Aventis v. Hospira – How to Meet the Therasense Standards
On April 9, 2012, The Fed. Cir. affirmed a holding by the district court that rendered two (then) Sanofi add-on patents on infusion vehicles for docetaxel unenforceable due to inequitable conduct. The inventors, particularly inventor/project manager Fabre, were found to have intentionally decided not to submit two material pieces of prior art to the PTO.
“Materiality” was not an issue on appeal, since the district court had invalidated the patents using the disclosures of the uncited references. Since the references were material under the “clear and convincing standard”, they had to be material under the PTO’s lower “preponderance of the evidence” standard.
The section on intent is more interesting. The references were not “knock-out” s. 102(b) disclosures of the invention, but rather were used to support invalidation based on s. 103. This left the contemporary relevance of the reference open to some debate, and both the district court and the Fed. Cir. relied heavily on the testimony of inventor Fabre who, unfortunately, testified in detail about his reasons for not submitting the references.
With respect to the “Vidal” reference, Fabre had testified that, because it reported failed experiments in using the recited surfactant for etoposide, a Sandoz drug, he did not need to send it to the PTO. However, Fabre also testified that he tried the surfactant because of what he read in the Vidal reference, and there was also an internal memo noting that Sandoz had used the recited surfactant with etoposide – apparently with success. The courts also relied on the fact that Fabre testified on direct that some of his experiments were failures but on cross, admitted that some of the experiments based on the reference were successes.
With respect to the GV reference – apparently a paper generated from the Sanofi in-house work, Fabre testified that he had only reviewed an early draft that did not contain a relevant sentence about the recited surfactant. But the court found that he had testified that he had in fact reviewed the article “with some care” and had later modified a product brochure to include a citation to the article.
While the Fed. Cir. gave weight to the fact that the trial court “did not rely solely on its finding that Fabre was not credible but instead viewed Fabre’s testimony in light of the other [documentary] evidence to reach its intent conclusion,” I can’t help but wonder if the outcome would have been different if Fabre had professed to have no recollection whatsoever of either reference, or of the non-prior art internal documents that the court used to impeach the credibility of the explanations he provided. Remember, under Therasense, the failure to offer an explanation for the failure to cite a material reference cannot per se support a finding of inequitable conduct. And the “culpable events” happened twenty years ago. Would the “other evidence” have been sufficient under Therasense? It’s likely that we will never know, but the outcome for Aventis-Sanofi and Mr. Fabre could not have been worse.