Docket: T-1555-12
Citation: 2014 FC 314
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BETWEEN:
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PFIZER CANADA INC.
AND G. D. SEARLE & CO.
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Applicants
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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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PUBLIC REASONS FOR ORDER
(Identical
to the Confidential Reasons for Order Issued April 1, 2014)
HARRINGTON J.
[1]
Pfizer and Searle seek an order to prohibit the
Minister of Health from issuing Apotex a Notice of Compliance which would allow
it to market its version of Celecoxib before the relevant Canadian patent
expires this coming November. Celecoxib, widely marketed under its brand name
Celebrex®, is known today to be useful in treating inflammation and associated
pain. It may, or may not, have fewer harmful side effects than other NSAIDs
(Non-Steroidal Anti-Inflammatory Drugs).
[2]
The patent in issue, Canadian Patent No.
2,177,576 (‘576) entitled Substituted Pyrazolyl Benzenesulfonamides for the
Treatment of Inflammation, held by Searle, was filed in Canada on 14
November 1994, issued 26 October 1999 and expires 14 November 2014. It is said
to relate to compounds, compositions and methods for treating inflammation. It
claims a class of compounds, eventually cascading down to three compounds
individually claimed and also claims uses in treating inflammation and
inflammation-associated disorders in general, as well as specific disorders
such as arthritis. One claim is for use in the preparation of a medicament for
the prevention of colorectal cancer.
[3]
As the patent was registered with the Minister
in accordance with the Patented Medicines (Notice of Compliance) Regulations,
Apotex cannot market its generic version of Celebrex® before the patent
expires, unless it successfully invokes one of the four grounds set out in the
Regulations: such that
a.
certain statements in the patent are false;
b.
the patent has expired;
c.
the patent would not be infringed; or
d.
the patent is not valid.
It served Pfizer, the successor to Searle,
with a Notice of Allegation setting forth several reasons for which it states
the patent is invalid. It did not raise other grounds.
[4]
Pfizer reacted by filing a Notice of Application
with this Court which has the effect of barring the Minister from issuing a
Notice of Compliance before the patent expires unless the Court decides that
Apotex’s allegations are not justified, or until two years have passed since
Pfizer’s application was filed, whichever comes first. The application was
filed on16 August 2012.
[5]
It should not be thought that Apotex’s goal is
simply to get its generic version of Celecoxib to market a few months before
the patent expires. Under s. 8 of the Regulations, if Pfizer’s application is
dismissed, it would be liable to Apotex for any loss during the period in which
a Notice of Compliance would have been issued absent the Regulations.
[6]
I recently had the occasion to briefly describe
the complicated process and to refer to the leading cases in another PM(NOC)
application by Pfizer under the same patent, Pfizer Canada Inc and G. D.
Searle & Co v Mylan Pharmaceuticals ULC and the Minister of Health,
2014 FC 38 [Mylan (Celebrex)], which is currently under appeal.
[7]
In order to succeed in this application, Pfizer
and Searle (collectively “Pfizer”) must persuade this Court on the balance of
probabilities that not a single one of Apotex’s several allegations of patent
invalidity is justified as against at least one of the sixteen claims therein.
[8]
In order to be patentable, the subject matter of
an invention must be new, not obviousness, and useful. Newness and obviousness
were not raised by Apotex. The specification must fully and correctly describe
its subject matter and its use so that the person skilled in the art or science
involved may, as in this case, make the medicine and use it as the inventor
intended, relying only on the patent itself.
[9]
No particular utility need be claimed. It need
not be demonstrated. Utility may also be based on a sound prediction (Apotex
Inc v Wellcome Foundation Ltd, 2002 SCC 77, [2002] 4 S.C.R. 153, [2002] SCJ No
78 (QL) [AZT]. It was held in AZT that the inventor must
establish utility as of the date of the patent application, either by
demonstration or by sound prediction based on the information and expertise
then available. The doctrine of sound prediction has three components:
a.
there must be a factual basis for it;
b.
the inventor must have had at that time an
articulate and “sound” line of reasoning from which the desired result can be
inferred from the factual basis; and
c.
there must be proper disclosure.
[10]
The specification discloses the invention and
ends with claims which distinctly define the subject matter for which an
exclusive privilege or property (monopoly) is claimed. If the patent contains
more than one claim, some of which are held to be valid and others not, the
valid claims remain in place (Patent Act, sections 2, (27(3)), (27(4)),
28.3 and 58).
[11]
According to Apotex, the purported invention
belongs to a class of compounds said to be useful in treating inflammation and
its associated pain in animals, including humans, with reduced harmful side
effects as compared to other NSAIDs.
[12]
These are the reasons it says the patent is
invalid:
a.
Even though Celebrex® is known today to be
useful in treating inflammation and associated pain, Searle had no basis for
making that assertion in 1994 when it applied for patent protection. It had
neither demonstrated nor had a sound basis for predicting that utility;
b.
Furthermore, Searle had neither demonstrated nor
had a basis for soundly predicting reduced harmful side effects. Even if it
did, it is now clear that Celebrex® has no better side effect profile than
other NSAIDs;
c.
Searle did not properly disclose the invention
because:
i.
it knew when the patent application was filed
that one of the compounds individually claimed (Claim 5) was toxic and
therefore useless;
ii.
one of the uses claimed, Claim 16, for the
prevention of colorectal cancer, is unfounded;
iii.
Searle failed to state in its patent application
that it had already intended to seek U.S. regulatory approval for one of the
compounds individually claimed (Claim 4), Celecoxib or Celebrex®. This was the
true invention which it was obliged to disclose rather than to hide it as a
“leaf in the forest” (Teva Canada Ltd v Pfizer Canada Inc, 2012 SCC 60,
2012 3 SCR 625, [2012] SCJ No 60 (QL) [Teva (Sildenafil/Viagra)], para
30).
[13]
Pfizer construes the patent differently.
According to it, the promised utility is that the claimed compounds would be
anti-inflammatories. There was no promise that the compounds would be useful in
treating humans and there was no promise of reduced side effects.
Alternatively, if there was actually a promise of reduced side effects, it did
not extend to humans. In any event, the evidence establishes that Celebrex®, in
fact, carries with it significantly reduced harmful side effects in humans as
compared to other NSAIDs.
[14]
Pfizer submits the patent met the disclosure
requirements of s. 27 of the Act. This case is quite distinct from the Supreme
Court’s decision in Teva (Sildenafil/Viagra), above. In that case, only
one of the claimed compounds was known to work. In the case at bar, all three
compounds individually claimed work. There was no obligation on Searle to
disclose its commercial intentions.
[15]
Both sides have to deal with two previous PM
(NOC) decisions on Patent ‘576. In G. D. Searle & Co v Novopharm Limited,
2007 FC 81, [2007] FCJ No 120 (QL), [Novopharm (Celebrex)] reversed at
2007 FCA 173, [2007] FCJ No 625 (QL), but not with respect to the construction
of the patent, Mr. Justice Hughes held that both the anti-inflammatory
properties and lesser side effects were necessary to the utility of the claimed
invention. In Mylan (Celebrex) above, I held there was no promise of
reduced side effects. Apotex asserts that the construction in Novopharm
was correct, but that the evidence of utility before me is different. Pfizer
says that although my decision in Mylan (Celebrex) is a departure from Novopharm,
it is consistent with recent jurisprudence of the Federal Court of Appeal, so
that comity is not in issue.
[16]
I shall consider exactly what was invented;
whether in 1994 there was a basis for asserting it was useful be it by way of
demonstration or prediction; whether it has reduced harmful side effects today
and whether it was properly disclosed. Finally, I have to decide whether
Pfizer’s submission that the patent did not promise reduced side effects is an
abuse of process, considering it conceded that utility in Novopharm
(Celebrex), above.
What Was Invented
[17]
The scope of the invention is of crucial
importance. If, as Apotex asserts, the purported patent promises
anti-inflammatory agents useful in treating animals including humans, then the
patent is invalid because at the time the application was filed, the inventors
had neither demonstrated nor had a sound basis for predicting use as an
anti-inflammatory in humans. If that is the case, it would not be necessary to consider
whether the patent also promised significantly less harmful side effects.
[18]
If, as Pfizer asserts, the scope of the
invention is a class of compounds useful for treating inflammation and
inflammation-associated disorders, to use the words of the patent, “in a
subject”, which does not include humans, then we must determine whether at the
time of filing that utility had been demonstrated or a sound basis had been
articulated to support the prediction.
[19]
I find that if less harmful side effects were
promised in humans, there certainly was no demonstration to that effect. Was
there a sound basis for that prediction and if so, has Pfizer established that
Apotex’s allegation in that regard is not justified?
[20]
The task facing Searle, and its pharmaceutical
competitors, in the early 1990s, was to develop a NSAID with reduced side
effects. That was the problem, and Searle may have found a solution. It does
not necessarily follow, however, that it patented the solution. Indeed, it
would be risky to claim reduced side effects in humans given that testing on
humans had not yet begun.
[21]
The known science at the time was that prostaglandins
induce pain and swelling associated with the inflammation process. Traditional
NSAIDs inhibit their production and thereby reduce pain. However high doses
thereof may produce severe side effects, particularly in the gastrointestinal
tract, including life threatening ulcers.
[22]
Traditional NSAIDs prevent the production of
prostaglandins by inhibiting enzymes particularly cyclooxygenase (COX).
However, COX also protects the stomach from the acid therein. Consequently its
inhibition leaves the stomach vulnerable.
[23]
Later, it was discovered that there are in fact
two cyclooxygenases, today known as COX I and COX II. While COX I is ever
active in protecting the stomach, COX II is latent and only comes to the fore
when there is an injury, or an inflammation, such as arthritis. The hypothesis
at the time was that if one could inhibit COX II more than COX I, there would
be fewer side effects than with the traditional NSAIDs which are non-selective
in that they inhibit both COX I and COX II.
[24]
This led to the development of Celecoxib or
Celebrex®.
[25]
The invention is described in the patent as “a
class of compounds useful in treating inflammation-related disorders [...]
defined by Formula I…” A great number of compounds were claimed, although no
one presented me with a calculation as to exactly how many compounds and
pharmaceutically-acceptable salts were covered. The patent goes on to state
that within Formula I, there is a subclass of compounds of “high interest”
represented by Formula II. Later on, it was said that “a family of specific
compounds of particular interest within Formula II consists of compounds and
pharmaceutically-acceptable salts thereof as follows…” Sixteen such compounds
were disclosed.
[26]
The specification ends with 16 claims over which
a monopoly is sought:
•
Claims 1 to 3 are for compounds of formula I or
II. They are per se claims.
•
Claims 4 (Celebrex®) through 7 are per se
claims for individual compounds. Compound 7 does not seem to be in issue.
•
Claims 8 through 15 are claims for use in the
treatment of inflammation and inflammation-associated disorders, including
arthritis, pain and fever.
•
Finally, Claim 16 is for use of a compound
according to any of claims 1 to 7 “…for preparing a medicament for the
prevention of colorectal cancer in a subject.”
[27]
To deal first with whether the patent promised
the compounds invented would be useful as anti-inflammatory agents in humans,
Pfizer points out that the patent speaks of treatment of a “subject” not
humans. Apotex’s answer is that the long litany of disorders set out at page 7
of the patent includes some diseases only known in man. Furthermore, the in
vitro tests used cloned human enzymes. Consequently, it submits that the
“subject” to be treated must include humans. Pfizer retorts that this line of
reasoning runs counter to recent decisions of the Federal Court of Appeal
including Sanofi–Aventis v Apotex Inc, 2013 FCA 186, 114 CPR (4th) 1,
2013 FCJ No 856 (QL) [Plavex], leave to appeal to the Supreme Court
granted, and Mylan Pharmaceuticals ULC v Pfizer Canada Inc, 2012 FCA
103, 100 CPR (4th) 203, 2012 FCJ No 386.
[28]
I find that there was no clear promise that
Celebrex® would be useful in treating inflammation in humans. That may have
been a wish, an aspiration, a goal, a target or an advantage, but basing myself
on the two decisions of the Federal Court of Appeal to which I have just
referred, there was no actual promise.
[29]
To support the proposition that the invention is
useful in treating inflammation and pain associated therewith, the patent
reveals that a rat carrageenan foot pad edema test and a rat
carrageenan-induced analgesia test were successfully carried out. The patent
thus demonstrated utility. That utility was demonstrated in a species of
animal: rats. That was all that was promised, and that is what was delivered. I
find no merit in Apotex’s suggestion that these tests did not establish useful
treatment because the inflammation was induced by infecting the rats with
seaweed, or that more than one species of animal had to be tested. The fact is,
there was inflammation, it was reduced and so was the pain. In June and July
1994, prior to filing its application for a Canadian patent, Searle had prepared
a “Product Alert” which was a confidential internal document. It revealed that in
vivo tests, other than those disclosed in the patent, had also been carried
out on guinea pigs and dogs. According to Apotex, these tests, even if they
were to establish utility, cannot be relied upon as no reference whatsoever was
made to them in the patent. I need not consider the point as I am satisfied
that the tests referred to in the patent were sufficient. The patent
demonstrates treatment of inflammation and reduction of pain in a “subject”.
Reduced Side Effects in Humans
[30]
Unlike utility as an anti-inflammatory, this
issue was fully canvassed in the Mylan (Celebrex) decision, above. While
Apotex has persuaded me that some of the justifications that were used to
support my reasoning that no such promise was made were inappropriate, I remain
of the view that there was no such promise. The field of the invention as
disclosed in the patent is an anti-inflammatory pharmaceutical agent. No
mention is made of reduced side effects. Not one of the 16 claims at the end of
the specification mentions side effects. Apotex’s case, like Mylan’s, is based
on the lengthy paragraph commencing on page 7 of the patent which lists various
disorders for which compounds of the formula would be useful in treating. The
paragraph ends as follows: “The compounds are useful as antiinflammatory
agents, such as for the treatment of arthritis, with the additional benefit of
having significantly less harmful side effects.”
[31]
That paragraph has to be read with the next one
which states the invention preferably includes compounds which selectively
inhibit COX II over COX I. The paragraph ends with: “Such preferred selectivity
may indicate an ability to reduce the incidence of common NSAID-induced
side effects” (my emphasis).
[32]
Apotex submitted that some side effects are less
harmful than others, and led evidence to that effect. It says that the
paragraph starting on page 7 deals with harmful side effects while the
paragraph at page 8 refers to common, i.e. less harmful, side effects.
[33]
No skilled addressee of the patent interpreted
those two paragraphs in that way. This interpretation is a lawyer’s construct
derived from the fact that some side effects are more harmful than others.
[34]
Pfizer has not focussed on the skilled addressee
of the patent. Apotex does not take issue with my adoption of Mylan’s
submission in Celebrex that the person skilled in the art includes a
chemist and pharmacologist with experience pertaining to anti-inflammatory
drugs and COX. The patent may also be addressed to a clinician treating
arthritis and to a medical doctor, but nothing appears to turn on that.
[35]
I am fortified in my opinion that the word “may”
within the context of the patent merely connotes a possibility, and does not
constitute a promise, by the opinion of Dr. Robert N. Young, a chemistry
professor and medicinal chemist who was involved in Merck’s development of
Rofecoxib, the active ingredient in Vioxx which is another COX II inhibitor,
subsequently withdrawn from the market. In his opinion, the skilled addressee
would not find such a promise in the disclosure.
[36]
I remain of the view, better stated by Mr.
Justice Zinn in Fournier Pharma Inc v Canada (Health), 2012 FC 741,107
CPR (4th) 32, 2012 FCJ No 901 (QL) at para 126, that a utility not expressed in
the claim portion of the specification “[…] should be presumed to be a mere
statement of advantage unless the inventor clearly and unequivocally states
that it is part of the promised utility”. I realize that my reference to the principle
that what is usually not claimed is disclaimed at para 7 of Mylan (Celebrex)
and the reference to paragraph 42 of Whirlpool Corp v Camco Inc, 2000
SCC 67, [2000] 2 S.C.R. 1067, [2000] SCJ No 68 (QL) of my Public Reasons for
Order, was out of context. If there was but one invention disclosed in the
specification, it cannot very well be disclaimed by not referring to it in the
claims. Indeed, a claim for a compound per se need not disclose any
utility. The utility is found by taking into account the patent as a whole.
What I should have said was that the scope of the invention did not extend to
reduced side effects.
[37]
In Mylan (Celebrex), I also mentioned
that a number of COX II selective NSAIDs have been used to treat animals, such
as horses and dogs. That is true. Indeed, the evidence in this case is that one
of the compounds, Claim 6, is used to treat arthritis in dogs. My point was not
that the inventors had soundly predicted treatment in animals other than
humans, which in the course of time proved to be true, but rather that one
should not construe the promise, if one was made, to extend to reduced side
effects in humans.
[38]
Apotex referred to a decision of Mr. Justice
Pumfrey of the England and Wales High Court (Patents Court) upheld in the Court
of Appeal. In first instance, it was cited as Monsanto Company, G.D. Searle
& Company and Pfizer Inc v Merck & Co Inc and Merck, Sharpe & Dohme
Limited, [2000] EWHC Patents 154, and in appeal as Pharmacia
Corporation, G.D. Searle & Company and Pfizer Inc v Merck & Co Inc and
Merck, Sharpe & Dohme Limited, [2001] EWCA Civ 1610. This was an action
by the patentees for infringement of their European patent for Celecoxib. From
the judgments, it is clear that the specification was somewhat different. More
experiments had been disclosed, and more claims were made. However, the
specification did contain language similar to the last sentences of the
paragraphs set out in pages 7 and 8 of the patent before me. At para 46, Mr.
Justice Pumfrey stated:
The diffident statement that “Such preferred
selectivity may indicate an ability to reduce the incidence of common
NSAID-induced side effects, such as ulcers” again does not indicate that the
class includes compounds which are not Cox II selective […] The whole thrust of
the specification is towards Cox II selectivity.
[39]
The action was dismissed as the patent was found
to be invalid on a number of grounds. The passage from Mr. Justice Pumfrey’s
reasons which I have just quoted relates to the fact that he held that not all
the compounds claimed worked. There is no evidence of that here. With respect
to the decision of the Court of Appeal, Apotex relied particularly on para 26
where Lord Justice Aldous said:
The compounds are said to be useful
anti-inflammatory agents and have the additional benefit of having less harmful
side effects. The reader would believe that the specification was teaching that
they were less harmful that the commonly made NSAIDS because they were Cox II
selective.
However, that paragraph begins with the
following sentence:
The reader would understand that the target was
anti-inflammatory compounds with reduced side-effects, such as stomach ulcers,
resulting from Cox II selection.
[My emphasis]
[40]
Patents are a creature of statute. The U.K. statute is different, and the jurisprudence has diverged. In Canada, a statement of mere advantage, or a target, without more, is not a promise.
[41]
What the in vitro tests demonstrated was
that the compounds tested were COX II selective. That might have led the
inventors to hope that eventually it would be established that this COX II
selectivity equated with reduced side effects. Perhaps, they could have made a
promise, but they did not. Consequently, it is not necessary to decide whether
or not the tests as set out in the record establish that Celebrex® has fewer
side effects. Pfizer does not have to meet a promise it never made.
Insufficient Disclosure
[42]
The submission that my finding in Mylan
(Celebrex) and again here that there was no promise of reduced side effects
is in contradiction to Mr. Justice Hughes’ interpretation in Novopharm
(Celebrex), above, is more a matter of form over substance. No one knows
more about the construction of patents than Mr. Justice Hughes. What he said in
paragraph 101 is:
The Canadian patent application, as filed
effective November 14, 1994, makes ample disclosure as to the utility of
celecoxib; it is described, a process for preparing it is disclosed as Example
2 and data demonstrating effectiveness in dealing with inflammation and having
appropriate COX II selectivity is all disclosed.
I too have found that the data within the
patent demonstrates effectiveness in dealing with inflammation and having
appropriate COX II selectivity.
[43]
There are three aspects to Apotex’s submissions
of insufficient disclosure:
•
First, one of the compounds individually
claimed, Claim 5, was toxic and therefore useless;
•
Second, Claim 16, which is for use in the
prevention of colorectal cancer is unfounded; and
•
Third, it was obliged to and failed to disclose
that the true invention was Celecoxib or Celebrex® (Claim 4) with respect to
which it had already formed the intention to seek regulatory approval.
[44]
Pfizer has persuaded me that the first
allegation is not justified. The fact that tests had revealed high doses of the
compound in Claim 5 were toxic in rats does not detract from the fact that
Claim 5 works as an anti-inflammatory. There was no promise it would receive
regulatory approval.
[45]
Apotex also alleged that Claim 16 is invalid. It
was for the use of a compound according to any of Claims 1 to 7 – for preparing
a medicament for the prevention of colorectal cancer in a “subject”. Pfizer did
not respond to this allegation. Indeed, it was not obliged to answer. If at the
end of the day at least one claim of the patent is left standing, all other
things being equal, a prohibition order would be issued against the Minister.
[46]
The evidence brought forth by Apotex, and
unanswered by Pfizer, appears to support the proposition that Claim 16 is
invalid. Pfizer’s response is that in accordance with s.58 of the Patent Act,
it would be severed and the rest of the patent remains valid. Apotex’s position
is that if the compounds are new, as these were, the claims need not state the
utility. The utility is to be found in the disclosure. However, that utility is
therefore inherent in every claim. Since Claim 16 is invalid, the entire patent
falls.
[47]
I find this allegation not to be justified. It
is not in accord with s. 58 of the Patent Act and the decision of the
Supreme Court in Teva (Sildenafil/Viagra).
[48]
The third allegation that the true invention was
Celebrex® (Claim 4) and that Searle was required to disclose that this was the
compound it intended to commercialize is based on the Supreme Court’s decision
in Teva (Sildenafil/Viagra).
[49]
This last Apotex allegation that the patent is
invalid for insufficient disclosure by way of failing to meet the statutory
requirements of s. 27(3) of the Act, imposes both a positive and a negative
obligation on the patentee. On the one hand, he must identify the best mode or
best use of the invention and on the other he cannot obscure it by hiding the
true invention within a school of red herrings.
[50]
On the positive side, in the oft cited decision
of President Thorson in Minerals Separation North America Corp v Noranda Mines
Ltd, [1947] ExCR 306, 12 CPR 99 at 102, he said at pages 316 and 317:
[…] It must not contain erroneous or misleading
statements calculated to deceive or mislead the persons to whom the
specification is addressed and render it difficult for them without trial and
experiment to comprehend in what manner the invention is to be performed. It
must not, for example, direct the use of alternative methods of putting it into
effect if only one is practicable, even if persons skilled in the art would be
likely to choose the practicable method. The description of the invention must
[page317] also be full; this means that its ambit must be defined, for nothing
that has not been described may be validly claimed. The description must also
give all information that is necessary for successful operation or use of the
invention, without leaving such result to the chance of successful experiment,
and if warnings are required in order to avert failure such warnings must be
given. Moreover, the inventor must act uberrima fide and give all information
known to him that will enable the invention to be carried out to its best
effect as contemplated by him.
[51]
However, the Patent Act, as it then was,
did not require that the best mode or use be disclosed. Under s.27(3)(c) of the
present Act:
[…] the specification of an invention must
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 …
[52]
As a matter of statutory interpretation it seems
to me that therefore there is no such requirement in this case, as a machine
was not invented. I agree with the recent decision of Madam Justice Snider in Teva
Canada Limited v Novartis AG, 2013 FC 141, [2013] FCJ No 182 (QL) where she
so held. That case was recently argued in the Court of Appeal. Judgment was
reserved.
[53]
The negative aspect, i.e. not to obscure,
derives from a long list of English and Canadian cases culminating with the
2012 decision of the Supreme Court in Teva (Sildenafil/Viagra), above.
[54]
The facts of that case are somewhat peculiar.
The patent specification revealed the use of compounds, or salts thereof, for
the treatment of erectile dysfunction (ED) in males. As is fairly common, a
great number of compounds were claimed, cascading down to especially preferred
claims, only one of which was known by Pfizer to work. Two individual compounds
were claimed including the one for Sildenafil, the active ingredient in Viagra.
[55]
Mr. Justice LeBel, speaking for the Court,
reiterated that adequate disclosure in a specification is a precondition for
the grant of a patent monopoly. As Mr. Brodkin put it on behalf of Apotex, the
pain-paying-public pays for the monopoly. Searle bamboozled the Commissioner of
Patents with a lot of puffery, smoke and mirrors. It did not mean what it said
then and now I am being asked to rewrite the patent in its favour.
[56]
In Teva (Sildenafil/Viagra), reference
was made to s. 53(1) of the Patent Act which provides that a patent is
void if any material allegation in a petition is untrue, or if the
specification includes an omission or addition wilfully made for the purpose of
misleading. Mr. Justice LeBel paid homage to Minerals Separation above,
Consolboard Inc v MacMillan Bloedel (Saskatchewan) Ltd, [1981] 1 S.C.R. 504,
Whirlpool Corp, above, Pioneer Hi-Bred v Canada (Commissioner of Patents),
[1989] 1 S.C.R. 1623, [1989] SCJ No 72 (QL) and Apotex Inc v Wellcome
Foundation Ltd (AZT, above), to reiterate, among other things that
(a) the entire specification, both the disclosure and the claims, must be
considered in determining the nature of the invention and whether the
disclosure was sufficient; and (b) at the end of the monopoly the skilled
addressee, having only the specification, must be able to both make and use the
invention as the inventor could have at the time of the patent application.
[57]
At paragraph 72, Mr. Justice Lebel noted that
Pfizer had conducted tests that demonstrated that Viagra was effective in
treating ED, and that none of the other compounds in the patent had been shown
to be effective. “Therefore, the invention was the use of Sildenafil for the
treatment of ED. This had to be disclosed in order to meet the requirements set
out in s 27(3) of the Act.” He went on to say Pfizer chose a method of drafting
that failed to clearly set out what the invention was, and to state why it
elected to withhold its information that Sildenafil was the only compound
tested which had been found useful. The disclosure failed to state in clear
terms what the invention was. Some work, outside the patent, would be required
for the skilled addressee to ascertain what the true invention was. He
concluded at paragraph 80 “as a matter of policy and sound statutory
interpretation, patentees cannot be allowed to “game” the system in this way.”
[58]
However, he also did not make much of the fact
that Claim 1 included over 260 quintillion compounds. In the United States a quintillion is a 1 followed by 18 zeros, while in the United Kingdom a quintillion
is 1 followed by 30 zeros. The practice of cascading claims is common and does
not necessarily interfere with the public’s right to disclosure.
The skilled reader knows that, when a patent
contains cascading claims, the useful claim will usually be the one at the end
concerning an individual compound. The compounds that do not work are simply
deemed invalid. In accordance with s. 58, any valid claim – in this case Claim
7 – survives despite the existence of invalid claims. However, the public’s
right to proper disclosure was denied in this case, since the claim ended with
two individually claimed compounds, thereby obscuring the true invention.”
(para 80)
[59]
Basing myself on the above passage, the skilled
reader in the case at bar was not misled by the fact that 16 compounds appeared
to be interesting. Unlike in Teva, above, the per se claims
cascaded down to three: Claims 4 (Celebrex®), 5 and 6. All three worked in that
it was demonstrated that, like other NSAIDs, they reduced inflammation and
associated pain but in addition were also COX II selective. There was no
promise that the level of toxicity in Claim 5 was such that it would be
approved for use in humans. Furthermore, Claim 6 is the basis of a treatment of
arthritis in dogs. Apart from the use claim with respect to cancer, it has not
been established that any of the compounds do not work. Nothing was put in play
to rebut the presumption of validity under s. 43(2) of the Patent Act.
In my opinion, Celecoxib, or Celebrex®, was not the true invention. The true
invention was a class of compounds.
[60]
There was no obligation upon Searle at the time
the patent was filed to disclose therein its hope to commercialize Claim 4. Its
internal Product Alert was a work in progress. If it changed its mind a year
later and decided to pursue one of the other claims more vigorously, would that
intention have to be disclosed? Dr. Flower, an expert called by Apotex, thought
it would be surprising if all the compounds made it to market, as commercial
viability depends on a number of factors which would be developed later in the
process such as absorption, metabolism and stability.
Abuse of Process
[61]
Apotex, like Mylan, says that Pfizer cannot be
seen to be speaking out of both sides of its mouth. In Novopharm (Celebrex),
it conceded that reduced harmful side effects were part of the invention.
Apotex says this is because in that case it was facing a claim of invalidity
based on obviousness. In Mylan and in this case it is not. However, no
one has been able to point to a single case in which a “concession” or
“admission” in one in personam case applies in another. The meaning of a
patent is determined by the Court reading it through the eyes of the skilled
reader based on his or her knowledge at the time it was made public. The Court
is not fettered by an interpretation given years later by the patentee or its
lawyers. There is no binding admission. See Apotex Inc v H. Lundbeck A/S,
2013 FC 192, 111 CPR (4th) 171, [2013] FCJ No 274 (QL) at paras 219 and ff. As
Mr. Justice Binnie stated in Whirlpool, above, at para 61:
Claims construction is a matter of law for the
judge, and he was quite entitled to adopt a construction of the claims that
differed from that put forward by the parties.
[62]
Furthermore, it must be kept in mind that in Novopharm
(Celebrex), Mr. Justice Hughes did not hold that it had been demonstrated
that Celebrex® had less harmful side effects in humans. In that case, as in
this, the patent demonstrated COX II selectivity.
[63]
In my opinion, there is no abuse of process.
[64]
For all these reasons, Pfizer has established
that Apotex’s allegations are not justified. A prohibition order shall issue.
Alcon Canada Inc v Cobalt Pharmaceuticals Co
[65]
During the hearing, Apotex referred to the very
recent decision of Alcon Canada Inc v Cobalt Pharmaceuticals Co, 2014 FC
149, and provided extracts therefrom. Pfizer was given leave to comment in
writing which led to a rather acrimonious exchange between counsel.
[66]
The issue is whether Madam Justice Gleason’s
decision relaxes the requirement that a Notice of Allegation must set out the
full “legal and factual basis” as to why, in this case, the patent is invalid.
Pfizer has taken the position that Apotex’s arguments at the hearing, with
respect to insufficient disclosure, did not fall within the four corners of its
NOA.
[67]
This is but another of the many arguments made
by one party or the other which is not necessary to decide. My decision is
based on Apotex’s Memorandum of Argument, and oral submissions without taking
into account whether they step out of the box of the NOA. Thus, on that broad
basis, I find that none of Apotex’s allegations was justified within the
meaning of the Regulations.
Costs
[68]
Rather than to have to seek directions with
respect to costs following my decision, the parties informed the Court that
they would attempt to agree a formula, irrespective of the outcome of the
application. They have done so. While the Court, of course, is not bound
thereby, I consider the joint proposal to be reasonable and, in my discretion,
have given force to it in the accompanying order.
[69]
As the Minister did not participate in these
hearings, he shall neither benefit from nor be burdened with costs.
Confidentiality
[70]
As much of the evidence and testimony was
covered by various confidentiality and sealing orders, Pfizer shall have ten
(10) days herefrom, hopefully in conjunction with Apotex, to inform the
Court if it thinks any portion thereof should be deleted or modified in the
public version, and, if so, to provide suggestions. Failing agreement, Apotex,
in the public interest, which supports an open court principle, shall have five
(5) days to make its own submissions in reply.
“Sean Harrington”
Vancouver, British Columbia
Confidential Reasons for Order dated April 1,
2014
Ottawa, Ontario
Public Reasons for Order (Identical to the Confidential
Reasons for Order) dated April 15, 2014
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