Date: 20080102
Docket: T-209-06
T-210-06
Citation: 2008 FC 11
Ottawa, Ontario, January
2, 2008
PRESENT: The Honourable Mr. Justice Hughes
BETWEEN:
PFIZER CANADA INC. and
PARKE, DAVIS & COMPANY LLC
Plaintiffs
and
THE MINISTER OF HEALTH and
NOVOPHARM LIMITED
Defendants
REASONS FOR JUDGMENT AND JUDGMENT
[1]
There
are two Applications considered in these proceedings both brought under the Patented
Medicines (Notice of Compliance) Regulations SOR/93-133 as amended (NOC
Regulations). The medicine at issue is that commonly known as quinapril which
is used in the treatment of hypertension. The Applicants, sometimes known as
brand companies, sell drugs including quinapril in Canada under the
name Accupril and, including
quinapril in conjunction with hydrochlorothiazide as Accuretic. The Respondent Novopharm Limited wants to sell
its generic version of those drugs and, in accordance with the NOC Regulations
served two Notices of Allegation on the Applicant Pfizer Canada Inc. asserting
that the patent it listed in respect of the drugs, Canadian Patent 1,341,330
(’330 patent), was invalid for a variety of reasons. This prompted the
Applicants to initiate these two proceedings to prohibit the Respondent
Minister of Health from issuing a Notice of Compliance (NOC) to Novopharm to
permit it to sell its generic versions of those drugs in Canada.
[2]
For
the reasons that follow, I find that the applications for prohibition are
allowed with costs.
NOTICES OF ALLEGATION
[3]
Novopharm
delivered two Notices of Allegation under the provisions of the NOC Regulations
to Pfizer Canada Ltd. on December 23, 2005. They are essentially identical
except that one is directed to a drug containing only quinapril as the active
ingredient in a variety of dosages. It is sold by Pfizer under the name Accupril. The other is directed to a
drug containing both quinapril and hydrochlorothiazide in a variety of
dosages. It is sold by Pfizer under the name Accuretic.
Both are directed to uses in the treatment of hypertension in humans and are known
as angiotensin-converting enzyme inhibitors, commonly called ACE inhibitors.
[4]
The
only issue raised by Novopharm in its Notices of Allegation is the validity of
the ’330 patent for a variety of reasons. Infringement is not an issue. By an
Order of this Court dated March 13, 2006 the two Applications brought by
Pfizer, one in respect of each Notice of Allegation, were consolidated. The Applications
have, thereafter, proceeded together and were argued together. One set of
Reasons and one Judgment is issued.
CHEMICAL BACKGROUND
[5]
A
brief discussion of the chemistry, specifically the stereochemistry, is
required. The class of compounds described in the ’330 patent is said to be
defined by a general formula - formula 1 - set out on the first page of the patent
as follows:
[6]
This
formula depicts a class of compounds often described as being comprised of a
head group which is the cyclic structure on the right side and a side chain
which is the long structure to the left. The head group shown in formula I is
derived from a molecule known as tetrahydroisoquinoline or THIQ.
[7]
Although
molecules can only be depicted in two dimensions on a piece of paper, in
reality, the molecules are three-dimensional. The three-dimensional features
of the molecule that are of interest in the present application are indicated
in formula I by the three asterisks. These asterisks indicate what are called
chiral centers, which identify carbon atoms that are bonded to four different
groups of atoms. When viewed in three dimensions, there are two distinct ways
that a single carbon atom can be bonded to four different groups. These are
referred to as configurations. The number of possible configurations for a
particular molecule is defined by the formula 2n where n is the
number of chiral centers. Here we have three chiral centres so that the number
of possible configurations is 23 or 8. Scientists sometimes use the
term ‘stereoisomer’ to describe the relationship between compounds that are
connected to the same atoms, but have different spatial configurations. Here
there are eight possible stereoisomers.
[8]
As
molecules with different spatial configurations have different chemical
properties, it is often important to determine which of the spatial configurations
a chemist is referring to in a given diagram. As a result, chemists have
adopted various conventions to distinguish the different spatial configurations.
One common convention is to use the labels R or S to identify the manner in
which a given carbon is bonded to the four groups. As the compounds described
in formula I have three such carbons, each carbon will be assigned either an R
or an S. The overall molecule will be identified by three letters, one
referring to each of the asterisks or chiral centres, such as R,R,R, S,S,S, R,S,S,
S,R,S, and so forth. There are eight possible three-letter combinations for
the compounds identified in formula I. Each of these eight compounds can be
described as a stereoisomer of the other seven compounds. Discussion in this
case will involve whether or not the inventors invented, whether the patent discloses
and whether the claims claim all 8 possible stereoisomers or just the S,S,S
stereoisomer.
EARLIER
LITIGATION OF THIS ’330 PATENT
[9]
There
has been previous litigation under the NOC Regulations dealing with the ’330
patent. That litigation involved a different generic, Apotex Inc. Novopharm
was not a party to the litigation.
[10]
That
litigation was instituted by Pfizer Canada Inc., Warner-Lambert Company LLC and
Parke, Davis & Company LLC as a result of a Notice of Allegation served by
Apotex in which the validity of the ’330 patent was contested. Infringement of
another patent, Canadian Patent 1,331,615 (’615 patent), which is a divisional
of the ’330 patent, was also at issue there. It is not at issue here. In the
present proceedings, Novopharm has directed its allegations only as against
validity of the ’330 patent, thus the infringement aspect of the earlier
proceedings is not important here.
[11]
The
Apotex proceeding (T-1633-03) was heard by Justice Heneghan of this Court who,
in edited reasons delivered September 28, 2005 indexed as 2005 FC 1205, held
that Pfizer et al. had not demonstrated that the allegations as to invalidity,
on the basis of overly broad claims, and of non-infringement with respect to
the ’615 patent, were not justified. Accordingly, the application for
prohibition was dismissed.
[12]
The
decision was appealed and, in a decision given May 31, 2007, cited as 2007 FCA
209 the Federal Court of Appeal reversed the Trial Judge, allowed the appeal,
and directed that an Order for prohibition be directed to preclude Apotex from
receiving an NOC for its generic quinapril drug.
[13]
As
raised in and disposed of by the Federal Court and Federal Court of Appeal the
invalidity allegations respecting the ’330 patent in the earlier Apotex
proceedings were:
a) Lack
of utility both as to actual utility and lack of sound production
The
Trial Judge held that Apotex’s allegations were not justified in that while for
some compounds actual utility had not been demonstrated, there was a sound
basis for predicting the utility of what was claimed in claims 3 to 5 of the
’330 patent (paras. 68 to 82).
The
Federal Court of Appeal agreed with this conclusion (paras. 150 to 154).
b) Anticipation
The
Trial Judge found that Apotex had not put its allegation of anticipation “in
play” and that the allegation was not supported by sufficient evidence (paras.
83 to 88).
The
Federal Court of Appeal upheld the Trial Judge’s findings (paras. 135 to 140).
c) Obviousness
The
Trial Judge held that the prior art cited by Apotex did not establish that the
invention was obvious and that Pfizer had met its burden in demonstrating that
this allegation was not justified (paras. 89 to 98).
The
Federal Court of Appeal upheld the Trial Judge’s findings (paras. 129 to 134).
d) Claims
Broader than the Invention or Disclosure
It
was on this ground that the Trial Judge found that Pfizer had failed to show
that the allegation was not justified hence the application was dismissed
(paras. 99 to 108). She said at paragraph 107:
[107] In my opinion, these
arguments are to be assessed relative to the construction of the patent. Since
I have concluded that claims three (3) and five (5) should be construed so as
to include compounds useful for reducing hypertension and having regard to the
expert evidence that the S-configuration is the optimal configuration for high
level ACE inhibition leading to anti-hypertensive results, I conclude that the
claims encompassing all possible stereoisomers are overly broad.
The Federal
Court of Appeal reversed the Trial Judge in this respect (paras. 101 to 128).
At paragraphs 126 and 127, they said:
[126] On
the basis of the evidence before the Court, however, Pfizer's invention can be
described as covering all stereoisomers of quinapril. The state of the art is
to the effect that all stereoisomers were within the inventor's contemplation,
as revealed by the use of a Markish [sic] formula and
the fact that patents for other ACE inhibitors claimed and disclosed all
stereoisomers. The wording of the claims and the expert evidence suggest that
all stereoisomers of quinapril are claimed in the patent. In fact, the Trial
Judge, in her introduction on the '330 patent, says that "... [t]he
compounds have three chiral centres and all the stereoisomers sharing this
common structure, that is both the S- and R-configurations stereoisomers, are
within the scope of the claims" (Reasons of Heneghan J., para. 9).
[127] In
my view, a person skilled in the art would read the two paragraphs from the
disclosure which I have reproduced at paragraph 120 of these Reasons as
disclosing that the invention includes all stereoisomers. The skilled reader
would be persuaded particularly by the clear statement in the second paragraph
that "... all optical isomers and diastereo isomers and mixtures thereof
are within the scope of this invention". Accordingly, in my view, a
skilled reader would therefore understand that claims 3 and 5, although silent
as to stereo configuration, include all stereoisomers. Thus, given that the
invention clearly covers all stereoisomers and that the patent claims all
stereoisomers, the patent cannot be described as claiming more than what was
invented.
e) Double Patenting
The
Trial Judge found that Pfizer had shown that the claims at issue of the ’330
patent were not invalid for double patenting having regard to a previously
issued patent (the ’615 patent), (paras. 109 to 115).
The
Federal Court of Appeal upheld the Trial Judge’s findings (paras. 141 to 149).
MULTIPLE NOC
PROCEEDINGS
[14]
The
Federal Court of Appeal in another decision, Sanofi-Aventis Canada Inc. v. Novopharm
Limited, 2007 FCA 163 at paragraph 50, has warned against multiple NOC
proceedings once a final determination has been made with respect to a
particular patent. The Court acknowledged however that a different generic
could challenge the validity of the same patent if it had “better evidence or a
more appropriate legal argument”. The Court is required to balance the effect
on the administration of justice against the unfairness to a party from
precluding it from bringing forward its case. At paragraph 50, Sexton J.A.
said:
[50] Finally,
Sanofi-Aventis and Schering argue that a finding of abuse of process in this
case will lead to unfairness. They say that while first persons will not be
permitted to defend against allegations by subsequent generics after the same
allegation made by an earlier generic has been found to be justified, subsequent
generics will be permitted to repeat allegations already made earlier by other
generics even if the earlier allegations were found to be unjustified. However,
there is no unfairness in this scenario. All parties are held to the same
standard: they must each put forward their entire case, complete with all
relevant evidence, at first instance. The innovator is prevented from
relitigating an issue already decided in a proceeding to which it was a party
with the aid of additional evidence it chose not to adduce in the earlier
proceedings. Generics likewise must put forward their full case at the first
opportunity. Multiple NOAs issued by the same generic relating to a particular
drug and alleging invalidity of a particular patent will generally not be permitted,
even if different grounds for establishing invalidity are put forward in each.
However, where one generic has made an allegation but has failed to put forward
the requisite evidence and argument to illustrate the allegation is justified,
it would be unjust to preclude a subsequent generic, who is apprised of better
evidence or a more appropriate legal argument, from introducing it. Although
this situation may give rise to the possibility of an inconsistent result, this
concern is overridden by the potential for unfairness to the generic that is
barred from bringing forward its case simply because another generic's approach
was inadequate. In each situation, it is necessary to balance the effect of a
proceeding on the administration of justice against the unfairness to a party
from precluding it from bringing forward its case.
[15]
I
faced the question of a previous determination by the Court in respect of a
patent in NOC proceedings in Eli Lilly Canada Inc. v. Novopharm Ltd.,
2007 FC 596. One of the difficulties canvassed there, and it is a difficulty
here as well, is that the record of the earlier proceedings is not of record in
these proceedings. Thus, the Court is left to determine if there is “better
evidence or a more appropriate legal argument” in the present proceeding as
against the earlier proceedings only from what is revealed in the Reasons of
the Courts in the earlier proceedings. I said in that case at paragraphs 62
and 99:
[62] The
jurisprudence therefore provides that this Court, in its own discretion, can
review the Reasons given in Apotex by Justice Gauthier and determine whether
there is "better evidence" or "more appropriate legal
argument" made by the generic in the present proceeding as to validity of
the '113 patent than was presented in Apotex. If so, the better evidence and
more appropriate arguments must be considered. If no better evidence or more
appropriate argument is found, it would be an abuse to permit the matter to be
considered again. The word "abuse" is not used in any sense so as to
imply that the second generic has acted improperly, it has not; it could not
have been known until a few days before the hearing of this case that the
decision in Apotex would be released. The word "abuse" is used in the
sense that it would be a waste of the Court's resources and possibly lead to
unwanted inconsistent results, were the matter to be considered as a matter of
first instance on this the subsequent occasion. The consideration in the second
instance should only be one as to "better evidence" or "more
appropriate" argument which, if determined to exist, must be considered as
a matter of first instance. Of course if a different attack on validity is
raised, one that was not raised in Apotex, it will be considered as a matter of
first instance.
.
. .
[99] In
the present proceedings therefore, I am required to determine as to each of the
arguments as to invalidity raised by Novopharm:
1.
Is the argument new and different, in which case it will be determined as a
matter of first instance.
2.
If the matter has been dealt with by Justice Gauthier is there, having regard
to her Reasons, "better evidence" or "more appropriate legal
argument" in this proceeding such that Justice Gauthier's finding should
not be followed.
[16]
Before
leaving the earlier proceedings, the question as to construction of the ’330
patent and the claims at issue, claims 3, 4 and 5, must be considered. Those
same claims are at issue in the present proceeding. Once a patent has been
construed in a proceeding, particularly where the Court of Appeal has construed
the patent, it would require strong argument for a subsequent Court to come to
a different result (see e.g. Procter & Gamble Pharmaceuticals Canada
Inc. v. Canada (Minister of Health) (2004), 32 C.P.R. (4th) 224
at para 19 (F.C.), aff’d 37 C.P.R. (4th) 289 (F.C.A.)).
[17]
In
the previous proceeding, 2007 FCA 209, the Federal Court of Appeal disagreed
with the construction put on the patent and, in particular, claims 3 to 5, by
the Trial Judge. The Court of Appeal construed the invention as claimed, to
include all stereoisomers. It said at paragraphs 120 and 126-127:
[120] Therefore,
it is necessary to review the disclosure in the '330 patent and to assess how
the claims should be read in the light of that disclosure. Several portions of
the '330 patent shed light on the invention being claimed. First, the abstract
specifies that the invention relates to anti-hypertensive agents:
The
compounds of the invention, their salts and pharmaceutical compositions thereof
are useful as antihypertensive agents.
Elsewhere,
the disclosure refers to the use of the invention for the treatment of
hypertension:
The
compounds of this invention intervene in the renin → angiotensin I →
angiotensin II sequence by inhibiting angiotensin I converting enzyme and
reducing or eliminating the formation of the pressor substance angiotensin II,
and therefore are useful in reducing or relieving hypertension. Thus by the
administration of a composition containing one or a combination of compounds of
formula I or pharmaceutically acceptable salts thereof, hypertension in the
species of mammal suffering therefrom is alleviated...
...The
compounds of the invention can be utilized to achieve the reduction of blood
pressure by formulating in compositions such as tablets, capsules or elixirs
for oral administration or in sterile solutions or suspensions for parenteral
administration. ('330 patent at 6, 9).
. . .
[126]
On the basis of the
evidence before the Court, however, Pfizer's invention can be described as
covering all stereoisomers of quinapril. The state of the art is to the effect
that all stereoisomers were within the inventor's contemplation, as revealed by
the use of a Markish [sic] formula and the fact that
patents for other ACE inhibitors claimed and disclosed all stereoisomers. The
wording of the claims and the expert evidence suggest that all stereoisomers of
quinapril are claimed in the patent. In fact, the Trial Judge, in her
introduction on the '330 patent, says that "... [t]he compounds have three
chiral centres and all the stereoisomers sharing this common structure, that is
both the S- and R-configurations stereoisomers, are within the scope of the
claims" (Reasons of Heneghan J., para. 9).
[127]
In my view, a person
skilled in the art would read the two paragraphs from the disclosure which I
have reproduced at paragraph 120 of these Reasons as disclosing that the
invention includes all stereoisomers. The skilled reader would be persuaded
particularly by the clear statement in the second paragraph that "... all
optical isomers and diastereo isomers and mixtures thereof are within the scope
of this invention". Accordingly, in my view, a skilled reader would therefore
understand that claims 3 and 5, although silent as to stereo configuration,
include all stereoisomers. Thus, given that the invention clearly covers all
stereoisomers and that the patent claims all stereoisomers, the patent cannot
be described as claiming more than what was invented.
[18]
With
this interpretation in mind, I will turn first to the question of construction
of claims 3, 4 and 5 of the ’330 patent.
CONSTRUCTION
[19]
Before
making a determination as to infringement or validity, the Court must construe
the patent and, in particular, the claims at issue (Whirlpool Corp. v. Camco
Inc., [2000] 2 S.C.R. 1067 at para 43).
[20]
The
parties have agreed that only claims 3, 4 (as it depends from 3) and 5 are at
issue. The parties have further agreed that, consistent with the construction of
claims 3, 4 and 5 by the Federal Court of Appeal in the earlier proceedings as previously
discussed, the claims cover all the stereoisomers of the compound described in
the claims.
[21]
These
claims 3, 4 (as it depends from 3) and 5 read as follows:
3. A substituted acyl
derivative of 1, 2, 3, 4 – tretrahydroisoquinoline-3-carboxylic acid of general
formula IIa:
Wherein R2
represents a group selected from H, -CH3 and -C 2H5,
and a pharmaceutically acceptable acid addition salt or solvated form thereof.
4. A pharmaceutical
composition comprising a substituted acyl derivative of 1, 2, 3, 4 –
tetrahydroisoquinoline-3-carboxylic acid of the general formula IIa as defined
in claim 3 or a pharmaceutically acceptable salt or solvated form thereof, and
a pharmaceutically acceptable carrier.
5. A compound having
the general formula A:
Wherein:
-
Ra
is selected from:
- hydrogen;
and
- C1-4
alkyl;
- Rb is
selected from:
- hydrogen;
and
- C1-4
alkyl;
And its pharmaceutically acceptable
salts.
[22]
Thus
to construe claim 3: it claims a compound as described, which is a class of
compounds, in every one of its stereoisomeric forms, plus, added to the
compound, is a pharmaceutically acceptable acid addition salt or a solvated
form of that salt.
[23]
Claim
4 claims all that which is claimed in claim 3 with the addition of a
pharmaceutically acceptable carrier.
[24]
Claim
5 claims a compound as described, which is a class of compounds, in every one of
its stereoisomeric forms, together with pharmaceutically acceptable salts of
that compound. The structure of the compound described in claims 3 and 4 is
structurally similar to that described in claim 5, even though the drawings are
oriented differently.
[25]
The
particular compound at issue, quinapril can be depicted as
and is described stereoisomerically as the
S,S,S stereoisomer.
[26]
Quinapril
is among those compounds as described in claims 3, 4 and 5. The medicine used
in Accupril is a pharmaceutically
acceptable salt of quinapril as claimed in claim 5 namely quinapril
hydrochloride.
ISSUES RAISED IN THESE
PROCEEDINGS
[27]
Counsel
for the parties did a commendable job, after a pre-trial conference, in
assembling materials for the hearing and in defining issues for the Court to
determine. Further, Counsel for Novopharm advised the Court by letter dated
November 27, 2007 that Novopharm will not be pursuing the issues of obviousness
and double-patenting in these applications. Counsel for Pfizer advised the
Court by letter dated December 12, 2007 that Pfizer will no longer be pursuing
the issue as to whether Novopharm is a “second person” within the meaning of
the NOC Regulations. As a result, the issues remaining for determination are:
1. Burden
of Proof
(a) What
is the correct test?
(b) To
which issues is the application of the burden of proof relevant?
2. Claims
broader than invention made and disclosed
(a) Is there any “additional evidence” or “more
appropriate legal argument” that would permit this Court to depart from the
decision in the Apotex case?
(b) Is “claims broader” a question of law, fact or
mixed fact and law?
(c) In the context of this case, is “claims broader”
a technical argument? If so, how does this impact the Court’s analysis?
(d) What is the proper construction of the claims?
[All parties agree that the claims cover all of the stereoisomers]
(e) What is the proper construction of the invention
as it was disclosed in the ’330 patent?
(i) To what extent may extrinsic evidence be used to
construe the specification of a patent?
(ii) To what extent should the court consider the
evidence of the drafter of the patent and for the inventors as to the nature of
the invention?
(iii) What (if any) use can or should the Court make
of other patents relating to ACE inhibitors in arriving at the proper
construction of the invention?
(f) Are
the claims broader than the invention made and disclosed?
3. Sound
prediction
(a) Is there any “additional evidence” or “more
appropriate legal argument” that would permit this Court to depart from the
decision in the Apotex case?
(i) Is the evidence of Hoefle, Blankley or Klutchko
any different in this case?
(ii) If so, is it different in a way that permits the
Court to depart from the previous decisions?
(b) Is
the test for lack of sound prediction met?
(i) What
is the correct date for assessing sound prediction?
(ii) Is
sound prediction a question of fact, law or mixed fact and law?
(iii) Does the test for sound prediction require the
Court to consider what the inventors were actually thinking or does it
look to the experts to say what the inventors could have predicted based
on what was known to the inventors at the relevant time?
(iv) Are the elements of the test for sound prediction
subjective or objective?
(v) Was there a factual basis to predict that the
claimed compounds would have activity as ACE inhibitors and antihypertensives?
This will include consideration of the following:
(A) Novopharm asserts that part of the factual basis
that Pfizer relies on (reported data from a publication) is caused by
contamination. Pfizer asserts that this is outside Novopharm’s Notice of
Allegation.
(B) Novopharm asserts that part of the factual basis
that Pfizer relies on (that all of the compounds have activity in the dosage range
given in the patent provided that in some cases there are administered at very
high doses intravenously) is not supported because the intravenous doses relied
upon are not realistic. Pfizer asserts that this is outside Novopharm’s Notice
of Allegation.
(vi) Was there an articulable line of reasoning to
predict that the claimed compounds would have activity as ACE inhibitors and
antihypertensives?
(vii) Is the disclosure of the ’330 patent proper?
(A) What is the impact of the last paragraph on page 3
of the ’330
patent?
BURDEN OF PROOF
[28]
The
issue as to who bears the burden of proof, in particular where validity issues
are raised in respect of a patent, continues to be raised by the parties in NOC
proceedings.
[29]
I
canvassed that issue in GD Searle & Co. v. Novopharm Limited, 2007
FC 81 and concluded at paragraph 39:
[39] The
question of burden of proof in NOC proceedings, where issues of validity are
raised, was canvassed in Pfizer Canada Inc. v. Canada, (2006), 46 C.P.R. (4th) 281,
at paragraphs 6 to 12, in Abbott Laboratories v. Apotex
Inc., 2006 FC 1558, at
paragraphs 85 to 94, and in Pfizer Canada Inc. v. Apotex
Inc., 2007 FC 26, at
paragraphs 5 to 12. The Respondent (generic) must put the invalidity
allegations in play, the Applicant may respond by asserting the presumption
of validity. Should the Applicant lead no evidence as to validity but the
Respondent does lead some evidence, the Applicant would place itself at a
serious disadvantage. Once the evidence is in, the Applicant bears the ultimate
burden to establish that the allegations of invalidity are not justified.
[30]
Sharlow
J.A. of the Federal Court of Appeal in a unanimous decision of a panel
comprising her, Malone and Ryer JJ.A. in Abbott Laboratories v. Canada
(Minister of Health), 2007 FCA 153 considered the matter and held that the
Applicant bears the burden of establishing its entitlement to an order for
prohibition. As to validity, the Applicant may rely on the presumption of validity
but, if the record contains any evidence capable of rebutting that presumption,
the Court must weigh that evidence. She said at paragraphs 9 and 10:
[9] It
is now beyond debate that an applicant for a prohibition order under the NOC
Regulations bears the burden of establishing its entitlement to the order.
Abbott argues that the Judge in this case failed to recognize and apply that
principle correctly, in light of the presumption of validity in subsection
43(2) of the Patent Act, R.S.C. 1985, c. P-4, which reads as follows:
43.
(2) After the patent is issued, it shall, in the absence of any evidence to the
contrary, be valid and avail the patentee and the legal representatives of the
patentee for the term mentioned in section 44 or 45, whichever is applicable.
* * *
43. (2) Une fois délivré, le brevet est, sauf preuve contraire,
valide et acquis au breveté ou à ses représentants légaux pour la période
mentionnée aux articles 44 ou 45.
[10] In
my view, the Judge made no such error. The presumption in subsection 43(2) is
weakly worded (Apotex Inc. v. Wellcome Foundation Limited, [2002] 4
S.C.R. 153, per Justice Binnie at
paragraph 43). It cannot determine the outcome of prohibition proceedings under
the NOC Regulations if, as in this case, the record contains any
evidence that, if accepted, is capable of rebutting the presumption (see Rubbermaid
(Canada) Ltd. v. Tucker Plastic Products Ltd. (1972), 8
C.P.R. (2d) 6 (F.C.T.D.) at page 14, and Bayer Inc. v. Canada
(Minister of National Health and Welfare) (2000), 6
C.P.R. (4th) 285, at paragraph (9).
[31]
Subsequently,
another panel of the Federal Court of Appeal comprising Linden, Nadon and
Sexton JJ.A. addressed the issue of burden but without reference to the decision
of the panel in Abbott, supra. This was the decision of the
Federal Court of Appeal in the earlier litigation involving quinapril and Apotex
which must be considered in light of the direction by Sexton J.A. in Sanofi
as to multiple proceedings. Apparently, Abbott had not been drawn to their
attention. Nadon J.A. for the Court reviewed some of the jurisprudence on the
issue of burden at paragraphs 101 to 111 in Pfizer Canada Inc. v. Canada
(Minister of Health), 2007 FCA 209, his conclusions are set out at
paragraphs 109 and 110:
[109] Thus,
a first person under the Regulations has the overall burden of establishing, on
a balance of probabilities, that the allegations of invalidity contained in a
second person's NOA are not justified. Although the first person has the
initial burden, because of the presumption of the validity of a patent set out
in section 45 of the pre-1989 Act, it can meet this burden merely by proving
the existence of the patent. The second person then has the burden of adducing
evidence of invalidity and of putting the allegations of invalidity contained
in its NOA "in play". To do so, the second person must adduce
evidence which is not clearly incapable of establishing its allegations of
invalidity. Hence, not only must the second person's NOA contain a sufficient
factual and legal basis for its allegations, but it must also adduce evidence
of invalidity at trial.
[110] Once
the second person has adduced sufficient evidence, on a balance of
probabilities, the first person must, also on a balance of probabilities,
disprove the allegations of invalidity set out in the NOA. As explained by my
colleague Sharlow J.A. at paragraph 9 of her Reasons in Bayer, supra:
[9]
The operation of the statutory presumption in the face of evidence of
invalidity depends upon the strength of the evidence. If the evidence proves,
on a balance of probabilities, that the patent is invalid, the presumption is
rebutted and is no longer relevant. ...
[32]
I
do not view the reasoning of the two panels of the Federal Court of Appeal to
be in substantial disagreement. Justice Mosley of this Court reconciled these
decisions in his Reasons in Pfizer Canada Inc. v. Apotex Inc., 2007 FC
971 at paragraphs 44 to 51. What is required, when issues of validity of a
patent are raised:
1. The second person, in its Notice of Allegation
may raise one or more grounds for alleging invalidity;
2. The first person may in its Notice of Application
filed with the Court join issue on any one or more of those grounds;
3. The second person may lead evidence in the Court
proceeding to support the grounds upon which issue has been joined;
4. The first person may, at its peril, rely simply
upon the presumption of validity afforded by the Patent Act or, more
prudently, adduce its own evidence as to the grounds of invalidity put in
issue.
5. The Court will weigh the evidence; if the first
person relies only on the presumption, the Court will nonetheless weigh the
strength of the evidence led by the second person. If that evidence is weak or
irrelevant the presumption will prevail. If both parties lead evidence, the Court
will weigh all the evidence and determine the matter on the usual civil
balance.
6. If the evidence weighed in step 5 is evenly
balanced (a rare event), the Applicant (first person) will have failed to prove
that the allegation of invalidity is not justified and will not be entitled to
the Order of prohibition that it seeks.
[33]
If
the matter were an ordinary action for, say, infringement of a patent where
validity is put in issue, the party challenging validity bears the burden such
that, it must put in evidence to support the allegation of invalidity. The
patentee may rely on the presumption but only to the extent that the attacking
party must lead some reliable evidence to support its allegation. At the end of
the day, the Court must weigh the evidence on the usual civil burden of proof (Tye-Sil
Corp. Ltd. v. Diversified Products Corp. (1991), 35 C.P.R. (3d) 350 at
357-359 (F.C.A.)). Only if the Court finds the evidence to be “evenly
balanced” (a rare event) would the question of burden arises in an ordinary
case the party attacking validity, bearing the burden, would fail.
VALIDITY OF
THE ’330 PATENT
(1) Effect
of Earlier Proceedings
[34]
In
the context of the NOC Regulations, Novopharm has challenged the validity of
the ’330 patent in its Notices of Allegation sent to Pfizer causing Pfizer to
institute the present proceedings. The objective of these proceedings is to prohibit
the Minister of Health from issuing a Notice of Compliance to Novopharm which
Notice, in the absence of any other restriction, would permit Novopharm to sell
generic versions of Pfizer’s quinapril drugs in Canada. I am
advised that there are other restrictions in the form of other proceedings
respecting another patent. That is not relevant here.
[35]
The
challenges made by Novopharm to the validity of the ’330 patent have been
reduced to two: (1) claims broader than the invention; and (2) lack of sound
prediction. Challenges to the validity of the same claims of the ’330 patent
as are at issue here were made by another generic, Apotex, in the earlier
proceedings as discussed previously. Pfizer was successful in the Federal
Court of Appeal in persuading the Court that Apotex’s assertions as to
invalidity on those grounds were not justified.
[36]
Accordingly,
under the provisions of subsection 6(2) of the NOC Regulations, the Court made
an Order prohibiting the Minister from issuing a Notice of Compliance to
Apotex. There were other issues in the earlier proceedings, all resolved
against the interests of Apotex, which are not relevant here.
[37]
The
Federal Court of Appeal in Sanofi, supra, has cautioned against
multiple proceedings by different generics in which the validity of the same
patent continues to be challenged in circumstances where such a challenge by a
generic in earlier proceedings has failed. That Court indicated that a
balanced approach was necessary which, on the one hand would consider whether
better evidence or more appropriate legal argument was made by a subsequent
generic thus making it unfair that such matters should not be raised, while, on
the other hand, being mindful that the resources of the Court and others, such
as the Minister who administers the NOC Regulations should not be wasted by
repeated proceedings, even if skilfully presented and argued.
[38]
NOC
proceedings are flooding the Court system at a rate which, roughly calculated,
at the current pace, means that three proceedings are instituted for each one
disposed of by the Court. The NOC Regulations require that the proceedings be
disposed of by the Court within 24 months from institution barring consent of
the parties to an extension. Rarely is such consent, except for perhaps a few
weeks, forthcoming. The Court accepts the challenge. However, where
essentially the same matters as were previously disposed of are raised again, the
Court must come to grips with the question as to whether there is an
unnecessary waste of the Court’s resources.
[39]
The
parties are not without their remedies. The NOC proceedings provide, to the
patent owner or its nominee, a chance to gain what amounts to a permanent
injunction for the lifetime of the patent(s) involved if successful and, at
least, a 24 month temporary injunction simply by instituting the proceeding.
The generic has gained the opportunity to reference data as to matters such as
safety and efficacy, previously submitted by the patentee/nominee, to the
Minister. However, regardless of the result of the NOC proceedings, free of
any jurisprudential constraint such as res judicata, the patentee can
always institute proceedings for infringement of the patent(s). The generic
can always institute proceedings to challenge the validity of the patent(s).
Whether or not a patentee or a generic is precluded from litigating or relitigating
a question in the context of the NOC Regulations, the fundamental right to an action
respecting infringement or validity is unaffected. A party may be required to
change its tactics but its fundamental rights are unaffected.
[40]
The
NOC Regulations are extra administrative processes tied to the protection of
public health. They provide remedies in unique circumstances that are directed
to the Minister that would, in certain circumstances, prohibit the Minister from
granting a Notice of Compliance to an applicant generic drug company. Two
decisions of the Federal Court of Appeal are instructive in this regard. One
is Pfizer Canada Inc. v. Canada (Attorney General), 2003 FCA
138 where Strayer J.A. said, for the Court at paragraph 26:
[26] Instead,
the Regulations provide an extra administrative process tied to the protection
of public health, designed, on the one hand, to assist the development and
preparation for marketing of generic drugs at a time prior to issue of an NOC
when their sale would still be an infringement of a current patent. At the same
time it gives patentees extra protection: by merely applying for prohibition
they can normally prevent the issue of an NOC to a generic for 24 months.
[41]
The
other is Novartis AG v. Apotex Inc., 2002 FCA 440 where Strayer J.A.,
again, for the Court said at paragraph 9:
[9]
I believe that the fundamental principles applicable are those stated in the
reasons of Isaac J.A. in the Pfizer case, as approved and followed by another
panel of this Court in the Rhoxalpharma case less than one year ago. The basic
principle is that the extraordinary procedures provided by the Regulations are
for the public law purpose of enabling the Trial Division to prevent a public
officer from issuing a Notice of Compliance, designed for the protection of the
public's health, if the patentee can show that the patents, as referred to by a
generic company in its notice of allegation seeking a Notice of Compliance, are
owned by the applicant "first person" and that the relevant claims
are not invalid and would be infringed. This is a finding of the Court for the
limited purpose of deciding whether or not the Minister can issue a Notice of
Compliance: no one could suppose that this is a scheme designed for res
judicata determinations of the scope or validity of patents. As Isaac J.A. said
at 253-54 of the Pfizer case:
[25]
It should be noticed that a decision by this Court that the appeals are moot
does not mean that the appellants are without remedies. They may commence
actions for infringement if so advised and the facts warrant. This Court has
been very clear on the fact that s. 6 proceedings are not adjudicative of the
rights of the patentee. In Merck Frosst Canada, [1994] F.C.J. No. 662, supra, at 319, Hugessen J.A.
rejected the notion that prohibition proceedings could be assimilated to an
action of any kind:
The
proceedings are not an action and their object is solely to prohibit the
issuance of a notice of compliance under the Food and Drug Regulations.
Manifestly, they do not constitute "an action for infringement of a
patent" ...
In
these circumstances, it is idle to suggest that any decision that this Court
makes in these appeals could be used to attack collaterally a judgment in an
infringement action.
As
Isaac J.A. also pointed out in Pfizer at 252, by subsection 7(4) of the
Regulations the period of automatic stay of the issue of an NOC expires when,
inter alia, the application for prohibition is "dismissed by the
court". This has been interpreted by this Court to mean "dismissed by
the Trial Division", given the special and self-contained scheme of the
Regulations. (Hoffman-LaRoche Ltd. v. Canada (1996), 70 C.P.R. (3d) 206). It does not mean
"dismissed by the Federal Court of Appeal".
[42]
Thus,
while it is recognized that a second generic is a different person than a first
generic and that the proceedings are two different proceedings, the remaining
matters are the same. The patentee, “first person”, is the same, the patent is
the same, the Minister is the same and the relief sought is the same,
prohibition against the Minister. Identity of parties or privies, even under
the strict doctrine of issue estoppel is not an essential requirement. Again,
I reference Strayer D.J. (as he is now) in Estenson v. Canada (Attorney
General),
2007 FC 538 at paragraphs 19 to 24:
[19] It
is well established that for issue estoppel to prevent further proceedings to
try a question:
i)
the same question must have been decided in an earlier proceeding;
ii) the decision in the earlier proceeding must be
final;
iii)
the parties to the previous decision or their privies are the same persons as
the parties to the proceedings in which the estoppel was raised or their
privies.
(see
e.g. Angle v. Minister of National Revenue, [1975] 2 S.C.R. 248 at paragraph 254; Danyluk v. Ainsworth
Technologies Inc., [2001] 2 S.C.R. 460 at paragraphs 54-61.)
[20] Looking
at the second condition first, I think it is not in dispute that the decision
of the Chairman of the Review Tribunal under the Agriculture and Agri-Food
Administrative Monetary Penalties Act is final. There is no provision for
appeal under that Act and the time for judicial review has long since passed.
[21] A
more difficult question is as to whether the same question was involved before
that Review Tribunal as would be before an adjudicator in respect of the
Applicant's accreditation under his AVA. Admittedly the legal issues are
different. The former involved a possible violation of paragraph 69(1)(b) of
the Health of Animals Regulations whereas the latter will involve what is
essentially a breach of contract of the Applicant's accredited veterinarian
agreement. It is sufficient, however, for issue estoppel that there be some
question vital to the outcome of both cases which is the same in all material
respects. See Rasanen v. Rosemount Instruments Ltd. (1994), 68 O.A.C. 284 at paragraphs 31, 32, 88, 89. While
the different legal framework might well preclude cause of action estoppel,
here we have a determination of fact which is equally applicable in both cases.
The factual question fundamental to any finding of responsibility in respect to
either the Applicant or Mr. Tebrinke is: was the OTM head discovered at the
Tyson plant from an animal in the load certified by the Applicant and exported
by Mr. Tebrinke to the United States? Unless
that question can be answered in the affirmative, then neither one should be
responsible: not Mr. Tebrinke under the Health of Animals Regulations, nor the
Applicant under his contract which requires him to certify accurately.
[22] The
most difficult question to answer is the third, namely are the same parties
involved or their privies? I should first say that in my view that test should
be applied more rigorously to the person who suffers the negative impact of
estoppel. In this case that party is in reality the same in both cases, namely
the CFIA. Admittedly in this case the party seeking to take advantage of
estoppel was not personally a party to the Tebrinke proceedings which found
Tebrinke not guilty but I have concluded that for these purposes the Applicant
and Mr. Tebrinke were privies. I think there must be some flexibility in
identifying privies for this purpose. In Sopinka, Lederman, Bryant, The Law of
Evidence in Canada
(Butterworth's, second edition) at paragraph 19.86 it is said:
It
is impossible to be categorical about the degree of interest which will create
privity. It has been said that "there must be a sufficient degree of
identification between the two to make it just to hold that the decision to
which one was party should be binding in proceedings to which the other is
party".
[23] An
authority cited there was the case of Gleeson v. J. Wippell & Co. Ltd.,
[1977] 3 All E.R. 54 at paragraph 60. This passage from the Law of Evidence in Canada
was quoted with approval by Justice Binnie in the Supreme Court of Canada
in the Danyluk case supra at paragraph 60. In the case of Rasanen, supra, an
employee who was terminated initiated proceedings under the Employment
Standards Act of Ontario for
termination pay and also brought an action in the Superior Court for damages
for constructive dismissal. Under the Employment Standards Act it was
ultimately held that he was not entitled to termination pay. In his court
action that decision was held to create issue estoppel so he could not
prosecute a claim there for termination pay. On appeal, the Ontario Court of
Appeal, in affirming the trial judge's decision noted that the parties in the
two proceedings were actually different: in the Employment Standards Act
proceeding the parties were the employer and an Employment Standards officer
whereas in the court action the parties were the employee and the employer.
Nevertheless, an identity of interest was found between the employee and the
Employment Standards officer and they were held to be privies: see particularly
paragraphs 34 and 88. Here, the Applicant and Mr. Tebrinke had an identical
interest in challenging the allegation that the offending cow had been in the
load which the Applicant certified and the grower exported. They had been
engaged in a joint enterprise to effect the exportation of authorized cattle.
The Applicant gave evidence for Mr. Tebrinke and the chairman of the Tribunal
attached considerable weight to his evidence. The CFIA having had the
opportunity to prove the identity of the OTM head and having failed to do so in
the Tebrinke case, should not have the opportunity to relitigate the exact same
question of fact even within a different legal setting.
[24] I
therefore find that the CFIA is estopped from further proceedings against the
Applicant in respect of this particular animal. As it was at liberty to proceed
until the decision in the Tebrinke case of November 2, 2006 estopped it, I will
direct that the suspension issued on April 3, 2006, be terminated as of
November 2, 2006 and that all further proceedings as notified to the Applicant
by the CFIA's letter of April 3, 2006 in respect of the animal bearing the CCIA
ear tag 271 629 357 be terminated.
[43]
Thus,
in the context of NOC proceedings, in particular this one, it is entirely
appropriate to consider whether the resources of the Court and the Minister are
being unduly taxed by a generic that raises essentially the same questions as
were raised by another generic in previous proceedings, and failed. The Court
must be mindful that the generic always has the remedy of a proceeding to
challenge the validity of a patent in the usual way. The Court is also mindful
that, if a different question is raised as to validity in subsequent
proceedings, that question should be considered as it was, for instance, in Eli
Lilly Canada Inc. v. Novopharm Ltd., 2007 FC 596, previously discussed.
[44]
Therefor,
where the same issue, validity, is raised, and the same questions in that
respect, are raised, here “claims broader” and “sound prediction”, this Court
will approach those questions having in mind that there was previous litigation
in the NOC context and there always remains, free from the constraints of res
judicata, the alternative for an action where there can be full discovery
and observation of witnesses, in person, by the Court.
(2) Claims
Broader
[45]
The
law as to whether validity of a claim in a patent can be challenged for
overbreadth has been succinctly and clearly stated by Thurlow J. (as he then
was) in Farbewerke Hoechst A/G v. Canada Commissioner of Patents),
[1966] Ex. C.R. 91 (aff’d, [1966] S.C.R. 604) at paragraph 20 in which he said:
There are two fundamental
limitations on the extent of the monopoly which an inventor may validly claim.
One is that it must not exceed the invention which he has made, the other is
that it must not exceed the invention which he has described in his
specification.
[46]
The
first limitation is a question of fact, what is the invention that the inventor(s)
have made. The second is a question of construction of the disclosure of the
patent to determine what it says. In both cases a comparison must then be made
of the claims at issue to determine if the “breadth” of the claim exceeds
either what the inventor(s) actually did or what the disclosure actually says.
In the event that evidence from the inventor(s) is not available and secondary
evidence such as notebooks, memoranda and evidence of colleagues is unavailable
or unsatisfactory, it is reasonable to assume that the disclosure of the patent
coincides with that which the inventor(s) invented.
[47]
Construction
of the disclosure of the patent, as well as construction of the claims, is the
task of the Court, not experts or the inventor(s). The Court may be informed
by experts as to the meaning of words, terms and the science and background
that are pertinent, but the Court must be careful not to let the experts
supplant the role of the Court. Construction does not become a battle of
experts; it is a duty of the Court. As I said in Eli Lilly Canada v.
Novopharm Ltd., 2007 FC 596 (appeal dismissed as moot, 2007 FCA 359) at
paragraphs 103 and 104:
[103] A
patent decision should, begin with a construction of the patent (Whirlpool Inc.
v. Camco Inc. [2000] 2 S.C.R. 1067 at para. 43). This applies not only
to the claims but to the whole of the patent as well when required (Burton
Parsons Chemicals Inc. v. Hewlett-Packard (Canada) Inc. [1976] 1 S.C.R. 555 at page 563; Western Electric Co. v.
Baldwin International Radio of Canada, [1934] S.C.R. 570 at page 572).
[104] Construction
is a task for the Court alone (Whirlpool supra; Burton Parsons supra.) the role
of an expert, if required, is limited to assisting the Court in putting the
Court in the position of a person skilled in the art of the relevant time (Halford
v. Seed Hawk Inc., [2006] F.C.J. No. 1205, 2006 FCA 275 at para 11). In Dableh v. Ontario
Hydro [1996] 3 F.C. 751 at paragraph 33 the Federal Court of
Appeal stated what the role of the expert is:
It
is a matter of accepted law that the task of constructing a patent's claim lies
within the exclusive domain of the trial judge. In strict legal theory it is
the role of expert witnesses, that is those skilled in the art, to provide the
judge with the technical knowledge necessary to construe a patent as though he
or she were so skilled. Where the experts disagree, it is incumbent on the
trial judge to make a binding determination.
[48]
In
the earlier proceedings respecting the ’330 patent, 2007 FCA 209, the Federal
Court of Appeal construed the same claims as are at issue here and as
previously discussed, concluded that a proper construction of those claims
meant that all stereoisomers of the compounds were included. The parties in
the present proceedings concur with that construction. The Federal Court of
Appeal also construed the disclosure (specification). That was their duty as a
matter of law. Their conclusion, as expressed by Nadon J.A. for the court was
summarized at paragraphs 126 and 127 of the Reasons:
[126]
On the basis of the
evidence before the Court, however, Pfizer's invention can be described as
covering all stereoisomers of quinapril. The state of the art is to the effect
that all stereoisomers were within the inventor's contemplation, as revealed by
the use of a Markish [sic] formula and the fact that
patents for other ACE inhibitors claimed and disclosed all stereoisomers. The
wording of the claims and the expert evidence suggest that all stereoisomers of
quinapril are claimed in the patent. In fact, the Trial Judge, in her introduction
on the '330 patent, says that "... [t]he compounds have three chiral
centres and all the stereoisomers sharing this common structure, that is both
the S- and R-configurations stereoisomers, are within the scope of the
claims" (Reasons of Heneghan J., para. 9).
[127]
In my view, a person
skilled in the art would read the two paragraphs from the disclosure which I
have reproduced at paragraph 120 of these Reasons as disclosing that the
invention includes all stereoisomers. The skilled reader would be persuaded
particularly by the clear statement in the second paragraph that "... all
optical isomers and diastereo isomers and mixtures thereof are within the scope
of this invention". Accordingly, in my view, a skilled reader would
therefore understand that claims 3 and 5, although silent as to stereo
configuration, include all stereoisomers. Thus, given that the invention
clearly covers all stereoisomers and that the patent claims all stereoisomers,
the patent cannot be described as claiming more than what was invented.
[49]
Novopharm’s
Counsel argues that two things are raised in the present proceedings that were
not raised in the earlier. One is that, as a matter of law, the Federal Court
of Appeal erred in referring to other patents for the purpose of construing the
’330 patent. This says Novopharm’s counsel is reflected in the statement in
paragraph 126, supra:
…and the fact that patents for
other ACE inhibitors claimed and disclosed all stereoisomers.
[50]
It
is quite correct to say that a patent cannot be construed with respect to extrinsic
evidence (see e.g. Whirlpool Corp. v. Camco Inc., [2000] 2 S.C.R. 1067
at paragraph 49(f)). It is also correct for the Court to put itself in a
position to consider the context and use to which words in the patent are put
(e.g. Whirlpool, supra at paragraph 49(d)). While it is not
entirely clear how the Federal Court of Appeal treated the “other ACE patents”,
whatever they may be, it is sufficient, in the context of NOC proceedings, to
conclude that a higher Court than this one did consider the issue of
construction of the patent and made a reasoned determination.
[51]
The
second matter raised by Novopharm in this context is that of evidence and, in
particular, the evidence from the inventors themselves which goes to the second
branch of the test as stated by Thurlow J. in Hoechst supra, namely, do
the claims exceed what the inventors actually invented. The named inventors of
the ’330 patent are Milton L. Hoefle and Sylvester Klutchko. Both filed
affidavits as fact witnesses in the present proceedings and both were
cross-examined. In addition, Dr. Clifton Blankley, a chemist who handwrote the
first draft of what ultimately became the ’330 patent filed an affidavit in the
present proceedings and was cross-examined. He was not a lawyer or patent
agent. He testified as a fact witness.
[52]
Justice
Heneghan, the Trial Judge in the earlier proceedings respecting the ’330
patent, 2005 FC 1205, at paragraphs 18 to 43 carefully listed the witnesses in
the proceeding before her including whether they were cross-examined. She
indicated at paragraph 22 that both Hoefle and Klutchko filed affidavits but did
not say that they were cross-examined. Given that she was careful to say when
other witnesses were cross-examined it is reasonable to conclude that neither
Hoefle nor Klutchko were cross-examined in the earlier proceeding. Heneghan J.
states at paragraph 21, that Blankley filed an affidavit and was
cross-examined.
[53]
Novopharm’s
counsel in the present proceeding submits that there is “better evidence” here
than in the earlier proceeding. That “better evidence” is in the
cross-examination of Hoefle which, Novopharm’s counsel asserts, indicates that
the invention worked only with compounds in the S,S,S configuration and not
with all 8 possible stereoisomers. Thus, it is argued, the claimed invention,
namely all stereoisomers, is broader than the inventors actually made, namely
only the S,S,S stereoisomer. Indicative of some of the cross-examination of
Hoefle is that found at pages 38 to 40 of the transcript (pages 567-569 of the
Application Record):
Q. And you say in the
sentence that begins five lines in, this was part of the appreciation that
there was a class of compounds with a common utility, the invention that
eventually got incorporated into the ’330 patent. Do you see that?
A. Yes.
Q. And again, these
aren’t your words, but what was the class of compounds with common utility
you’re referring to here?
A. We’re referring to
the Merck derivatives of the tetrahydroisoquinoline. In other words, we were
only interested in one compound, and that was the tetrahydroisoquinoline
derivative. And there are others like the substituted dimatoxies [sic] that we looked
at, but we didn’t see any, you know, advantage in them.
Q. Right.
A. -- those were the
compounds that were made at that point in time, that we knew.
Q. And those –
A. And that’s what
were included in the patent.
Q. And that’s what you
were interested in?
A. Yes.
Q. And that included
only compounds with the THIQ moiety in the S configuration, correct?
A. Of the compounds we
made, that is a correct statement. How the patent is written, I’m not sure. I
mean the—you know.
Q. Your invention
wasn’t a THIQ in the R configuration, was it?
A. No. We were – our
invention was the Merck analogue. As far as we knew, that was the S, S, S, all
the way through.
Q. Because that’s what
you thought was required for activity, correct?
A. Correct.
[54]
Pfizer’s
counsel on the other hand argues that Hoefle’s evidence must be read in its entirety
whereby a different picture would emerge, namely that while work proceeded with
the S,S,S compounds, more than just that was conceived by the inventors.
Typical of the portions indicated by Pfizer’s counsel is the answer given by
Hoefle in cross-examination at pages 24 and 25 of the transcript (pages 553 and
554 of the Application Record):
Q. Okay. In paragraph
17, seven lines down, there’s a sentence that begins, thus. Do you see that?
A. Got it.
Q. Thus, it was my
understanding that the novel compound which Mr. Klutchko and I had conceived
would also have an S configuration at each of its three chiral centers. Do you
see that?
A. Yes.
Q. And that’s correct?
A. Yes.
Q. That was the
compound you had conceived, correct?
A. Well,
actually we had conceived more than that. The point is that it was our best
educated guess based on prior history and the literature that the most active
compound in this series would be the one that had the S, S, S, configuration.
[55]
The
evidence of Hoefle is not conclusive as to what it was exactly that the
inventors had invented, whether just the S,S,S stereoisomer or all eight
stereoisomers. It would be far preferable to observe Hoefle as a witness at
trial than to make a conclusion based on evidence that, arguably, could be
interpreted one way or the other. It cannot be said that this evidence is
truly “better” in the NOC proceeding context, than that which the Courts gave
consideration in the earlier proceeding.
[56]
The
other named inventor Klutchko, was not examined in this area. If Novopharm believed
that it was important to do so in order to achieve “better” evidence, it should
have done so. It didn’t. The evidence of Blankley in these proceedings does
not assist in resolving this question.
[57]
Thus
there is no “better evidence” in this proceeding such that this Court should
re-visit the finding of the Federal Court of Appeal in the earlier proceeding.
As previously discussed, this Court will not disturb in the NOC context, the legal
findings of the Federal Court of Appeal.
[58]
Therefore,
on the “claims broader” question, there is no basis for re-visiting the
conclusion reached in the earlier proceeding by the Federal Court of Appeal, which
was that the attack on the validity of the claims asserted of the ’330 patent
is not justified within the context of the NOC Regulations. There is no need
to address the detailed list of matters raised as issues by the parties other
than or has been done here.
(3) Sound
Prediction
[59]
The
question of sound prediction was considered by the Federal Court of Appeal in
the earlier proceeding under the caption “Lack of Utility” at paragraphs 150 to
154 of its Reasons, 2007 FCA 209. It said:
[150] Although
Heneghan J. found that Pfizer had not demonstrated utility at the date of invention,
she nevertheless found that the patent was valid because of the doctrine of
sound prediction.
[151] Apotex
argues that Heneghan J. was wrong to conclude that the utility of the compounds
claimed in the '330 patent was soundly predicted at the relevant time of
October 3, 1980 (the priority date). In its view, because there was no evidence
that any of the claimed compounds had been tested as of that date, the
prediction of utility was unsound. I cannot agree.
[152] In
support of its argument that some testing is required before the utility of an
invention will be found to be sound, Apotex points to the decision of the
Federal Court in Apotex v. Wellcome Foundation Ltd. (1998),
145 F.T.R. 161. However, on appeal, the Supreme Court (at [2002] 4
S.C.R. 153) took a different view of the
doctrine of sound prediction. In its view, in order for a prediction to be
sound, "... there must be a factual basis for the prediction" (at
paragraph 70). Although in two earlier Supreme Court decisions, "... the
factual basis was supplied by the tested compounds," the Supreme Court in Apotex,
supra was satisfied that "other factual underpinnings, depending on the
nature of the invention, may suffice" (at paragraph 70). Accordingly,
testing is not an absolute requirement for a patent based on sound prediction.
Moreover, in a case such as the one before us where there is considerable data
about the utility of related compounds such as captopril, enalapril and the
Tanabe compound, there was evidence on which Heneghan J. could find that there
was a factual basis to predict the utility of the invention disclosed in the
'330 patent.
[153] In
any event, Pfizer points, correctly in my view, to this Court's recent decision
in Aventis Pharma Inc.v Apotex Inc., 2006 FCA
64, which held that the relevant date for assessing the soundness of a prediction was the Canadian filing
date, in this case, September 30, 1981. Contrary to Apotex's NOA and to
Heneghan J.'s finding, the relevant date is not the priority date which, in
this case, is October 3, 1980. Further, in ts NOA of July 24, 2003, Apotex
refers to testing of quinapril that showed the compound reduced blood pressure
in rats. The results of those tests were received on December 8, 1980, well
before the Canadian filing date. Accordingly, even if some testing were
required to establish a sound prediction, such testing was conducted in this
case.
[154] The
issue of sound prediction is a mixed question of fact and law, in respect of
which there was evidence in the record. In particular, Dr. Wasley and Dr.
Anderson testified that a person of ordinary skill would have a sound basis to
predict that all compounds claimed would have utility, on the basis of the
captopril patents, enalapril disclosure and application, Tanabe patent and the
inventor's knowledge regarding certain other compounds. It cannot be said that
in concluding as she did, that the Judge made an overriding and palpable error.
[60]
Novopharm’s
counsel argues that the Federal Court of Appeal erred in law in asking the
wrong question. Counsel argues that the Court of Appeal incorrectly considered
whether a “skilled person” such as Wasley or Anderson would have had a sound
basis to predict the utility of all stereoisomers. The proper question, counsel
argues, is whether its inventors themselves, as a factual matter, had a sound
basis to make such a prediction.
[61]
All
parties agree that what is called the “AZT” decision of the Supreme Court of
Canada (Apotex Inc. v. Wellcome Foundation Ltd., [2002] 4 S.C.R. 153) is
the appropriate authority to consider in respect of “sound prediction”. A
later question has arisen as to what date is appropriate for considering
whether a sound prediction could have been made, the priority date or the
Canadian filing date. In the present proceeding it is unnecessary to resolve
that debate since whether it is one date or the other the evidence is the same.
[62]
The
AZT case, particularly at paragraph 70, provided a three part test for
considering sound prediction: (1) a factual basis for prediction (2) the
inventors must have an articulable and sound line of reasoning and (3) there
must be proper disclosure. More particularly Binnie J. for the Court said at
paragraph 70:
70 The
doctrine of sound prediction has three components. Firstly, as here, there must
be a factual basis for the prediction. In Monsanto and Burton
Parsons, the factual basis was supplied by the tested
compounds, but other factual underpinnings, depending on the nature of the
invention, may suffice. Secondly, the inventor must have at the date of the
patent application an articulable and "sound" line of reasoning from
which the desired result can be inferred from the factual basis. In Monsanto
and Burton Parsons,
the line of reasoning was grounded in the known "architecture of chemical
compounds" (Monsanto, at p. 1119), but other lines of reasoning, again
depending on the subject matter, may be legitimate. Thirdly, there must be
proper disclosure. Normally, it is sufficient if the specification provides a
full, clear and exact description of the nature of the invention and the manner
in which it can be practised: H. G. Fox, The Canadian Law and Practice Relating
to Letters Patent for Inventions (4th ed. 1969), at p. 167. It is generally not
necessary for an inventor to provide a theory of why the invention works.
Practical readers merely want to know that it does work and how to work it. In
this sort of case, however, the sound prediction is to some extent the quid pro
quo the applicant offers in exchange for the patent monopoly. Precise
disclosure requirements in this regard do not arise for decision in this case
because both the underlying facts (the test data) and the line of reasoning
(the chain terminator effect) were in fact disclosed, and disclosure in this
respect did not become an issue between the parties. I therefore say no more
about it.
[63]
It
is important to remember the context in which the “AZT” case arose. The patent
was directed to a new use of an old compound. The question as to sound
prediction was whether, as of the relevant date, the inventor had a proper
basis for making a sound prediction as to that new use. Binnie J. said at
paragraph 52:
52 It
is important to reiterate that the only contribution made by
Glaxo/Wellcome in the case of AZT was to identify a new use. The
compound itself was not novel. Its chemical composition had been described 20
years earlier by Dr. Jerome Horwitz. Glaxo/Wellcome claimed a hitherto
unrecognized utility but if it had not established such utility by tests
or sound prediction at the time it applied for its patent, then it was offering
nothing to the public but wishful thinking in exchange for locking up
potentially valuable research turf for (then) 17 years. As Jackett C.J.
observed in Procter & Gamble Co. v. Bristol-Myers Canada Ltd. (1979), 42
C.P.R. (2d) 33 (F.C.A.), at p. 39:
By
definition an "invention" includes a "new and useful
process". A "new" process is not an invention unless it is
"useful" in some practical sense. Knowing a new process without
knowing its utility is not in my view knowledge of an "invention".
[64]
The
factual basis for the determination as to sound prediction was addressed by
Binnie J. at paragraphs 65 and 69:
65 However,
where, as here, the trial judge accepts on the evidence that the inventors could
in fact make a sound prediction that an old compound (AZT) offers a hitherto
unexpected utility in the treatment and prophylaxis of HIV/AIDS, then (and only
then) does their disclosure of "the invention" offer real
consideration for the monopoly benefits they seek.
…
69 With
respect, I think Parliament intended to get something more than speculation in
exchange for the grant of a patent monopoly (a point which is further discussed
below). On the other hand, I do not think, with respect, that the doctrine of
sound prediction is limited to the narrow ambit ascribed to it by the trial
judge. Once it is accepted that in appropriate circumstances utility can be
predicted in advance of complete testing (whether of untested chemical
compounds or otherwise), there seems no reason in principle why the doctrine
should not be applied more generally, depending, of course, on the expert
evidence. There is no doubt that care must be taken that the doctrine is not
abused, and that sound [page186] prediction is not diluted to include a lucky
guess or mere speculation. The public is entitled to obtain a solid teaching in
exchange for the patent rights.
[65]
Each
case will turn on its facts as Binnie J. stated at paragraph 71:
71 It
bears repetition that the soundness (or otherwise) of the prediction is a
question of fact. Evidence must be led about what was known or not known at the
priority date, as was done here. Each case will turn on the particularities of the
discipline to which it relates. In this case, the findings of fact necessary
for the application of "sound prediction" were made and the
appellants have not, in my view, demonstrated any overriding or palpable error.
[66]
The
Federal Court of Appeal in the earlier ’330 patent NOC proceedings did not
address itself to the wrong question. To repeat paragraph 154 of their
decision (2007 FCA 209):
[154]
The issue of sound
prediction is a mixed question of fact and law, in respect of which there was
evidence in the record. In particular, Dr. Wasley and Dr. Anderson testified
that a person of ordinary skill would have a sound basis to predict that all
compounds claimed would have utility, on the basis of the captopril patents,
enalapril disclosure and application, Tanabe patent and the inventor's
knowledge regarding certain other compounds. It cannot be said that in
concluding as she did, that the Judge made an overriding and palpable error.
[67]
The
question is one of mixed fact and law. The Court of Appeal considered the “inventors
knowledge regarding certain other compounds” as well as the knowledge that
would have been possessed of persons of ordinary skill. There is no error of
law such that this Court, in the context of an NOC proceeding, should not
follow the conclusion reached by the Federal Court of Appeal that the
allegation of invalidity of the asserted claims of the ’330 patent is not
justified. There is no reason to address in any more detail than has been done
here the list of issues raised by the parties.
IN CONCLUSION
[68]
In
conclusion, in the context of an NOC proceeding, there has not been
demonstrated that, on the same questions as to invalidity as raised by another
generic in earlier NOC proceedings respecting the asserted claims of the ’330
patent, there is any better evidence or more appropriate argument in the
present proceeding. The applications by Pfizer for prohibition will,
therefore, be allowed with costs.
COSTS
[69]
Pfizer
is entitled to its costs and disbursements. Neither party has asserted that
costs be assessed at other than at the default level being the middle of Column
III. I find that that is the appropriate level for taxation. At the hearing,
each of Pfizer and Novopharm had three counsel gowned. Pfizer may tax costs
for one senior and one junior counsel. For attendance when Pfizer counsel were
conducting cross-examination, costs for one senior and one junior counsel, if
present, may be taxed. When attending cross-examination of a Pfizer witness by
Novopharm, only one counsel’s costs, at the senior level, may be taxed.
[70]
As
to disbursements, there is a continued concern as to experts. Only five
experts can put in evidence without leave of the Court. Here Pfizer had six
and no leave. Only the costs of five experts can be allowed; Maycock was frequently
referred to by Pfizer in argument and his costs are allowed. Costs of four
other experts only may be taxed. Pfizer may choose which four.
[71]
The
fees charged by the experts must be carefully scrutinized. They must be
reasonable and should not exceed fees charged by Pfizer’s senior counsel for
the same amount of time. Nothing is to be allowed for any in-house Pfizer
counsel or outside counsel or attorneys other than counsel of record.
Disbursements as to photocopies are to be carefully scrutinized. Multiple
copies of material beyond that provided to the Court and the other side are to
be limited to three. If any non-arms length copying service was used, than the
actual cost of copies is to be assessed. If an arms length service was used
then the actual cost, if reasonable, is to be assessed. Travel costs if incurred
for counsel who appeared at trial or cross-examination is to be reasonable.
[72]
Since
applications T-209-06 and T-210-06 were heard together, no duplication as to
costs or disbursements is allowed unless shown to have been actually incurred.
JUDGMENT
For the Reasons given:
THIS COURT ORDERS AND
ADJUDGES that:
1. Each
of Applications T-209-06 and T-210-06 is allowed;
2. The Respondent, the Minister of Health, is
prohibited from issuing a Notice of Compliance to the Respondent Novopharm
Limited in respect of its Applications respecting quinapril hydrochloride and
quinapril hydrochloride and quinapril hydrochloride and hydrochlorothiazine at
issue in these proceedings, at least until the expiry of Canadian Patent No. 1,341,330;
3. The Applicants are entitled to their costs and
disbursements to be taxed in accordance with the Reasons given.
"Roger
T. Hughes"
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