PTAB

IPR2015-01096

Coalition for Affordable Drugs VI LLC v. Celgene Corp

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Key Events
Petition
petition

1. Case Identification

2. Patent Overview

  • Title: 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
  • Brief Description: The ’720 patent discloses methods for the controlled distribution of drugs with known adverse side effects, particularly teratogenic drugs like thalidomide. The methods involve a computer-based system where prescribers, pharmacies, and patients are registered, patients are assigned to risk groups, and a prescription approval code is generated only after risk acceptability is confirmed, thereby preventing contraindicated patients from receiving the drug.

3. Grounds for Unpatentability

Ground 1: Anticipation over Thalomid PI - Claims 1-32 are anticipated under 35 U.S.C. § 102(b) by the THALOMID™ Package Insert.

  • Prior Art Relied Upon: Thalomid PI (the July 1998 THALOMID™ (thalidomide) Capsules Revised Package Insert).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that the Thalomid PI, which describes the FDA-approved "System for Thalidomide Education and Prescribing Safety" (S.T.E.P.S.) program, disclosed every limitation of claims 1-32. The S.T.E.P.S. program was a restricted distribution system requiring registration of prescribers, pharmacies, and patients in a central database before thalidomide could be dispensed. Petitioner asserted that Thalomid PI explicitly taught defining patient risk groups (e.g., "WOMEN of childbearing potential," "sexually mature MALES"), defining and obtaining patient information probative of risk (e.g., consent forms, mandatory pregnancy tests), and assigning patients to risk groups within a computer medium. The final step of generating a "prescription approval code" was argued to be inherently disclosed, as the restricted system required a confirmation of compliance before a pharmacy was permitted to dispense the drug, which would have been recognized by a person of ordinary skill in the art (POSITA) as an approval code mechanism. Dependent claims relating to counseling, informed consent, specific diagnostic tests (pregnancy, genetic), and periodic surveys were also mapped to explicit requirements and forms detailed in the Thalomid PI for the S.T.E.P.S. program.

Ground 2: Obviousness over Thalomid PI and Cunningham - Claims 1-32 are obvious under 35 U.S.C. § 103 over Thalomid PI in view of Cunningham.

  • Prior Art Relied Upon: Thalomid PI (the July 1998 package insert) and Cunningham (Patent 5,832,449).
  • Core Argument for this Ground:
    • Prior Art Mapping: This ground asserted that even if the "prescription approval code" of independent claims 1(e) and 28(e) was not explicitly or inherently disclosed by Thalomid PI, it would have been obvious to a POSITA to implement one. Cunningham disclosed a computerized method for dispensing pharmaceutical trial products by linking prescribers and pharmacies to a central computing station. Crucially, Cunningham taught that after a pharmacy uploads required information, the central station validates it and "issues a pharmacy approval code" that the pharmacy must retrieve before dispensing the product. Petitioner argued that Cunningham provided the explicit approval code mechanism to implement the restricted access goals of the S.T.E.P.S. program described in Thalomid PI.
    • Motivation to Combine: A POSITA tasked with implementing the S.T.E.P.S. program from Thalomid PI would have been motivated to use a computerized approval system like that taught in Cunningham. The goal of the S.T.E.P.S. program was to create a strict, auditable gatekeeping system to prevent fetal exposure to thalidomide. Using an automated approval code system was a well-known, predictable, and reliable method to enforce such compliance checks before dispensing a drug, making the combination a matter of applying a known technique to a similar problem.
    • Expectation of Success: A POSITA would have had a high expectation of success in combining the references. The combination merely involved using a known computerized validation and code-generation system (Cunningham) to implement a known set of rules for restricted drug distribution (Thalomid PI). This represented a simple automation of a known process with predictable results.

4. Key Claim Construction Positions

  • "Consulted": Petitioner argued this term means "accessed and considered." This construction supports the argument that the prior art's requirement for a pharmacist to check a database before dispensing meets the claim limitation.
  • "Teratogenic effect": Defined as "any effect that disturbs the normal growth and development of an embryo or fetus."
  • "Adverse side effect": Defined as "any unfavorable abnormality, defect, mutation, lesion, degeneration or injury which may be caused by taking the drug."

5. Relief Requested

  • Petitioner requests institution of an inter partes review (IPR) and cancellation of claims 1-32 of the ’720 patent as unpatentable.