Recent decisions by appellate courts in Canada and the United States highlight the sharp conflict in judicial application of the statutory "utility" requirements under the patent laws of those countries. The decisions involved a U.S. patent and its Canadian counterpart claiming the method of using a known compound for the treatment of attention deficit/hyperactivity disorder ("ADHD"). In parallel litigations, generic drug manufacturers alleged that the patents were invalid for failure to disclose experimental data demonstrating the effectiveness of the claimed treatment. While the U.S. court rejected the challenge and held the U.S. patent valid, the Canadian court reached the opposite result and held the Canadian counterpart invalid. The outcome in Canada is a result of a unique interpretation of the statutory requirement that patented inventions be "useful," recently adopted by intermediate appellate courts. That interpretation is out of step with international norms for the disclosure of utility, has significant negative ramifications for pharmaceutical development, and warrants the intervention of the Supreme Court of Canada.
The patents at issue in the U.S. and Canadian litigations are directed to the use of a drug called "atomoxetine" to treat ADHD. Atomoxetine is approved by U.S. and Canadian regulatory authorities for this indication and is marketed by Eli Lilly and Company under the brand name STRATTERA. The patents contain identical disclosures, and include a specific description of how to use atomoxetine to treat ADHD, the criteria for identifying the relevant patient population, the preferred routes of administration, and the preferred daily doses.
However, the patents contain no data proving that atomoxetine is effective to treat ADHD. Because there is no in vitro or animal model of ADHD, such proof can be obtained only from clinical trials of the drug on human patients having the disease. A clinical trial of atomoxetine to treat ADHD had begun but was not completed before the U.S. patent application was filed. That trial ultimately proved successful before the filing one year later of the Canadian application.
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