Useful in the United States, But Not in Canada: Divergent Applications of the Statutory Utility Requirements


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.

Please see full article below for more information.

LOADING PDF: If there are any problems, click here to download the file.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

© Finnegan | Attorney Advertising

Written by:


Finnegan on:

JD Supra Readers' Choice 2016 Awards
Reporters on Deadline

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:

Sign up to create your digest using LinkedIn*

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.

Already signed up? Log in here

*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.