T-187-95
IN THE MATTER of an application for an Order pursuant to Section
55.2(4) of the Patent Act and Section 6 of the Patented Medicines
(Notice of Compliance) Regulations.
BETWEEN:
ELI
LILLY AND COMPANY and
ELI
LILLY CANADA INC.
Applicants
AND:
NOVOPHARM
LIMITED and
THE
MINISTER OF NATIONAL HEALTH AND WELFARE
Respondents
REASONS
FOR ORDER
JOYAL,
J.:
This
case arose out of a motion brought by Eli Lilly and Company and Eli Lilly
Canada Inc. ("the Applicants"), pursuant to section 6(1) of the Patented
Medicines (Notice of Compliance) Regulations ("the NOC Regulations").
The Applicants sought an order prohibiting the Minister of National Health and
Welfare from issuing to the respondent manufacturer, Novopharm Ltd. ("the
Respondent"), notices of compliance in connection with its 500mg, 1g, and
10g powder form of the drug vancomycin hydrochloride for intravenous
administration, until after the expiration of the patent owned by the
Applicants. After closely considering the written submissions provided by the
parties and upon hearing their oral arguments, I rendered judgment in the
matter by order dated July 30th, 1997, wherein the prohibition order was
granted with respect to the 1g and 10g dosage forms and the application
dismissed with respect to the 500mg dosage form. I now give my reasons for
judgement.
I
find it unnecessary to dwell on the facts surrounding this case. It is
sufficient, in my opinion, to state briefly that as part of the procedure to
market the impugned dosage forms of the drug vancomycin hydrochloride in
Canada, the Respondent submitted to the Minister an application for a notice of
compliance, alleging that the Applicants' patent would not be infringed by the
making, constructing, using or selling of the three dosage forms. Notice of
these allegations was served on the Applicants, as well as a detailed statement
outlining the factual and legal basis of the Respondent's allegations.
The
Applicants contested the Respondent's allegations, claiming that they were
unjustified. Two arguments were submitted for the Court's consideration.
The
first one pertains solely to the 1g and 10g dosage forms. The Applicants
contend that the Respondent's allegations of non-infringement relating to these
two dosage forms are unjustified and the notices of allegations invalid, given
that the allegations are devoid of any factual basis. The Applicants are
referring here to the absence of material relating to the 1g and 10g dosage
forms in Novopharm's new drug submission, which was filed with the Minister in
order to obtain approval for the sale and advertising of the drug in Canada.
It is my understanding of the Applicants' position that for every notice of
allegation listing a specific dosage form of a given drug, the NOC
Regulations require that there be a corresponding new drug submission
containing information relating to that particular dosage. In other words, the
listing of one dosage form in the new drug submission is not sufficient to
cover all other forms.
At
the hearing of the motion, the Respondent took a different stand. Counsel
argued that since all dosage forms are prepared using the same methods and
processes, the mention of one dosage form in the new drug submission is
sufficient to comply with the requirements of the NOC Regulations. With
this proposition, I disagree. It is my interpretation of the regulatory
framework which governs the process by which new drugs are approved for sale in
Canada - that is the scheme provided for by the NOC Regulations
and the Food and Drug Regulations - that the new drug submission, notice
of allegation and notice of compliance are intimately linked. My colleague
McGillis J. states that they are "inextricably linked". What
is meant by this is that in order for a generic manufacturer to obtain a notice
of compliance for which a notice of allegation can be served on the patentee,
it is necessary to submit a new drug submission The Minister cannot issue a notice of
compliance before it is satisfied that the new drug is safe and effective. It
is the comprehensive information and materials contained in the new drug
submission which allows the Minister to reach such a conclusion. Hence, if
there is no new drug submission, there can be no notice of allegation and
furthermore, no notice of compliance can be issued.
However,
the question remains: can a reference of the medicine in one dosage form on the
new drug submission be sufficient to comply with the requirements of the
regulations and protect the other dosage forms of the product? I do not think
so. In the event that such a proposition were valid, it would be possible for
generic companies to have approval for other dosage forms of drugs for which a
notice of compliance has already been issued, this despite the fact that they
were using different methods. Not only does this pose an obvious problem for
patentees mindful of their proprietary rights, but it also potentially creates
a larger problem for the public, that is how could the Minister properly ascertain
the safety and effectiveness of a drug without the relevant information usually
set out in the new drug submission.
Finally,
if the Respondent wants to include other dosage forms in its new drug
submission, the Food and Drug Regulations already provides it with a
proper mechanism. In fact, whenever a notice of compliance is issued to the
Respondent in connection with its drug, it can avail itself of section
C.08.003(1) of the Regulations and file with the Minister a supplement
to it submissions, detailing such information pertaining to its new dosage
forms.
As
a result, it appears that in the case at bar, the Minister can only issue a
notice of compliance for the 500mg product. This leads us to the second
argument raised by the Applicants. In their originating notice of motion, they
maintained that contrary to the Respondent's assertions, their patent did
indeed have claims to the medicine itself as well as to the use of the
medicine, and that the methods used by Novopharm to make vancomycin hydrochloride
infringed their patent. However, it is interesting to note that in their
written brief, the Applicants addressed this issue only in passing.
Specifically, they asserted that their patent disclosed a formulation claim,
which claims have been held in the past to be valid claims to the medicine
itself.
The Respondent replied in turn by alleging that the claim disclosed in the
Applicants' patent is a process claim which is clearly outside the ambit of the
statutory definition of "claims to the medicine itself".
Whether
or not the Applicants' patent is truly a formulation or a process one, it is my
respectful opinion that they have not satisfied their legal burden of proof.
In proceedings of this nature, the Court always starts from the premise that
the allegations of fact in the generic company's notice of allegation are true,
except to the extent that the contrary is shown by the applicant. It is up to
the latter to prove that its patent contains a claim to the medicine itself and
that it would be infringed if a notice of compliance is issued. In the case at
bar, the Applicants have not satisfied this legal burden. Insufficient
evidence in their affidavits was adduced. On the preponderance of the
evidence, they have not proved that their patent contains a claim to the
medicine itself and that it would be infringed if the Minister issued a notice
of compliance to the Respondent.
In
any event, the case for the 1g and 10g dosage forms is not before the Court and
cannot be dealt with at this time. Thus, a prohibition order is granted for
the 1g and 10g product forms and is denied for the 500mg dosage form. As for
costs, there are no special reasons for awarding them.
L-Marcel
Joyal
_________________________
J
U D G E
O T T A W A, Ontario
August
11, 1997.
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