Duke University v. Biomarin Pharmaceutical, Inc.

Docket No. 2016-1106 (IPR2013-00535)

April 25, 2017


Brief Summary: FC panel modified the construction of “precursor” in claim 9 and therefore reversed and vacated/remanded the Board’s anticipation and obviousness conclusions, respectively. Obviousness conclusion regarding claim 19 also reversed because, e.g., “[t]he expert testimony relied on by the Board to bridge the gap between the disclosure in Brady and claim 19 falls short”.

Summary: Duke appealed Board decision holding claims 1-9, 11, 12, 15 and 18-21 of US 7,056,712 directed to methods for treating the genetic disorder glycogen storage disease II (“GSD-II” or “Pompe disease”) by administering recombinant human acid alpha glucosidase (“rhGAA”) to infants unpatentable for anticipation and obviousness, which the Board affirmed on rehearing as to claim 19. Independent claim 1 requires administration of a “therapeutically effective amount of human [GAA (“hGAA”)] periodically at an administration interval, wherein the human [GAA] was produced in chinese [sic] hamster ovary cell cultures” (CHO cells). Claim 9 depends from claim 1 and requires the hGAA to be “a precursor of” rhGAA “that has been produced in” CHO cells. Claim 18 requires administration “in conjunction with an immunosuppressant” and claim 19 (dependent on claim 18) requires administration of the immunosuppressant “prior to any administration of” hGAA (to prevent immune reactions against rhGAA). Independent claim 20 is similar but directed to “[a] method of treating cardiomyopathy associated with” GSD-II. In its anticipation decision, the Board disagreed with Duke that the administration amounts and intervals used in transgenic mice in the cited art (van Bree) “would not have been applicable to hGAA produced in [CHO cells] because of the difference in properties, e.g., glycosylation and phosphorylation patterns”. And regarding claim 9, the Board concluded that “ ‘precursor’ ‘encompass[es] administering both precursor and non-precursor forms of rhGAA at the same time, and [is] not limited to administering exclusively a precursor form and no other form’” and that one of the references (van Bree ‘410) teaches administration of a mixture. The Board also concluded the claims would have been obvious in view of a combination of references and “rejected Duke’s contention that a skilled artisan would have understood CHO cells to be relatively inferior source of GAA” and its above-mentioned arguments regarding the mouse/CHO cell differences. Regarding claim 9, the FC panel noted “[t]he Board did not discuss whether Reuser discloses administering exclusively a precursor of rhGAA.” The Board also “concluded that claims 18 and 19 would have been obvious” over prior art (Reuser/Van Hove/Brady) since “Brady teaches administering…immunosuppressant”. On rehearing, the Board found administration of the immunosuppressant before or after rhGAA “are predictable variations producing the same result” (dissenting APJ disagreed, concluding Biomarin did not show a teaching or suggestion of pre-rhGAA administration). The Board also found Duke failed to show a nexus between the claims and its evidence of secondary considerations (KSR, US 2007).

The FC panel agreed with the Board’s anticipation findings as to independent claims 1 and 20 but not claim 9 since, e.g., “[w]hen referring to particular forms of GAA, [the specification] does not describe administering a mixture of those forms” but only “a precursor form” that is not disclosed by the cited art. On obviousness, the FC panel explained that “[b]ecause we have modified the construction of ‘precursor,’ we do not have the benefit of the Board’s considered analysis of whether claim 9 would have been obvious under the correct construction” and therefore remanded that issue. The FC panel also agreed with Duke that the Board erred in concluding that claim 19 was unpatentable as obvious” because “[t]he expert testimony relied on by the Board to bridge the gap between the disclosure in Brady and claim 19 falls short…because it does not address what an ordinary artisan would have done or understood regarding prophylactic administration of immunosuppressants in the context of GAA enzyme replacement therapy prior to the priority date of the ‘712 patent” and “there was no evidence that ‘a high indicence of patients’ developed, or were expected to develop, ‘high antibody titers’” to the same. The Board’s determination as to claim 19 was therefore also vacated and remanded.

This entry was posted in Anticipation (35 USC 102), Claim Construction, Inter Parties Review (IPR), IPR, Obviousness. Bookmark the permalink.

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