PTAB

IPR2015-01981

Amneal Pharmaceuticals LLC v. Yeda Research & Development Co Ltd

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Petition
petition

1. Case Identification

2. Patent Overview

  • Title: Low Frequency Glatiramer Acetate Therapy
  • Brief Description: The ’302 patent describes a method for treating a human patient with a relapsing form of multiple sclerosis (MS) by administering three subcutaneous injections of a 40 mg/ml dose of glatiramer acetate (GA) per week.

3. Grounds for Unpatentability

Ground 1: Anticipation of Claims 1-3, 6-10, and 12 under 35 U.S.C. §102

  • 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 MS by administering a 40 mg dose of GA "every other day." This dosing schedule resulted in alternating weeks of three and four subcutaneous injections. Because independent claims 1 and 10 used the open-ended transitional phrase "comprising," Petitioner asserted that Pinchasi's schedule literally met the limitation of "three subcutaneous injections... per week" as it was not limited to only three injections. Pinchasi also explicitly disclosed the formulation details required by claim 10, including the use of mannitol, a pH range of 5.5 to 7.0, and administration via a prefilled syringe for self-injection.

Ground 2: Obviousness of Claims 1-12 under 35 U.S.C. §103

  • Prior Art Relied Upon: Pinchasi (International Publication No. WO 2007/081975).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner contended that even if the claims were narrowly construed to require exactly three injections per week, this regimen would have been obvious over Pinchasi's disclosure of an "every other day" 40 mg GA therapy. A POSA would have understood that a regimen of exactly three injections per week (totaling 120 mg) was therapeutically equivalent to Pinchasi's schedule, which averaged 3.5 injections per week (totaling 140 mg).
    • Motivation to Combine: A POSA would be motivated to modify Pinchasi’s "every other day" schedule to a fixed three-times-per-week schedule to improve patient compliance and convenience. A fixed schedule (e.g., Monday, Wednesday, Friday) is easier for patients to follow than an alternating one, and reducing the total number of injections over a two-week period from seven to six would decrease patient discomfort and side effects.
    • Expectation of Success: Given that Pinchasi established the safety and efficacy of 40 mg doses of GA, a POSA would have had a reasonable expectation of success that a slight reduction in the weekly dose would remain safe and effective, while providing the known benefits of a less frequent and more regular injection schedule.

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

  • Prior Art Relied Upon: Pinchasi (International Publication No. WO 2007/081975) and the 1996 FDA SBOA (a 1996 FDA Summary Basis of Approval for Copaxone®).
  • Core Argument for this Ground:
    • Prior Art Mapping: This ground combined Pinchasi's teaching of a 40 mg GA dose with the 1996 FDA SBOA's pharmacokinetic data and explicit recommendations. The SBOA disclosed that GA has a half-life of approximately 80 hours, making daily injections unnecessary. The FDA reviewer explicitly recommended that the sponsor "evaluate the necessity of daily s.c. injections as opposed to more infrequent intermittent administration of the drug" to reduce patient discomfort.
    • Motivation to Combine: A POSA, aware of the higher 40 mg dose taught by Pinchasi, would have been directly motivated by the SBOA to develop a less frequent dosing schedule. The SBOA provided a strong rationale—grounded in official regulatory feedback and pharmacokinetic data—to move away from daily or every-other-day injections toward a reduced-frequency regimen like three times per week.
    • Expectation of Success: The SBOA's disclosure of an 80-hour half-life provided a firm scientific basis for a POSA to expect that administering a 40 mg GA dose three times per week (i.e., with intervals of 48-72 hours) would be safe and effective, as this frequency is well within the drug's pharmacokinetic profile for maintaining a steady-state concentration.
  • Additional Grounds: Petitioner asserted an additional obviousness challenge (Ground 4) against claims 1-12 based on Pinchasi in view of Flechter 2002A (a clinical study on alternate-day 20 mg GA dosing), which similarly taught that less frequent dosing was safe, effective, and improved patient compliance.

4. Key Claim Construction Positions

  • "comprising": Petitioner argued this term should be given its standard open-ended meaning, which does not exclude additional, unrecited steps. This construction was central to the anticipation argument, as it allowed Pinchasi's "every other day" schedule (alternating 3 and 4 injections per week) to meet the "three... injections per week" limitation.
  • "per week": Petitioner argued this phrase defines a rate of administration (at least three injections in a single week) and not a required duration of treatment extending beyond a single week. This interpretation supported the view that Pinchasi's regimen, which includes weeks with three injections, met the claim language.

5. Relief Requested

  • Petitioner requested institution of an inter partes review and cancellation of claims 1-12 of the ’302 patent as unpatentable under 35 U.S.C. §§ 102 and 103.