDA products are capsules containing pomalidomide as the active ingredient. ¶86, ¶90 col. 9:16-43
...from about 1 mg to about 5 mg per day... Defendants seek approval for 1 mg, 2 mg, 3 mg, and 4 mg capsules, which are dosages falling within the claimed range and intended for daily administration. ¶86, ¶90 col. 18:15-18
...for 21 consecutive days followed by seven consecutive days of rest... The proposed product labels will allegedly instruct administration according to this specific 28-day cycle. ¶33 col. 37:12-23
...and (b) 40 mg of dexamethasone. The proposed product labels will allegedly instruct for co-administration with dexamethasone. ¶33 col. 37:12-23

U.S. Patent No. 8,673,939 Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A method of treating... multiple myeloma... [in] a patient who has received previous therapy... The FDA-approved use for POMALYST®, which the proposed generic labels will allegedly copy, is for patients who have received prior therapies. ¶30 col. 17:56-62
...wherein the multiple myeloma is relapsed, refractory, or relapsed and refractory... The proposed product labels will allegedly instruct use for relapsed and/or refractory multiple myeloma, matching the approved indication. ¶30 col. 35:10-14
...from about 1 mg to about 5 mg per day of a compound having the formula [pomalidomide]... Defendants seek approval for capsules in 1, 2, 3, and 4 mg strengths, consistent with the claimed daily dosage. ¶86, ¶90 col. 18:4-8
...administered in one or more cycles, each of which comprises administering the compound for a period of time followed by a period of rest. The proposed product labels will allegedly instruct administration according to a cyclic regimen. ¶33 col. 24:5-13

Identified Points of Contention

  • Scope Questions: For the method patents (’262, ’939, ’428), a central question will be whether the language of the proposed generic labels will induce infringement by instructing physicians and patients to perform all steps of an asserted claim. For the formulation patent (’427), the dispute will focus on whether the excipients and composition of the generic capsules fall within the literal scope of the claims or are equivalent.
  • Technical Questions: An evidentiary question will be whether the Defendants' proposed products have substantial non-infringing uses. Defendants may argue that physicians could prescribe the generic drugs in a manner that deviates from the patented methods (e.g., for a different indication, at a different dose, or on a different schedule), thereby avoiding infringement.

V. Key Claim Terms for Construction

The Term: "about 1 mg to about 5 mg per day" (’262 Patent, Claim 1)

  • Context and Importance: The construction of "about" will define the scope of the claimed dosage range. A narrow construction might allow a defendant to argue that a slightly different dosage is non-infringing, while a broader construction would cover minor variations. Practitioners may focus on this term because the defendants' products (1, 2, 3, and 4 mg) fall squarely within the range, but the flexibility of the term "about" could be relevant to arguments regarding non-infringing uses.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specification discloses a wide range of potential dosages, including from "about 0.10 to about 150 mg/day," suggesting the inventors contemplated significant flexibility around specific dose amounts (Compl. Ex. A, ’262 Patent, col. 18:15-18).
    • Evidence for a Narrower Interpretation: The detailed description of clinical studies in the patent discloses specific dose cohorts of 1, 2, 5, and 10 mg/day, which could be used to argue that "about" should be limited to the values tested or small variations thereof (Compl. Ex. A, ’262 Patent, col. 33:21-22).

The Term: "relapsed, refractory, or relapsed and refractory multiple myeloma" (’939 Patent, Claim 1)

  • Context and Importance: This phrase defines the specific patient population for the claimed method. The dispute may turn on whether the proposed generic label is limited to this population or if it allows for treatment of newly diagnosed patients, which could constitute a substantial non-infringing use.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The complaint does not provide sufficient detail for analysis of this element.
    • Evidence for a Narrower Interpretation: The patent claims are specifically directed to this patient population. Claim 1 of the '939 patent explicitly requires that the patient "has received previous therapy" and that the myeloma is "relapsed, refractory, or relapsed and refractory," distinguishing it from first-line treatments (Compl. Ex. B, ’939 Patent, col. 39:12-23).

VI. Other Allegations

Indirect Infringement

The complaint's core theory is indirect infringement. It alleges that Defendants will induce infringement under 35 U.S.C. § 271(b) because their proposed product labeling will instruct physicians and patients to use the generic drugs in accordance with the patented methods (Compl. ¶¶ 110, 119). It also alleges contributory infringement under 35 U.S.C. § 271(c), asserting the generic products are especially adapted for an infringing use and have no substantial non-infringing use (Compl. ¶¶ 111, 120).

Willful Infringement

The complaint does not explicitly plead willfulness. However, it alleges that Defendants had knowledge of the patents-in-suit, as evidenced by the Paragraph IV certification letters sent to Celgene, and requests a finding that the case is "exceptional" and an award of attorneys' fees under 35 U.S.C. § 285, which is the procedural mechanism for seeking enhanced damages (Compl. ¶¶ 88-89; Prayer for Relief Against Hetero (J)).

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

  • A central issue will be one of induced infringement: Will the final, FDA-approved product labels for the Defendants' generic drugs instruct users to perform every step of at least one asserted method claim, thereby encouraging direct infringement by physicians and patients?
  • A key validity question, arising from the Defendants' Paragraph IV certifications, will be obviousness: Can Defendants prove by clear and convincing evidence that the claimed methods of treatment—combining specific doses and schedules of pomalidomide with dexamethasone for a particular patient population—were obvious in light of prior art treatments for multiple myeloma?
  • For the ’427 patent, a dispositive issue will be literal infringement: Does the precise chemical composition of the Defendants' generic capsules, including the specified excipients and their amounts, fall within the literal scope of the formulation claims, or can Celgene prove they are equivalent?