PTAB

IPR2015-00643

Mylan Pharmaceuticals Inc v. Yeda Research Development Co Ltd

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Key Events
Petition
petition

1. Case Identification

2. Patent Overview

  • Title: Low Frequency Glatiramer Acetate Therapy
  • Brief Description: The ’250 patent describes methods for treating relapsing-remitting multiple sclerosis (RRMS). The core claimed method involves administering a regimen of at least three subcutaneous injections of a 40 mg dose of glatiramer acetate (GA) over a seven-day period.

3. Grounds for Unpatentability

Ground 1: Anticipation of Claims 1-13 and 19-20 by Pinchasi

  • Prior Art Relied Upon: Pinchasi (International Publication No. WO 2007/081975).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that Pinchasi expressly disclosed every element of the challenged claims. Pinchasi taught a method for treating RRMS by administering 40 mg of GA on an "every other day" basis. Petitioner contended this dosing schedule inherently meets the limitation of "at least three subcutaneous injections... over a period of seven days," as it results in alternating weeks of three and four injections. This reading relies on the open-ended claim term "comprising." Pinchasi also allegedly disclosed that this regimen alleviates symptoms and reduces the frequency of relapses, meeting the preamble limitations of independent claims 1 and 19. Dependent claims directed to specific clinical endpoints (e.g., reducing lesions) and administration via a prefilled syringe were also asserted to be explicitly taught by Pinchasi.
    • Key Aspects: The central thesis for anticipation hinged on the construction of "comprising," which Petitioner argued encompasses Pinchasi's every-other-day schedule that provides at least three, and sometimes four, injections per week.

Ground 2: Obviousness of Claims 1-20 over Pinchasi and the 1996 FDA SBOA

  • Prior Art Relied Upon: Pinchasi (WO 2007/081975) and the 1996 FDA SBOA (Original NDA Review for Copaxone®).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner asserted that Pinchasi disclosed a 40 mg dose of GA for treating RRMS, while the 1996 FDA SBOA provided pharmacokinetic data and an explicit rationale for reducing injection frequency. The SBOA, in reviewing the 20 mg daily version of Copaxone®, noted its half-life was approximately 80 hours and questioned the necessity of daily injections, recommending that the sponsor evaluate "more infrequent intermittent administration."
    • Motivation to Combine: A POSITA would combine Pinchasi's teachings of a safe and effective 40 mg dose with the SBOA's clear motivation to develop less frequent dosing schedules. The primary drivers for this combination were improving patient compliance and reducing the discomfort associated with daily injections, both of which were known problems in the art.
    • Expectation of Success: A POSITA would have a reasonable expectation of success. The SBOA's pharmacokinetic data suggested that a less frequent schedule (e.g., three times per week) would maintain therapeutic efficacy. Combining this with Pinchasi's clinical data showing that a 40 mg dose was safe and well-tolerated would lead a POSITA to expect that a 40 mg, three-times-weekly regimen would be both safe and effective.

Ground 3: Obviousness of Claims 1-20 over Pinchasi and Flechter 2002A

  • Prior Art Relied Upon: Pinchasi (WO 2007/081975) and Flechter 2002A (a 2002 clinical study on alternate-day GA administration).

  • Core Argument for this Ground:

    • Prior Art Mapping: This ground combined Pinchasi's disclosure of a 40 mg GA dose with Flechter's clinical findings for a 20 mg GA dose. Flechter 2002A concluded that alternate-day administration of 20 mg GA had similar efficacy to daily administration, improved patient compliance, and that "daily injections are unnecessary."
    • Motivation to Combine: A POSITA would be motivated to apply Flechter's successful less-frequent dosing strategy to Pinchasi's higher, safe 40 mg dose. The goal would be to achieve the known benefits of a higher dose while simultaneously gaining the compliance and convenience advantages demonstrated by Flechter's alternate-day schedule.
    • Expectation of Success: Success was predictable. Since Flechter 2002A established that a less-frequent schedule was effective for a 20 mg dose, and Pinchasi established that a 40 mg dose was safe, a POSITA would reasonably expect that administering the safe 40 mg dose on a less-frequent schedule would also be safe and therapeutically effective. The combination represented an optimization of known parameters, not an inventive leap.

  • Additional Grounds: Petitioner asserted an additional obviousness challenge against claims 1-20 based on Pinchasi alone, arguing that even if Pinchasi did not anticipate, it would have been obvious to modify its every-other-day dosing to a fixed three-times-per-week schedule to improve patient adherence and convenience.

4. Key Claim Construction Positions

  • "Comprising": Petitioner argued this transitional phrase must be given its standard, open-ended meaning. This construction is critical to the anticipation ground, as it allows the claims to read on Pinchasi's every-other-day dosing schedule, which includes at least three injections per seven-day period (alternating between three and four). Under this construction, the claims are not limited to a regimen of only three injections per week.
  • "Regimen": Petitioner contended this term should be construed as "a systemic plan of treatment." It argued that the use of this term, especially with the indefinite article "a," does not narrow the scope of the open-ended "comprising" transition and supports the understanding that the claims cover an ongoing course of therapy rather than a single, isolated seven-day period.

5. Relief Requested

  • Petitioner requested institution of an inter partes review and cancellation of claims 1-20 of Patent 8,232,250 as unpatentable under 35 U.S.C. §§ 102 and 103.