Hospira v. Eli Lilly

Drug: gemcitabine

In this patent infringement action, the Prothonotary granted an order for the further production of documents. This order was upheld by the Trial Judge and is now the subject of the within appeal to the Federal Court of Appeal.

Hospira challenged Lilly’s evidence on the motion, arguing it should be automatically rejected because it consists of expert evidence from an employee of Lilly and lacks independence and impartiality required of an expert witness. The Court held that it was unaware of any basis for such a sweeping proposition that would have such wide ranging consequences. The Court then considered the law relating to expert evidence and held that the Prothonotary was not clearly wrong nor did she misdirect herself by assessing the evidence in light of the cross-examination and the expert opinion tendered by Hospira.

Hospira also argued that there is a presumption of veracity which attaches to its regulatory filings and that this should “raise the bar” on whether it was likely that the batch record documents sought would advance Lilly’s case, impair Hospira’s case or suggest a train of inquiry that could lead to either result. The Court held that while regulatory filings provide a basis for administrative action and, to that extent, can be taken to be true unless and until some basis for disbelieving them is made, the practical reality is that a party cannot resist production of documents in an infringement action on the basis that in a regulatory context, it has filed documents that are inconsistent with the Plaintiff’s allegations. The likelihood that the requested documents are relevant does not depend on the party’s good faith, but rather upon the content of those documents. Once Hospira conceded that the batch records at issue would constitute direct evidence of the process actually used in the manufacture of gemcitabine, the relevance is obvious notwithstanding any regulatory filings. Thus, Hospira’s appeal was dismissed.