2,209,735 – atomoxetine – STRATTERA
In the decision appealed from this in this case, Barnes J declared Eli Lilly’s patent for the use of atomoxetine in the treatment of ADHD to be invalid on the basis of lack of utility. Barnes J held that the results of the sole study conducted prior to the filing date (the “MGH Study”) “were promising but only preliminary” [113] and “interesting but inconclusive” [114], and were therefore inadequate to establish demonstrated utility based on the promise of the patent. He also held that the study could not be relied upon to support a sound prediction of utility because the study had not been referred to in the patent disclosure.
Lilly appealed, arguing that with respect to demonstrated utility, Barnes J had misconstrued the promise of the patent and had required too high a standard of proof of utility, and that with respect to sound prediction, he had erred in holding that the factual foundation of sound prediction must be disclosed in the patent [FCA 3].
On the sound prediction point, I have argued in a previous post that the requirement that the factual basis for sound prediction must be disclosed in the patent is conceptually unsound as there is no distinction in the Act between demonstrated utility and utility based on sound prediction, and that it is inconsistent with the Supreme Court decision in Wellcome / AZT 2002 SCC 77 and the cases on which the Supreme Court relied. With that said, the FCA jurisprudence is clear on this point. The FCA decision in this case affirms its own prior case law [47], and adds nothing of significance in terms of analysis of the prior cases or policy justification for the doctrine. It should be noted that in this case it is not clear whether the sound prediction would have helped the patentee; Barnes J did not consider whether the MGH Study would have supported sound prediction had it been disclosed.
I will discuss the demonstrated utility point in a subsequent post.
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