PTAB

IPR2015-00830

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 ’302 patent discloses methods for treating a relapsing form of multiple sclerosis (MS) in a human patient. The claimed method involves administering three subcutaneous injections per week of a 40 mg/ml dose of glatiramer acetate (GA).

3. Grounds for Unpatentability

Ground 1: Anticipation of Claims 1-3, 6-10, and 12 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 of treating relapsing forms of MS by administering 40 mg of GA via subcutaneous injection on an "every other day" basis. Petitioner contended that this every-other-day schedule necessarily results in a dosing regimen that alternates between three and four injections per week. Because independent claim 1 uses the open-ended transitional phrase "comprising" to require "three subcutaneous injections... per week," the claim is met by a schedule that provides at least three injections. Thus, Pinchasi's regimen, which always meets or exceeds three injections per week, anticipated the claim.
    • Key Aspects: Petitioner further argued that Pinchasi anticipated the additional limitations of independent claim 10 and various dependent claims. Specifically, Pinchasi disclosed a 40 mg GA composition in 1 ml of solution containing mannitol, having a pH between 5.5 and 7.0, and provided in a pre-filled syringe for self-administration—disclosing all key limitations of claim 10 and its dependent claims.

Ground 2: Obviousness of Claims 1-12 over Pinchasi in view of the 1996 FDA SBOA

  • Prior Art Relied Upon: Pinchasi (WO 2007/081975) and the 1996 FDA SBOA (Jessop, Review and Evaluation of Pharmacology Toxicology Data Original NDA Review (1996)).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner asserted that even if Pinchasi's every-other-day schedule did not anticipate the claims, the claimed three-times-per-week regimen was obvious. Pinchasi established the safety and efficacy of a 40 mg GA dose administered less frequently than daily. The 1996 FDA SBOA, a review of the original 20 mg daily Copaxone® NDA, provided crucial pharmacokinetic data showing an approximate 80-hour half-life for GA. Based on this, the FDA reviewer questioned the necessity of daily injections and recommended that Teva evaluate "more infrequent intermittent administration."
    • Motivation to Combine: A person of ordinary skill in the art (POSITA) would have been motivated to modify Pinchasi's every-other-day regimen to a fixed three-times-per-week schedule for clear reasons. The primary motivation, articulated in the SBOA, was to reduce patient discomfort and improve compliance by minimizing the number of injections. A fixed weekly schedule (e.g., Mon-Wed-Fri) is more convenient and easier for patients to adhere to than a schedule that shifts days each week.
    • Expectation of Success: The SBOA's disclosure of an 80-hour half-life provided a strong scientific rationale that injections could be spaced approximately every three days without loss of efficacy. This, combined with Pinchasi's demonstration that a 40 mg dose was safe and well-tolerated, would have given a POSITA a reasonable expectation of success in developing a safe and effective three-times-per-week 40 mg regimen.

Ground 3: Obviousness of Claims 1-12 over Pinchasi in view of Flechter 2002A

  • Prior Art Relied Upon: Pinchasi (WO 2007/081975) and Flechter 2002A (Flechter et al., a 2002 clinical neuropharmacology article).
  • Core Argument for this Ground:
    • Prior Art Mapping: This ground presented an alternative combination to prove obviousness. Flechter 2002A was a clinical study that compared daily 20 mg GA injections with alternate-day 20 mg injections. The study found similar efficacy rates and noted that the alternate-day regimen increased patient compliance, leading the authors to conclude that daily injections were "unnecessary." Pinchasi taught the safety of a higher 40 mg dose.
    • Motivation to Combine: A POSITA would have been motivated to apply the learnings from Flechter 2002A to the higher 40 mg dose disclosed in Pinchasi. Flechter 2002A provided direct clinical evidence that less frequent dosing was not only effective but preferred by patients and improved compliance. A POSITA would logically seek to combine this known benefit of reduced frequency with the potential for improved efficacy from the higher, safe 40 mg dose taught by Pinchasi.
    • Expectation of Success: The positive clinical outcomes in Flechter 2002A for a less-frequent dosing schedule provided a strong expectation that a similar reduction in frequency (e.g., to three times per week) for the 40 mg dose would also be safe and effective. The combination represented a routine optimization of a known drug therapy.

4. Key Claim Construction Positions

  • "Comprising": Petitioner argued that the independent claims' use of the open-ended term "comprising" means the claims are not limited to only three injections per week. A method that includes three or more injections per week, such as Pinchasi's every-other-day schedule that alternates between three and four weekly injections, falls within the scope of the claims. This construction was central to the anticipation argument.
  • "Per week": Petitioner contended this phrase defines a rate of administration, not a required duration of treatment. Therefore, any single week of a prior art regimen that meets the claimed rate is sufficient to satisfy the claim limitation.

5. Relief Requested

  • Petitioner requested institution of an inter partes review and cancellation of claims 1-12 of Patent 8,969,302 as unpatentable under 35 U.S.C. §§ 102 and 103.