Genzyme Therapeutics Products Ltd. Partnership v. BioMarin Pharmaceutical, Inc.

Docket No. 2015-1720, -1721

IPR2013-00534, -00537
June 14, 2016

Brief Summary: Board decision after IPR finding Genzyme’s claims invalid as obvious affirmed.

Summary: Genzyme appealed Board obviousness findings regarding its US 7,351,410 and 7,655,226 directed to methods for treating Pompe’s disease by “administering biweekly…a therapeutically effective amount of human acid alpha glucosidase, whereby the concentration of accumulated glycogen in the patient is reduced and/or further accumulation of glycogen is arrested” (‘410 claim 1; ‘226 claims include the same “whereby” clause). The Board found by a preponderance of the evidence that the challenged claims would have been obvious because the prior art “disclosed every limitation other than a biweekly dosing schedule, and that the claimed dosing schedule would have been arrived at by routine optimization” (including ‘226 claim 6 requiring a reduction in heart muscle symptoms (skilled artisan “would have understood a treatment for Pompe’s disesase would treat that condition as well”)) (“[A]ll that remained…was the determination that a specific dose within a previously suggested dose range, and its corresponding dosing schedule, would have been safe and effective.”)) The FC opinion explained that the “notice and opportunity to be heard provisions of the APA…have been applied ‘to mean that an agency cannot change theories in midstream without giving respondents reasonable notice’…and ‘the opportunity to present argument under the new theory’” (Belden, FC 2015). Genzyme argued the Board cited references in its final decision that were not specifically included in the references relied on in making the decision to institute review (two references regarding “dealing with in vivo testing” were introduced during IPR). However, the FC panel concluded that the Board did not violate this provision as the parties were “given notice of the evidence and opportunity to respond to it”. Genzyme’s argument that the Board changed its construction of the “whereby” clause in the final decision from that in the institution was also rejected, as was its argument that the “whereby” clause only referred to skeletal muscles and not elsewhere in the patient (Board’s construction proper under its broadest reasonably interpretation standard (In re Cuozzo, FC 2015) in view of the specification and prosecution history). Genzyme’s argument that the Board did not present an explicit finding as to the level of skill in the art was also rejected because “both parties proposed nearly identical language” to the Board on this point. Genzyme also argued Biomarin’s expert did not provide evidence regarding those of ordinary skill in the art because, e.g., he used the word “I” in his declaration, was “hindsight-infected”, and did not support the Board’s conclusions regarding obviousness. The FC panel disagreed on these points, finding the Board knew the expert was referring to those of ordinary skill in the art and “there was little left to do but to confirm that the strategy suggested by the various prior art references would work.” Thus, the Board decision was affirmed.

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

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