PTAB

IPR2015-00830

Mylan Pharmaceuticals Inc. 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 relates to a method for treating relapsing forms of multiple sclerosis (MS) in a human patient 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 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, a published patent application from the Patent Owner’s commercial partner, Teva, expressly disclosed every element of the challenged claims. Pinchasi taught a method of treating relapsing-remitting MS (RRMS) by administering 40 mg of GA. Critically, Pinchasi disclosed an "every other day" dosing schedule. Petitioner asserted that, based on their proposed claim construction, this schedule inherently meets the "three subcutaneous injections ... per week" limitation of independent claim 1. An every-other-day schedule results in an alternating sequence of three and four injections per week. The week with three injections directly meets the claim limitation, and the week with four injections is covered because the claim term "comprising" is open-ended and does not exclude additional steps.
    • Key Aspects: Petitioner’s anticipation argument hinges on its construction of "comprising," which allows an every-other-day dosing regimen to fall within the literal scope of a "three ... injections per week" claim. Pinchasi also disclosed the specific formulation details recited in independent claim 10, including the use of mannitol, a pH range of 5.5 to 7.0, and administration via a self-administered prefilled syringe.

Ground 2: Obviousness of Claims 1-12 under 35 U.S.C. §103 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 (SBOA) for Copaxone®.
  • Core Argument for this Ground:
    • Prior Art Mapping: Pinchasi disclosed administering 40 mg of GA on an every-other-day basis. The 1996 FDA SBOA, a public document reviewing the original 20 mg daily Copaxone®, taught that the drug has a long half-life of approximately 80 hours. A reviewing pharmacologist for the FDA explicitly questioned the necessity of daily injections, noting that less frequent, intermittent administration should maintain efficacy while reducing patient discomfort.
    • Motivation to Combine: A Person of Ordinary Skill in the Art (POSA), starting with Pinchasi’s 40 mg every-other-day dosing regimen, would be motivated by the 1996 FDA SBOA to explore less frequent dosing. The SBOA provided an explicit rationale: to reduce the burden of injections for a chronic therapy, a well-known goal to improve patient compliance. A POSA would combine Pinchasi's higher dose with the SBOA's rationale for less frequent administration, leading directly to a three-times-per-week schedule as a logical, more convenient alternative to an alternating three/four-per-week schedule.
    • Expectation of Success: The SBOA's pharmacokinetic data (80-hour half-life) provided a strong scientific basis for a POSA to expect that a three-times-per-week schedule would be safe and effective. This schedule would easily maintain a steady-state drug concentration, giving a POSA a high degree of confidence that modifying Pinchasi's schedule to a fixed three-times-per-week regimen would succeed.

Ground 3: Obviousness of Claims 1-12 under §103 over Pinchasi in view of Flechter 2002A

  • Prior Art Relied Upon: Pinchasi (WO 2007/081975) and Flechter 2002A (a 2002 clinical neuropharmacology article).
  • Core Argument for this Ground:
    • Prior Art Mapping: As in the other grounds, Pinchasi provided the 40 mg dose of GA for treating MS. Flechter 2002A disclosed a study comparing daily vs. alternate-day administration of 20 mg of GA. Flechter found that alternate-day dosing had similar efficacy to daily dosing but resulted in significantly higher patient compliance, concluding that daily injections were "unnecessary."
    • Motivation to Combine: A POSA would combine Pinchasi’s 40 mg dose with Flechter’s validated alternate-day dosing strategy. Flechter provided clear clinical evidence that less frequent dosing was not only possible but preferable for improving patient adherence. This provided a compelling motivation to apply the same principle to the 40 mg dose taught in Pinchasi, a dose already known to be safe. Modifying Pinchasi’s every-other-day schedule to a fixed three-times-per-week schedule was a minor and predictable optimization to further improve convenience.
    • Expectation of Success: Flechter’s positive results showing equivalent efficacy and improved compliance with a lower (20 mg) dose on an alternate-day schedule would provide a POSA with a strong expectation of success. It would have been a routine and predictable step to apply this successful, less-frequent dosing concept to the known-safe 40 mg dose to achieve the same benefits.
  • Additional Grounds: Petitioner also asserted that claims 1-12 are obvious over Pinchasi alone, arguing that even if not anticipatory, modifying Pinchasi’s every-other-day schedule to a fixed three-times-per-week schedule was an obvious design choice to improve patient convenience and compliance.

4. Key Claim Construction Positions

  • "comprising": Petitioner argued this transitional phrase must be given its standard open-ended meaning. This construction is central to the anticipation ground, as it allows an every-other-day regimen (which includes a week with four injections) to be read on a claim reciting "three subcutaneous injections ... per week," because the claim sets a floor, not a ceiling.
  • "per week": Petitioner contended this phrase defines a rate of administration, not a required duration of treatment. This construction means the claims do not require continuous administration over an extended period, broadening their scope to encompass methods that meet the injection rate even for a single week.

5. Relief Requested

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