• Biomarin Pharmaceutical Inc. v. Duke UniversityRehearing granted
  PTAB · Jul 14, 2015 · IPR2013-00535 · APJ Sheridan K Snedden · IPR · Rehearing

  The Board granted rehearing but again held claim 19 unpatentable as obvious over Reuser ’771, Van Hove 1997, and Brady.

  RulingsRehearing decision

  • RehearingRehearing, grantedGranted

    “In relation to Patent Owner’s contentions in this regard, we grant a rehearing to reconsider the teachings of Brady in relation to “Day 1.” Taking a closer look at the reference as a whole, we see that Brady discloses, in the paragraph discussed above, that “[t]he effort to immunosuppress the patient was initiated on July 26, 1993.” Ex. 1012, 3. Reading the entire paragraph, it is clear that July 26, 1993, corresponds to “Day 1” as presented in Table 1, i.e., the first day that the patient received both an immunosuppressant and enzyme therapy. Id. Earlier in the reference, Brady states that the “patient was admitted to NIH for periodic evaluation on January 21, 1992, 6 months after the initiation of enzyme replacement therapy.” Id. at 2 (under the heading “Clinical Course”). The reference also states that “[o]n March 19, 1993, 1 day after routine intravenous infusion of Ceredase, the patient experienced severe pain in his left shoulder . . . .” Id. Thus, we are persuaded by Patent Owner’s contentions that Brady does not disclose administering immunosuppressant prior to any and all administration of hGAA, as required by claim 19. Req. Reh’g 6. Accordingly, we now reconsider the arguments and evidence, including the aspects of Brady discussed above, and address the question of whether claim 19 is obvious over the combination of Reuser ’771, Van Hove 1997, and Brady.” slip op. at 6

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successUnpatentableMotivation foundUnpatentable

    “We agree with Patent Owner that Brady does not teach prophylactically administering an immunosuppressant under our construction of claim 19. We determine, however, that the preponderance of evidence shows that the prophylactic administration of an immunosuppressant would have been a predictable variation of the use of immunosuppressant disclosed in Brady. Brady teaches administering the immunosuppressant in an “effort to immunosuppress the patient” and to reduce neutralizing antibodies in the individual. Ex. 1012, 3 (including sections titled “Intervention” and “Reduction of Neutralizing Antibody Titer”). Dr. Pastores testifies that administration of foreign protein could lead to an immune response (Pastores Dec. ¶ 94), such as the adverse immune response seen in Brady, and that hypersensitivity to replacement enzyme may be addressed by pretreatment with antihistamines or widely used immunosuppressants such as corticosteroids (Dr. Pastores ¶ 95 (citing Ex 1011, 130)).” slip op. at 12

  • Expert testimonyPetitioner expert creditedDecided for petitioner
  § 103 obviousnesscites KSR
  Patents in suitUS 7,056,712

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