Date:
20090622
Docket:
A-373-08
Citation: 2009 FCA 212
CORAM: NADON
J.A.
LAYDEN-STEVENSON
J.A.
TRUDEL
J.A.
BETWEEN:
APOTEX INC.
Appellant
and
JANSSEN-ORTHO INC. and
DAIICHI SANKYO COMPANY, LIMITED
Respondents
and
THE MINISTER
OF HEALTH
Respondent
REASONS FOR
JUDGMENT
NADON J.A.
[1]
This
is an appeal from a decision of Shore J. dated June 17, 2008, 2008 FC 744, prohibiting
the Minister of Health (the “Minister”) from issuing a Notice of Compliance (a “NOC”)
to the appellant Apotex Inc. (“Apotex”) in respect of its levofloxacin
hemihydrate tablets until the expiry of Canadian Patent No. 1,304,080 (the “ ’080
patent”).
[2]
The
proceedings which led to the issuance of the learned Judge’s order of
prohibition were commenced by the respondents pursuant to subsection 6(1) of
the Patented Medicines (Notice of Compliance) Regulations, S.O.R./93-133
(the “Regulations”).
[3]
I
conclude that the appeal must be allowed.
THE FACTS
The
patent at issue:
[4]
The
‘080 patent which issued to the respondent Daiichi-Sankyo Company, Limited (“Daiichi”),
on June 23, 1992, discloses and claims levofloxacin, an antibiotic that treats
the most severe forms of pneumonia. The patent expires on June 22, 2009.
[5]
Daiichi
is also the owner of Canadian Patent 1,157,840 (the “ ‘840 patent”) which expired
on May 22, 2001. This patent disclosed and claimed the antibiotic ofloxacin,
which Daiichi licensed to the respondent Janssen-Ortho Inc. (“Janssen”) for
marketing in Canada.
[6]
The
only claim of the ‘080 patent which is at issue in these proceedings is claim
4, which reads:
S(-)-9-fluoro-3-methyl-10-1-piperazinyl)-7-oso-2,3-dihydro-7H-pyrido[1,2,3-de][1,4]benzoxaine-6-carboxylic
acid.
The parties
are in agreement that another name for the compound described in claim 4 is
levofloxacin.
[7]
Levofloxacin
is a chiral compound. Chiral compounds can exist in two different
three-dimensional configurations, known as enantiomers. Enantiomers have the
same two-dimensional structures, but are non-superimposable mirror images of
each other. When the two enantiomers are present in a 50-50 mixture, the
mixture is known as a racemate. In the case of levofloxacin, the racemate is
given the name “ofloxacin”. Levofloxacin’s mirror enantiomer is called
“dextrofloxacin”.
[8]
While
similar in many respects, enantiomers have different chemical properties and
may have different biological effects when administered. The disclosure of the
‘080 patent reveals that levofloxacin has reduced toxicity, increased
solubility and twice the antimicrobial activity as compared to racemic
ofloxacin. The ‘080 patent also discloses processes to make levofloxacin
substantially free of the dextrofloxacin enantiomer.
[9]
As
disclosed in the ‘080 patent, levofloxacin can exist in both hydrous and
anhydrous forms. The anhydrous form (the anhydrate), consists of levofloxacin free
from any associated water molecules. Hydrous levofloxacin (the hydrate) is
formed of levofloxacin closely associated with water molecules. Levofloxacin
hemihydrate is a type of hydrate.
[10]
Janssen
manufactures levofloxacin for sale in Canada. Apotex, a “generic”
company or “second person” under the Regulations, seeks to obtain regulatory
approval for its levofloxacin hemihydrate tablets. In accordance with section 5
of the Regulations, Apotex sent a Notice of Allegation (“NOA”) to Janssen,
alleging, inter alia, that the ‘080 patent was invalid and that even if
valid, its tablet would not infringe it.
[11]
On
September 2, 2005, Janssen and Daiichi responded to Apotex’s NOA by commencing
proceedings under the Regulations for an order prohibiting the Minister from
issuing a NOC to Apotex for its levofloxacin hemihydrate tablets until after the
expiry of the ‘080 patent.
Previous
litigation of the ‘080 patent:
[12]
The
‘080 patent has already been the subject of legal proceedings in Canada. First, in Janssen-Ortho
v. Novopharm Limited, 2004 FC 1631, 264 F.T.R. 202 (the “Novopharm
proceedings”), Mosley J. of the Federal Court considered the ‘080 patent in the
context of an application for prohibition under the Regulations brought by
Janssen in response to a NOA filed by Novopharm Limited. Mosley J. held that
Novopharm’s levofloxacin hemihydrate tablets infringed claim 4 of the ‘080
patent, but that claim 4 was invalid for obviousness. An appeal was launched to
this Court by Janssen, but it was held to be moot because the NOC had already
been issued to Novopharm by the Minister by the time the appeal was heard (see:
2005 FCA 6, 337 N.R. 259); motion for extension of time for leave to appeal to
the Supreme Court refused, 2005 SCC 33, [2005] 1 S.C.R. 776.
[13]
Second,
as a result of Mosley J.’s decision and the dismissal of its appeal by this
Court, Janssen commenced an action against Novopharm for infringement of the
‘080 patent. In Janssen-Ortho v. Novopharm Limited, 2006 FC 1234, 300
F.T.R. 166 (the “Novopharm trial”), Hughes J. found the ‘080 patent to be valid
and allowed Janssen’s action. I should point out that because Novopharm had conceded
that its product infringed claim 4 of the ‘080 patent, Hughes J. was not called
upon to make specific findings in that regard.
[14]
While
coming to a conclusion different from that reached by Mosley J. on obviousness,
Hughes J. noted that his colleague had not had the benefit of the extensive
evidence before him and that he had not had the opportunity of seeing and
hearing the witnesses who had appeared before him during the course of the
trial.
[15]
In
Novopharm Limited v. Janssen-Ortho, 2007 FCA 217 (the “Novopharm appeal”),
this Court upheld Hughes J.’s decision and found the ‘080 patent to be valid. Leave to appeal this
Court’s decision was denied by the Supreme Court of Canada, 2007 S.C.C.A. No.
442 (Q.L.).
THE DECISION OF THE
FEDERAL COURT
[16]
Because
he was of the view that “no demonstration has been made as to invalidity nor
infringement” (see: para. 203 of his Reasons), Shore J. concluded that the
respondents were entitled to an order of prohibition. In reaching that
conclusion, he made the following findings.
[17]
Shore
J. held that claim 4 of the ‘080 patent, when properly construed, must include
the hemihydrate form of levofloxacin because the patent specifically teaches,
in example 7, how to produce levofloxacin hemihydrate. Shore J. also noted that
claim 17 of the ‘080 patent includes the hemihydrate of all the compounds of
claim 2, which includes levofloxacin.
[18]
On
the issue of infringement, Shore J. concluded that Apotex’s tablets would
infringe Janssen’s ‘080 patent and, as a result, he rejected Apotex’s
allegation that its product would not infringe because the ‘080 patent did not
cover the hemihydrate form of levofloxacin. Shore J. noted that Apotex admitted
that the active ingredient in its tablets was levofloxacin hemihydrate and that
consequently, if claim 4 of the patent covered the hemihydrate, its allegation
of non-infringement could not be justified.
[19]
With
respect to anticipation, Shore J. rejected Apotex’s argument that each claim of
the ‘080 patent was anticipated by the prior disclosure of ofloxacin in the ‘840
patent. Shore J. relied on the findings made by Hughes J. in the Novopharm trial
and concluded that Apotex had not provided any evidence that would justify a
deviation from Hughes J.’s determination on this issue.
[20]
On
the question of obviousness, Shore J. rejected Apotex’s argument that the
inventors were merely verifying predictable qualities of known compounds. On
the contrary, Shore J. held that there could not have been verification because
the inventors had found unexpected and unpredictable properties of new
compounds.
[21]
In
order to analyse the question of obviousness, Shore J. determined what could be
considered as prior art, and concluded that none of the prior art references
alleged by Apotex would have led a skilled person directly and without
difficulty to the invention disclosed in the ‘080 patent, i.e., levofloxacin
and its unexpected beneficial properties. In particular, Shore J. did not
accept as prior art the “Gerster papers”, which related to a poster that
publicly disclosed the fact that the (-)- enantiomer of flumequine was the more
antimicrobially active of the two enantiomers and, thus, more active than its racemate.
Shore J. concluded that the Gerster papers did not contain sufficient
information to enable a person of ordinary skill and knowledge in the field to
understand the nature of the invention and carry it into practical use by
purely mechanical skill, without the aid of inventive genius.
[22]
Shore
J. concluded that Apotex misconstrued the promise of the ‘080 patent and the
utility of the invention. Shore J. referred to the findings of Hughes J. in the
Novopharm trial, who had found that the utility of claim 4 of the ‘080 patent
was that the (S)- or (-)- form of ofloxacin had increased antimicrobial
activity, reduced toxicity and markedly high water solubility, giving it an
expectation to be a very useful pharmaceutical agent.
[23]
Shore
J. held that the ‘080 patent was not void pursuant to subsection 30(1) of the Patent
Act, R.S. 1985, c. P-4 (the “Patent Act”), which stipulates that the
application may be deemed abandoned if the applicant fails to answer an examiner’s
requirement. Apotex argued that Daiichi had not answered the required questions
within the given timeframe, and that it had breached paragraphs 40(1)(a) and
(c) of the Patent Rules, C.R.C., c. 1250 (the “Patent Rules”), on the
basis that Daiichi had not provided the examiner with particulars of interference
proceedings or with prior art cited against the application.
[24]
With
respect to paragraph 40(1)(c) of the Patent Rules, Shore J. concluded that
there was no breach of this provision on the ground that Daiichi’s patent agent
had innocently and inadvertently failed to answer within the time prescribed only
one of the examiner’s eight questions. Shore J. noted that the patent agent did
answer the question at a later stage.
[25]
With
respect to paragraph 40(1)(a) of the Patent Rules, Shore J. concluded that
Daiichi’s patent agent had disclosed all of the prior art references cited
against the corresponding U.S. and European applications. Shore J.
appeared to accept that it was sufficient to provide the examiner with
citations to requests for prior art, and that it was unnecessary to provide the
documents themselves.
[26]
Further,
Shore J. rejected Apotex’s argument that Daiichi had breached its duty of
candour as a result of the alleged breaches of paragraphs 40(1)(a) and (c)
of the Patent Rules. Shore J. held that such a duty of candour did not exist in
Canada and that
even if such a duty were to be implied, there was nothing in the prosecution of
the ‘080 patent to suggest that the applicant had failed to act with candour
and in good faith.
[27]
Finally,
Shore J. considered whether, in the light of this Court’s decision in Sanofi-Aventis
v. Novopharm Ltd., 2007 FCA 163, [2008] 1 F.C.R. 174, Apotex had provided
“better evidence or a more appropriate legal argument” (this expression is
taken from paragraph 50 of Sanofi-Aventis, supra, to which I shall
shortly return) than that which had been offered in the Novopharm trial so as
to entitle it to challenge the prohibition proceedings brought by the
respondents.
[28]
The
learned Judge concluded that Apotex had not met the requirements set out in Sanofi-Aventis,
supra, according to which either better evidence or better legal arguments
had to be put forward in order to justify a relitigation of the same or similar
issues. As a result, the Judge concluded that it was an abuse for Apotex to
relitigate the issues which had been litigated in the Novopharm proceedings and
in the Novopharm trial.
APOTEX’S SUBMISSIONS
[29]
First,
Apotex argues that Shore J. erred in his construction of claim 4 of the ‘080
patent. According to Apotex, claim 4 simply provides an unambiguous description
of the molecule levofloxacin and resorting to the remainder of the
specification to expand or contract the scope of the claim is impermissible.
Apotex argues that Shore J. erred by departing from the text of claim 4, by
adopting a results-oriented construction of the claim and by failing to
distinguish claim 4 from the other claims in the ‘080 patent.
[30]
Second,
Apotex contends that Shore J. erred by rejecting its allegation of
non-infringement. Apotex argues that there can be no infringement if its
construction of claim 4 is correct, i.e. if the claim does not cover the
hemihydrate form of levofloxacin.
[31]
Third,
Apotex says that Shore J. erred by concluding that the ‘080 patent was not
invalid for anticipation. According to Apotex, the properties of levofloxacin
and the process to make it are irrelevant in an analysis of anticipation.
Furthermore, Apotex submits that since Shore J. held that the ‘840 patent
discloses ofloxacin as a compound that contains levofloxacin, the ‘840 patent
also necessarily disclosed levofloxacin to the skilled addressee. In fact,
Apotex argues that the evidence clearly established that skilled addressees
knew the techniques available to resolve enantiomers from racemic mixtures and
that since Shore J. did not refer to this evidence, he must be taken to have
ignored it. Apotex also contends that Shore J. appeared to have decided the
question of anticipation by adopting the decision of Hughes J. in the Novopharm
trial, instead of deciding the question based only on the evidence adduced
before him.
[32]
Fourth,
Apotex submits that Shore J. erred by failing to assess the ‘080 patent as a
selection patent. According to Apotex, the ‘080 patent purports to be a
selection patent, but it fails to meet the test for one because levofloxacin
does not possess special, substantial and unobvious advantages over ofloxacin
and because no advantages are properly disclosed. In particular, Apotex argues
that Shore J. made palpable and overriding errors in his appreciation of the
record with respect to the level of activity, the toxicity, and the solubility
of levofloxacin as compared with ofloxacin. Apotex also contends that Shore J.
incorrectly stated that Novopharm had unsuccessfully made the same argument in
the Novopharm trial when, in fact, Hughes J. had not analysed the ‘080 patent
as a selection patent in that decision.
[33]
Fifth,
Apotex says that Shore J. erred by concluding that the ‘080 patent was not
invalid for obviousness. Apotex argues that Shore J. made a number of palpable
and overriding errors in his appreciation of the record and, in particular,
that he failed to properly appreciate the evidence before him when he concluded
that Daiichi’s competitors were not motivated to separate the enantiomers and
that Daiichi had taken four years to accomplish the separation. To the
contrary, Apotex submits that the evidence suggests that Daiichi’s competitors
were indeed motivated to resolve ofloxacin and that during most of the
four-year period, Daiichi was doing no work to resolve the enantiomers. Apotex
also submits that Shore J. adopted the conclusions of Hughes J. in the
Novopharm trial, even though the record before Shore J. could not lead him to
the same conclusion. In addition, Apotex argues that Shore J. assessed
obviousness on the wrong date, prior to the date of invention, and that this
prevented him from considering various pertinent pieces of prior art, including
the Gerster 1985 poster.
[34]
Sixth,
Apotex submits that Shore J. erred in failing to find that the application for
the ‘080 patent was deemed abandoned. According to Apotex, Shore J. erred in
concluding that answering 7 out of 8 requirements was sufficient to advance the
application and in concluding that an innocent or inadvertent failure excuses
an applicant from responding within the required delay. In fact, Apotex
contends that such reasons for not responding to a requirement are not
stipulated in the Patent Rules. Apotex also argues that Shore J. erred in
holding that there was no applicable duty of candour or good faith, when the
case law confirms that there is.
[35]
Finally,
Apotex submits that Shore J. erred in applying the test for abuse of process.
According to Apotex, Shore J. applied an extreme form of estoppel that
prevented it from having a fair hearing, and that, in effect, meant that the
Novopharm trial defined its rights for all purposes. In particular, Apotex
contends that Shore J. should not have required it to lead better evidence than
in the Novopharm trial, given that neither Apotex nor Shore J. had access to
the evidentiary record in that case. In addition, Apotex contends that the
burden of proof was different in the Novopharm trial: Novopharm had the burden
of proving invalidity, whereas in this case, it is the respondents who had the
burden of proving that Apotex’s allegations were not justified. Apotex submits
that since it is a first time litigant of the ‘080 patent, it should not have
been required to meet a higher burden of proof, and that it is the respondents
who should be barred from litigating against Apotex the issues which they have
already litigated against Novopharm on two occasions.
THE ISSUES
[36]
The
appeal raises the following issues:
1.
Did
Shore J. err in his construction of claim 4 of the ‘080 patent?
2.
Did
Shore J. err in holding that Apotex’s marketing of its levofloxacin tablets would
infringe claim 4 of Janssen’s ‘080 patent?
3.
If
Shore J. did not err in his conclusions on infringement, did he err in concluding
that the ‘080 patent is not invalid? In particular, did Shore J. err in concluding
that the patent is not invalid on the following bases: (a) Anticipation; (b) Obviousness;
(c) Should Shore J. have analysed the ‘080 patent as a selection patent and
found that it was an invalid selection patent?
4.
Did
Shore J. err in concluding that the ‘080 patent is not void for abandonment?
5.
Did
Shore J. err in applying the test for abuse of process?
ANALYSIS
[37]
For
the reasons that follow, I need only address the issue of abuse of process. I
have already set out the submissions made by Apotex on this issue. The
respondents, not surprisingly, do not agree with Apotex’s position. They say
that Shore J. correctly applied the test for abuse of process and that the
arguments raised on this issue
by Apotex have already been weighed and considered by this Court against the
interest in avoiding inconsistent results that threaten the integrity of the
administration of justice. The respondents contend that Shore J. was entitled
to decide issues of fact with reference to the findings in prior court
decisions, such as the decision of Hughes J. in the Novopharm Trial. In
addition, the respondents contend that the evidence from the Novopharm Trial
was publicly available but Apotex made no effort to introduce it. The
respondents also dispute Apotex’s argument that only the results of prior
proceedings under the Regulations should be considered for abuse of process,
and not the results of an action, because the burden on the generic in an
action on invalidity is more onerous. The respondents submit that this argument
disregards the effect on the administration of justice.
[38]
In
my view, the learned Judge clearly erred in concluding, as he does at paragraph
205 of his Reasons, that “the Court does agree with the applicants’ argument on
the abuse of process”. Specifically, the Judge agreed with the respondents’
submissions that because the validity of the ‘080 patent had already been
determined by the Federal Court in the Novopharm trial and by this Court in the
Novopharm appeal, Apotex’s attempt in these proceedings to contest the validity
of the patent as a selection patent was simply an attempt, under the guise of
differently-cloaked arguments, to relitigate the issues which had been litigated
in the Novopharm trial and in the Novopharm appeal. Since most, if not all, of
the arguments made by Apotex in these proceedings had been considered and dealt
with by the Federal Court and this Court, there was simply no basis for
allowing Apotex to contest the validity of the ‘080 patent unless it had either
“better evidence or a more appropriate legal argument”.
[39]
In
determining whether Apotex’s conduct in sending a NOA to the respondents and in
contesting their application for prohibition constitutes an abuse of process,
Shore J. considered this Court’s decision in Sanofi-Aventis, supra. On
the basis of that decision, he found that a second person challenging a patent on
grounds similar to those put forward in a prior litigation by another generic had
to establish, as a condition precedent to the pursuance of its case, that it
had either “better evidence or a more appropriate legal argument” to offer than
that offered in the previous litigation.
[40]
In
Sanofi-Aventis, supra, Sexton J.A., writing for the majority, made the
following remarks at paragraph 50 of his Reasons:
[50]
Finally, Sanofi-Aventis and Schering argue that a finding of abuse of process
in this case will lead to unfairness. They say that while first persons will
not be permitted to defend against allegations by subsequent generics after the
same allegation made by an earlier generic has been found to be justified,
subsequent generics will be permitted to repeat allegations already made
earlier by other generics even if the earlier allegations were found to be
unjustified. However, there is no unfairness in this scenario. All parties are
held to the same standard: they must each put forward their entire case,
complete with all relevant evidence, at first instance. The innovator is
prevented from relitigating an issue already decided in a proceeding to which it
was a party with the aid of additional evidence it chose not to adduce in the
earlier proceedings. Generics likewise must put forward their full case at the
first opportunity. Multiple NOAs issued by the same generic relating to a
particular drug and alleging invalidity of a particular patent will generally
not be permitted, even if different grounds for establishing invalidity are put
forward in each. However, where one generic has made an allegation but has
failed to put forward the requisite evidence and argument to illustrate the
allegation is justified, it would be unjust to preclude a subsequent generic,
who is apprised of better evidence or a more appropriate legal argument, from
introducing it. Although this situation may give rise to the possibility of an
inconsistent result, this concern is overridden by the potential for unfairness
to the generic that is barred from bringing forward its case simply because
another generic’s approach was inadequate. In each situation, it is necessary
to balance the effect of a proceeding on the administration of justice against
the unfairness to a party from precluding it from bringing forward its case.
[Emphasis added]
[41]
This
is the paragraph on which the Judge specifically relies for his view on abuse
of process in the present matter. It is also the paragraph on which the
respondents rely in making their submissions on abuse of process. It is
important to note that in Sanofi-Aventis, supra, the issue was whether a
first person (Sanofi-Aventis), which had failed to establish in a prior NOC proceeding
against a different generic company (Apotex) that an allegation of invalidity found
in the NOA was not justified, abuses the NOC process by seeking to relitigate
the same allegation of invalidity when made by a second generic company (Novopharm).
[42]
In
Sanofi-Aventis, supra, the question of abuse of process arose by reason
of paragraph 6(5)(b) of the Regulations, which provides that on a motion
by a second person, the Federal Court may dismiss an application for prohibition
on the ground that it is redundant, scandalous, frivolous or vexatious, or that
it is otherwise an abuse of process.
[43]
In
this appeal, however, the question is not whether the first person’s
application constitutes an abuse of process, but rather whether the second
person’s allegations found in its NOA amount to an abuse of process. Paragraph
6(5)(b) of the Regulations clearly does not apply in the present matter and
this Court is not asked to dismiss an application for prohibition on a motion
brought by a second person. There can be no doubt that Sexton J.A.’s comments
in Sanofi-Aventis, supra, were made in obiter and, thus, are not
binding and, in any event, they do not support the position adopted by the
Judge.
[44]
In
my view, a fair reading of paragraph 50 of Sexton J.A.’s Reasons in Sanofi-Aventis,
supra, does not lead to the conclusion that a second person can only put
forward a NOA on grounds similar to those put forward by a different generic in
other proceedings when it has better evidence to offer or better legal
arguments to make. I believe that at paragraph 50 of his Reasons, Sexton J.A.
was simply attempting to explain his view that notwithstanding the possibility
that different judgments might be rendered with respect to identical or similar
NOAs, fairness required that a generic, such as Apotex in the present case, which
had not yet litigated the issues which it raised in its NOA, be allowed to have
its day in court. In my view, it cannot be seriously argued that Sexton J.A. was
advocating that an assessment of the second generic’s evidence and legal
arguments had to be made before it could send its NOA and respond to the
application for prohibition.
[45]
I
am therefore satisfied that nothing said in our decision in Sanofi-Aventis,
supra, supports the Judge’s conclusion that a second person, unless it is
in a position to show that it has “better evidence or a more appropriate legal
argument”, cannot send a NOA to a patentee and, hence, respond to the
patentee’s application for prohibition on grounds similar to those put forward
by a different generic in other proceedings with the same patentee. I therefore
conclude that the Judge erred in concluding as he did on the issue of abuse of
process.
[46]
Consequently,
although Shore J. erred in his understanding of this Court’s opinion in Sanofi-Aventis,
supra, the question which must now be answered is whether his error
warrants our intervention. In other words, was the Judge’s assessment of the
evidence before him tainted by his mistaken view on abuse of process?
[47]
Because
there was no abuse of process on the part of Apotex, the Judge was required to
assess the evidence put before him by both parties independently of the
findings made by Hughes J. in the Novopharm trial. I therefore turn to that
question. Before answering it, however, it is worth repeating the arguments
which Apotex makes in support of its assertion that the Judge erred in applying
the test for abuse of process and that, as a result, this Court must intervene.
[48]
Reduced
to its essentials, Apotex’s position is that this was the first time that it
raised the issues which are now before the Court and that, as a result, it was
entitled to a fresh determination by the Judge of these issues on the evidence
before him, which determination had to be made irrespective of the findings made
and conclusions reached by Hughes J. in the Novopharm trial. Thus, it submits
that it did not have a fair hearing and that its fate was determined by the
Novopharm trial.
[49]
Contrary
to my colleague Madam Justice Layden-Stevenson, I am unable to conclude, as she
does, that the Judge conducted an enquiry with respect to the issues before
him, namely, claim construction, anticipation and obviousness, distinct from
his analysis on abuse of process. Although the Judge purports to make findings
of fact, I am uncertain as to the nature of these findings. Is he making truly
independent findings or is he making findings in accordance with those made by
Hughes J. in the Novopharm trial? Is he of the view that Apotex, in order to
succeed, was bound to adduce evidence that was better and to muster more
appropriate legal arguments than what had been adduced and submitted by
Novopharm in its litigation?
[50]
I
am led to this conclusion in great part by the difficulty which I have had in
understanding the Judge’s Reasons. I therefore propose to review the Judge’s
Reasons to highlight that difficulty.
[51]
The
learned Judge expressly considered abuse of process and whether Apotex had
provided “better evidence or a more appropriate legal argument” than had been
provided in the Novopharm trial and the Novopharm appeal, both at the beginning
of his analysis and subsequently at the end thereof. The Judge also appears to
have had in mind the principles of abuse of process throughout the entire
course of his Reasons.
[52]
Commencing
at paragraph 40 of his Reasons, under the heading “Abuse of Process
Consideration”, the Judge sets out the principle established by this Court
in Sanofi-Aventis, supra. Following that, he sets out, under the
sub-heading “Better evidence”, the parties’ respective arguments as to
whether Apotex has submitted better evidence than that which was before Hughes
J. in the Novopharm trial. And then, under the sub-heading “More appropriate
legal argument”, he sets out the “novel legal arguments” which Apotex
submits that it has to offer in the present proceedings. He also sets out the
respondents’ response thereto.
[53]
Then,
after having listed the witnesses, both expert and factual, who appeared before
him, the Judge turned to the issue of claim construction. He states at
paragraph 62 of his Reasons that all court decisions which have considered
claim 4 of the ‘080 patent have construed it “in a way consistent with Justice
Hughes’ construction [in the Novopharm trial]”.
[54]
At
paragraphs 63 and 64 of his Reasons, the Judge cites extensively the
construction of claim 4 arrived at by Hughes J. in the Novopharm trial. He concludes
on this issue by saying at paragraph 70 of his Reasons:
[70]
Recognizing the decision of Justice Hughes and the subsequent agreement
of that decision voiced in the Federal Court of Appeal judgment, presided by
justice Karen Sharlow, claim 4 is construed as not placing any limitations on
whether the compound is hydrated and to what degree:
S(-)
Ofloxacin, different from that contained in the racemate, obtained in a
reasonably pure state.
[Emphasis added]
[55]
I
am unable to understand the exact meaning of paragraph 70 of Shore J.’s
Reasons. As I have a similar problem in regard to his reasons with respect to
the other issues which were before him, I will continue my outline of his
Reasons and then, at the end of this exercise, will state the reasons which
lead me to conclude as I do that his assessment of the evidence was tainted by
his misunderstanding of the concept of abuse of process.
[56]
After
his analysis of claim construction, the Judge turned to the issue of
infringement, under the heading “Is Apotex’ allegation of infringement
justified?”. This part of his Reasons runs from paragraph 71 to paragraph
83, which he conducts as follows at paragraphs 82 and 83:
[82]
Justice Hughes concludes in the Novopharm Trial that the ‘840 patent
did not contain any direction that the enantiomers of ofloxacin would be more
active than the racemate nor does it instruct the reader as to how to effect
such separation or to produce an enantiomer. (Novopharm Trial, above
as described in para. 104).
Conclusion
[83]
The Court concludes that Apotex’ 250 mg, 500mg and 750 mg tablets would
infringe Janssen’s ‘080 patent.
[57]
After
his analysis of infringement, the Judge turned to the issue of invalidity under
the heading “Are Apotex’ allegations of invalidity justified?”. This
part of his Reasons commences at paragraph 84 and concludes at paragraph176. Here,
the Judge deals with the issues of anticipation and obviousness at paragraphs
87 to 104 and at paragraphs 105 to 176 respectively.
[58]
With
respect to anticipation, after reviewing the arguments and the evidence, the Judge
concludes at paragraphs 103 and 104, in the following terms:
[103] Justice
Hughes determined, in the Novopharm Trial:
[104]
Neither the ‘840 patent nor the publication contain any direction that the
optical isomers of Ofloxacin would be more active than the racemate nor do
either instruct the reader as to how to effect such separation or to produce an
[enantiomer].
…
[108] The
Supreme Court test requires that the “flag” be planted at the point of the
claimed invention and that the direction as to how to arrive at that point must
be so clear such that an ordinary person skilled in the art would in every
case, without possibility of error, be led to that point. No such flag is
planted and no such direction is given in either the ’840 patent or the Daiichi
publication. There is no anticipation of what is claimed in claim 4 of the
Patent.
[104]
Apotex has not provided this Court with any evidence that would justify a
deviation from Justice Hughes’ determination on this issue. Consequently, there
is no anticipation of what is claimed in claim 4 of the ‘080 patent.
[59]
There
can be no doubt that the judge simply adopted Hughes J.’s findings in the
Novopharm trial regarding anticipation.
[60]
The
Judge then turned to obviousness. In the course of his discussion of that
issue, he determined whether claim 4 was inventive and constituted a valid
claim. At paragraph 170, he made the following remarks:
[170]
In the Novopharm Trial, Justice Hughes held that claim 4 of the ‘080
patent was inventive and a valid claim. His decision was upheld on appeal. In
this application, the same issue is being raised along with the same prior art
references and substantially the same evidence.
(Novopharm
Trial, above at paras. 109-115; Novophann Appeal, above at paras. 23-45; Sanofi-Aventis
v. Novopharm, above at para. 50, Eli Lilly, 2007 FC 596, above at 238-239.)
[61]
The
learned Judge’s final paragraph on obviousness is paragraph 176 and it reads:
[176]
Based on the foregoing, this Court finds that the Respondent has failed to
establish that claim 4 is invalid on the basis of obviousness or lack of inventive
ingenuity. Consequently, the ‘080 patent was not obvious.
[Emphasis added]
[62]
At
paragraphs 177 to 187, the Judge dealt with a different issue, namely, whether
the claims were broader than the invention made and whether they lacked sound
prediction. He concludes on that issue as follows, at paragraph 187:
[187]
Apotex misconstrues the promise of the ‘080 patent and the utility of the
invention. Apotex states in its NOA that the “reported in vitro
antimicrobial testing was but a single test relied upon in an attempt to
predict levofloxacin's utility - that it would be a very useful pharmaceutical
agent as compared with ofloxacin"; however, the ‘080 patent merely states
that it is "expected" that levofloxacin will be a very useful
pharmaceutical agent as compared to ofloxacin. Justice Hughes eloquently
summarized the utility of claim 4 in the Novopharm Trial:
[126]
…What the Patent asserts, at the end of the day, is set out at page 2. The
S(-) form of Ofloxacin has increased antimicrobial activity, reduced toxicity
and markedly high water solubility, giving it an expectation to be a very
useful pharmaceutical agent. This statement is correct. To even find this
distribution of attributes, namely, more of the beneficial properties and at
least no more of the detrimental, was itself remarkable.
[63]
Finally,
at paragraphs 203 and 204 of his Reasons, the Judge comes to a crucial
conclusion with regard to the issues which he has dealt with in the course of
his Reasons:
[203]
Subsequent to all considerations, on every issue raised, in this NOC
proceeding, no demonstration has been made as to invalidity nor infringement. Recognition
is given to the previous Federal Court Trial and Federal Court of Appeal
proceedings that had, in effect, exhausted all analysis of the asserted ‘080
patent claims. No better evidence, nor more appropriate legal argument, has
been submitted in the present proceeding.
[204]
The Applicants are thus granted the prohibition order for which they applied.
[Emphasis added]
[64]
It
would appear that by reason of this conclusion, all analysis had been
exhausted, the respondents having been granted the order sought. Unexpectedly,
however, the Judge then moves on a new subject entitled “Abuse of Process
Analysis and Conclusion”. I say unexpectedly because by then, as I have
just indicated, the Judge has granted the remedy sought by the respondents and
has indicated that the principle enunciated in Sanofi-Aventis, supra, has
not been met.
[65]
At
paragraph 205, the Judge says that he agrees with the respondents’ submissions
on abuse of process and then states at paragraph 210:
[210]
Subsequent to the Federal Court of Appeal having disposed of this matter in direct
regard,
the resulting precedent from the Court of higher instance concludes the matter
for this Court.
[66]
I
have reproduced those paragraphs of the Judge’s Reasons which, in my opinion, shed
greater light on his reasoning. In other words, these paragraphs bear greater
importance in determining whether his reasoning was tainted because of his
mistaken view on abuse of process. In fact, in the course of his Reasons, the
Judge refers on no less than 43 occasions to the decision and opinion of Hughes
J. in the Novopharm trial. I am not saying nor suggesting that the number of
references per se is the determining factor. However, when I read the
Judge’s Reasons as a whole, I am left in considerable doubt as to whether he in
fact conducted an assessment of the facts independent of that made by Hughes J.
in the Novopharm trial.
[67]
As
I have already indicated, at paragraph 203 of his Reasons, immediately
following what could be characterized as his analysis of the merits of the
case, the Judge states in unequivocal terms that Apotex has not led better
evidence nor has it put forward stronger legal arguments than what had been put
before Hughes J. in the Novopharm trial. This conclusion seems to suggest that
the Judge, in assessing the evidence before him, was attempting to determine
whether the evidence led by Apotex was such so as to allow him to reach a
conclusion different from that reached by Hughes J. in the Novopharm trial. The
considerable number of references to both Hughes J.’s findings and conclusions
provide, in my view, strong support for the argument that the Judge did not
make findings independent of those made by Hughes J. If he did so, that is not
sufficiently apparent, in my respectful view, from his Reasons.
[68]
It
is also remarkable that notwithstanding the fact that at paragraph 204 of his
Reasons, the Judge grants the prohibition order sought by the respondents, he then
continues his analysis by engaging once again in a discussion regarding abuse
of process. After his conclusion that the prohibition order was granted, one
would have expected the Judge to simply set out his order and deal with the
issue of costs. This discussion of abuse of process appears to be, with all due
respect, totally irrelevant. As I understand the Judge’s Reasons, this
discussion does not lead to any conclusion other than the remarks found at paragraph
247:
[247]
Viewed as a whole, the “new evidence” concerning inventive ingenuity is no more
than conflicting evidence or a repetition of the evidence before Justice
Hughes. As stated above, where the “better evidence” in the second case can be
capable of different interpretations, it does not meet the standard set for
when a second case can be considered in the face of opposite findings in the
first case. The Apotex evidence, at its highest, is capable of different
interpretations. In such a case “it would be far preferable to observe the
witness at trial”. (Sanofi-Aventis v. Novopharm, above at para. 39; Pfizer
v. Novopharm, above at para 55.)
[69]
In
other words, as the Judge has clearly indicated at paragraph 203 of his
Reasons, when he says “No better evidence, nor more appropriate legal argument,
has been submitted in the present proceeding”, that the requirements set out in
Sanofi-Aventis, supra, have not been met, it is difficult to understand
what the purpose of the further discussion is. In my respectful view, it makes
the Reasons that more difficult to understand.
[70]
To
sum up, I have read the Judge’s Reasons on numerous occasions. On each
occasion, I have attempted to understand the rationale behind his Reasons so as
to determine whether he conducted an assessment of the evidence independent of
that made by Hughes J. in the Novopharm trial. As I am unable to so conclude, I
am inevitably led to the view that the Judge’s misunderstanding of the
principles set out in Sanofi-Aventis, supra, has tainted his assessment
of the evidence before him. Formulated in another way, it is my view that the
Judge did not conduct a parallel enquiry, but an enquiry which co-mingled the
evidence before him and the findings made by Hughes J. in the Novopharm trial.
[71]
In
the circumstances, it is my view that it would be preferable for the matter to
be returned to the learned Judge for redetermination of the issues in
accordance with these Reasons.
[72]
Before
concluding, I wish to address one additional matter.
[73]
In
its written submissions and before us at the hearing of the appeal, counsel for
Apotex drew out attention to the fact that a minimum of 90 paragraphs from the
Respondents’ Memorandum filed at first instance had been reproduced verbatim by
the Judge in his Reasons. In fact, upon verification, the Judge reproduced
verbatim, without so saying, approximately 100 paragraphs, including many of the
headings, the underlining, the footnotes and the references to the evidence.
[74]
I
am somewhat troubled by this, as the matters in respect of which the Judge
reproduced verbatim the Respondents’ Memorandum concern all the key issues
before him and, in particular, anticipation and obviousness. These include a
substantial portion of the Judge’s findings with regard to the evidence given
by the expert witnesses.
[75]
This
state of affairs has led Apotex to say that the Judge did not fully consider
the evidence that it put before him.
[76]
For
example, paragraphs 146 to 175 of the Judge’s Reasons, which deal with whether
the properties of levofloxacin were beneficial, surprising and unexpected, are
a verbatim reproduction of the Respondents’ Memorandum at first instance. Another
noteworthy example is the abandonment issue, where the Judge, at paragraphs 188
to 202, deals with paragraphs 40(1)(a) and (c) of the Act. Every
single paragraph of the Judge’s Reasons is taken verbatim from the Respondents’
Memorandum at first instance.
[77]
It
would, in my respectful view, be advisable for a judge who intends to adopt a
substantial part of a party’s written submissions to say so explicitly. Where a
judge is confronted with a complex factual case such as the one before us, the
adoption of a party’s written submissions without an acknowledgment may lead to
the impression that the judge has not done the work which he is called upon to
do, namely, to examine all of the evidence before him and to make the
appropriate findings.
[78]
One
must bear in mind that when parties file written submissions, they do not have
to make allowances for the other side’s case. Specifically, parties tend to
maximize the strong points of their case and to minimize their weaknesses. It
is up to the Judge, after careful consideration of all the evidence and the
arguments, to draw the line at the appropriate place.
[79]
I
am not prepared to conclude, nor is there any basis to so conclude in this
matter, that the Judge did not perform his duty to examine the evidence as he
was called upon to do. Although the Judge erred by reason of his
misunderstanding of our decision in Sanofi-Aventis, supra, this error
cannot, in any way, support an argument that the Judge did not perform his
duty.
DISPOSITION
[80]
For
these reasons, I would therefore allow the appeal with costs, set aside the
Judge’s judgment and remit the matter back to him for redetermination on the
basis that there was no abuse of process on the part of Apotex in making the
allegations found in its NOA and in contesting the application for a
prohibition order commenced by the respondents. I would also instruct the Judge
to assess the evidence before him independently of any findings made by Hughes
J. in the Novopharm trial. With respect to the proceedings in the Federal
Court, I would make no order as to costs.
“M.
Nadon”
“I agree.
Johanne Trudel J.A.”
LAYDEN-STEVENSON
J.A. (Dissenting Reasons)
[81]
I
have read the reasons of my colleague and I agree, for the reasons given by
him, this Court’s decision in Sanofi-Aventis does not stand for the
proposition that, unless a second person is in a position to show it has
“better evidence or a more appropriate legal argument”, it cannot send a NOA to
a patentee and respond to the patentee’s application for prohibition on grounds
similar to those put forward by a different generic in other proceedings with
the same patentee. It necessarily follows that the applications judge erred in
concluding as he did on the issue of abuse of process.
[82]
There
are additional reasons why the abuse of process conclusion cannot stand. The
issue of whether claim 4 of the '080 Patent encompassed both anhydrous and
hydrous forms of levofloxacin had not been previously litigated. As well,
Apotex’s allegation that the '080 Patent was deemed abandoned during
prosecution had not been raised before. Although, in the end, both allegations
were found to be not justified, advancing them could not and should not have
been regarded as an abuse of process.
[83]
I
also agree with my colleague’s observations regarding the inappropriateness of
an adoption by the judge of a party’s written submissions without a formal
acknowledgement to that effect. I endorse and adopt my colleague’s comments in
this respect. However, Apotex specifically renounced any suggestion of mala
fides on the part of the judge and it did not advance any ground of
appeal or specific allegation of error in this regard. The reasons for
judgment comprise 250 paragraphs. As noted by my colleague, there is no basis
to conclude that the applications judge “did not perform his duty to examine
the evidence as he was called upon to do.” In the circumstances, I am not
prepared to attach undue weight to this factor.
[84]
Although
I agree with my colleague that the applications judge erred in concluding as he
did with respect to the issue of abuse of process, with respect, I do not agree
that Justice Shore’s
findings regarding anticipation and obviousness were tainted by the abuse of
process issue. As I read his reasons, the applications judge conducted
parallel inquiries. That is to say, his analyses regarding anticipation and
obviousness were distinct and separate from his analysis on abuse of process.
[85]
In
relation to both anticipation and obviousness, the applications judge addressed
the allegations, analysed the evidence as he saw it, had regard to the legal
arguments, and arrived at his conclusions. He did so without reference or regard
to whether the Apotex NOA constituted an abuse of process. In each instance, after
delineating his conclusions on anticipation and obviousness respectively, he
turned to the question of abuse of process in relation to each of them. His
comments regarding abuse of process were in addition to his previous
conclusions. While the abuse of process issue related to, at least in part,
the anticipation and obviousness determinations, the analyses of the
anticipation and obviousness issues yielded stand-alone conclusions unrelated
to the abuse of process issue. In my view, the applications judge’s commentary
on abuse of process had no effect on his earlier, independent determinations
regarding anticipation and obviousness. Consequently, I do not share my colleague’s
view that the latter were tainted by the former.
[86]
Apotex
argues that the applications judge erred in construing the claim in issue and was
guilty of factual errors and oversights in relation to anticipation,
obviousness and valid selection. Claims construction is a question of law
reviewable on a standard of correctness: Whirlpool Corp. v. Cameo Inc.
(2000), 9 C.P.R. (4th) S.C.C.) (Whirlpool). In all other respects,
Apotex must transcend the test articulated in Housen v. Nikolaisen,
[2002] 2 S.C.R. 235. A standard of palpable and overriding error applies to
findings and inferences of fact as well as to questions of mixed fact and law
unless it is clear the applications judge made an extricable error in principle
with respect to the characterization of the law, or its application, in which
case the error may amount to an error of law and the standard of correctness
would apply.
Claims Construction
[87]
I
do not find any error on the part of the applications judge regarding his
construction of the claim. Apotex submits that the applications judge adopted
a “results-oriented” construction and incorrectly construed claim 4 of the '080
Patent in two respects: (1) to only include levofloxacin in a reasonably pure
state; and (2) to include levofloxacin hemihydrate.
[88]
These
allegations can be addressed summarily. First, I reject the notion of a
“results oriented” construction. The applications judge did nothing other than
identify the issue in relation to an analysis of infringement. Second,
although it is not permissible to look to the patent disclosure to expand the
monopoly, the disclosure may be examined to construe the patent claims: Whirlpool;
Freeworld Trust v. Électro Santé Inc., [2000] 2 S.C.R. 1024. The
principles set out in these authorities are well-known, often cited and need
not be repeated here.
[89]
Third,
although Apotex contends that claim 4 is not ambiguous, thus resort to the
disclosure is unnecessary and should not have occurred, its position ignores
the fact that the claim 4 language does not specify whether the claimed
compound is hydrous or anhydrous, a matter of significance. The applications
judge did not err in having regard to the specification.
[90]
Fourth,
in my view, it is not an error to refer to the construction of the claim, as
construed in previous proceedings by different judges (one of whom has been
affirmed by this Court). Such constructions may be persuasive, depending on
the evidence, as found by the applications judge in this case.
[91]
Further,
I do not find that the applications judge erred in agreeing with Hughes J.’s
construction of claim 4 as being levofloxacin “different from that contained in
the racemate, obtained in a reasonably pure state.” The invention of the '080
Patent clearly related to producing reasonably pure levofloxacin, rather than
racemic ofloxacin. Moreover, the applications judge did not err in construing
claim 4 as including both levofloxacin hemihydrate and levofloxacin anhydrate.
As the applications judge observed, the disclosure explicitly provided instructions
regarding how to make both of these compounds.
[92]
In
sum, the applications judge did not err in construing claim 4. It was
uncontested that the Apotex product would contain levofloxacin hemihydrate.
Therefore, the conclusion that Apotex’s allegation of non-infringement was not
justified was correct.
Anticipation and
Obviousness
[93]
In
relation to the various alleged factual errors, I am not persuaded that the
identified errors, if they exist at all, approach the requisite level to warrant
setting aside the decision.
[94]
Apotex
argues the evidence of commercially-available equipment that could be used to
separate the ofloxacin enantiomers was ignored and notes that Daiichi had used
such equipment.
[95]
The
applications judge, at paragraph 102 of his reasons, acknowledged the existence
of techniques available to separate enantiomers, generally. However, he found
that these techniques offered no assurance that a substantially optically pure
enantiomer of a new racemate itself or even a substantially optically pure
enantiomer of an intermediate, could be obtained. He noted Dr. Kellogg’s
admission that Dr. Kellogg did not locate the three processes disclosed in the
'080 Patent to produce levofloxacin (Processes A, B and C) in any prior art
reference.
[96]
Apotex
has not demonstrated palpable and overriding error in this regard. Moreover,
the fact that commercial equipment could be used to separate ofloxacin would
not be sufficient to anticipate claim 4 of the '080 Patent. No prior
publication or patent disclosed isolated levofloxacin or its advantages.
[97]
Apotex
also argues the applications judge “relied upon Mr. Hayakawa’s affidavit to say
that it took Daiichi four years to obtain levofloxacin, but overlooked that Mr.
Hayakawa had admitted on cross-examination that no work was being done by
Daiichi during most of this period, and that the Daiichi scientists had very
little knowledge and experience in performing resolutions when they initiated
their work.”
[98]
Mr.
Hayakawa did admit there were no documented attempts by Daiichi to separate the
ofloxacin enantiomers between November 1982 and June 16, 1984 and that most
members of the research group would not have had actual experience separating
enantiomers (Hayakawa Cross-examination, Appeal Book, Vol. XXXI, Tab 50). However,
even if the applications judge “overlooked” this evidence, it does not
constitute palpable and overriding error. These facts, taken with the other
evidence, do not support the proposition that levofloxacin and its advantages
were disclosed and enabled by any prior patent or publication.
[99]
Apotex
asserts the applications judge failed to consider evidence that Daiichi’s
competitors were motivated to resolve ofloxacin and did so at approximately the
same time as Daiichi. Specifically, Apotex states that on December 10, 1985,
Bayer AG, a Daiichi competitor, filed a German Patent Application for
levofloxacin that disclosed its increased antimicrobial activity over ofloxacin
and a method for its synthesis. Although this patent application does not
constitute ‘prior art’, according to Apotex, it contradicts the applications
judge’s finding that Daiichi’s competitors were not motivated to resolve
ofloxacin.
[100] At paragraph
232 of his reasons, the applications judge acknowledged Apotex’s evidence
demonstrated that “in 1985 four competitors came to levofloxacin shortly after
Daiichi.” Although this observation is not included in the obviousness
analysis, it nonetheless indicates the applications judge did not “ignore” or
“overlook” the evidence. In any event, whether competitors were motivated to
pursue the invention is but one factor to consider in an obviousness analysis.
The applications judge listed a number of factors pointing to a determination
that claim 4 of the '080 Patent was not obvious, including:
·
at
least until June 1985, no researcher other than Gerster had obtained the
enantiomers of any racemic fluoroquinolone, despite the competitive nature of
this field;
· the only other
fluoroquinolone that had been resolved into its enantiomers (flumequin) had a
different structure than ofloxacin;
·
other
similar fluoroquinolones taught away from the importance of the chirality of
the methyl group;
·
there
was no generalized expectation that the bulk of the antibacterial activity of
ofloxacin would lie in one enantiomer;
·
levofloxacin’s
lower toxicity was unexpected, as was the fact that the enantiomer having the
lower toxicity was also the more active enantiomer; and
·
levofloxacin’s
increased solubility was unexpected.
[101] Apotex also
claims the applications judge erred by assessing obviousness as of June 1985
rather than as of the date of invention (December 1985). This failure
ostensibly prevented him from considering various pieces of prior art,
including the Gerster 1985 Poster. I do not agree. The applications judge
clearly considered the Gerster 1985 Poster in his obviousness analysis. He
acknowledged that the Gerster 1985 Poster taught that the “S” flumequine
enantiomer was more active that the “R” enantiomer. However, he found, since
flumequine and ofloxacin are structurally distinct, the properties of the
former could not be used to predict those of the latter.
[102] The remaining
allegations of “palpable and overriding errors” constitute mere disagreement
with the manner in which the applications judge weighed the evidence. To the
extent that any errors were made, they are not palpable or overriding.
Selection
Patent
[103] Apotex claims
that if the applications judge had considered its selection patent argument,
the results in relation to anticipation and obviousness would have been
different. I am not persuaded that is so. In Sanofi, Justice Rothstein
conducted his analysis by reference to the facts as found by the applications
judge. In Apotex Inc. v. Pfizer Canada Inc. et al. (2009), 74 C.P.R. (4th)
141 (F.C.A.), Justice Noël of this Court did likewise. I propose to do the
same.
[104] Upon review
of his reasons, I am satisfied the applications judge conducted a proper
analysis for anticipation notwithstanding that, at the time of the hearing, he
did not have the benefit of the Supreme Court’s reasons in Sanofi. As
for the issues concerning validity of the selection and obviousness, the
applications judge’s factual determinations, when applied to the Sanofi
analysis, point to a conclusion that the '080 Patent is valid.
(a) Valid
Selection
[105] In Sanofi,
the Supreme Court referred to a line of authority stemming from I.G.
Farbenindustrie A.G.’s Patents (1930), 47 R.P.C. 289 (Ch. D.) in support of
its conclusion that a system of genus and selection patents is acceptable in
principle. Three conditions must be satisfied for a selection patent to be
valid.
1. There must be a
substantial advantage to be secured or disadvantage to be avoided by the use of
the selected members.
2. The whole of the
selected members (subject to “a few exceptions here and there”) possess the
advantage in question.
3. The selection must be
in respect of a quality of a special character peculiar to the selected group.
If further research revealed a small number of unselected compounds possessing
the same advantage, that would not invalidate the selection patent. However,
if research showed that a larger number of unselected compounds possessed the
same advantage, the quality of the compound claimed in the selection patent
would not be of a special character (Sanofi, paragraph 10).
[106] The
applications judge concluded that the combination of higher activity,
low toxicity and increased solubility properties of levofloxacin resulted in an
advantage over ofloxacin. There was evidence before him to support this
factual finding. Although Apotex claims the applications judge’s failure to
refer to certain evidence constitutes error, I do not accept its argument. A
review of the noted evidence reveals that some of it, when read in context,
does not support the position for which it is cited. In other instances, the
evidence was contradicted by other evidence. Again, it boils down to the
weight assigned to the evidence. Apotex has failed to establish palpable and
overriding error in this respect.
[107] The selection
in this case was comprised of one enantiomer. Therefore, the second condition
is not relevant in this case. The applications judge also found that the
unselected R(+) ofloxacin enantiomer did not have the quality of special
character. The factual findings made by the applications judge satisfy the Sanofi
test for a selection patent.
(b) Anticipation
[108] Sanofi refined the
test for anticipation. The inquiry now encompasses the requirements of prior
disclosure and enablement, considered separately. The Sanofi reasoning
is synthesized in the paragraphs below.
[109] With respect
to disclosure, the skilled person is reading the prior art to understand
whether it discloses the second invention. No trial and error or
experimentation is permitted. If the disclosure requirement is satisfied,
enablement requires the skilled person to have been able to perform the
invention.
[110] In the case
of a selection patent, the compound made for the selection patent was only
soundly predicted at the time of the genus patent. It was not made and its
special advantages were not known. Thus, a patent should not be denied to the
inventor who made and discovered the special advantages of the selection
compound for the first time. If the genus patent discloses the special advantages
of the invention covered by the selection patent, there is prior disclosure and
the test for anticipation fails. If the special advantages of the invention of
the selection patent are not disclosed, the enablement requirement comes into
play, that is, the skilled person must be able to perform or make the invention
of the patent without undue burden. The Supreme Court, at paragraph 37, set
out a non-exhaustive list of factors that should normally be considered.
1. Enablement
is to be assessed having regard to the prior patent as a whole including the
specification and the claims. There is no reason to limit what the skilled
person may consider in the prior patent in order to discover how to perform or
make the invention of the subsequent patent. The entire prior patent
constitutes prior art.
2. The skilled person
may use his or her common general knowledge to supplement information contained
in the prior patent. Common general knowledge means knowledge generally known
by persons skilled in the relevant art at the relevant time.
3. The prior patent must
provide enough information to allow the subsequently claimed invention to be
performed without undue burden. When considering whether there is undue
burden, the nature of the invention must be taken into account. For example,
if the invention takes place in a field of technology in which trials and
experiments are generally carried out, the threshold for undue burden will tend
to be higher than in circumstances in which less effort is normal. If
inventive steps are required, the prior art will not be considered as
enabling. However, routine trials are acceptable and would not be considered
undue burden. But experiments or trials and errors are not to be prolonged
even in fields of technology in which trials and experiments are generally
carried out. No time limits on exercises of energy can be laid down; however,
prolonged or arduous trial and error would not be considered routine.
4. Obvious errors or
omissions in the prior patent will not prevent enablement if reasonable skill
and knowledge in the art could readily correct the error or find what was
omitted.
[111] The
applications judge’s analysis that the '080 Patent was not anticipated by the
'840 Patent was in keeping with the Sanofi analysis. He correctly
stated and applied the requirements of disclosure and enablement. He
determined that the '840 Patent disclosed a process to make racemic ofloxacin
and not levofloxacin in a reasonably pure state. Although the non-disclosure
in the '840 Patent, in and of itself, was sufficient to conclude that it did
not anticipate the claim, the applications judge additionally found that the
'840 Patent did not enable the skilled person to make the invention of claim 4
because there were no routine techniques in which the skilled person could
isolate levofloxacin.
(c) Obviousness
[112] Sanofi endorsed the
inquiry for obviousness set out in Windsurfing International Inc. v. Tabur
Marine (Great Britain) Ltd., [1985] R.P.C. 59 (C.A.) (Windsurfing),
restated in Pozzoli SPA v. BDMO SA, [2007] EWCA Civ 588 (Pozzoli).
1. (a) Identify the
notional “person skilled in the art”;
(b) Identify
the relevant common general knowledge of that person;
2. Identify the
inventive concept of the claim in question or if that cannot readily be done,
construe it;
3. Identify what, if
any, differences exist between the matter cited as forming part of the “state
of the art” and the inventive concept of the claim or the claim as construed;
4. Viewed without any
knowledge of the alleged invention as claimed, do those differences constitute
steps which would have been obvious to the person skilled in the art or do they
require any degree of invention.
[113] At the fourth
stage of the Windsurfing approach, the issue of “obvious to try” arises.
To find that an invention was “obvious to try”, and therefore invalid for
obviousness, Sanofi teaches “there must be evidence to convince a judge
on a balance of probabilities that it was more or less self-evident to try to
obtain the invention. Mere possibility that something might turn up is not
enough” (paragraph 66). The “obvious to try” test will be appropriate in areas
of endeavour where advances are often won by experimentation, such as in the
pharmaceutical industry. A non-exhaustive list of factors to be taken into
consideration is proposed at paragraph 69.
1. Is it more or less
self-evident that what is being tried ought to work?
Are there a finite
number of identified predictable solutions known to persons skilled in the art?
2. What is the extent,
nature and amount of effort required to achieve the invention? Are routine
trials carried out or is the experimentation prolonged and arduous, such that
trials would not be considered routine?
3. Is there a motive
provided in the prior art to find the solution the patent addresses?
[114] The actual
course of conduct that culminated in the making of the invention may be an
important factor. In this inquiry, it is not enough that there is a
possibility of finding the invention. The invention must be self-evident from
the prior art and common general knowledge in order to satisfy the “obvious to
try” test.
[115] At paragraph
85, Justice Rothstein specifically referred to isolating enantiomers of a
racemate as follows:
Just because
there are known methods of separating a racemate into its isomers does not mean
that a person skilled in the art would necessarily apply them. The fact that
there are such known methods of separation will be of no account if the
evidence does not prove that it was more or less self-evident to try them. It
is true that at the relevant time there was evidence that a skilled person
would know that the properties of a racemate and its isomers might be
different. However, a possibility of finding the invention is not enough. The
invention must be self-evident from the prior art and common general knowledge
in order to satisfy the “obvious to try” test.
[116] It is common
ground that the applications judge did not conduct the precise obviousness
analysis taught in Sanofi. Notwithstanding, his factual determinations,
applied to the Sanofi analysis, support the conclusion that claim 4 is
inventive.
Identify the
notional person skilled in the art
[117] No issue was
taken in relation to the applications judge’s finding that the skilled person
would be “a person with at least a first level university education, and at
least a few years of experience concerned with chemical compounds and deriving
optically active compounds therefrom particularly in the area of compounds
having medicinal uses” (paragraph 57).
Identify the relevant
common general knowledge of that person
[118] The
applications judge concluded that the skilled person would be familiar with the
principles of stereochemistry and nomenclature (paragraphs 56, 58) and,
although there were general techniques known in the art to separate enatiomers,
no specific techniques existed that could be used to separate the ofloxacin
enatiomers (paragraphs 100, 102, 144, 173).
Identify the
inventive concept of the claim in question or if that cannot readily be done,
construe it
[119] The
applications judge identified the inventive concept of claim 4 to be isolated
levofloxacin with the unexpected advantages of increased solubility and
activity and lowered toxicity over ofloxacin (paragraphs 143-168). He further
found that the combination of the three beneficial properties was an unexpected
advantage (paragraph 169).
Identify
what, if any, differences exist between the matter cited as forming part of the
“state of the art” and the inventive concept of the claim or the claim as
construed
[120] The
applications judge found that levofloxacin was fundamentally different from
ofloxacin and that the former was twice as potent, less toxic and ten times
more water soluble than the latter (paragraphs 143-169). He additionally concluded
that levofloxacin could not be made following prior art references (paragraph
102).
Viewed without any
knowledge of the alleged invention as claimed, do those differences constitute
steps which would have been obvious to the person skilled in the art or do they
require any degree of invention?
(a) Is
it more or less self-evident that what is being tried ought to work?
[121] The
applications judge found that determining the properties of levofloxacin
required more than mere verification (paragraph 111). He properly concluded
that one cannot “verify” unexpected and unpredictable properties (paragraph
111). The applications judge further found that the improved properties of
levofloxacin were unpredictable (paragraphs 143-169) and that there were no
standard techniques which could be used to separate the enantiomers (paragraph
102). If there was more than mere verification, the advantage of the selection
of levofloxacin would not have been more or less self-evident. The factual
determinations clearly indicate that the invention was not self-evident.
(b) What
is the extent, nature and amount of effort required to achieve the invention?
[122] The
applications judge found, as a fact, that the inventors of levofloxacin had to
devise new processes to isolate this enantiomer from racemic ofloxacin, since
they were unable to obtain it using standard techniques (paragraph 173).
(c) Is
there a motive from the prior art to find the solution that the '080 Patent
addresses?
[123]
The
applications judge recognized the competitiveness of the pharmaceutical
industry (paragraph 126). However, his factual conclusion, at the end of the
day, was that nothing in the '840 Patent or common general knowledge provided a
specific motivation for a skilled person to isolate the enantiomers of ofloxacin,
including the fact that there was no general expectation that one enantiomer
would possess the unexpected properties of levofloxacin (paragraph 127).
(d) What
is the course of conduct which was followed which culminated in the making of
the invention?
[124] The
applications judge found that Daiichi first began trying to separate the
enantiomers of ofloxacin in April, 1981 (paragraph 24) but did not succeed
until April, 1985 (paragraph 25) when its improved activity was also
discovered. Further, levofloxacin’s increased solubility and reduced toxicity
were only discovered in September and October 1985, respectively (paragraphs 26
and 27).
[125] Applying the
noted factual findings of the applications judge to the Sanofi analysis,
the inescapable conclusion is that the applications judge did not err in
finding that the '080 Patent was not rendered obvious by the '840 Patent.
Although the analyses on the issues of selection and obviousness were not
performed strictly in accordance with the manner in which they are delineated
in Sanofi, the Sanofi decision was not available at the time the
applications judge arrived at his determinations. When the Sanofi
analysis is conducted, utilizing the factual findings of the applications
judge, the conclusion is that the '080 Patent was a valid selection and was not
obvious.
Deemed
Abandonment
[126] Apotex did
not address this issue during oral argument. In its written submissions, it
asserted that the applications judge erred in failing to find that the
application for the '080 Patent was deemed abandoned during prosecution. The
issue is one of mixed fact and law and is reviewable on a standard of
overriding and palpable error.
[127] In addressing
this argument, the applications judge had to have regard to the Patent Act
as it stood immediately prior to October 1, 1989. The applications judge made
a number of factual findings, none of which disclose palpable or overriding
error. Applying those findings to the applicable law and, in particular, Bourgault
Industries Ltd. v. Flexi-Coil Ltd. (1999), 86 C.P.R. (3d) 221 (F.C.A.),
leave to appeal dismissed, [1999] S.C.C.A. No. 223 (Flexi-Coil), he
determined that the patent was not deemed abandoned. More specifically, he
concluded that the ruling in Flexi-Coil was dispositive. That conclusion,
in my view, was correct.
[128] For the
foregoing reasons, I would dismiss the appeal with costs.
“Carolyn Layden-Stevenson”
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