Docket: A-483-15
Citation:
2017 FCA 161
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CORAM:
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PELLETIER J.A.
NEAR J.A.
RENNIE J.A.
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BETWEEN:
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IDENIX
PHARMACEUTICALS, INC.
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Appellant
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and
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GILEAD
PHARMASSET LLC,
GILEAD
SCIENCES, INC. and
GILEAD SCIENCES
CANADA, INC.
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Respondents
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REASONS
FOR JUDGMENT
RENNIE J.A.
I.
Introduction
[1]
This is an appeal from a judgment of the Federal
Court per Justice Annis (the judge), reported as 2015 FC 1156. The
respondents Gilead Sciences, Inc., Gilead Sciences Canada, Inc., and Gilead
Pharmasset LLC (collectively, Gilead) challenged the appellant Idenix
Pharmaceuticals, Inc.’s (Idenix) Canadian Patent No. 2,490,191 (the 191
Patent). By way of counterclaim, Idenix challenged Gilead’s subsequent Canadian
Patent No. 2,527,657 (the 657 Patent) for infringement, lack of novelty and wilful
misleading. Both impugned patents claimed compounds having activity against the
family of Flaviviridae viruses, which includes, for example, Hepatitis C. The judge
found the 191 Patent to be invalid on the grounds of insufficiency of
disclosure and lack of sound prediction of utility. His conclusion on the
invalidity of the 191 Patent led him to dismiss Idenix’s counterclaim against Gilead.
[2]
On appeal, Idenix seeks an order declaring the
191 Patent valid and infringed by Gilead, that Gilead’s 657 Patent is invalid, and
costs and interest in this Court and the Federal Court. In the alternative, it
seeks an order directing that this matter be sent back to the Federal Court for
a new trial by a different judge.
[3]
As this case raises no new issues of principle
or novel application of established principles to the facts, these reasons are
intended to simply deal with allegations of error advanced by Idenix. As a
result, the narrative portions of these reasons are fairly summary as they are
addressed to the parties who are already familiar with the factual and legal
context.
II.
Background and history of proceedings
[4]
A nucleoside is a chemical compound that
consists of a base attached to a 5-carbon sugar ring. Both patents at issue
claim nucleosides analogues with various bases and a particular structure at
the 2’ (2 Prime) position on the sugar ring, specifically a methyl group in the
“up” position and a fluorine atom in the “down” position. For the purposes of this appeal, the
Claimed Compound will be denoted as 2’-C-Me/F, which reflects the particular
structure at the 2’ position on the sugar ring as outlined above.
[5]
In the early 2000s, Idenix filed two patent
applications in the United States for synthesized 2’-C-Me/OH nucleoside
analogues that have activity against Flaviviridae viruses, a family of viruses
that includes Hepatitis C. Idenix then set out to synthesize several similar
compounds, including the Claimed Compound. A number of Idenix’s scientists
worked toward its synthesis, including Drs. Griffon and Stewart and Ms. Wang,
to whose evidence I will later refer. Before they succeeded in synthesizing the
compound, Idenix filed US patent applications in 2002 and 2003 that establish
priority for the Canadian 191 Patent at issue.
[6]
In May 2003, a Pharmasset Inc. (now Gilead)
chemist, Mr. Clark, succeeded in synthesizing 2’-C-Me/F. He submitted a
provisional US patent application in 2004. This application is the foundation for
Gilead’s 657 Patent. It discloses the step-by-step synthesis of the 2’-C-Me/F
compound and its antiviral activity against Hepatitis C virus infections (HCV)
in some detail.
[7]
In 2012, Gilead brought a challenge to the
validity of the 191 Patent in the Federal Court. The judge found in Gilead’s
favour that the 191 Patent was invalid on the basis that it did not
sufficiently disclose the steps required to synthesize the Claimed Compound,
and that there was no sound prediction of utility.
[8]
The judge recognized that there are three
pathways by which the Claimed Compound can be synthesized: the nucleoside
approach, the sugar approach and the Gemcitabine approach. While all three
approaches have since been found to result in the successful synthesis of the
Claimed Compound, the judge found that, at the relevant time, the skilled
person would not have been directed to any particular starting point for
synthesis through the 191 Patent.
[9]
At trial and on appeal, Idenix argued that the
191 Patent taught the skilled person to select the nucleoside or sugar pathways
or that it would have been apparent to the skilled person that those were the
appropriate pathways to embark upon. According to Idenix, the references in the
patent to the diastereomer of an intermediate or precursor compound (the
Intermediate Compound) and the discussion of stereochemistry in the 191 Patent
would have directed the skilled person to either of these pathways rather than
the Gemcitabine pathway. This is because the Intermediate Compound is a
necessary step in the nucleoside and sugar approaches, but not the Gemcitabine
approach.
[10]
Even on the basis of the two pathways Idenix preferred,
the judge found that multiple steps in the synthesis of the Claimed Compound were
not disclosed. Of particular relevance on appeal, the judge found that the
Intermediate Compound was not referenced, the methylation step required to make
the Intermediate Compound was not disclosed, and it is common ground that the
191 Patent does not include instructions for how to install a fluorine group necessary
to make the Claimed Compound. Despite Idenix’s arguments to the contrary, the
judge found that these gaps could not be filled by the common general knowledge
and/or routine experimentation such that the person skilled in the art could
have made the invention.
[11]
The judge found further that the inventors of
the 191 Patent did not soundly predict the utility of the Claimed Compound. As
noted, the 191 Patent claims antiviral activity of the Claimed Compound against
the family of viruses including HCV. Idenix filed the 191 Patent prior to
having successfully synthesized the Claimed Compound. Although the judge found some
evidence of a factual basis for sound prediction, he concluded that it was not
sufficient.
[12]
Although of no consequence given his findings
with respect to the invalidity of the 191 Patent, the judge found that Gilead’s
activities fell within the scope of the claims asserted in the 191 Patent. As a
result of the invalidity of the 191 Patent, the judge determined that Gilead’s
657 Patent was not anticipated and dismissed Idenix’s counterclaim.
III.
Issues
[13]
Idenix alleges a substantial number of factual
and legal errors in the decision below. Idenix argues that, once the errors are
corrected, this Court will be in a position to make the decision that the judge
should have made, which would involve upholding the validity of the 191 Patent
and finding the 657 Patent to be anticipated and invalid.
[14]
With respect to the finding of invalidity of the
191 Patent, Idenix alleges that the judge made errors in his appreciation and
application of the substantive law of sufficiency of disclosure and sound
prediction including misappreciating the evidence of the expert witnesses,
making unsupported findings of fact, unjustifiably preferring the evidence of
certain expert witnesses, failing to read the disclosure through the eyes of a
person skilled in the art with the benefit of common general knowledge and altering
the test for sound prediction. With respect to Gilead’s 657 Patent, Idenix
alleges that the judge misinterpreted the requirements of inventorship and
materiality and made numerous palpable and overriding errors in his factual
findings.
[15]
The task of this Court on appeal remains
determining whether the judge committed an error of law or a palpable and
overriding error of fact or mixed law and fact to warrant intervention,
regardless of the number of errors alleged or the manner in which those errors
are plead (Housen v. Nikolaisen, 2002 SCC 33, [2002] 2 S.C.R. 235 [Housen]).
[16]
Given that the judge found the 191 Patent
invalid for both insufficiency of disclosure and lack of sound prediction of
utility, Idenix must identify errors that justify intervention on both grounds
of invalidity in order to be successful. For the reasons that follow, I am of
the view that Idenix has not met this burden. I would dismiss the appeal.
IV.
Analysis
A.
Sufficiency of the disclosure of the 191 Patent
[17]
Subsection 27(3) of the Patent Act states:
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(3) The
specification of an invention must
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(3) Le
mémoire descriptif doit :
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(a)
correctly and fully describe the invention and its operation or use as
contemplated by the inventor;
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a) décrire
d’une façon exacte et complète l’invention et son application ou
exploitation, telles que les a conçues son inventeur;
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(b) set
out clearly the various steps in a process, or the method of constructing,
making, compounding or using a machine, manufacture or composition of matter,
in such full, clear, concise and exact terms as to enable any person skilled
in the art or science to which it pertains, or with which it is most closely
connected, to make, construct, compound or use it;
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b) exposer
clairement les diverses phases d’un procédé, ou le mode de construction, de
confection, de composition ou d’utilisation d’une machine, d’un objet
manufacturé ou d’un composé de matières, dans des termes complets, clairs,
concis et exacts qui permettent à toute personne versée dans l’art ou la
science dont relève l’invention, ou dans l’art ou la science qui s’en
rapproche le plus, de confectionner, construire, composer ou utiliser
l’invention;
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(c) in the
case of a machine, explain the principle of the machine and the best mode in
which the inventor has contemplated the application of that principle; and
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c) s’il
s’agit d’une machine, en expliquer clairement le principe et la meilleure
manière dont son inventeur en a conçu l’application;
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(d) in the
case of a process, explain the necessary sequence, if any, of the various
steps, so as to distinguish the invention from other inventions.
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d) s’il
s’agit d’un procédé, expliquer la suite nécessaire, le cas échéant, des
diverses phases du procédé, de façon à distinguer l’invention en cause
d’autres inventions.
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[18]
The Supreme Court of Canada in Teva Canada
Ltd. v. Pfizer Canada Inc., 2012 SCC 60, [2012] 3 S.C.R. 625 [Teva]
confirmed the requirements for sufficient disclosure under subsection 27(3)
of the Patent Act. At paragraph 70, the Court re-asserted its position
in Consolboard Inc. v. MacMillan Bloedel (Sask.) Ltd., [1981] 1 S.C.R.
504, 56 C.P.R. (2d) 145, and stated that the patent specification “must define the precise and exact extent of the privilege
being claimed so as to ensure that the public can, having only the
specification, make the same use of the invention as the inventor”. The
patent must disclose both the invention and how to make the invention.
[19]
At paragraph 79 of Apotex Inc. v. Astrazeneca
Canada Inc., 2017 FCA 9, [2017] F.C.J. No.22 (QL) [Apotex], this
Court held that “[i]t is well established in patent law
that when one claims a new and inventive product, an inventor is only required
to enable the person skilled in the art to work the invention. He or she need
only describe one method or process for making it”. While a patent will
not be found to be invalid for insufficient disclosure where routine experimentation
is required of the skilled person, the Supreme Court of Canada in Pioneer
Hi-Bred v. Canada (Commissioner of Patents), [1989] 1 S.C.R. 1623 at 1641,
1989 CanLII 64 [Pioneer], held that disclosure is insufficient if the
specification “necessitates the working out of a
problem”.
(1)
Perspective of the skilled person
[20]
Idenix alleges that the judge did not read the
191 Patent’s disclosure from the perspective of the person skilled in the art
with the benefit of common general knowledge. Idenix argues that the judge’s
misunderstanding as to the appropriate perspective coloured his analysis; for
example, causing him to find that the methylation step in the synthesis of the
Claimed Compound was not disclosed.
[21]
At paragraph 455 of his Reasons, the judge
states in reference to the 191 Patent’s disclosure of the synthesis of the
Claimed Compound that:
[t]he Court is here considering the express
written disclosure contained in the ‘191 Patent without the added
disclosure of synthesis from the common general knowledge [emphasis in
original].
[22]
Considered in isolation, the judge’s use of the
term “express written disclosure” may suggest
that he applied a lawyer’s or judge’s perspective to the wording of the patent,
as opposed to that of the person skilled in the art. I agree with Idenix that
such an error would justify this Court’s intervention (Free World Trust v. Électro Santé Inc., 2000 SCC 66, [2000] 2 S.C.R. 1024 at p. 1050 [Free World Trust]).
However, a fair reading of the Reasons with “a mind
willing to understand” (Apotex Inc. v. Astrazeneca Canada Inc.,
2017 FCA 9, at para. 100, [2017] F.C.J. No. 22 (QL)) demonstrates that although
his description of his analytical approach does not withstand critical
scrutiny, the analysis he actually undertook does.
[23]
Immediately preceding the paragraph of concern,
at paragraphs 452-53, the judge set out his approach to the sufficiency
analysis. First, he explained that he would consider, “whether
and to what extent the synthesis of the 2’-C-Me/F nucleoside is expressly
disclosed in the ‘191 Patent”. He noted that he would then move on to “consider whether the common general knowledge and routine
experimentation are sufficient to disclose the synthesis,” based upon
the testimony of the expert witnesses before him. I do not wish to have these
reasons to be taken as endorsing such an approach, but, for the purposes of
this appeal, I find that in the end the judge considered the words of the
patent in light of the perspective of the person skilled in the art.
[24]
The judge referenced the guidance set out in Free
World Trust, noting that patents must be read as a person skilled in the
art would have understood them at the date of issue (Reasons at para. 464). This
section of the Reasons includes references to, and consideration of, expert
witness testimony, as one would expect (see, for example paras. 482, 485,
489-90). For example, I note that the judge agreed with Idenix’s expert, Dr. Damha,
that the interpretation of the patent proposed by Gilead’s expert, Dr. Wnuk, was
“too literal” and not “what
the skilled person would have eventually taken from it” (Reasons at
para. 465).
[25]
The judge noted the jurisprudence concerning
common general knowledge and routine experimentation (Reasons at paras. 421-25),
and found that:
Idenix is relying on common general
knowledge to advise the skilled reader, both that the 2’-C-OH/Me is the [I]ntermediate
[Compound] required to make the 2’-C-Me/F nucleosides, as well as how to make
that intermediate, with at best snipits of useful information well buried in
the ‘191 Patent (Reasons at para. 491).
[26]
Further, the judge accepted Dr. Wnuk’s evidence
to the effect that, “the fact that, in hindsight,
individual steps in a chemical synthesis have some precedent in the literature
does not mean that the overall sequence of steps for making a new compound was
easy to determine,” and that undertaking such an endeavour “often requires significant creativity and/or an extensive
amount of experimentation” (Reasons at paras. 547-548).
[27]
The judge concluded that Gilead had established
that the 191 Patent, together with the common general knowledge, did not
sufficiently disclose how to synthesize the Claimed Compound. While the judge’s
choice of the term “express written disclosure”
is not appropriate, it is apparent on a fair reading of the Reasons that he was
concerned with how the skilled person would have understood the patent. For
these reasons, Idenix’s allegations on this point fail.
(2)
Dr. Griffon and the notional skilled person
[28]
Idenix argues that the judge erred by using Dr.
Griffon as a proxy for the skilled person and that this legal error justifies
reversal of his decision. However, by the time the judge reached the parties’
arguments regarding Dr. Griffon, he had already independently determined that
the 191 Patent insufficiently disclosed how to make the Claimed Compound. As
such, the error Idenix alleges is of no consequence. The judgment is able to
stand on other grounds.
[29]
However, an observation must be made before
leaving this point. Judges must be careful not to lose sight of the identity of
the person of ordinary skill in the art. This person is a “mythical creature (the man in the Clapham omnibus of patent
law)” (Beloit Canada Ltée/Ltd. v. Valmet Oy, 64 N.R. 287, 8 C.P.R
(3d) 289 (F.C.A.)); Healthcare at Home Limited v. Common Services Agency for
the Scottish Health Service, [2014] UKSC 49 at para. 3; [2014] W.L.R. (D)
351. In patent litigation the courts must be informed by the evidence as to
what knowledge a person of ordinary skill in the art would have had and what
that person would have been able to do with said knowledge.
(3)
Treatment of expert and fact witness evidence
[30]
Idenix alleges that the judge made palpable and overriding
errors in appreciating, weighing and preferring the evidence of certain
experts. In particular, Idenix alleges that the judge erred in preferring the
evidence of Gilead’s expert, Dr. Wnuk, over that of Idenix’s experts, Drs.
Damha and Barrett. It alleges that the judge erred in making an adverse
credibility finding against Dr. Damha, and misinterpreted a comment made by Dr.
Damha at trial, in a manner that requires correction. Further, Idenix argues
that the judge improperly admitted factual evidence of Dr. Stewart filed by
Gilead, and erred in his treatment of the evidence relating to Idenix’s fact
witness, Ms. Wang.
(a)
Dr. Damha
[31]
The alleged errors in relation to Dr. Damha’s
evidence may be readily disposed of.
[32]
I disagree with Idenix that the judge made an
unwarranted adverse credibility finding in respect of Dr. Damha. Idenix impugns
the particular comment of the judge that it was “incomprehensible
that [Dr. Damha] could testify that the ‘191 Patent provided the same level of
specificity of synthesis” as the 657 Patent at paragraph 493 of his
Reasons. It is my view that the judge did not, at this stage, make a finding on
credibility. My view on this point is supported by the fact that the judge in
fact relied on Dr. Damha’s evidence at other points of his Reasons (see paras.
465, 503, 807, 828, 845, 872, 875).
[33]
Idenix submits further that the judge made a
palpable and overriding error by misinterpreting a comment made by Dr. Damha
when he said that the steps to make the Claimed Compound were common general
knowledge. I disagree that the judge misunderstood this statement when
incorporating it at paragraph 432 of his Reasons, which I read as discussing
inventiveness generally, not the inventiveness of the method of producing the
Claimed Compound.
(b)
Dr. Wnuk
[34]
Idenix argues that the judge’s preference for
Dr. Wnuk’s evidence resulted from his mistaken view that Dr. Wnuk was the only
expert with fluorination experience at the relevant time. Further, Idenix impugns
the judge’s reliance on Dr. Wnuk’s expert reports despite Dr. Wnuk allegedly having
changed his testimony during cross-examination. I would not accede to these
arguments.
[35]
First, the judge was entitled to prefer one
witness over the other (Actavis Pharma Company v. Alcon Canada Inc.,
2015 FCA 192 at para. 13, 476 N.R. 309). He rejected Gilead’s argument that
Drs. Damha and Barrett should not be qualified to give opinion evidence on the
fluorination of nucleosides, but “weighed as a factor
in the evidence of the contending experts that favours Gilead” Dr. Wnuk’s
particular expertise (Reasons at para. 61). For example, it was open to the
judge to consider and weigh the evidence that, although Dr. Damha published a
paper on the topic in 2002, he did not have first-hand experience with the
fluorination of nucleosides in 2003-04 (Reasons at para. 62) as did Dr. Wnuk. I
note that the judge found that “Dr Wnuk focused his
career on the synthesis of nucleosides, including an extensive amount of time
dealing with the fluorination of nucleosides.”
[36]
The judge recognized that Idenix was able to
extract certain concessions from Dr. Wnuk on cross-examination. It was for the
judge to assess the impact of these concessions. He found that Dr. Wnuk’s evidence
reflected his role as an expert attempting to assist the Court, nor did it undermine
the essential points of his testimony regarding the common general knowledge at
the relevant time (Reasons at para. 535). This conclusion was open to him to
draw. It must be remembered that the judge had the benefit of observing, first-hand,
the testimony of the witness in direct and cross-examination, and was in a
position to draw the inferences and conclusions that he did (Housen, at
para. 25).
(c)
Dr. Stewart
[37]
Idenix alleges that the judge erred in admitting
into evidence a witness statement and transcript of cross-examination of Dr.
Stewart from parallel proceedings in the United Kingdom. Gilead sought leave to
admit these documents at the end of the trial. The judge determined that the
transcripts constituted hearsay, and although he found them to be unnecessary under
the principled approach, he ultimately determined that they were admissible
under the common law exception of admissions against interest (Reasons at para.
737).
[38]
While it is clear to me that the judge did not
follow the proper analysis for admitting the transcripts, I will not address
the admissibility of this evidence here, as nothing turns on this point. The
judge noted, at para 740 of his Reasons, that neither the evidence of Dr.
Stewart or Ms. Wang would have affected his conclusion, already drawn, that the
191 Patent did not disclose the fluorination step in the synthesis of the
Claimed Compound.
(d) Ms. Wang
[39]
Idenix submits further that the judge erred in
finding that Ms. Wang did not make the Claimed Compound before learning how to
do so from a Pharmasset Inc. (now Gilead) employee or the Clark publication.
According to Idenix, the judge was not entitled to rely on Dr. Wnuk’s report to
find that Ms. Wang did not make the claimed compound because of his admission
on cross-examination that, on reviewing her lab notes, he “[couldn’t] really tell” whether she made the compound
in an experiment conducted in December 2005.
[40]
Essentially, Idenix asks this Court to reweigh
the evidence. Dr. Wnuk’s admission is not sufficient to support the conclusion
that Ms. Wang made the Claimed Compound prior to receiving information
regarding Mr. Clark’s method. The burden to establish this rested with Idenix.
[41]
It was established in the evidence that Dr.
Stewart received information on Mr. Clark’s method prior to the publication of
the 657 Patent, and that he and Ms. Wang were working together on the project
for Idenix. It was open to the judge to find on a balance of probabilities that
Dr. Stewart conveyed this information to Ms. Wang, who then altered her
experiments to incorporate it.
(4)
Errors relating to synthesis of the Claimed
Compound
[42]
It is not contentious that the 191 Patent does
not teach the fluorination step necessary to synthesize the Claimed Compound. However,
Idenix alleges that it would have been straightforward to the skilled person in
light of the common general knowledge. Idenix alleges that the judge erred in his
analysis related to the fluorination step.
[43]
Specifically, Idenix submits that the judge
mistakenly understood that specific reaction conditions were required for
methylation, leading him to believe that methylation required more
experimentation to achieve than the evidence showed. Nothing turns on this
point, given the judge’s finding that the skilled person was not directed by
the 191 Patent or the common general knowledge to either the Intermediate
Compound, or the methylation step necessary for making the Intermediate
Compound (Reasons at paras. 457-58, 469, 483-84, 491). The difficulty of
carrying out the methylation step is irrelevant if the skilled person would not
know that methylation was the next step towards creating the Claimed Compound.
[44]
As noted above, Idenix argued that the 191
Patent either taught the skilled person to begin the synthesis process by
selecting the nucleoside or sugar ring pathways or that it would have been
apparent to do so, given the references in the 191 Patent directing the skilled
person to the Intermediate Compound. The judge rejected these submissions. At
paragraph 509 of the Reasons, the judge accepted the evidence of Dr. Wnuk that:
the skilled person would have had multiple
different starting materials to choose from, multiple reagents to choose from,
multiple possible routes that could have been tried, multiple protecting groups
available, and multiple possible reaction conditions that could have been
attempted for each step in the chosen route.
[45]
The judge found that Idenix was attempting to
read something into the 191 Patent that was not there (Reasons at paras. 491,
494, 512).
[46]
Since the filing date, all three synthesis
pathways (nucleoside, sugar ring and Gemcitabine) have been proven to work (Reasons
at para. 512). According to Idenix, this fact supports the sufficiency of its
disclosure because no matter which pathway the skilled person chose, they would
arrive at the Claimed Compound. Though reversed on other points, this Court
held in Novopharm Limited v. Pfizer Canada Inc., 2010 FCA 242 at
paragraph 79, [2012] 2 F.C.R. 69, that courts must “determine
whether the disclosure was sufficient as of the date of filing. As a result,
anything which occurred subsequent thereto is of no relevance.” In my
view, Idenix’s argument reflects the benefit of hindsight rather than the
knowledge of the skilled person at the relevant date.
[47]
Although dealing with the question of
sufficiency of disclosure, analogy may be made to the Supreme Court of Canada’s
decision in Teva. The Supreme Court held that, since Pfizer’s patent
disclosed two compound claims, only one of which worked, the skilled person
would have had to “undertake a minor research project
to determine which claim is the true invention” (Teva at paras.
74-75). The Supreme Court held that Pfizer had not met its obligation to fully
disclose the invention.
[48]
I agree with the judge and Dr. Wnuk that “the fact that, in hindsight, individual steps in a chemical
synthesis have some precedent in the literature does not mean that the overall
sequence of steps for making a new compound was easy to determine”
(Reasons at para. 548). In the case at bar, since at the date of filing the
skilled person would not have known which pathway, along with the associated
choices of reagents and reaction condition, would successfully lead to the
claimed invention, the skilled person was faced with a similar task, at a
conceptual level, as in Teva.
[49]
Rather than leading the skilled person step by
step through the synthesis of the Claimed Compound, the specification “necessitates the working out of a problem” (Pioneer
Hi-Bred v. Canada (Commissioner of Patents), [1989] 1 S.C.R. 1623 at 1641,
1989 CanLII 64). The judge accepted the evidence of Dr. Wnuk at paragraph 516
of his Reasons that:
there was no teaching as to how to
fluorinate a tertiary carbon at a nucleoside's 2' position in a stereoselective
manner. I also accept his evidence that it was not common general knowledge
that using a nucleophilic fluorination approach, or indeed any fluorination
approach, would successfully synthesize a 2'-C-Me/F compound.
[50]
In the absence of any teaching from the 191
Patent, this constituted a burden beyond that borne by the text of paragraph
27(3)(b) of the Patent Act as interpreted and applied in the
jurisprudence. I would uphold the judge’s finding that the disclosure of the
191 Patent was insufficient.
[51]
Further, I note that the judge found that
neither the 191 Patent nor the common general knowledge directed the skilled
person to the Intermediate Compound. Even if the fluorination step was
disclosed, and even if the skilled person was directed to either the nucleoside
or sugar ring approach, a step necessary for sufficient disclosure of how to
make the Claimed Compound using either of those methods remained missing. In
the event that Idenix was able to satisfy this Court that the judge made
numerous errors with respect to the fluorination step, unless these errors also
go to identification of the Intermediate Compound, and I find that they do not,
the judge’s conclusions on this point stand.
B.
Sound prediction of utility
[52]
Idenix next challenges the judge’s finding that
the 191 Patent was invalid for lack of sound prediction. Having found no
reversible error in the judge’s conclusion that the 191 Patent was invalid due
to insufficiency of disclosure, it is not necessary for this Court to deal with
Idenix’s submissions on utility. However, I do not wish for these reasons to be
taken as endorsing the judge’s approach to sound prediction.
C.
The 657 Patent
[53]
Having found no reversible error in the judge’s
conclusion that the 191 Patent is invalid due to insufficiency of disclosure,
the 657 Patent was not anticipated nor did it infringe the 191 Patent.
V.
Conclusion
[54]
For the reasons above, the appeal should be
dismissed with costs.
“Donald J. Rennie”
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“I agree
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J.D. Denis Pelletier J.A.”
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“I agree
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D.G. Near J.A.”
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