Date: 20080415
Docket: A-458-07
Citation: 2008 FCA 138
Present: SEXTON
J.A.
BETWEEN:
RANBAXY LABORATORIES LIMITED
Appellant
and
PFIZER CANADA INC.,
WARNER-LAMBERT COMPANY, LLC and
THE MINISTER OF HEALTH
Respondents
REASONS FOR ORDER
SEXTON J.A.
[1]
In a NOC
proceeding, the Federal Court on September 11, 2007 granted an order of
prohibition to Pfizer Canada Inc. and Warner-Lambert Company, LLC (“Pfizer et
al.”) against Ranbaxy with respect to Canadian Patent No. 2,220,018 (the
“018 Patent”) and dismissed a request for an order of prohibition with respect
to Canadian Patent No. 2,220,455 (the “455 Patent”): Pfizer Canada
Inc. v. Canada (Minister of Health) 2007 FC 898. Both patents were related
to the drug LIPITOR, an anti-cholesterol drug. The NOC proceeding results from
Ranbaxy’s application to the Minister of Health for approval to sell its drug,
Ran-Atorvastatin, into Canada.
[2]
Ranbaxy
has appealed the order with respect to the 018 Patent and Pfizer has
cross-appealed the order with respect to the 455 Patent.
[3]
The appeal
was filed on October 9, 2007 and some of the memoranda of fact and law have
been served and filed. The last one must be filed by April 29, 2008 and a
requisition for hearing must be filed twenty (20) days later.
[4]
Apotex
Inc. (“Apotex”) seeks leave to intervene in this appeal. Apotex launched its
motion to intervene on March 13, 2008, although they learned of the decision in
question in November 2007.
[5]
One of
Ranbaxy’s bases for its allegation of non-infringement was that the
intermediates purported to infringe the 018 Patent (and used to make LIPITOR)
were used in India, not Canada. Therefore, so the argument went, the Canadian
018 Patent could not be infringed. Justice Snider rejected this argument,
applying the following excerpt from the United Kingdom High Court of Justice’s
decision of Saccharin Corp. Ltd. v. Anglo-Continental Chemical Works, Ltd
(1900), 17 R.P.C. 307 (Ch.) at 319:
If the patented process were the last stage in
the production of the article sold, the importation and sale of the product
would, in my opinion, plainly be an infringement. Does it make it any the less
an infringement that the article produced and sold is manufactured by the use
of the patented process which is subjected to certain other processes? In my
opinion it does not. By the sale of saccharin, in the course of the production
of which the patented process is used, the Patentee is deprived of some part of
the whole profit and advantage of the invention, and the importer is indirectly
making use of the invention.
[6]
Apotex strenuously
disagrees with this aspect of Justice Snider’s decision, specifically arguing
that the Saccharin doctrine ought to have no application in Canada at all. However, Apotex fears
its position would not be represented by Ranbaxy, suggesting that “…Ranbaxy's
position on the appeal is extremely narrow: Ranbaxy argues that Snider J. was
only incorrect to the extent that a patent claims what can be characterized as
a chemical intermediate.”
[7]
Apotex has
been sued for patent infringement by Eli Lilly in an unrelated patent and is
scheduled to commence a 95 day trial on April 21, 2008. Apotex claims that an
issue in that trial will be affected by the decision in the present appeal.
Specifically it alleges that:
If this Court
simply rejects the statement of the law of Snider J. concerning the
extra-territorial scope of patent rights, it is certain that the entirety
of the claim against Apotex will be dismissed. If this Court departs from the
reasons of Snider J., and judicial comity is observed, the manner of assessing
Apotex's liability will change. A partial resolution of the
extra-territoriality issue by this Court, as would occur if Apotex is not
permitted to intervene, would result in Apotex being compelled to appeal its
trial decision and ask this Court to revisit the territoriality issue in a few
short months, on the basis of a misdirected or academic factual
record. [Emphasis
in original.]
[8]
Ranbaxy
takes no position on the notice to intervene by Apotex, but says the motion
should be "dealt with urgently so as not to delay the timing of the main
appeal".
[9]
Pfizer et
al. opposes the motion. Specifically they say that the legal issue raised
by Apotex has not been raised by the parties to the appeal and that Apotex, if
allowed to intervene, would be seeking to have this Court answer a legal question
which was not raised by any of the parties. They further say that this question
was not raised by Ranbaxy in its NOA nor was it addressed in the decision
below, nor is it addressed in the parties' factums in this Court.
[10]
Pfizer et
al. further argues that Apotex's participation would disrupt and delay the
appeal and that Apotex, although having known about the decision under appeal
for several months has waited until the "eve of its trial" against
Eli Lilly to bring this motion.
[11]
Contrary
to the submissions of Apotex, it is far from clear that a decision by this
Court in the NOC appeal between two parties unrelated to Apotex would absolutely
resolve the issue in the infringement action between Apotex and Eli Lilly. As a
majority of this Court stated, in Eli Lilly Canada Inc. v. Novopharm Ltd. 2007 FCA 359 (leave to appeal
refused, [2008] S.C.C.A. No. 9):
NOC proceedings were never intended to be
substitutes for an infringement action: Merck Frosst Canada Inc. v. Canada (Minister of
National Health and Welfare) (1994), 55 C.P.R. (3d) 302 (F.C.A.) at 319
(leave to appeal to the S.C.C. dismissed [1994] S.C.C.A. 330); Pfizer, supra
at paragraph 17. Similarly, it is inappropriate to rely on NOC proceedings
to set binding precedent on controversial and uncertain questions in patent law
(see Sanofi-Aventis, supra, at paragraph 49). NOC proceedings are
supposed to be summary in nature and do not lend themselves to such
determinations. [Emphasis added.]
I do not wish to be understood as commenting at all on the
proposition cited by Justice Snider. It would simply be preferable for the
larger issue squarely raised by Apotex to be determined in the litigation in
which it is presently engaged with Eli Lilly.
[12]
Indeed, if
Apotex were allowed to intervene, one would expect Eli Lilly to require the
same relief. It would be difficult for this Court to exclude Eli Lilly if
Apotex was allowed to transport the main issue in its proceeding with Eli Lilly
into this appeal. Allowing both Apotex and Eli Lilly to intervene would undoubtedly
complicate and delay the appeal, keeping in mind that there is no agreement by
the present parties to the appeal that the issue raised by Apotex is pertinent
to the appeal.
[13]
This Court
has emphasized - time and again – that NOC proceedings are intended to be
summary in nature and of short duration. Allowing intervention in NOC
proceedings should be done only in the clearest of cases and only where it is
clearly warranted. Such is not the case here. See Eli Lilly v. Novopharm
2007 FCA 329, Docket A-274-07.
[14]
For these
reasons, the application to intervene by Apotex should be dismissed with costs.
"J.
Edgar Sexton"
Email this Content