CA: jurisprudence récente-brevetabilité de méthode de traitement médical

Janssen Inc. v. Mylan Pharmaceuticals ULC, 2010 FC 1123, (November 10, 2010) http://decisions.fct-cf.gc.ca/en/2010/2010fc1123/2010fc1123.html

Extraits pertinents:

[26]           What I take from the above authorities is that a patent claim over a method of medical treatment that, by its nature, covers an area for which a physician’s skill or judgment is expected to be exercised is not patentable in Canada.  This would include the administration of a drug whereby the physician, while relying upon the dosage advice of the patentee, would still be expected to be alert and responsive to a patient’s profile and to the patient’s reaction to the compound.

[…]

Should the Ratio in Tennessee Eastman Be Reconsidered in Light of The Repeal of S. 41 of the Act and Having Regard to the Decision in Amazon.com, Inc. v. Canada and the Commissioner of Patents, 2010 FC 1011?

 [53]           Janssen argues that the ratio of Tennessee Eastman, above, should be revisited in light of the subsequent repeal of s. 41 of the Act – a provision which Janssen says was the foundation for the decision.  As noted above, this is an argument that has been raised before and consistently rejected in this Court.  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.  Quite apart from the problem of “evergreening”, 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).  This is a particularly obvious concern in a case like this where the ‘950 Patent effectively blocks the use of a known compound (galantamine) for an established purpose (treating Alzheimer’s disease) using a well-known treatment methodology (titration).  Indeed, the ‘950 Patent claims a monopoly over a method of treatment that, in the United States patent proceeding, Dr. Raskind and Janssen maintained was available and workable by any practicing physician who wanted use galantamine to treat Alzheimer’s disease. 

 

[54]           This situation is closely analogous to the circumstances addressed by the United States Court of Appeals for the Federal Circuit in King Pharmaceuticals, Inc. v. Eon Labs, Inc., 09-1437 (Fed. Cir. 2010).  That case involved a patent claim over the administration of a known drug (metaxalone) for a known use (muscle relaxant) and the “unexpected” finding that its bioavailability was enhanced when taken with food.  The prior art had recommended that the drug be taken with food but only as a means of reducing nausea.  The Court held that a patent was not available for the discovery of a previously unknown benefit that was inherent in the already known and practised use of the drug.  The Court stated that “[t]o hold otherwise would remove from the public a method of treating muscle pain that has been performed for decades”.  I appreciate that the principles of patent law in the United States are different from those applicable here, but that does not make the Court’s policy concern any less compelling.

 

[55]           Janssen maintains that the recent decision by my colleague Justice Michael Phelan in Amazon.com, Inc., above, concerning the patentability of business methods ought to inform my approach to the ‘950 Patent.  While I have no difficulty with Justice Phelan’s analysis in that case, it does not present a helpful legal analogy.  Indeed, Justice Phelan recognized that there are areas of discovery that, on grounds of public policy, cannot be monopolized.  The extension of patent protection over some business methodologies involves issues largely of a commercial nature and does not raise the kinds of public policy concerns that apply to the provision of medical care to patients whose lives or wellbeing may be dependent upon it. 

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