Genpharm
Inc. v. The Minister of Health and Procter
& Gamble Pharmaceuticals Canada, Inc. and The
Procter & Gamble Company
Indexed as: Procter & Gamble Pharmaceuticals Canada,
Inc. v.
Federal Court of Appeal per Rothstein J.A. (
The
PM(
If
a generic producer sells a product and infringement by anyone using the product
results, that is the infringement the Regulations are
intended to preclude.
In
the case of use claims, it is not necessary for a patentee to demonstrate that
a generic producer's actions will induce or procure patent infringement by
patients or others.
[44]In the case of a use patent, if the generic producer
sells its product and infringement results by patients using the product for a
use protected in a patent, there will be infringement of that patent for
purposes of the Regulations. The connection between the generic producer and
infringement by the patient is in the generic producer selling its product.
[45]Paragraph 55.2(4)(e) of the Patent Act, R.S.C., 1985, c. P-4 as
amended [as enacted by S.C. 1993, c. 2, s. 4; 2001, c. 10, s. 2], which
authorizes the Governor in Council to make the
Patented Medicines (Notice of Compliance) Regulations, provides that a
regulation may be promulgated dealing with circumstances in which the issuance
of a notice of compliance might result directly or indirectly in the
infringement of a patent. Paragraph 55.2(4)(e)
provides:
55.2 (1) . . .
(4) The
Governor in Council may make such regulations as the Governor in Council
considers necessary for preventing the infringement of a patent by any person
who makes, constructs, uses or sells a patented invention in accordance with
subsection (1), including, without limiting the generality of the foregoing,
regulations
. . .
(e) generally governing the issue of a notice, certificate,
permit or other document referred to in paragraph (a) in circumstances where
the issue of that notice, certificate, permit or other document might result
directly or indirectly in the infringement of a patent.
Where infringement is by a patient in the case of a use
patent, the issuance of the notice of compliance can be said to result in the
infringement of the patent, if not directly, then at least indirectly. This is
the conclusion reached by Richard J. (as he then was) in Zeneca Pharma Inc. v. Canada (Minister of National Health and
Welfare) (1995), 61 C.P.R. (3d) 190 (F.C.T.D.), at page 203. I think that
conclusion was correct and I reach the same result in this case.
[46]I think this interpretation is further supported by the
definition of "claim for the use of the medicine" in section 2 of the
Regulations:
2. . . .
"claim for the use of the medicine" means a claim for
the use of the medicine for the diagnosis, treatment, mitigation or prevention
of a disease, disorder or abnormal physical state, or the symptoms thereof.
[47]If the words of the definition are read into
subparagraph 5(1)(b)(iv), i.e. "[no] claim for
the use of the medicine for the diagnosis, treatment, mitigation or prevention
of a disease, disorder or abnormal physical state, or the symptoms
thereof", it is
apparent that the use contemplated includes use by patients. That is, medicine used for diagnosis, treatment, mitigation or
prevention of a disease, disorder or abnormal physical state, or the symptoms
thereof, must contemplate use of the medicine by a patient. The point is
that use claims
referred to in subparagraph 5(1)(b)(vi) contemplate use, not just
by the generic producer, but by
patients as well, and that infringement will result by patients using a medicine sold by a generic
producer, even if there is no inducement or procurement by the generic producer.
[48]The
scheme of the Regulations seems obvious. If a generic producer sells a product
and infringement by anyone using the product results, that
is the infringement the Regulations are intended to preclude. There is no
suggestion that the generic producer must have induced or procured patients or
others to infringe the patent.
[49]For this reason, I am satisfied that in the case of use claims, it is
not necessary for a patentee to demonstrate that a generic producer's actions
will induce or procure patent infringement by patients or others. Provided that the generic producer cannot
establish that no claim for the use of the medicine would be infringed by
patients or others by its selling of its product, it will not satisfy the
justification test in subsection 6(2) of the Regulations and a prohibition
order must be made.