PTAB

IPR2015-01981

Amneal Pharmaceuticals LLC v. YEDA RESEARCH & DEVELOPMENT CO. LTD.

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1. Case Identification

2. Patent Overview

  • Title: Low Frequency Glatiramer Acetate Therapy
  • Brief Description: The ’302 patent is directed to methods of treating a relapsing form of multiple sclerosis (MS) by administering a 40 mg/ml dose of glatiramer acetate (GA) via subcutaneous injection three times per week.

3. Grounds for Unpatentability

Ground 1: Anticipation over Pinchasi - Claims 1-3, 6-10, and 12 are anticipated under 35 U.S.C. §102 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 discloses every element of the challenged claims. Pinchasi teaches a method of treating MS by administering a pharmaceutical composition comprising 40 mg of GA. Crucially, a disclosed embodiment in Pinchasi is the administration of this 40 mg dose on an "every other day" basis. Petitioner contended that this dosing schedule inherently meets the "three subcutaneous injections... per week" limitation of the independent claims. An "every other day" schedule results in an alternating pattern of three and four injections per week, which Petitioner argued is encompassed by the open-ended "comprising" language of the claims. For claim 10, Pinchasi was asserted to disclose the required formulation details, including the 1 ml volume, the presence of mannitol, a pH range of 5.5 to 7.0, and administration via a prefilled syringe for self-injection. The dependent claims were also argued to be disclosed, as Pinchasi specifies treating relapsing-remitting MS (RRMS).

Ground 2: Obviousness over Pinchasi - Claims 1-12 are obvious under 35 U.S.C. §103 over Pinchasi.

  • Prior Art Relied Upon: Pinchasi (WO 2007/081975).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner asserted that even if Pinchasi’s "every other day" dosing schedule is not found to be an exact anticipation, the claimed three-times-per-week regimen would have been obvious from Pinchasi alone. A POSA would have viewed Pinchasi’s schedule (averaging 3.5 injections per week) as therapeutically equivalent to the claimed schedule (3 injections per week), as both deliver a similar total weekly dose (140 mg vs. 120 mg) that falls within a known safe and effective range.
    • Motivation to Combine (for §103 grounds): The motivation to modify Pinchasi’s "every other day" schedule to a fixed three-times-per-week schedule was driven by the well-understood goal of improving patient compliance and convenience. A fixed schedule (e.g., Monday, Wednesday, Friday) is easier for patients with chronic conditions to adhere to than a schedule that shifts days each week. Reducing the number of injections, even by one every other week, was also a known strategy to reduce side effects and improve adherence.
    • Expectation of Success (for §103 grounds): A POSA would have had a high expectation of success because Pinchasi already established the safety and efficacy of a 40 mg dose administered on a similar schedule. A minor reduction in dosing frequency was predictable to maintain efficacy while improving the treatment experience for the patient.

Ground 3: Obviousness over Pinchasi and 1996 FDA SBOA - Claims 1-12 are obvious over Pinchasi in view of the 1996 FDA SBOA.

  • Prior Art Relied Upon: Pinchasi (WO 2007/081975) and the 1996 FDA Summary Basis of Approval for Copaxone (1996 FDA SBOA).
  • Core Argument for this Ground:
    • Prior Art Mapping: This ground combined Pinchasi's disclosure of a 40 mg GA dose with the explicit rationale for less frequent dosing provided by the 1996 FDA SBOA for the original 20 mg Copaxone product. The SBOA disclosed that GA has a long half-life of approximately 80 hours and that an FDA reviewer explicitly questioned the necessity of daily injections, recommending that the sponsor "evaluate the necessity of daily s.c. injections as opposed to more infrequent intermittent administration of the drug."
    • Motivation to Combine (for §103 grounds): A POSA, knowing from Pinchasi that a higher 40 mg dose was safe and effective, would be directly motivated by the SBOA to develop a less-frequent dosing schedule for it. The SBOA provided a clear scientific and regulatory-endorsed reason to pursue fewer injections to reduce patient discomfort and improve compliance, a known challenge with injectable MS therapies.
    • Expectation of Success (for §103 grounds): The SBOA's pharmacokinetic data provided a strong scientific basis to expect that a three-times-per-week schedule (i.e., dosing every ~56 hours) would be safe and effective, as this interval is well within the drug's 80-hour half-life. Combining Pinchasi's dose strength with the SBOA's dosing rationale would lead a POSA to the claimed invention with a reasonable expectation of success.
  • Additional Grounds: Petitioner asserted an additional obviousness challenge against claims 1-12 based on Pinchasi in view of Flechter 2002A, which provided further evidence of the similar efficacy, safety, and increased patient compliance of alternate-day dosing compared to daily dosing.

4. Key Claim Construction Positions

Petitioner argued for the broadest reasonable interpretation of two key claim terms, which was central to its anticipation ground.

  • "comprising": Petitioner argued this transitional phrase is open-ended and inclusive, meaning a claim reciting "three subcutaneous injections...per week" is not limited to only three injections. It would therefore read on a schedule that includes four injections in a given week, such as the "every other day" dosing disclosed in Pinchasi.
  • "per week": Petitioner contended this phrase defines a rate of administration, not a fixed duration or rigid regimen. This construction allows an "every other day" schedule, which has a rate that averages 3.5 injections per week, to satisfy the claim limitation of "three...injections per week."

5. Relief Requested

  • Petitioner requests institution of an inter partes review and cancellation of claims 1-12 of Patent 8,969,302 as unpatentable.