DCT

2:18-cv-13477

Celgene Corp v. Hikma Pharma Intl Ltd

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Key Events
Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:18-cv-13477, D.N.J., 08/31/2018
  • Venue Allegations: Venue is alleged to be proper in the District of New Jersey based on Defendant Hikma Pharmaceuticals USA, Inc.’s principal place of business in the district, both defendants' systematic and continuous business contacts with New Jersey, and the fact that Defendants’ notice of infringement was directed to Plaintiff’s headquarters in New Jersey.
  • Core Dispute: Plaintiff alleges that Defendants' filing of an Abbreviated New Drug Application (ANDA) to market generic versions of Plaintiff's THALOMID® (thalidomide) drug product constitutes an act of infringement of nine U.S. patents covering both pharmaceutical compositions and methods for safe drug distribution.
  • Technical Context: The patents primarily relate to computer-implemented risk management systems designed to control the distribution of drugs with known teratogenic properties, like thalidomide, thereby preventing birth defects while allowing therapeutic use.
  • Key Procedural History: The litigation was initiated under the Hatch-Waxman Act, triggered by Defendants' filing of ANDA No. 211947 with the U.S. Food and Drug Administration (FDA), which included a Paragraph IV certification alleging that Plaintiff's patents are invalid and/or will not be infringed by the proposed generic products.

Case Timeline

Date Event
2000-10-23 Earliest Priority Date for ’720, ’977, ’784, ’399, ’018, ’566, ’886, ’531 Patents
2001-11-13 U.S. Patent No. 6,315,720 Issues
2002-11-14 Earliest Priority Date for ’012 Patent
2003-05-13 U.S. Patent No. 6,561,977 Issues
2004-06-29 U.S. Patent No. 6,755,784 Issues
2005-03-22 U.S. Patent No. 6,869,399 Issues
2006-11-28 U.S. Patent No. 7,141,018 Issues
2007-06-12 U.S. Patent No. 7,230,012 Issues
2011-06-14 U.S. Patent No. 7,959,566 Issues
2012-11-20 U.S. Patent No. 8,315,886 Issues
2014-01-07 U.S. Patent No. 8,626,531 Issues
2018-07-19 Defendants send Paragraph IV Notice Letter to Plaintiff
2018-08-31 Complaint Filed

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

U.S. Patent No. 6,315,720 - "Methods for Delivering a Drug to a Patient While Avoiding the Occurrence of an Adverse Side Effect Known or Suspected of Being Caused by the Drug," Issued November 13, 2001

The Invention Explained

  • Problem Addressed: The patent’s background section describes the challenge of safely distributing beneficial drugs that are known to have severe side effects, such as teratogenicity (causing birth defects), in certain patient populations. The patent notes a need for a controlled distribution system to prevent exposure to contraindicated individuals, such as a fetus. (’720 Patent, col. 1:21-48).
  • The Patented Solution: The invention is a computer-implemented method for controlling drug distribution. The system requires that the prescriber, pharmacy, and patient are all registered in a "computer readable storage medium" before a prescription can be filled. The method involves defining patient risk groups based on predefined parameters, collecting patient-specific information to assign them to a group, and entering this risk assignment into the medium before the patient is approved to receive the drug. (’720 Patent, Abstract; col. 2:50–col. 3:5).
  • Technical Importance: This technology established a framework for a centralized, data-driven Risk Evaluation and Mitigation Strategy (REMS), enabling the marketing of high-risk but medically important drugs like thalidomide by creating auditable safety controls. (’720 Patent, col. 2:1-13).

Key Claims at a Glance

The complaint alleges infringement of "one or more claims" of the ’720 patent without specifying which claims are asserted (Compl. ¶47). Independent claim 1 is representative and includes the following essential elements:

  • In a method for delivering a drug where prescriptions are filled only after consulting a computer readable storage medium, an improvement comprising:
  • defining a plurality of patient risk groups based on predefined risk parameters;
  • defining a set of information to be obtained from the patient probative of the risk of an adverse side effect;
  • in response to the information, assigning the patient to at least one risk group and entering the assignment into the medium;
  • determining, based on the information and risk group, whether the risk of the side effect is acceptable; and
  • upon determining the risk is acceptable, generating a prescription approval code to be retrieved by the pharmacy.

U.S. Patent No. 6,561,977 - "Methods for Delivering a Drug to a Patient While Restricting Access to the Drug by Patients for Whom the Drug May be Contraindicated," Issued May 13, 2003

The Invention Explained

  • Problem Addressed: The patent addresses the same problem as the parent ’720 Patent: the need for a robust system to control the distribution of potentially hazardous drugs to prevent contraindicated individuals from being exposed to them. (’977 Patent, col. 1:18-51).
  • The Patented Solution: As a continuation of the ’720 patent’s application, the ’977 Patent refines the controlled distribution method. It centrally features the step of a pharmacy retrieving a "prescription approval code" from the computer readable storage medium. The generation of this code is conditioned on a series of verifications within the system, including confirming patient registration, risk group assignment, and informed consent, thereby acting as a critical gatekeeper for dispensing the drug. (’977 Patent, Abstract; col. 4:51-61).
  • Technical Importance: This invention further solidifies the concept of an auditable, centralized electronic checkpoint—the approval code—that must be passed before a high-risk drug can be dispensed, shifting a key safety control step to an automated, verifiable system. (’977 Patent, col. 18:41-49).

Key Claims at a Glance

The complaint alleges infringement of "one or more claims" of the ’977 patent without specification (Compl. ¶56). Independent claim 1 is representative and includes the following essential elements:

  • A method for delivering a drug to patients in need, while restricting access to contraindicated patients.
  • The method comprises permitting prescriptions to be filled only after a pharmacy has retrieved a "prescription approval code" from a computer readable storage medium.
  • The generation of this code involves steps of: defining patient risk groups, defining and obtaining patient information, assigning the patient to a risk group, and determining if the risk is acceptable.

Multi-Patent Capsule: U.S. Patent No. 6,755,784

  • Patent Identification: U.S. Patent No. 6,755,784, "Methods for Delivering a Drug to a Patient While Restricting Access to the Drug by Patients for Whom the Drug May be Contraindicated," Issued June 29, 2004.
  • Technology Synopsis: This patent, part of the same family as the '720 and '977 patents, further describes the computer-implemented system for controlling access to hazardous drugs. It emphasizes the roles of the prescriber and pharmacy in registering with the system and using it to verify patient eligibility before dispensing medication. (’784 Patent, Abstract).
  • Asserted Claims: One or more unspecified claims (Compl. ¶65).
  • Accused Features: The proposed system for distributing generic thalidomide that Defendants would implement as part of their ANDA (Compl. ¶65).

Multi-Patent Capsule: U.S. Patent No. 6,869,399

  • Patent Identification: U.S. Patent No. 6,869,399, "Methods for Delivering a Drug to a Patient While Restricting Access to the Drug by Patients for Whom the Drug May be Contraindicated," Issued March 22, 2005.
  • Technology Synopsis: A continuation in the same family, this patent discloses methods for treating specific conditions (e.g., erythema nodosum leprosum) with thalidomide using the claimed controlled distribution system. The claims integrate the medical treatment with the safety and logistics framework. (’399 Patent, col. 18:24-33).
  • Asserted Claims: One or more unspecified claims (Compl. ¶74).
  • Accused Features: The required risk management system associated with Defendants' proposed generic thalidomide product (Compl. ¶74).

Multi-Patent Capsule: U.S. Patent No. 7,141,018

  • Patent Identification: U.S. Patent No. 7,141,018, "Methods for Delivering a Drug to a Patient While Restricting Access to the Drug by Patients for Whom the Drug May be Contraindicated," Issued November 28, 2006.
  • Technology Synopsis: This patent continues to build on the risk management system, with claims directed to a method of treating a disease with thalidomide that requires use of the controlled distribution system, including the generation of a prescription approval code based on patient information and risk assessment. (’018 Patent, Abstract; col. 18:29-52).
  • Asserted Claims: One or more unspecified claims (Compl. ¶83).
  • Accused Features: The risk management plan necessary for the marketing and sale of Defendants' generic thalidomide (Compl. ¶83).

Multi-Patent Capsule: U.S. Patent No. 7,230,012

  • Patent Identification: U.S. Patent No. 7,230,012, "Pharmaceutical Compositions and Dosage Forms of Thalidomide," Issued June 12, 2007.
  • Technology Synopsis: Unlike the other asserted patents, this patent is directed to pharmaceutical compositions and specific dosage forms of thalidomide. It claims single unit dosage forms comprising specific weights of thalidomide and excipients, designed to provide a higher weight percent of the active ingredient than prior art formulations. (’012 Patent, Abstract; col. 4:8-14).
  • Asserted Claims: One or more unspecified claims (Compl. ¶92).
  • Accused Features: The formulation and physical composition of Defendants' proposed 50 mg, 100 mg, 150 mg, and 200 mg generic thalidomide capsules (Compl. ¶¶1, 92).

Multi-Patent Capsule: U.S. Patent No. 7,959,566

  • Patent Identification: U.S. Patent No. 7,959,566, "Methods for Delivering a Drug to a Patient While Restricting Access to the Drug by Patients for Whom the Drug May be Contraindicated," Issued June 14, 2011.
  • Technology Synopsis: This patent claims methods of treating male patients with thalidomide. It recites specific acknowledgements the patient must make regarding the drug's risks (e.g., understanding of potential birth defects, need for barrier contraception) as part of the computer-managed approval process. (’566 Patent, col. 18:1-55).
  • Asserted Claims: One or more unspecified claims (Compl. ¶101).
  • Accused Features: The comprehensive risk management system that would be required for Defendants' generic thalidomide, including patient counseling and acknowledgements (Compl. ¶101).

Multi-Patent Capsule: U.S. Patent No. 8,315,886

  • Patent Identification: U.S. Patent No. 8,315,886, "Methods for Delivering a Drug to a Patient While Restricting Access to the Drug by Patients for Whom the Drug May be Contraindicated," Issued November 20, 2012.
  • Technology Synopsis: This patent claims methods for treating a male patient with a teratogenic drug where dispensing is conditioned on retrieving a prescription approval code. It further details the specific acknowledgements required from the patient, such as understanding not to donate semen or blood. (’886 Patent, col. 18:25-50).
  • Asserted Claims: One or more unspecified claims (Compl. ¶110).
  • Accused Features: The necessary safety and distribution protocols for Defendants' proposed generic thalidomide product (Compl. ¶110).

Multi-Patent Capsule: U.S. Patent No. 8,626,531

  • Patent Identification: U.S. Patent No. 8,626,531, "Methods for Delivering a Drug to a Patient While Restricting Access to the Drug by Patients for Whom the Drug May be Contraindicated," Issued January 7, 2014.
  • Technology Synopsis: This patent claims a communication system, comprising a computer device and readable medium, for authorizing delivery of a contraindicated drug. It focuses on the system architecture, including interfaces for receiving pharmacist prescriptions and generating approval codes based on stored registration information and risk assignments. (’531 Patent, Abstract; col. 18:10-48).
  • Asserted Claims: One or more unspecified claims (Compl. ¶119).
  • Accused Features: The computer system and network infrastructure that Defendants would need to implement to manage their generic thalidomide distribution program (Compl. ¶119).

III. The Accused Instrumentality

Product Identification

  • The accused instrumentalities are the proposed generic versions of Celgene’s 50 mg, 100 mg, 150 mg, and 200 mg THALOMID® drug products ("West-Ward’s ANDA Products") that are the subject of Defendants’ Abbreviated New Drug Application (ANDA) No. 211947 filed with the FDA (Compl. ¶1). The complaint also implicates the methods and systems that would be used to distribute these products (Compl. ¶16).

Functionality and Market Context

  • The complaint is an action under 35 U.S.C. § 271(e)(2), where the act of infringement is the filing of the ANDA itself for the purpose of obtaining approval to market a generic drug before patent expiration (Compl. ¶42, 47). The complaint alleges that upon FDA approval, West-Ward will manufacture, use, sell, and import these generic products (Compl. ¶43). Because generic drugs must have labeling that is substantially identical to the brand-name drug, the complaint alleges that the labeling for West-Ward's products will instruct and encourage physicians, pharmacists, and patients to administer the drug according to the patented methods (Compl. ¶18). The complaint does not provide specific details on the functionality of the risk management system West-Ward intends to implement, but bases its infringement allegations on the premise that any FDA-mandated Risk Evaluation and Mitigation Strategy (REMS) for generic thalidomide will necessarily practice the patented inventions.

No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint does not provide claim charts or detailed, element-by-element infringement contentions. Instead, it presents a narrative infringement theory common in ANDA litigation.

For the method and system patents (’720, ’977, ’784, ’399, ’018, ’566, ’886, and ’531), the core allegation is that Defendants' submission of an ANDA to engage in the commercial manufacture and sale of generic thalidomide constitutes infringement under 35 U.S.C. § 271(e)(2)(A) (Compl. ¶¶ 47, 56). The complaint further alleges that upon approval, Defendants will directly infringe, induce infringement by others (e.g., doctors, patients) through its product labeling, and contributorily infringe by providing a product especially adapted for an infringing use (Compl. ¶¶ 49-51). The underlying theory is that because thalidomide can only be marketed with a mandatory and comprehensive REMS program, any such program implemented by Defendants for their generic product will meet the limitations of the asserted claims.

For the composition patent (’012), the complaint alleges that the ANDA products themselves—the pharmaceutical compositions containing thalidomide—will infringe one or more claims (Compl. ¶¶ 16, 92).

  • Identified Points of Contention:
    • Technical Questions: A primary question for the court will be factual: what are the specific features and steps of the REMS program that West-Ward has designed or will implement for its generic product? Does that specific program include every element of the asserted claims, such as the generation and retrieval of a "prescription approval code" from a "computer readable storage medium" as defined in the patents?
    • Scope Questions: The dispute may center on whether West-Ward’s system, even if functionally similar, avoids literal infringement by omitting a claimed step or performing it in a different way. This raises the question of how broadly key claim terms will be construed and whether West-Ward can successfully "design around" the patents while still meeting FDA safety requirements.

V. Key Claim Terms for Construction

  • The Term: "prescription approval code" (from ’720 Patent, Claim 1; ’977 Patent, Claim 1)

    • Context and Importance: This term appears central to the patented method, representing the ultimate electronic gatekeeper that authorizes a pharmacy to dispense the drug. The definition will be critical because if West-Ward’s system uses a different type of authorization—for example, a simple eligibility flag rather than a distinct "code" for each prescription—it may argue non-infringement. Practitioners may focus on this term to determine if it requires a unique, transaction-specific identifier or can cover a more general system status confirmation.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The claims themselves describe the term functionally as a "code to be retrieved by said pharmacy" (’720 Patent, col. 18:41-43). This language may support an interpretation that covers any form of electronic signal or data that serves the function of authorizing dispensation.
      • Evidence for a Narrower Interpretation: The specification discusses the generation of the code "depending upon the risk group assignment" and retrieving it via specific means like an "on-line transmission or via telephone via IVR" (’977 Patent, col. 13:3-7). This context may support a narrower construction requiring a distinct code generated for each specific prescription transaction based on a real-time or near-real-time risk assessment.

  • The Term: "computer readable storage medium" (from ’720 Patent, Claim 1; ’977 Patent, Claim 1)

    • Context and Importance: This term defines the central repository of information (registrations, risk assignments) that the system relies on. Whether this requires a single, unified database or can be read on a distributed system of linked databases will be a key question. A defendant could argue its decentralized system does not meet the "a ... medium" limitation.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The term itself is technologically broad. The specification states the medium for the patient may be the "same as, or different from the computer readable storage medium in which the prescriber and/or pharmacy is registered" (’720 Patent, col. 6:62-67), which suggests the possibility of multiple, interoperable media rather than a single monolithic database.
      • Evidence for a Narrower Interpretation: The abstract describes a process where "a computer readable storage medium has been consulted to assure that the prescriber, pharmacy and patient have been properly registered." (’720 Patent, Abstract). This could be interpreted to imply a single point of consultation that holds all necessary registration data, potentially excluding systems where these checks are performed against separate, un-integrated databases.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges both induced and contributory infringement for all asserted patents. The basis for these allegations is that Defendants, upon receiving FDA approval, will market and sell their generic thalidomide products with labeling that instructs physicians, pharmacists, and patients on how to prescribe, dispense, and use the drug in a manner that practices the steps of the patented methods (Compl. ¶¶ 50, 51, 59, 60).
  • Willful Infringement: The complaint does not explicitly allege willful infringement. However, for each count, it asserts that the case is "an exceptional one" and requests an award of reasonable attorneys' fees under 35 U.S.C. § 285 (Compl. ¶¶ 54, 63, 72, etc.). The factual basis for this allegation is not detailed in the complaint, but is predicated on the act of filing the ANDA with knowledge of the patents-in-suit.

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

  • A core issue will be one of infringement by design: Can West-Ward implement an FDA-compliant REMS for its generic thalidomide that meets all federal safety mandates without practicing every element of Celgene’s asserted method and system claims? This will turn on a technical comparison of West-Ward's specific system architecture against the patent claims and may become a central question of whether it is possible to "design around" the patents.
  • A second central issue, arising from West-Ward's Paragraph IV certification, will be one of validity: Do earlier computer-based systems for managing patient data, or prior safety programs for other drugs, render the claimed combination of patient registration, risk-group assignment, and generation of a prescription approval code obvious to a person of ordinary skill in the art?
  • A key question specific to the ’012 patent will be one of composition scope: Does West-Ward’s proposed generic thalidomide formulation—specifically its combination of active ingredient weight and excipients—fall within the literal scope of the ’012 patent’s claims, or is it sufficiently different in its composition to be non-infringing?