Teva Pharm. Indus. Ltd. v. AstraZeneca Pharms. LP, No. 2011-1091 (Fed. Cir.)
In a precedential opinion filed today, the Federal Circuit affirmed the invalidity of Teva's U.S. Patent No. RE39,502 under 35 U.S.C. § 102(g)(2). Teva's '502 patent claims a rosuvastatin formulation comprising "a stabilizing effective amount" of crospovidone. This post describes the district court decision and provides background on the case.
There was no dispute in this case that AstraZeneca manufactured rosuvastatin tablets falling within the scope of the '502 patent claims before Teva conceived and reduced to practice its claimed invention. Instead, the principal dispute was whether, to prove prior invention under § 102(g)(2), AstraZeneca was required to prove that it "appreciated the stabilizing effect of crospovidone in its drug formulation."
In affirming the district court's answer to that question in the negative, the Federal Circuit traced a line of cases that it said demonstrate "consistent applications of the same rule." According to the court, "[t]o establish prior invention, the party asserting it must prove that it appreciated what it had made." In other words, an "unrecognized, accidental duplication" is not a prior invention. But, the court continued, "[t]he prior inventor does not need know everything about how or why its invention worked. Nor must it conceive of its invention using the same words as the patentee would later use to claim it."
Applying the rule to this case, the court explained:
AstraZeneca had to appreciate that the [formulation] it asserted as its invention was stable and what the components of this formulation were. There is no question that AstraZeneca had this appreciation. However, AstraZeneca did not need to appreciate which component was responsible for the stabilization.
Teva made other arguments as well, but the Federal Circuit summarily disposed of them.
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