Docket: T-852-14
Citation:
2016 FC 344
Ottawa, Ontario, April 1, 2016
PRESENT: The
Honourable Mr. Justice Zinn
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BETWEEN:
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ALLERGAN INC.
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Applicant
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and
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APOTEX INC. AND
THE MINISTER OF
HEALTH
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Respondents
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and
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SENJU
PHARMACEUTICAL CO., LTD AND
KYORIN
PHARMACEUTICAL CO., LTD.
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Respondents/Patentees
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PUBLIC JUDGMENT AND REASONS
(Confidential Judgment and Reasons
released March 22, 2016)
[1]
Allergan Inc. [Allergan] seeks an Order,
pursuant to the Patented Medicines (Notice of Compliance) Regulations,
SOR/93-133, prohibiting the Minister of Health from issuing a Notice of
Compliance to Apotex Inc. [Apotex] for its gatifloxacin ophthalmic product
until after the expiration of Canadian Patent No. 2,307,632 [the 632 Patent].
[2]
The 632 Patent claims aqueous liquid
pharmaceutical compositions (in the form of eye drops, ear drops, or nasal
drops) containing gatifloxacin and disodium edetate [EDTA]. It has a priority
date of August 21, 1998, a filing date of August 20, 1999, and a publication
date of March 3, 2000.
[3]
The 632 Patent contains 10 claims. Claims 6-8
are method claims that relate to positive effects that can be brought about by
adding EDTA to gatifloxacin. Claim 6 covers a method for raising gatifloxacin’s
corneal permeability by adding EDTA. Claim 7 covers a method for preventing
the precipitation of gatifloxacin crystals in solution by adding EDTA. Claim 8
covers a method for preventing the coloration of a gatifloxacin solution by
adding EDTA.
[4]
Claims 1-5, 9, and 10 are pharmaceutical
composition claims involving variations in the amount of gatifloxacin claimed,
the amount of EDTA claimed, the pH level of the solution, and the form of
delivery (eye drops, ear drops, or nasal drops).
[5]
In this application, Allergan relies solely on Claim
10 of the 632 Patent, as it reads on Claims 9, 3, 2, and 1. These claims are
as follows:
1. An aqueous liquid pharmaceutical
composition which comprises Gatifloxacin or its salt and disodium edetate.
2. The aqueous liquid pharmaceutical
composition according to claim 1, wherein pH of the composition is within the
range of 5 to 8.
3. The aqueous liquid pharmaceutical
composition according to claim 1 or 2, where the composition is in the form of
eye drops.
9. The aqueous liquid composition according
to any one of claims 1 to 5, wherein Gatifloxacin or its pharmaceutically
acceptable salt is contained in an amount of 0.1 to 1.0 w/v% and disodium
edetate is contained in an amount of 0.001 to 0.2 w/v%.
10. The aqueous liquid composition
according to claim 9, wherein the amount of disodium edetate is 0.01 to 0.1
w/v%.
[6]
Allergan submits, and I agree, that when read in
conjunction with Claims 9, 3, 2, and 1, Claim 10 covers:
An aqueous liquid pharmaceutical composition
in the form of eye drops wherein the pH of the composition is within the range
of 5 to 8 which comprises Gatifloxacin or its pharmaceutically acceptable salt
in an amount of 0.1 to 1.0 w/v% and [EDTA] in an amount of 0.01 to 0.1 w/v%
[the Invention].
[7]
Apotex alleged in its Notice of Allegation [NOA]
and in its submissions that the 632 Patent is invalid because it is obvious and
lacks utility. The issue is whether either allegation is justified. Apotex
must show that there is evidence that, if accepted, is capable of rebutting the
presumption of patent validity enshrined in subsection 43(2) of the Patent
Act, RSC, 1985, c P-4. If Apotex does that, then Allergan must demonstrate
on a balance of probabilities that the allegations of obviousness and inutility
are not justified: Abbott Laboratories v Canada (Minister of Health),
2007 FCA 153 at paras 9-10; Allergan Inc v Canada (Minister of Health),
2012 FC 767 at para 42.
[8]
In light of the few issues raised and my
preference for the evidence of one of the expert witnesses, only brief reasons
are required to explain my finding that Allergan has not demonstrated that
Apotex’s allegations are not justified.
THE
EVIDENCE
[9]
Allergan relied on the expert evidence of Dr.
Joseph Fix, who attests that he has expertise in “the
area of drug delivery and formulation.”
[10]
Apotex relied on the expert evidence of Dr. Paul
Myrdal, a formulator, and Dr. Heather Sheardown, “a
chemical engineer with a focus on studying and developing delivery formulations
for ophthalmic applications.”
[11]
Apotex urges that little weight be given to the
evidence of Dr. Fix:
His evidence is flawed: (a) he was not
“blinded” to the issues, having reviewed the NOA and the 632 Patent prior to
preparing his opinion; (b) he was not properly instructed on obviousness and
utility; (c) he construed the patent from his perspective (with over 30 years’
experience) rather than a skilled person; (d) he construed the inventive
concept and the promise by determining what would make the 632 Patent different
than the prior art; (d) he was out of touch with the state of the art in formulating
ophthalmic products in 1998, e.g., he opined that EDTA was not then a
conventional excipient used in ophthalmic formulations when the evidence
clearly shows that it was; (f) he reviewed each reference in isolation instead
of construing a mosaic of the prior art; and (h) he did not closely review all
the documents relied on by Apotex in its NOA and, consequently, missed or
ignored critical aspects of the prior art. [references omitted]
[12]
While I am not convinced that all of these
alleged flaws are made out, I am satisfied, for the following reasons, that the
evidence of Dr. Sheardown is to be preferred and given more weight than that of
Dr. Fix and Dr. Myrdal.
[13]
As noted by Apotex, Dr. Fix was not blinded; he
offered his opinion after having read the 632 Patent and Apotex’s NOA and after
having discussed both with Allergan. The Supreme Court of Canada in Apotex
Inc v Sanofi-Synthelabo Canada Inc, 2008 SCC 61, [2008] 3 S.C.R. 265 [Plavix
SCC] at para 67, directs that an obviousness assessment is to be
made “without any knowledge of the alleged invention as
claimed.” Relying on this observation, this Court has recognized that
evidence from experts who have not seen the patent nor been apprised of the
positions of the litigants is to be given greater weight on issues going to obviousness
and patent construction than the evidence of an expert with full knowledge of
the patent’s disclosure and the positions of the parties: AstraZeneca Canada
Inc v Apotex Inc, 2014 FC 638 [Esomeprazole FC] at para 321; Teva
Canada Innovation v Apotex Inc, 2014 FC 1070 at paras 94-97; Takeda
Canada Inc v Canada (Minister of Health), 2015 FC 570 at paras 27-29.
[14]
Like Dr. Fix, Dr. Myrdal had prior
knowledge of the 632 Patent (or the U.S. equivalent) and the positions of the
parties. As acknowledged by Apotex, “[Dr. Myrdal]
testified in a United States case on the corresponding patent and his evidence
… in the present proceeding was consistent with his U.S. evidence.”
[15]
Apotex brought to the Court’s attention two proceedings
before the United States Court for the District of Delaware, in which Dr.
Myrdal testified. Apotex submits that in both cases, the court concluded that
the U.S. equivalent to the 632 Patent was found invalid for obviousness. Those
findings are clearly not binding on this Court, nor are those decisions of any
persuasive value in the absence of expert evidence as to the relevant law in
that jurisdiction and its similarity, if any, to the jurisprudence binding on
this Court. In any event, even if the patents are “equivalent,”
their language is not identical.
[16]
Unlike the other experts in pharmaceutical
formulation, Dr. Sheardown expressed her opinion on the common general
knowledge and the prior art with no knowledge of the patent at issue or the
positions of the parties. As such, her responses to the questions asked of her
came without any influence, conscious or unconscious. Moreover, of the three, only
Dr. Sheardown’s expertise focused on “studying and
developing delivery formulations for ophthalmic applications.” Dr. Fix
and Dr. Myrdal are expert formulators. However, given that the alleged invention
in the claims at issue is specifically directed to an ophthalmic medication in
the form of an eye drop, I am of the view that the evidence of the one expert
specializing in that area, whose opinion is offered with no possible influence,
is to be preferred.
OBVIOUSNESS
[17]
If a claimed invention is obvious, then it is
not patentable because it fails to meet the definition of “invention” in
section 2 of the Patent Act, and it fails to meet the test set out in section
28.3 of being “subject-matter that would not have been
obvious on the claim date to a person skilled in the art or science to which it
pertains.”
[18]
The Supreme Court of Canada in Plavix SCC
at para 67 set out a four-step approach to assessing whether a claimed
invention is obvious:
(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?
Step 1: Person of Skill in the Art and
Common General Knowledge
[19]
The parties agree that the person of skill in
the art [POSITA] would have expertise in drug formulation and delivery and
pharmaceutical chemistry, be able to follow the instructions of the prior art
to make formulations, and would have some knowledge of statistics by virtue of
their scientific education.
[20]
Allergan submits that the 49 references cited in
Apotex’s NOA are not representative of the common general knowledge because they
were collected by Apotex, with the benefit of hindsight, and with a view to invalidating
the 632 Patent. Moreover, it notes that Apotex’s two experts did no
independent prior art search.
[21]
I agree with Apotex that these objections are
without merit. Apotex’s experts provided reasons as to why these references
would have been easily located during a prior art search or stated that they
would already have been known to the POSITA. Dr. Sheardown attests that “many of the documents are well-known references in the field
of pharmaceutical formulation, in particular the field of ophthalmic
formulations,” that she is familiar with many of the articles and texts,
and that any of the others would have been easily located by a formulator
conducting a diligent search in 1998. More importantly, Allergan has offered
no evidence that there are other material references constituting the prior art
that are not included in the NOA, or that those referenced in the NOA do not
constitute the common general knowledge.
[22]
Much of the relevant common general knowledge is
set out in the specification of the 632 Patent, and may be summarized as
follows:
•
Gatifloxacin is a quinolone;
•
Gatifloxacin is an antimicrobial agent which is
known to have strong antimicrobial activity against Gram-negative and
Gram-positive bacteria, anaerobes and mycoplasmas;
•
Gatifloxacin had been proposed to treat
ophthalmic infectious diseases;
•
Passage of the active ingredient in eye drops is
inhibited by tearing and by the barrier function of the cornea and thus
increasing corneal permeability by using an absorption enhancer is advantageous;
•
EDTA lowers “the calcium
concentration in corneal epithelium cells and expand[s] intercellular spaces,
thereby accelerating passing of a water-soluble medicament into the inside of
eyes;” and
•
“[T]he solubility of
gatifloxacin depends on its pH and its solubility at about physiological pH is
very low.”
[23]
In addition, I accept the evidence of Dr.
Sheardown that the following is also part of the common general knowledge:
•
That fluoroquinolones (other than gatifloxacin)
were being used in ophthalmic formulations;
•
That the ophthalmic fluoroquinolone formulations
on the market were Ciloxan (ciprofloxacin), Chibroxin (norfloxacin), and
Ocuflox (ofloxacin);
•
That two of these fluoroquinolone formulations,
Ciloxan and Chibroxin, contained EDTA;
•
That Ciloxan contained a 0.3% concentration of
ciprofloxacin and a 0.05% concentration of EDTA; and
•
That EDTA was an approved excipient used in FDA
approved ophthalmic solutions; and
•
That EDTA was a metal chelator.
Step 2: The Inventive Concept
[24]
Step two requires that the Court discern the
inventive concept of the claim, starting with the claim itself. However, if
the inventive concept is not readily discernable from the claim, the Court may
look to the specification, provided that, in doing so, it does not construe the
claim more narrowly or broadly than the text of the claim will allow (Plavix
SCC at para 77).
[25]
Allergan submits that the incentive
concept of Claim 10 is not discernible from the claim itself but submits that
the disclosure shows that the inventive concept, as attested by Dr. Fix, “is the finding that formulating gatifloxacin in the amount
of 0.1 to 1.0 w/v% with EDTA concentrations in the range of 0.01 to 0.1 w/v%
increases the corneal permeability of gatifloxacin, or prevents the
precipitation of gatifloxacin, or prevents discoloration of the formulation.”
[26]
Apotex submits, as Dr. Myrdal attests, that the
inventive concept of Claim 10 is discernible from the claim itself and is “an aqueous composition containing from 0.1 to 1.0%
gatifloxacin and from 0.01 to 0.1% EDTA for use as an eye drop solution.”
[27]
Dr. Sheardown’s evidence, which I prefer and
accept, closely accords with the submission of Allergan. She attests that:
The inventive
concept of claims 1 to 3 of the 632 Patent is an aqueous composition containing
some amount of gatifloxacin and EDTA. The 632 Patent says that these
compositions are useful to provide one of the three purposes stated in the 632
Patent, namely, to: increase corneal permeability of gatifloxacin; prevent
precipitation of gatifloxacin crystals; and prevent coloration of the
gatifloxacin solution.
…
The inventive concept of claim 9 and 10 is
similar to that of claims 1 to 3 above, except that the amount of gatifloxacin
is between 0.1 and 1.0% and the amount of EDTA is either 0.001 to 0.2% (claim
9) or 0.01 to 0.1% (claim 10).
Step 3: The
Difference Between the State of the Art and the Inventive Concept
[28]
It is not disputed that combining
gatifloxacin and EDTA in the amounts set out in Claim 10 for use as an eye drop
was novel. Although, as attested by Dr. Sheardown, U.S. Patent 4,980,470 dated
December 25, 1990, disclosed that “gatifloxacin can be
formulated as eye drops” and it was also known that “EDTA was a conventional excipient used in ophthalmic
solutions as of August 1998.”
[29]
The parties differ on whether it was known in
the art that combining gatifloxacin and EDTA would increase corneal
permeability of gatifloxacin, prevent precipitation of gatifloxacin crystals,
and prevent coloration of the gatifloxacin solution.
[30]
Dr. Sheardown attests that penetration enhancers
improve corneal permeability thus permitting more of the active ingredient to
cross the cornea and enter the aqueous humour. As noted above, EDTA was known
as one such penetration enhancer.
[31]
She attests that a skilled person would have
expected that EDTA “in some circumstances” would have prevented precipitation:
[S]ince ETDA has some surfactant-like
properties, a skilled person would have expected that its addition to an
aqueous solution could assist in solubilizing a poorly soluble compound and
thus, in some circumstances, prevent precipitation.
[32]
She further attests that it was known that EDTA
was a chelating agent and that adding such an agent would prevent a gatifloxacin
solution from changing colour.
[33]
Thus, while the three advantages of the
Invention were not known with absolute certainty to be a consequence of
combining EDTA and gatifloxacin in the amounts set out in Claim 10, each was
known to some degree and was not an unexpected consequence of the combination.
Step 4: Do the differences
constitute steps which would have been obvious to the POSITA or do they require
any degree of invention?
[34]
Dr. Sheardown opines that there is nothing
inventive:
There is no practical difference between the
inventive concept of the claims of the 632 Patent and the common general
knowledge. Any differences between the inventive concept and the claims of the
632 Patent and what was known to the skilled person as of August 1998
constituted steps that would have been obvious to the skilled person. There
was nothing inventive to formulate gatifloxacin as a topical ophthalmic
solution with EDTA. The skilled person knew that EDTA in an ophthalmic
solution would have the effect of increasing the corneal permeability of polar
compounds. Gatifloxacin is a polar compound, and thus the skilled person would
have expected that incorporating EDTA into a gatifloxacin would serve to
increase the corneal permeability of gatifloxacin. The skilled person would
also have expected that incorporating EDTA into gatifloxacin solution would
prevent precipitation of gatifloxacin and prevent colorization due to
complexing of gatifloxacin with metal ions. [emphasis added]
[35]
Allergan’s counsel submits that the emphasized
passages show that this expert is using the utility test of “reasonable inference” rather than the obviousness
test of “ought to work.” With respect, counsel’s
parsing of the words of this expert’s affidavit results in a conclusion that is
not warranted and it is telling that this interpretation was not ever put to
her in cross-examination.
[36]
I begin by noting that obviousness is “largely concerned with how a skilled worker would have acted
in the light of the prior art:” Plavix SCC at para 70. That
inquiry proceeds using the four-step approach adopted by the Supreme Court
cited above at para 18. It is at the last step, when assessing whether the
differences between the claimed invention and the prior art constitute steps
which would have been obvious or that require a degree of invention, that the “obvious to try” test may be used when answering the
question.
[37]
The United States law on the obvious to try test
in KSR International Co v Teleflex Inc, 127 S Ct 1727 (2007) at 1742, as
recited in Plavix SCC at para 58, provides an excellent statement, in my
view, of the use of the obvious to try test when assessing obviousness:
When there is a design need or a market
pressure to solve a problem and there are a finite number of identified,
predictable solutions, a person of ordinary skill has good reason to pursue the
known options within his or her technical grasp. If this leads to the
anticipated success, it is likely the product not of innovation but of ordinary
skill and common sense. In that instance the fact that a combination was
obvious to try might show that it was obvious…
[38]
Where the obvious to try test is used, then one
must ask whether the step taken from the prior art to the claimed invention was
obvious in that there was a fair or reasonable expectation of success in
obtaining the invention: Eli Lilly Canada Inc v Mylan Pharmaceuticals ULC,
2015 FC 178 at para 150; Janssen Inc v Teva Canada Ltd, 2015 FC 184 at
paras 12-13; Pfizer Canada Inc v Apotex Inc, 2009 FCA 8 at para 44.
[39]
Dr. Sheardown opines, and I agree, that a POSITA
would have a fair and reasonable expectation that combining gatifloxacin with
EDTA would produce an effective ophthalmic compound that would have the three
advantages set out in the 632 Patent. It would not be a certainty, but it would
be higher than a fair expectation of success. In my view, it rises to the
level of being more or less self-evident: Eli Lilly Canada Inc v Mylan
Pharmaceuticals ULC, 2015 FCA 286.
[40]
I reach that conclusion based on the following
being known at the time:
•
That gatifloxacin, a fluoroquinolone, is an
antimicrobial agent which had been proposed to treat ophthalmic infectious
diseases;
•
That corneal permeability is enhanced using an
absorption enhancer and EDTA is an absorption enhancer;
•
That EDTA is an excipient that was used in two
other ophthalmic fluoroquinolone formulations on the market - Ciloxan and
Chibroxin;
•
That Ciloxan contained a 0.3% concentration of
ciprofloxacin and 0.05% concentration of EDTA;
•
That the Handbook of Professional Excipients
describes the application of EDTA in pharmaceutical formulations and states
that it is commonly used in amounts between 0.005 to 0.1%;
•
That EDTA is a known metal chelator; and
•
That adding EDTA to an aqueous solution could
assist in solubilizing a poorly soluble compound, such as gatifloxacin, and
thus, in some circumstances, prevent precipitation.
[41]
Given the state of the art, a person of ordinary
skill had good reason to pursue the known options within his or her technical
grasp; namely, combining gatifloxacin with EDTA in an ophthalmic solution.
Admittedly, the amount of each to include in the solution required testing, but
the nature of the testing was of the usual sort routinely carried out when developing
ophthalmic solutions and the range of concentrations was well within that known
in the literature. As such, the anticipated success was the product, not of
innovation but of ordinary skill and common sense.
UTILITY
[42]
To be patentable, the invention must be useful: Patent
Act, s 2.
[43]
The law as it currently stands is that an
invention need only possess a scintilla of utility and there is no requirement
that an inventor describe any particular utility for the invention. However,
if an inventor explicitly, using clear and unambiguous language, promises a
specific result, then he or she will be held to that promise and utility will
be assessed against that promise: Pfizer Canada Inc v Canada (Minister of
Health), 2008 FCA 108, [2009] 1 FCR 253 at para 53; Astrazeneca Canada
Inc v Mylan Pharaceuticals ULC, 2012 FCA 109 at para 7; Apotex Inc v
Pfizer Canada Inc, 2014 FCA 250 at paras 65-66.
[44]
Apotex submits that the 632 Patent “provides an explicit promise of a specific result, namely,
that the composition of Claim 10 will result in increased corneal permeability,
will not precipitate and will not discolour.” Allergan, in oral submissions,
stated that the utility of the 632 Patent is that “it’s
an effective antibiotic” thus taking the position that increased corneal
permeability, the prevention of precipitation, and the prevention of
colorization, are “objects” or “goals” of the patent, but not promises.
[45]
The Federal Court of Appeal in Pfizer Canada
Inc v Canada (Minister of Health), 2011 FCA 236 at para 17 instructs me
that, assisted by expert evidence, I am to purposively ascertain the promise of
the patent within the context of the patent as a whole, through the eyes of the
POSITA in relation to the science and information available at the time of
filing.
[46]
Dr. Sheardown, the POSITA whose evidence I
prefer, offers her opinion that the promised utility encompasses the three advantages
which Allergan submits are mere goals:
The promised utility is clearly and unequivocally described in the
632 Patent. The skilled person would understand that the patent explicitly
states that the gatifloxacin and EDTA compositions of the invention are useful
as follows: to increased or raise corneal permeability of gatifloxacin
compared to an aqueous solution that does not contain EDTA; to prevent
precipitation of gatifloxacin crystals compared to an aqueous solution that
does not contain EDTA; and to prevent colorization of gatifloxacin compared to
an aqueous solution that does not contain EDTA.
I agree.
[47]
The patent as a whole makes it clear that these
three items are promises of the invention. Aside from Claims 6, 7 and 8 where
these three results are method claims, the disclosure of the 632 Patent
contains statements that promise these when the patent is used:
…the present invention provides a method for
increasing corneal permeability of Gatifloxacin … a method for preventing
precipitation of Gatifloxacin crystals …and a method for preventing
colorization of Gatifloxacin …
Moreover, when
describing the three experiments conducted, similar statements of promised
utility are made:
…these results show that corneal
permeability of Gatifloxacin has been improved…
These results show that precipitation of
Gatifloxacin crystals under storage conditions at a low temperature is
prevented …
…these results show that addition of
disodium edetate can prevent coloration of Gatifloxacin.
[48]
The most telling statement in the 632 Patent
leading to the conclusion that these three aspects of the invention are
promises of utility, is the final statement in the specification:
As shown in Experiment 1, according to the
eye drops of the present invention, corneal permeability of the effective
component, Gatifloxacin, can be improved even by using disodium edetate in 1/10
amount as much as normally used. Further, as shown in Experiment 2, the
aqueous liquid preparation of the present invention can prevent precipitation
of Gatifloxacin crystals under storage as [sic] a low temperature.
Furthermore, as shown in Experiment 2, colorization of Gatifloxacin by a metal
ion can be prevented. Thus the aqueous liquid preparation of the present
invention is very useful. [emphasis added]
In using the words
“thus” and “useful”
the inventor provides a clear statement that he is promising the three aspects
of the invention under discussion. These are promises of utility.
[49]
Were these promises of utility established by
the filing date of August 20, 1999, or were they soundly predicted?
[50]
Given the many compositions covered by Claim 10,
and the very limited testing done by the inventors, Allergan’s witness, Dr.
Fix, correctly conceded that this is not a case where the utility, as I have
described it, was demonstrated. Was it soundly predicted?
[51]
Allergan urges the Court to follow the decision
of Justice Rennie in Esomeprazole FC; aff’d 2015 FCA 158, wherein he expressed
his view that there is no disclosure requirement in cases of sound prediction
except in new use patents, that is to say, the factual basis for a sound
prediction of utility does not need to be disclosed in the patent itself. I
note that his discussion of his view on this was not necessary for the
disposition he reached (see para 139) and was not addressed by the Federal
Court of Appeal.
[52]
Apotex submits that the Federal Court of Appeal
in a number of prior cases and the Supreme Court of Canada in 2002, concluded
in cases of sound prediction, that the patentee may only rely on the facts and
line of reasoning disclosed in the patent: Apotex Inc v Wellcome Foundation
Ltd, 2002 SCC 77, [2002] 4 S.C.R. 153 at paras 70-72; Eli Lilly Canada v
Apotex Inc, 2009 FCA 97 at paras 12-15; Eli Lilly and Company v Teva
Canada Limited, 2011 FCA 220 at paras 47 & 50; Apotex Inc v Pfizer
Canada Inc, 2011 FCA 236 at paras 42-44 & 51-52. It argues that this
remains the law in Canada unless, as is suggested by Justice Rennie and
Allergan, it was reversed by the Supreme Court of Canada in Teva Canada Ltd
v Pfizer Canada Inc, 2012 SCC 60, [2012] 3 S.C.R. 625 [Teva sildenafil].
[53]
Justice Rennie acknowledges at paragraph 142 of
his Reasons that the passage in Teva sildenafil he relies upon is an obiter
remark. Indeed at paragraph 43 of his Reasons, Justice LeBel states that sound
prediction is not an issue in the case and “whether
there is an ‘enhanced’ or ‘heightened’ disclosure requirement does not arise in
this case and need not be addressed.” He repeats this observation at
paragraph 89.
[54]
The Federal Court of Appeal in Bell
Helicopter Textron Canada Limitée v Eurocopter, 2013 FCA 219, which was decided
after Teva sildenafil and referenced that decision, in my view held that,
with the exception of matters of common general knowledge, the factual basis
and the line of reasoning must be included in the patent:
[151] In Teva Canada Ltd. v. Pfizer
Canada Inc., 2012 SCC 60, [2012] 3 S.C.R. 625 (“Teva”), LeBel J. recently
noted (at para. 37) that “[t]he lack of certainty that comes from predicting
rather than demonstrating an invention's utility has led some courts to
conclude that there is a ‘heightened’ or ‘enhanced’ disclosure requirement in
cases in which a claim of utility is based on sound prediction: see e.g. Eli
Lilly Canada Inc. v. Apotex Inc., 2009 FCA 97, 78 C.P.R. (4th) 388
(F.C.A.), at paras. 14-15.” However, LeBel J. refused to address the question
since the issue did not arise in that case (Teva at para. 43). He
nevertheless made comments (at paras. 38 to 40 of Teva) suggesting that
nothing in the Patent Act requires that the utility of the invention be
disclosed, and he referred approvingly to the comments of Dickson J. in Consolboard,
at p. 521, “that s. 36(1) [now s.27(3)] [of the Patent Act] does not
impose upon a patentee the obligation of establishing the utility of the
invention.” In Sanofi-Aventis v. Apotex Inc., 2013 FCA 186 at paras.
47-49, Pelletier J.A. recently also noted that while an inventor need not
describe the utility of his invention in the patent, if he does so, he will be
held to the promise he made.
[152] In my opinion, the factual basis, the
line of reasoning and the level of disclosure required by the doctrine of sound
prediction are to be assessed as a function of the knowledge that the skilled
person would have to base that prediction on, and as a function of what that
skilled person would understand as a logical line of reasoning leading to the
utility of the invention.
[153] Where the factual basis can be found
in scientifically accepted laws or principles or in information forming part of
the common general knowledge of the skilled person, then no disclosure of such
factual basis may be required in the specification. On the other hand,
where the factual basis is reliant on data which does not form part of the
common general knowledge, then disclosure in the specification may indeed be
required to support a sound prediction.
[154] As noted in the Manual of Patent
Office Practice issued by the Canadian Patent Office (at paras. 12.08.04b and
12.08.04c), since a sound line of reasoning is directed to a skilled person,
those elements of the doctrine of sound prediction that would be self-evident
to that person in view of the common general knowledge need not be explicitly
disclosed in the specification. The soundness of a line of reasoning can also
be effectively assessed by asking whether the skilled person would accept the
logic presented in the specification and derive from the sound prediction as a
whole an expectation that the invention will provide the promised utility.
[155] As a result, where the sound
prediction is based on knowledge forming part of the common general knowledge
and on a line of reasoning which would be apparent to the skilled person (which
is often the case in mechanical inventions), the requirements of disclosure may
readily be met by simply describing the invention in sufficient detail such
that it can be practiced. A contextual approach is thus appropriate in
each case. [emphasis added]
[55]
Indeed, the observation at paragraph 155 above
is precisely the situation Justice Gauthier spoke of in Sanofi-Aventis v
Apotex Inc, 2013 FCA 186, [2015] 2 FCR 644, referenced and relied upon by
Justice Rennie, where she said at para 134: “In
contradistinction with the situation in AZT, where the invention claimed was
the new use/utility and thus the quid pro quo for the grant of the monopoly was
a full disclosure in respect of such utility, the public here received all
the information necessary to make and use clopidogrel, the invention claimed in
the ‘777 Patent” [emphasis added]. As was the case in Teva
sildenafil, these are obiter comments (see para 123).
[56]
After these decisions, this Court has applied
the law as it stood prior to Teva sildenafil: see Laboratoires
Servier v Canada (Minister of Health), 2015 FC 108 at paras 219-225.
[57]
With the greatest of respect to the views of
Justice Rennie, I am not prepared to depart from established jurisprudence directly
on point from the higher courts by relying on obiter statements of a few
judges in cases where the issue of utility was not fully and thoughtfully
addressed. In my view, until the Federal Court of Appeal or the Supreme Court
of Canada rules otherwise, Canadian jurisprudence is that, with the exception
of matters of common general knowledge, the factual basis and the line of
reasoning must be included in the patent.
[58]
Apotex in its Notice of Allegation detailed why,
in its view, the inventors had no sound basis to predict that the composition
of Claim 10 would prevent precipitation. Dr. Sheardown offered evidence to
this effect:
According to Experiment 2 in the 632 Patent,
three formulations were tested (Formulations B, C and D) and the two formulations
that contained ETDA (C and D) did not precipitate after ten freeze/thaw cycles,
whereas precipitation occurred after three cycles with Formulation B. Although
these data suggest that the inventors could have predicted that EDTA
concentrations equal to or greater than 0.05% [being the amount of EDTA in
Formulation C, while Formulation D had 0.1%] will prevent precipitation of gatifloxacin,
it is my opinion that the inventors could not have predicted that lower
concentrations, such as 0.01% or 0.001% would have prevented precipitation of
gatifloxacin. There is no basis discussed in the patent from which a
prediction could be made that these lower concentrations of EDTA would prevent
precipitation.
[59]
In response, Allergan offered the evidence of
Dr. Fix. After observing that the only difference in the three formulations
tested was the presence of EDTA in formulations C and D, he states that “a skilled person would infer that EDTA was the component of
the formulation impacting gatifloxacin’s precipitation.”
[60]
In my view, Dr. Fix is saying no more than Dr.
Sheardown; i.e. in the amounts in the tested formulations (0.05% and 0.1%), the
skilled person would infer that EDTA was the component impacting on
precipitation. What he does not say in his affidavit is that the skilled
person would also infer or know that this result would be obtained with the
much lower levels of ETDA specified in Claim 10. Nowhere does Dr. Fix assert
that it would be inferred that precipitation would be prevented if any amount
of ETDA within the range set out in Claim 10 was added to the solution, let
alone provide the basis for such a conclusion.
[61]
For these reasons, I find that the utility of
the 632 Patent is not established by Allergan.
[62]
Allergan has failed to disprove the allegations
of Apotex in respect of Claim 10 of the 632 Patent, namely that it is obvious
and lacks utility. Accordingly, this application for a prohibition order must
be dismissed with costs to Apotex.
[63]
If the parties are unable to agree on costs,
they may exchange and file submissions with the Court within 20 days of the
release to them on a confidential basis of the Judgment and Reasons.
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