Dosage regimen invalid as a method of medical treatment

A quick... OK, long blog post on yesterday's PM(NOC) decision concerning a Janssen patent covering galantamine. Matt Dugas, who wrote this, Nathaniel Lipkus and Tim Gilbert argued the case.

On November 10, 2010, the Federal Court released its judgment in Janssen Inc. v. Mylan Pharmaceuticals ULC, 2010 FC 1123. In this Patented Medicines (Notice of Compliance) decision, Justice Barnes found that the claimed dosage regimens are, as methods of medical treatment, unpatentable subject matter.

The 950 Patent

The subject of the decision is Patent No. 2,310,950 (the “950 Patent”), which relates to galantamine. Galantamine is drug used to treat Alzheimer’s disease. The compound galantamine was known well before the 950 Patent, as was its use as a treatment for Alzheimer’s disease.

The 950 Patent claims an escalating dosage titration schedule. Specifically, the 950 Patent claims a dosage schedule where a smaller initial dose of galantamine is slowly increased to a final effective dose.

The decision

Mylan Pharmaceuticals ULC (“Mylan”) applied to the Minister of Health to obtain a Notice of Compliance for its generic version of galantamine, alleging that Janssen’s 950 Patent was invalid.

The present decision concerns the resulting Application brought under the PM(NOC) regulations. The Federal Court found Mylan’s allegation of invalidity justified on the grounds that the subject matter claimed is unpatentable as a method of medical of medical treatment, and denied Janssen Inc.’s (“Janssen”) Application for an Order prohibiting the Minister of Health from issuing a Notice of Compliance to Mylan.

Method of medical treatment

The doctrine of method of medical treatment was articulated by the Supreme Court of Canada in Tennessee Eastman Co. v. Canada (Commissioner of Patents) [1974 S.C.R. 111, 8 C.P.R. (2d) 202. There is a general distinction in the case law between vendible products on the one hand, and decisions related to the professional skill and judgment of the medical profession on the other hand. The former is patentable, the latter is not.[1]

The Federal Court’s rationale is that physicians should not be prevented or restricted by patented monopolies from applying their best skill and judgment in treatment decisions.

As it has done in the past, the Federal Court once again dismissed the argument raised by Janssen that the doctrine should be reformulated or abandoned because of the repeal of a section of the Patent Act which was partially at issue in Tennessee Eastman. Justice Barnes states: “Notwithstanding the intervening repeal of s.41, Tennessee Eastman, above, remains good law in Canada because the policy concerns it recognized continue to be valid.”

Stating that the policy concerns apply in both jurisdictions, the Federal Court also references a decision by the United States Court of Appeals for the Federal Circuit[2]. The Federal Court also sees no problem reconciling the method of medical treatment doctrine and the recent Amazon.com Inc. v. Canada and the Commissioner of Patents, 2010 FC 1011 decision on business method patents because of the policy rationale of the method of medical treatment doctrine.

The method of medical treatment doctrine applies to the dosage regimen claimed in the 950 Patent

The claims of the 950 Patent cover the dosing schedule recommended in the Product Monograph for galantamine and other sources. Janssen originally led evidence that physicians prescribing galantamine more or less rigidly follow the recommended dosing schedule, which does not involve any professional skill and judgment.

However, all of Janssen’s expert witnesses (except one expert witness who was impeached and had his testimony strongly rejected by the Federal Court) admitted on cross-examination that, while the recommended dosing schedule may be a helpful starting point, there are many examples where a physician must employ an individualized treatment approach.

The Federal Court stated that “Contrary to the affidavit evidence put forward by Janssen’s witnesses, [consideration of individualized factors] does not begin and end with the manufacturer’s dosing advice” and that “It is simply not a valid argument that, in the face of a manufacturer’s dosing recommendation, the exercise of all professional judgment by treating physicians goes out the window.” Physicians used their professional skill and judgment in selecting appropriate dosage schedules for their patients, and this process is therefore covered by the doctrine of method of medical treatment.

Other grounds of invalidity

The Federal Court did not formally address any of the other allegations of invalidity because it found the method of medical treatment analysis sufficient.

However, the decision briefly suggests that the 950 Patent may also be invalid because of either obviousness or lack of utility. Justice Barnes notes that one inventive promise of the 950 Patent was well-known prior to the 950 Patent, and that the other inventive promise relies on conclusions not supported by the evidence.

- Matthew Dugas -