Aventis Pharma S.A. et al. v. Hospira, Inc. et al., No. 2011-1018 (Fed. Cir.)
In a precedential decision earlier this week, the Federal Circuit affirmed a district court decision holding two patents on TAXOTERE (docetaxel), U.S. Patent Nos. 5,750,561 and 5,714,512, unenforceable for inequitable conduct. The Federal Circuit also affirmed findings that claim 5 of the '561 patent and claim 7 of the '512 patent are invalid for obviousness and that claim 7 of the '512 patent is not infringed.
The decision is notable as one of the few cases--and the first Hatch-Waxman case--involving inequitable conduct that the Federal Circuit has decided since Therasense, which raised the bar for proving inequitable conduct. In addition, the decision illustrates how losing a claim construction argument can lead to losing on validity, which in turn can lead to losing on inequitable conduct.
Claim 5 of the '561 patent recites:
5. A perfusion, which contains approximately 1 mg/ml or less of [docetaxel], and which contains less than 35 ml/l of ethanol and less than 35 ml/l of polysorbate, wherein said perfusion is capable of being injected without anaphylactic or alcohol intoxication manifestations being associated therewith.
Claim 7 of the '512 patent depends from claims 1 and 6. When the claims are considered together, claim 7 effectively recites:
7. A composition comprising docetaxel, said composition being dissolved in polysorbate, said composition being essentially free or free of ethanol.
On appeal, Sanofi argued that the term "perfusion" in claim 5 of the '561 patent should have been construed to mean that the composition is effective for treatment, safe, and stable for at least eight hours. Citing its recent decision in Thorner v. Sony Computer, the Federal Circuit refused to read those limitations into the claim. And, because Sanofi's counsel conceded at oral argument that under the district court's construction of "perfusion," claim 5 was obvious over the prior art (the "GV reference" and the "Vidal reference"), the Federal Circuit affirmed the district court's judgment that claim 5 is invalid as obvious.
With respect to claim 7 of the '512 patent, Sanofi disputed the district court's construction of "essentially free or free of ethanol." But the Federal Circuit ignored that dispute because the parties agreed that the "composition" of claim 7 encompassed both stock solutions and perfusions and, according to the Federal Circuit, "Sanofi has not addressed the district court's obviousness finding with respect to stock solutions in its opening brief." The Federal Circuit therefore held that Sanofi waived any argument that the claimed stock solutions were not obvious over the prior art.
Turning to inequitable conduct, the Federal Circuit described the issues as follows:
The district court found that the Vidal and GV references were material to patentability and that inventor Fabre intentionally withheld them with the intent to deceive the U.S. Patent and Trademark Office. Based on these findings, the court concluded that the '512 patents were unenforceable for inequitable conduct. Sanofi argues that we should reverse the court's inequitable conduct judgment because Fabre explained why he did not disclose these references to the PTO and, thus, the court's finding that he acted with the intent to deceive was not the single most reasonable inference that could be drawn from the evidence. Additionally, Sanofi contends that these references were not material to patentability because they were duplicative of references that were before the PTO.
The Federal Circuit addressed materiality first, quoting from Therasense: "when a 'claim is properly invalidated in district court based on the deliberately withheld reference, then that reference is necessarily material' for purposes of the inequitable conduct inquiry." The court stated:
Here, we have affirmed the district court's finding that the '561 and '512 patents were invalid based on, inter alia, the withheld GV and Vidal references. Because such references are necessarily material to patentiablity, the district court did not err in finding that the materiality requirement was established.
Thus, a claim-construction loss led to a validity loss, which led to an inequitable-conduct loss.
Of course, inequitable conduct also requires intent to deceive, which, according to the Federal Circuit (quoting Therasense again), is shown by proving "by clear and convincing evidence that the applicant knew of the reference, knew that it was material, and made a deliberate decision to withhold it." Here, the court concluded that, even though the district court reached its decision before Therasense, "Based on the district court's thorough discussion of its factual findings and its well-reasoned analysis that is consistent with Therasense, this determination was not an abuse of discretion."
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