DCT

2:19-cv-15343

Celgene Corp v. DR Reddy's Laboratories Ltd

Log In

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:19-cv-15343, D.N.J., 07/12/2019
  • Venue Allegations: Plaintiff alleges venue is proper in the District of New Jersey based on Defendant Dr. Reddy's Laboratories, Inc.'s incorporation and principal place of business in New Jersey, and because the district is a likely destination for the accused generic drug product.
  • Core Dispute: Plaintiff alleges that Defendants’ filing of an Abbreviated New Drug Application (ANDA) for generic versions of Plaintiff's POMALYST® drug product constitutes infringement of five U.S. patents related to methods of use and formulations of the active ingredient, pomalidomide.
  • Technical Context: The dispute is in the field of oncology therapeutics, specifically concerning chemical compounds and formulations used to treat multiple myeloma, a type of blood cancer.
  • Key Procedural History: This action was initiated under the Hatch-Waxman Act following Defendants' submission of ANDA No. 213234 and issuance of a Paragraph IV Certification notice letter to Celgene. The complaint notes that Defendants have previously been sued in this district and have not challenged personal jurisdiction, suggesting a history of litigation between the parties or within the district.

Case Timeline

Date Event
2002-05-17 Priority Date for ’262, ’939, and ’428 Patents
2009-05-19 Priority Date for ’427 and ’467 Patents
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
2018-06-12 U.S. Patent No. 9,993,467 Issues
2019-05-31 DRL sends Paragraph IV Notice Letter to Celgene
2019-07-12 Complaint Filed

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

Issued June 12, 2012.

The Invention Explained

  • Problem Addressed: The patent addresses the need for new, safe, and effective methods for treating cancer, particularly cancers that are refractory or resistant to conventional therapies like surgery, radiation, and chemotherapy, which often have significant toxicities and side effects (’262 Patent, col. 2:19-54).
  • The Patented Solution: The invention provides methods for treating, preventing, or managing cancer, specifically multiple myeloma, by administering an immunomodulatory compound identified as 4-(amino)-2-(2,6-dioxo(3-piperidyl))-isoindoline-1,3-dione, also known as pomalidomide (’262 Patent, Abstract; col. 31:18-35). This compound is described as inhibiting the production of tumor necrosis factor-alpha (TNF-α), a cytokine implicated in a diverse range of cellular signaling events, including those that may play a pathological role in cancer (’262 Patent, col. 5:35-41). The attached ’262 Patent includes a figure comparing the inhibitory effects of pomalidomide (Revimid™) and thalidomide on multiple myeloma cell proliferation, which may be used to illustrate the compound's mechanism of action (’262 Patent, FIG. 1).
  • Technical Importance: The invention provided a therapeutic option for multiple myeloma, a difficult-to-treat cancer, by using a compound with immunomodulatory properties distinct from conventional cytotoxic chemotherapy (’262 Patent, col. 2:55-64).

Key Claims at a Glance

  • The complaint does not identify specific asserted claims, stating only that Defendants' actions infringe "one or more of the claims" of the patent (Compl. ¶30). The complaint reserves the right to identify asserted claims at a later stage.

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

Issued March 18, 2014.

The Invention Explained

  • Problem Addressed: The patent addresses the same problem as the ’262 Patent: the need for effective treatments for multiple myeloma, including for patients who are relapsed or refractory to prior therapies (’939 Patent, col. 2:19-54).
  • The Patented Solution: The invention is directed to a specific method of treating multiple myeloma by administering pomalidomide according to a defined dosing schedule. The method involves a cyclical therapy of daily administration for a set period, followed by a rest period, which is a common approach in oncology to manage toxicity while maintaining efficacy (’939 Patent, Abstract; col. 39:1-col. 40:40).
  • Technical Importance: This patent claims a specific, structured dosing regimen for pomalidomide, reflecting clinical development that optimized the drug's therapeutic window for treating multiple myeloma patients (’939 Patent, col. 33:1-36:53).

Key Claims at a Glance

  • The complaint does not identify specific asserted claims (Compl. ¶39). However, independent claim 1 of the ’939 Patent recites a method with the following essential elements:
    • A method of treating multiple myeloma in a patient who has received previous therapy.
    • Administering from about 1 mg to about 5 mg per day of pomalidomide or a salt, solvate, or stereoisomer thereof.
    • The administration occurs for 21 consecutive days followed by seven consecutive days of rest in a 28-day cycle.
    • 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

Issued May 27, 2014.

  • Technology Synopsis: This patent is in the same family as the ’262 and ’939 patents and is also directed to methods of treating multiple myeloma with pomalidomide (’428 Patent, Abstract). The claims cover specific patient populations who have received prior therapies and subsequently demonstrated disease progression, defining a method of use for second-line or later treatment settings (’428 Patent, col. 39:20-40:5).
  • Asserted Claims: The complaint does not identify specific asserted claims (Compl. ¶48).
  • Accused Features: The accused features are Defendants' proposed generic pomalidomide products and the methods of use for which they seek FDA approval, as will be described in their proposed product labeling (Compl. ¶¶25, 48).

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

Issued September 9, 2014.

  • Technology Synopsis: This patent shifts focus from the method of treatment to the pharmaceutical composition itself. It claims specific oral dosage forms (capsules) of pomalidomide combined with particular inactive ingredients (excipients) such as mannitol and pregelatinized starch, which are intended to ensure the stability and proper delivery of the active drug (’427 Patent, Abstract; col. 32:1-12).
  • Asserted Claims: The complaint does not identify specific asserted claims (Compl. ¶57).
  • Accused Features: The accused instrumentalities are the physical compositions of Defendants’ proposed generic pomalidomide capsules, which are alleged to contain the claimed formulations (Compl. ¶¶25, 57).

U.S. Patent No. 9,993,467 - Formulations of 4-amino-2-(2,6-dioxopiperidine-3-yl)isoindoline-1,3-dione

Issued June 12, 2018.

  • Technology Synopsis: As a continuation of the ’427 patent, this patent also claims specific pharmaceutical formulations of pomalidomide. It covers oral dosage capsules containing pomalidomide in combination with a binder or filler comprising starch and mannitol, protecting specific ratios and components designed for effective drug formulation (’467 Patent, Abstract; col. 32:1-13).
  • Asserted Claims: The complaint does not identify specific asserted claims (Compl. ¶66).
  • Accused Features: The infringement allegation targets the specific composition of Defendants' proposed generic pomalidomide capsules (Compl. ¶¶25, 66).

III. The Accused Instrumentality

Product Identification

The accused instrumentalities are Defendants' ("DRL's") proposed generic pomalidomide capsules in 1 mg, 2 mg, 3 mg, and 4 mg dosage strengths, for which DRL filed ANDA No. 213234 with the U.S. Food and Drug Administration ("FDA") (Compl. ¶¶1, 25).

Functionality and Market Context

DRL's proposed products are generic versions of Celgene’s brand-name drug POMALYST®, which is an FDA-approved medication for the treatment of multiple myeloma (Compl. ¶¶1, 12). By filing an ANDA, DRL seeks FDA approval to manufacture and sell these generic versions in the United States prior to the expiration of the patents-in-suit, which are listed in the FDA's "Orange Book" with respect to POMALYST® (Compl. ¶¶14, 25). The act of filing the ANDA to obtain approval for a drug claimed in a patent or for a use claimed in a patent is the statutory act of infringement at issue (Compl. ¶30).

IV. Analysis of Infringement Allegations

The complaint does not identify specific asserted claims for any of the patents-in-suit and does not provide a claim chart or other detailed, element-by-element infringement analysis. The infringement theory is based on the legal framework of the Hatch-Waxman Act, where the filing of an ANDA is an artificial act of infringement under 35 U.S.C. § 271(e)(2)(A) (Compl. ¶30).

For the method-of-use patents (’262, ’939, ’428), the complaint's infringement theory suggests that DRL's proposed product label will inevitably instruct physicians and patients to administer the generic pomalidomide capsules in a manner that practices the patented methods (Compl. ¶15). For the formulation patents (’427, ’467), the theory is that the physical composition of DRL’s proposed capsules will contain the claimed combination of active ingredient and excipients. DRL's notice letter, sent pursuant to the ANDA filing, allegedly informed Celgene that DRL seeks approval to market its products before the patents-in-suit expire and that the patents are invalid and/or will not be infringed (Compl. ¶28).

  • Identified Points of Contention:
    • Scope Questions: A central question for the method patents will be whether the scope of DRL's proposed label, which is expected to mirror the POMALYST® label, falls within the scope of the patent claims. For the formulation patents, a key question will be whether the specific excipients and their quantities in DRL's generic product are the same as or equivalent to those recited in the claims.
    • Technical Questions: A factual dispute will likely arise over the precise composition of DRL's proposed generic product and whether it meets the limitations of the formulation patent claims. For the method claims, the dispute will be legal and interpretive, centering on whether the instructions on DRL's proposed label direct users to perform all steps of the claimed methods.

V. Key Claim Terms for Construction

The complaint does not provide sufficient detail for analysis of claim terms that will be in dispute. However, based on the language of the independent claims of the lead patents, practitioners may focus on the following terms:

  • The Term: "about" (from Claim 1 of the ’939 Patent)

  • Context and Importance: This term modifies the claimed dosage range ("from about 1 mg to about 5 mg per day"). The definition of "about" will determine the precise boundaries of the claimed dosage range, which is critical for assessing infringement, as even a small deviation could support a non-infringement argument.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The specification discusses a wide range of potential dosages and notes that the specific amount can be tailored by a physician, which may support a flexible interpretation of the claimed range (’939 Patent, col. 17:56-18:4).
    • Evidence for a Narrower Interpretation: The patent discloses specific clinical trial data with defined dose cohorts (e.g., 5, 10, 25, and 50 mg/day), which a defendant may argue provides a more concrete and limited context for what the inventor regarded as the invention (’939 Patent, col. 35:25-36:53).

  • The Term: "treating" (from Claim 1 of the ’939 Patent)

  • Context and Importance: This term defines the intended outcome of the claimed method. Its construction is critical because infringement of a method claim requires that the accused infringer perform all steps of the claim for its intended purpose. The parties may dispute what clinical or biological endpoints constitute "treating" multiple myeloma.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The specification describes "treating" as encompassing managing and preventing cancer, as well as alleviating symptoms, suggesting a broad definition that includes more than just curing the disease (’939 Patent, col. 15:8-16:53).
    • Evidence for a Narrower Interpretation: The detailed clinical trial results provide specific endpoints, such as M-protein quantification and response criteria based on Southwest Oncology Group standards, that could be argued to define the specific meaning of "treating" in the context of the patent (’939 Patent, col. 35:24-34).

VI. Other Allegations

  • Indirect Infringement: The complaint alleges both induced and contributory infringement for all five patents-in-suit (Compl. ¶¶33-34, 42-43, 51-52, 60-61, 69-70). The basis for inducement is the allegation that DRL's product labeling will intentionally encourage and instruct physicians and patients to use the generic drug in an infringing manner (Compl. ¶33). The basis for contributory infringement is the allegation that DRL's proposed products are especially adapted for an infringing use and have no substantial non-infringing use (Compl. ¶34).
  • Willful Infringement: The complaint does not contain an explicit allegation of willful infringement. However, it alleges for each patent count that the case is an "exceptional one" and requests an award of attorneys' fees under 35 U.S.C. § 285 (Compl. ¶¶37, 46, 55, 64, 73). The factual basis for this appears to be DRL's alleged knowledge of the patents-in-suit through their listing in the FDA's Orange Book and prior litigation, followed by the filing of the ANDA (Compl. ¶¶14, 21-23, 28).

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

This litigation presents a classic Hatch-Waxman dispute triggered by a generic drug manufacturer's challenge to a brand-name pharmaceutical product. The case will likely focus on two central issues for the court:

  • A core issue will be one of validity: Can Celgene's patents, which cover both methods of using pomalidomide in specific dosing cycles and the physical formulation of the drug in a capsule, withstand DRL's challenges? These challenges will likely focus on obviousness, arguing that the claimed methods or formulations were predictable advancements over the prior art at the time of invention.
  • A key secondary question will be one of infringement and claim scope: Assuming the patents are valid, will the specific formulation of DRL’s proposed generic product and the language of its proposed FDA-approved label fall within the scope of Celgene’s claims? The construction of terms defining the dosage range ("about") and the specific excipients will be determinative.