Methods of Medical Treatment in Canada

Methods of Medical Treatment in Canada
Kay Palmer, June 2012

Claims directed to methods of medical treatment are considered to be directed to non-statutory subject matter and therefore are non-patentable in Canada.  While such claims are not patentable in Canada, meaningful protection for inventions relating to methods of medical treatment can be achieved in Canada.  In particular, claims to medical uses (i.e.  claims directed to “Use of X to treat disease Y” and “Use of X in the manufacture of a medicament to treat disease Y) are patentable in Canada.  In addition, composition for use claims (i.e. claims to “X for use in treatment of Y.)  are also patentable in Canada.  Accordingly, Applicants by simply re-drafting their method of medical treatment claims into medical use claims or composition for use claims may be able to obtain meaningful protection for their inventions relating to methods of medical treatment in Canada.  
 
When facing objections to non-statutory subject matter during prosecution of their applications which contain method of medical treatment claims or voluntarily re-drafting method of medical treatment claims into medical use claims a number of factors should be considered by the Applicant.  

•    Use claims which recite active steps will be objected to methods of medical treatment.  Accordingly, care must be taken when re-drafting such claims to not include active steps.  For example, language such as “is administered” should be replaced with language such as “for administration”.
•    In order to be considered a method of medical treatment in Canada, the method treats or prevents a pathological condition. Conditions, such as ageing or pregnancy, are not considered pathological and therefore methods of treating or preventing such conditions are not considered methods of medical treatment. 
•    Even if the primary or the intended purpose of the method is not to treat disease but the method results in a therapeutic benefit, the method is considered a method of medical treatment.
•     Cosmetic methods and methods of diagnosis are not considered methods of medical treatment so long as there is no therapeutic effect.  Accordingly, should an Examiner object to claims to cosmetic methods or methods of diagnosis as methods of medical treatment  because these methods include a secondary therapeutic effect, it may be possible to address such objections by amending the claims to exclude methods of medical treatment.  For example, a claim to a diagnostic method which has a secondary therapeutic effect may be amended to include the phrase “diagnostically effective amount” to exclude therapeutic methods.
•     Methods of surgery are not patentable in Canada even if there is no therapeutic effect.  For example, a diagnostic method which includes the step of removing a tissue sample may be objected to as including a surgical step.  Such objections can often be overcome by simply deleting this step.
•     A number of Canadian court decisions have found that medical use claims which include specific dosage regimes (i.e.  claims that include instructions to the medical professional  how to use the medicine by specifying a particular dosing schedule or range) were directed to methods of medical treatment and therefore unpatentable.  In particular, in Axcan Pharma Inc. v. Pharmascience Inc., 2006 FC 527 it was found that a claim directed to a pharmaceutical composition for treatment of biliary cirrhosis which specifies a particular dose (i.e.  13 to 15 mg/kg/day) is directed to a method of medical treatment and is therefore unpatentable.  In Janssen Inc. v. Mylan Pharmaceuticals ULC 2010, FC 1123), use claims which included a dose titration (e.g.  wherein the use of the first dosage from about two weeks to ten weeks results in a lower final dosage) were also found to be directed to methods of medical treatment.
•     Use claims which specify a dosage form are not considered methods of medical treatment.  In particular, the courts (in Merck & Co. v. Pharmascience 2010 FC 510 and Merck & Co. v. Apotex Inc., 2005 FC 755) have found medical use claims construed to specify a specific unit dosage taken on a fixed dosing schedule (e.g. 1mg tablet daily) are directed to a vendible product and not directed to methods of medical treatment.  Accordingly, non-statutory subject matter objections to use claims which include a specific dosage regime may be overcome by amending the claims to recite a specific unit dosage if there is sufficient support in the application for such an amendment.

In conclusion, meaningful protection to inventions relating to methods of medical treatment is possible in Canada if care is taken when drafting the application and claims.  Furthermore, this area of Canadian patent practice is still evolving and as such the expertise of a Canadian patent agent prior to entering the Canadian patent regime is strongly recommended for Applicants with inventions relating to methods of medical treatment.