DCT

2:17-cv-05314

Celgene Corp v. DR Reddy's Laboratories Ltd

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: Celgene Corporation v. Dr. Reddy's Laboratories, Ltd., 2:17-cv-05314, D.N.J., 07/20/2017
  • Venue Allegations: Plaintiff alleges venue is proper in the District of New Jersey based on Defendant Dr. Reddy's Laboratories, Inc. being incorporated in and having its principal place of business in New Jersey, thereby establishing a regular and established place of business in the district. The complaint also alleges that intended future acts of patent infringement will occur in New Jersey.
  • Core Dispute: Plaintiff alleges that Defendant’s filing of an Abbreviated New Drug Application (ANDA) seeking to market generic versions of Plaintiff's REVLIMID® (lenalidomide) product constitutes an act of infringement of three patents related to methods of using lenalidomide to treat certain cancers.
  • Technical Context: The technology concerns methods of using the small molecule compound lenalidomide for the treatment of Myelodysplastic Syndromes (MDS), a group of disorders caused by poorly formed or dysfunctional blood cells.
  • Key Procedural History: This action was initiated under the Hatch-Waxman Act following Defendant’s submission of ANDA No. 209348 to the FDA. The ANDA included a Paragraph IV Certification, asserting that Plaintiff's patents are invalid, unenforceable, and/or will not be infringed by the proposed generic products.

Case Timeline

Date Event
2002-10-15 Priority Date for ’740, ’717, and ’120 Patents
2007-03-13 U.S. Patent No. 7,189,740 Issues
2013-03-26 U.S. Patent No. 8,404,717 Issues
2015-06-16 U.S. Patent No. 9,056,120 Issues
2017-06-08 Defendant Sent Paragraph IV Notice Letter (earliest date)
2017-07-20 Complaint Filed

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

U.S. Patent No. 7,189,740 - "Methods of Using 3-(4-amino-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione for the Treatment and Management of Myelodysplastic Syndromes"

  • Patent Identification: U.S. Patent No. 7,189,740, titled "Methods of Using 3-(4-amino-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione for the Treatment and Management of Myelodysplastic Syndromes," issued March 13, 2007 (’740 Patent, cover; Compl. ¶7).

The Invention Explained

  • Problem Addressed: The patent describes Myelodysplastic Syndromes (MDS) as a diverse group of hematopoietic stem cell disorders characterized by ineffective blood cell production and a risk of progression to acute leukemia. It notes that existing treatments, such as bone marrow transplantation, are limited in applicability, particularly for the elderly population primarily affected by MDS, and that other therapies like hematopoietic growth factors have shown limited efficacy (’740 Patent, col. 2:26-31, col. 3:17-30).
  • The Patented Solution: The invention provides methods of treating or managing MDS by administering a specific immunomodulatory compound, 3-(4-amino-1-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione, known as lenalidomide. The patent discloses that this compound demonstrates "remarkable erythropoietic and cytogenetic remitting activity" in MDS patients, offering a novel therapeutic approach (’740 Patent, Abstract; col. 27:55-58).
  • Technical Importance: The invention represented a significant development by providing a novel, orally administered small molecule therapy for MDS, a disease for which treatment options were previously limited and often invasive (’740 Patent, col. 2:48-52).

Key Claims at a Glance

  • The complaint asserts "one or more claims" without specifying which ones (Compl. ¶27). Independent claim 1 is representative of the invention's core.
  • The essential elements of independent claim 1 are:
    • A method of treating a myelodysplastic syndrome,
    • which comprises administering to a patient in need thereof,
    • about 5 to about 50 mg per day,
    • of 3-(4-amino-1-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione, or a pharmaceutically acceptable salt, solvate, or stereoisomer thereof (’740 Patent, col. 30:60-67).
  • The complaint does not explicitly reserve the right to assert dependent claims, but the general allegation for infringement of "one or more" claims implicitly includes them.

U.S. Patent No. 8,404,717 - "Methods of Treating Myelodysplastic Syndromes Using Lenalidomide"

  • Patent Identification: U.S. Patent No. 8,404,717, titled "Methods of Treating Myelodysplastic Syndromes Using Lenalidomide," issued March 26, 2013 (’717 Patent, cover; Compl. ¶8).

The Invention Explained

  • Problem Addressed: The ’717 Patent, which is a continuation of the same family as the ’740 Patent, addresses the same underlying technical problem of providing effective treatments for MDS (’717 Patent, col. 2:40-42, col. 3:32-37).
  • The Patented Solution: This patent claims methods of use for lenalidomide that are tailored to specific subsets of MDS patients. The claims focus on patients with particular characteristics, such as "transfusion dependent anemia due to low to intermediate-1-risk" MDS, and specify particular dosing regimens for these populations (’717 Patent, col. 28:25-33).
  • Technical Importance: The invention provides more refined treatment protocols for specific MDS patient populations, potentially allowing for more targeted and effective therapy based on disease characteristics.

Key Claims at a Glance

  • The complaint asserts "one or more claims" (Compl. ¶36). Independent claim 1 is representative.
  • The essential elements of independent claim 1 are:
    • A method of treating a patient having transfusion dependent anemia due to low to intermediate-1-risk myelodysplastic syndrome,
    • which comprises administering to said patient in need thereof,
    • about 5 to about 25 mg per day,
    • of 3-(4-amino-1-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione, or a pharmaceutically acceptable salt, solvate, or stereoisomer thereof (’717 Patent, col. 28:25-33).
  • The complaint's general allegations implicitly include dependent claims.

U.S. Patent No. 9,056,120 - "Methods of Treating Myelodysplastic Syndromes with a Combination Therapy Using Lenalidomide and Azacitidine"

  • Patent Identification: U.S. Patent No. 9,056,120, titled "Methods of Treating Myelodysplastic Syndromes with a Combination Therapy Using Lenalidomide and Azacitidine," issued June 16, 2015 (’120 Patent, cover; Compl. ¶9).
  • Technology Synopsis: The ’120 Patent addresses the treatment of MDS by disclosing a combination therapy. The invention is a method of treating MDS that involves administering lenalidomide in combination with 5-azacytidine (azacitidine), another chemotherapy agent used for MDS (’120 Patent, Abstract; col. 2:23-35).
  • Asserted Claims: The complaint asserts infringement of "one or more claims" (Compl. ¶45). Independent claim 1 is asserted.
  • Accused Features: The complaint alleges that Defendant’s ANDA submission for its proposed generic lenalidomide products infringes the ’120 Patent (Compl. ¶45). An infringement theory would likely be based on the proposed product label instructing or encouraging co-administration with azacitidine.

III. The Accused Instrumentality

Product Identification

  • The accused instrumentalities are "DRL's Proposed Products," which are generic versions of Celgene's REVLIMID® (lenalidomide) capsules in 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 25 mg dosage strengths (Compl. ¶¶1, 22). The suit was triggered by Defendant's filing of Abbreviated New Drug Application (ANDA) No. 209348 with the FDA (Compl. ¶1).

Functionality and Market Context

  • The proposed products contain the active pharmaceutical ingredient lenalidomide and are intended to be generic equivalents to Plaintiff's REVLIMID® product, which is approved for the treatment of MDS (Compl. ¶¶10, 22). The act of infringement alleged in the complaint is the submission of the ANDA itself, which seeks FDA approval to market these generic versions prior to the expiration of the patents-in-suit, an act defined as infringement under 35 U.S.C. § 271(e)(2) (Compl. ¶27).

No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint does not contain a detailed claim chart or the proposed product label upon which infringement allegations are based. The following summary is constructed from the narrative allegations.

’740 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A method of treating a myelodysplastic syndrome, Defendant's proposed product label will allegedly instruct physicians and patients to use its generic lenalidomide product for the treatment of MDS, the same indication for which REVLIMID® is approved. ¶¶1, 10, 12, 22 col. 2:26-31
which comprises administering to a patient in need thereof The proposed product label will allegedly instruct or encourage administration of the generic product to patients who have been diagnosed with MDS. ¶12 col. 27:13-16
about 5 to about 50 mg per day of 3-(4-amino-1-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione...or a...thereof. Defendant seeks approval to market multiple dosage strengths of lenalidomide, and its proposed product label will allegedly instruct daily dosing regimens for MDS that fall within the claimed range of about 5 to 50 mg per day. ¶22 col. 30:62-64
  • Identified Points of Contention:
    • Scope Questions: Because this is an ANDA case, the central dispute will be whether the language of the Defendant's proposed product label will induce direct infringement by physicians and patients. The analysis will depend entirely on the specific instructions, indications, and dosing information included in the label that Defendant submitted to the FDA, which is not provided in the complaint.
    • Technical Questions: A potential point of contention arises from Defendant seeking approval for a 2.5 mg dosage strength (Compl. ¶22), which is outside the literal range of "5 to about 50 mg per day" recited in Claim 1 of the ’740 Patent. This raises the question of whether the administration of a 2.5 mg dose could be considered to meet this limitation under the doctrine of equivalents or through construction of the term "about."

V. Key Claim Terms for Construction

The complaint does not identify any specific claim terms as being in dispute. However, based on the context of an ANDA litigation involving method-of-use claims, certain terms are likely to be central to the dispute.

  • The Term: "treating" (’740 Patent, Claim 1)
    • Context and Importance: The definition of "treating" is critical for determining the scope of the method claim. Practitioners may focus on this term because Defendant could argue that its proposed label describes outcomes that provide palliative care or symptom management without rising to the level of "treating" the underlying syndrome as claimed in the patent.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The specification provides a broad definition, stating the term "treating" "includes but is not limited to, inhibition or the averting of symptoms associated with MDS" (’740 Patent, col. 17:7-9).
      • Evidence for a Narrower Interpretation: The specification's detailed description of clinical study results focuses on specific, significant outcomes such as "RBC transfusion-independence" and "cytogenetic response" (’740 Patent, col. 27:40-48). A party might argue these examples limit the term "treating" to methods that achieve such measurable clinical endpoints.
  • The Term: "about 5 to about 50 mg per day" (’740 Patent, Claim 1)
    • Context and Importance: This term defines the dosage range of the claimed method. Its construction is crucial because Defendant is seeking approval for a 2.5 mg dosage form (Compl. ¶22). The case may turn on whether a 2.5 mg dose is "about 5 mg."
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: A party could argue that "about" is intended to have its ordinary meaning of "approximately," and that in the context of pharmaceutical dosing, a 2.5 mg dose is functionally and numerically approximate to 5 mg, especially if doses are titrated.
      • Evidence for a Narrower Interpretation: The patent claims recite other, different dosage ranges, such as "about 5 to 25 mg per day" in the ’717 Patent (col. 28:29-30). A party could argue that the patentee's choice to claim different ranges demonstrates that the endpoints are not meant to be read so broadly as to encompass dosages that are half of the lower limit.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges both induced and contributory infringement for all three patents-in-suit (Compl. ¶¶30-31, 39-40, 48-49). The basis for inducement is the allegation that Defendant, with knowledge of the patents, will intentionally encourage infringement by physicians and patients through the instructions for use on its proposed product label (Compl. ¶30). The basis for contributory infringement is the allegation that the proposed products are especially adapted for infringing uses and have no substantial non-infringing use (Compl. ¶31).
  • Willful Infringement: The complaint does not use the term "willful," but it alleges that the case is "exceptional" and requests attorneys' fees under 35 U.S.C. § 285 (Compl. ¶¶34, 43, 52). This allegation is based on Defendant's knowledge of the patents-in-suit, as evidenced by its filing of a Paragraph IV certification with the FDA and its subsequent notice letter to Celgene (Compl. ¶¶24, 25).

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

  • A core issue will be one of induced infringement: Will the final, FDA-approved label for Defendant's generic lenalidomide products contain an indication for MDS and provide instructions for use that direct or encourage physicians to prescribe the drug in a manner that practices all the elements of the asserted method claims?
  • A key question will be one of claim scope: Can the dosage limitation "about 5 mg per day" be construed to read on the 2.5 mg dosage form for which Defendant seeks approval, or does this lower dosage provide a non-infringing alternative?
  • The case will also depend on patent validity: As indicated by its Paragraph IV certification, Defendant will challenge the validity of the patents-in-suit (Compl. ¶24). The strength of Defendant's arguments for invalidity, likely based on obviousness over prior art cancer treatments, will be a central battleground in the litigation.