PTAB

IPR2015-01092

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 Preventing the Exposure of a Foetus or Other Contraindicated Individual to the Drug
  • Brief Description: The ’501 patent discloses methods for the controlled distribution of teratogenic drugs, such as thalidomide, to prevent fetal exposure. The method involves using a computer-readable storage medium to register qualified prescribers, pharmacies, and patients, counseling at-risk patients, and authorizing drug delivery only after confirming non-pregnancy.

3. Grounds for Unpatentability

Ground 1: Obviousness over Powell, Mitchell, and Dishman - Claims 1-10 are obvious over Powell and Mitchell in view of Dishman.

  • Prior Art Relied Upon: Powell (a 1994 medical journal article), Mitchell (a 1995 medical journal article), and Dishman (a 1994 pharmacy journal article).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that the combination of prior art taught every element of the challenged claims. Powell (guidelines for thalidomide) and Mitchell (Accutane pregnancy prevention program) were asserted to teach the core safety protocols for a teratogenic drug, including identifying at-risk patient subpopulations, counseling them on fetal exposure risks, and requiring pregnancy tests prior to dispensing. Petitioner contended that Dishman disclosed the claimed computerized implementation. Dishman described the Clozaril® National Registry, a system for the hazardous drug clozapine that required registration of prescribers and patients and used a "computerized clozapine prescription lockout system" to prevent dispensing unless specific medical criteria (e.g., white blood cell counts) were met. For dependent claims, these references were argued to teach the specific use for thalidomide (claim 2), pregnancy testing (claim 4), prescription duration limits of about 28 days (claim 7), and contraception counseling (claim 9).
    • Motivation to Combine: Petitioner contended that a person of ordinary skill in the art (POSITA), tasked with creating a safe distribution program for thalidomide, would be motivated to implement the known safety protocols from Powell and Mitchell using the proven, successful computerized registry model from Dishman. The motivation was to solve the known problem of safely distributing a teratogenic drug by applying an existing, robust technological solution to automate the necessary checks and balances, thereby improving upon less reliable, non-computerized safety programs.
    • Expectation of Success: A POSITA would have a reasonable expectation of success because the combination involved applying a "proven successful" computerized control system (Dishman) to a different drug with an analogous safety-check requirement. The adaptation would merely involve substituting one medical condition check (non-pregnancy) for another (WBC count) within an established framework.

Ground 2: Obviousness over NIH and Honigfeld - Claims 1-10 are obvious over NIH in view of Honigfeld.

  • Prior Art Relied Upon: NIH (a 1997 public scientific workshop publication) and Honigfeld (a 1996 psychiatric journal article).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that a POSITA would consult authoritative guidance from the National Institutes of Health (NIH) on managing thalidomide risks and would implement the recommended safety measures using the well-known computerized clozapine registry system detailed in Honigfeld. The NIH workshop publication was asserted to teach key method steps, including identifying subpopulations of fertile men and women, counseling on teratogenicity using consent forms and brochures, and requiring monthly pregnancy tests. Honigfeld was alleged to disclose the computerized framework for implementing these steps. It described the Clozaril national registry as an "integrated, computerized database" that registered physicians and pharmacies and operated on a "no blood-no drug" basis, authorizing dispensing only if weekly blood tests met safety criteria.
    • Motivation to Combine: Petitioner argued that a POSITA, having learned the necessary risk management steps from the authoritative NIH source, would naturally look to existing solutions for the analogous problem of safely distributing other dangerous drugs. Honigfeld provided an obvious technological template for a computerized registry system. A POSITA would be motivated to apply its established logic to thalidomide, simply replacing the condition precedent for dispensing—a safe WBC count—with the relevant condition for thalidomide, a negative pregnancy test.
    • Expectation of Success: A POSITA would expect success in combining these references because it constituted the application of a known type of computerized control system to a known problem. The system in Honigfeld was designed for conditional dispensing based on medical data, making its adaptation to the thalidomide context straightforward and predictable.

4. Key Claim Construction Positions

  • "Registering": Petitioner proposed this term means "recording in a written format (including by mail, facsimile transmission, online transmission) information relating to a person or entity." This broad construction supports finding the limitation in prior art that describes either paper-based or electronic record-keeping.
  • "Determination of non-pregnancy": Petitioner proposed this term means "the process of establishing that a patient is not pregnant, for example, through consultation, examination, self-report, or chemical test." This construction encompasses the various testing and confirmation methods described across the prior art references.
  • "The risks attendant to fetal exposure": Petitioner proposed this term means "exposure to danger, harm, or loss associated with the drug if a fetus is subjected to it through use by the mother or the father." This construction aligns with the well-understood teratogenic effects of drugs like thalidomide discussed in the prior art.

5. Relief Requested

  • Petitioner requests institution of an inter partes review (IPR) and cancellation of claims 1-10 of Patent 6,045,501 as unpatentable under 35 U.S.C. §103.