The Canadian Federal Court of Appeal has recently indicated its interest in revisiting patentability of methods of medical treatment in future in a case where the issue is squarely raised. The issue has again arisen due to controversy in case law about when dosage forms and dosage regimens are eligible subject matter for patenting. In some cases, courts have considered them to be unpatentable methods of medical treatment. In the clearest case for patentability, a specific new dosage form, such as a tablet having specific mg dose can be patented if the dose is new and inventive. However, if the patent claims arguably go more toward a broad dosage range, or how a drug is to be used (eg. different time points of administration), then this may arguably be considered an unpatentable method of medical treatment. Certain Federal Court cases have held patent claims that could prevent physicians from exercising their skill and judgment in using a drug are not patentable subject matter because they cover methods of medical treatment.
This Appeal Court flagged the method of medical treatment issue in its May 4, 2015 decision in Cobalt Pharmaceuticals Company v. Bayer Inc. (2015 FCA 116). The Court stated, “The current law in this Court is that methods of medical treatment are not patentable… The provenance of this is Tennessee Eastman Co. et al. v. Commissioner of Patents,  S.C.R. 111, 33 D.L.R. (3d) 459, a decision based on former subsection 41(1) of the Patent Act, now repealed. In his blog, “Sufficient Description,” Professor Norman Siebrasse has forcefully advanced arguments of policy and logic against the current position. In my view, this calls for full consideration by this Court or the Supreme Court in a case where the issue is squarely raised on the facts.”
Separate from this case, the Canadian Intellectual Property Office has recently given patent applicants some revised guidance via its March 2015 practice notice for examination of medical use patent claims. The notice takes a less strict approach to the patentability of medical use claims relating to a dosage regimen as discussed in our firm’s article by Patricia Folkins. CIPO had previously taken the position in an earlier notice that unpatentable subject matter generally included claims relying on essential elements that were dosing schedules of any type, that specified where the treatment was to be used or that were for a specific patient population.
Since Courts, CIPO and patent applicants are having difficulty finding common ground on what is patentable in this area of practice, we agree with the Federal Court of Appeal that detailed guidance is needed from an appeal court in the near future.