Janssen Inc. v. Mylan Pharmaceuticals ULC

Drug: galantamine

In a proceeding under the NOC Regulations, the Court dismissed the proceeding on the basis that it had concluded that the relevant claims constitute unpatentable subject matter. The Court held that it did not need to address the other substantive issues raised in the NOA.

The patent claims a dosing regime with a titration schedule starting with a dose of 8mg/day, working up to 16mg and then 24mg per day.

The Court considered a number of previous cases and held that a patent claim over a method of medical treatment, covers an area for which a physician’s skill or judgment is expected to be exercised. This includes administration of a drug where a physician, while relying on the dosage advice of the patentee, would be expected to be alert and responsive to a patient’s profile and to the patient’s reaction to the compound. The Court held that by attempting to monopolize an effective titration regime for galantamine, the patent interferes with the ability of physicians to exercise their judgment in the administration of the drug. The Court also held that this is because, in theory, any physician who attempted to prescribe the drug to a patient in the manner claimed by the patent would infringe the patent.

The Court also considered the argument that the rationale of excluding methods of medical treatment from patentable subject matter should be revisited in light of the repeal of s.41 of the old Patent Act. The Court held that this exclusion remains good law in Canada because of public policy concerns. The rationale for excluding such patents is that, for ethical and public health reasons, physicians should not be prevented or restricted from applying their best skill and judgment for fear of infringing a patent covering a pure form of medical treatment, as distinct from a vendible medical or pharmaceutical product.