Teva Pharmaceutical Industries, Inc. v. AstraZeneca Pharmaceuticals LP, et al.


Docket No. 2011-1091

RADER, LINN, DYK
December 1, 2011

Brief summary: The FC affirmed DC grant of SJ that Teva’s claims were invalid under 102(g)(2) because of AZ’s prior invention of CRESTOR®. In its opinion, the panel explained that “[t]o establish prior invention, the party asserting it must prove that it appreciated what it had made” but need not “know everything about how or why its invention worked” or “conceive of its invention using the same words as the patentee would later use to claim it.”

Summary: Teva appealed ED PA decision that its RE39,502 patent relating to statin formulations (using an amido-group containing polymeric compound (“AGCP compound”) or an amino-group containing polymeric compound) was invalid under 35 USC § 102(g)(2) because of AstraZeneca’s prior invention of CRESTOR®. AZ’s drug is rosuvastatin stabilized by tribasic calcium and also includes crospovidone, an AGCP compound. Teva’s earliest claimed date of invention was December 1, 1999 but AZ showed it had made a 10,000-unit batch of its drug in mid-1999. While AZ “included crospovidone…as a disintegrant, but did not understand crospovidone to have a stabilizing effect”, which the DC concluded was not required to show anticipation. In this appeal, Teva argued that this was incorrect, the DC misapplied 102(b) precedent, and AZ must have suppressed or concealed its invention if it was the first to invent. The FC reviewed Dow (FC 2001; isobutane), Mycogen Plant Sciences (FC 2001; synthetic genes), and Invitrogen (FC 2005; inventors were “unaware, until too late, that they had accidentally created two genes encoding RNase H minus reverse transcriptase”), noting that each consistently apply the rule that “[t]o establish prior invention, the party asserting it must prove that it appreciated what it had made” but need not “know everything about how or why its invention worked” or “conceive of its invention using the same words as the patentee would later use to claim it.” Thus, the panel concluded that the DC was correct because while AZ “had to appreciate that the compound it asserted as its invention was stable and what the components of this formulation were”, it “did not need to appreciate which component was responsible for the stabilization.” Teva’s other arguments were rejected for similar reasons. Thus, the DC entry of SJ was affirmed.

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