In a decision last month, the U.S. Supreme Court in a 9-0 ruling
has held that the method claims of two patents directed to
optimizing the dose of a specific drug for treating an autoimmune
disease are not patentable because they merely recite laws of
The outcome of this decision brings Canada and the U.S. to the
same end result for these types of patents (no enforceable patent),
but how we get there differs.
The U.S. Supreme Court decision reverses the Federal
Circuit's earlier rulings, which had upheld the validity of the
claims. Claim 1 of U.S. Patent 6,355,623 reads as
"A method of optimizing therapeutic efficacy for treatment
of an immune-mediated gastrointestinal disorder, comprising:
administering a drug providing 6-thioguanine to a subject
having said immune-mediated gastrointestinal disorder, and
determining the level of 6-thioguanine in said subject having
said immune-mediated gastrointestinal disorder,
wherein the level of 6-thioguanine less than about 230 pmol per
8 x 108 red blood cells indicates a need to increase the
amount of said drug subsequently administered to said subject
wherein the level of 6-thioguanine greater than about 400 pmol
per 8 x 108 red blood cells indicates a need
to decrease the amount of said drug subsequently administered to
The Court held that the claims did not do "significantly
more" than describe the laws of nature and accordingly were
not patentable. The steps in the claimed methods (apart from
the natural laws themselves) were found to involve
"well-understood, routine, conventional activity previously
engaged in by researchers in the field". The Court
expressed the view that upholding the patents at issue would
"risk disproportionately tying up the use of the underlying
natural laws, inhibiting their use in the making of further
This decision, which is perceived as a blow to the protection of
advances in personalized medicine in the U.S., is in line with more
recent Canadian jurisprudence.
In Canada, claims directed to dosage regimens have been rejected
as being directed to a method of medical treatment requiring the
application of professional skill, thus falling outside an economic
area related to trade, commerce or industry and outside of the
definition of "invention". On the basis of a different
legal reasoning, the U.S. and Canadian Courts have ultimately
reached the same conclusion.
Also, watch for a more in depth article in the upcoming Life
Sciences and Law: Current Issues 2012-2013 book available in
June 2012 online and at the BIO International Convention in
The content of this article is intended to provide a general
guide to the subject matter. Specialist advice should be sought
about your specific circumstances.
To print this article, all you need is to be registered on Mondaq.com.
Click to Login as an existing user or Register so you can print this article.
The prospect of an internal investigation raises many thorny issues. This presentation will canvass some of the potential triggering events, and discuss how to structure an investigation, retain forensic assistance and manage the inevitable ethical issues that will arise.
From the boardroom to the shop floor, effective organizations recognize the value of having a diverse workplace. This presentation will explore effective strategies to promote diversity, defeat bias and encourage a broader community outlook.
Staying local but going global presents its challenges. Gowling WLG lawyers offer an international roundtable on doing business in the U.K., France, Germany, China and Russia. This three-hour session will videoconference in lawyers from around the world to discuss business and intellectual property hurdles.
Effective September 1, 2016, the Disposition of Surplus Real Property Regulation to the Ontario Education Act was amended with the intention to reduce barriers to the formation of health and community hubs in Ontario.
This appeal relates to two generic drug submissions for two different products: exemestane and infliximab. Both submissions cross-referenced the submission of another generic company that had received a Notice of Compliance.
Two recent decisions from the Supreme Court of Canada directly affect Quebec's farm businesses by confirming La Financière Agricole du Québec's discretion in the administration of the farm income stabilization program...
On October 6, 2016, the Ontario Legislature reintroduced the Patients First Act, 2016 as Bill 41. Bill 41 is very similar to its predecessor, Bill 210, which was introduced in June 2016, but makes some important changes to the previous bill.
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).