Date: 20070531
Docket: A-457-05
Citation: 2007 FCA 209
CORAM: LINDEN J.A.
NADON
J.A.
SEXTON
J.A.
BETWEEN:
PFIZER CANADA INC., WARNER-LAMBERT
COMPANY LLC
and PARKE, DAVIS & COMPANY LLC
Appellants
and
THE MINISTER OF HEALTH
and APOTEX INC.
Respondents
REASONS FOR JUDGMENT
NADON J.A.
[1]
We are
once again, but certainly not for the last time, called upon to determine a
dispute between a patentee and a generic competitor which arises pursuant to
the Patented Medicines (Notice of Compliance) Regulations, SOR/93-133,
March 12, 1993 (the “Regulations”).
[2]
More
particularly, the matter before us arises from an application brought by the
appellants (“Pfizer”) pursuant to section 6 of the Regulations for an order prohibiting
the Minister of Health (the “Minister”) from issuing a notice of compliance (a
“NOC”) to the respondent Apotex in respect of its drug product apo-quinapril
until the expiration of Canadian letters patent numbers 1,341,330 (the “ ‘330
patent ”) and 1,331,615 (the “ ‘615 patent ”).
[3]
Pfizer’s
application was heard by Heneghan J. of the Federal Court who, on September 28,
2005, dismissed it (2005 FC 1205). By its appeal, Pfizer seeks an order setting
aside the Federal Court’s decision and declaring that the Minister is
prohibited from issuing a NOC to Apotex until the expiration of the ‘330 and
‘615 patents.
[4]
For a
proper understanding of the questions which this appeal raises, the following review
of the facts will be helpful.
THE FACTS
[5]
Not
surprisingly, the ‘330 patent, a genus patent for a novel group of compounds,
including quinapril, and the ‘615 patent, a species patent for quinapril hydrochloride
in various solid forms, are at the heart of this appeal.
[6]
Quinapril-hydrochloride
is an angiotensin-converting enzyme (ACE inhibitor). By inhibiting the
transformation of angiotensin I to angiotensin II (the form which raises blood
pressure), quinapril hydrochloride is useful in the treatment of high blood
pressure, congestive heart failure and the prevention of kidney failure.
Pfizer markets quinapril-hydrochloride in tablet form under the trade name Accupril.
[7]
The ‘330
patent, entitled “Substituted Acyl Derivatives of 1,2,3,4-
tetrahydroisoquinoline-3-Carboxylic Acids”, was applied for in the Canadian
Patent Office on September 30, 1981, with a priority date of October 3, 1980.
Because of conflict proceedings which were initiated in respect of the ‘330
patent and a patent involving a German patent owned by Hoechst Aktiengessellschaft
(Hoechst), the patent was not issued until January 1, 2002. This followed a
consent judgment entered on December 22, 1999 which allowed the claims of the
patent to issue in Canada. The patent was issued to
Parke, Davis & Company LLC. The ‘330 patent is a genus patent which claims
a novel group or family of chemical compounds, including quinapril and other
ACE inhibitors. All of the compounds claimed share a common structure
consisting of a THIQ head and an enalapril tail.
[8]
The ‘615
patent, entitled “Substituted Acyl Derivatives of
1,2,3,4,-Tetrahydroisoquinoline-3-Carboxylic Acids” was applied for, as a
divisional application derived from the ‘330 patent, on June 23, 1992, by the
assignee, Warner-Lambert Company LLC. The patent, which issued on August 23,
1994 claims a narrow subclass of the compounds claimed in the ‘330 patent,
including the hydrochloride salt of quinapril.
[9]
On July
18, 2003, pursuant to subsection 5(3) of the Regulations, Apotex filed and
served a Notice of Allegation (“NOA”) which says that the ‘615 patent would not
be infringed by the manufacturing and marketing of its drug product apo-quinapril
in tablet form, on the grounds that its tablets would not comprise any of the
compounds covered by the ‘615 patent, nor would such compounds be made,
constructed or used in the manufacture of its tablets. As a result, Apotex says
that the claims of the ‘615 patent would not be infringed.
[10]
On July
24, 2003, Apotex filed a second NOA which says that the ‘330 patent is invalid
for lack of utility, lack of sound prediction, anticipation, obviousness,
overly-broad claims and double patenting.
[11]
On
September 5, 2003, Pfizer filed its application for an order of prohibition before
the Federal Court, asserting that Apotex’s allegations of non-infringement and of
invalidity were not justified.
[12]
In
dismissing Pfizer’s application, the learned Judge held that the claims of the
‘330 patent were broader than the invention disclosed and, thus, that Apotex’s
allegation of invalidity was justified. She further concluded that since there
was no evidence that Apotex’s drug product contained any quinapril hydrochloride,
Pfizer had not met its burden of demonstrating that Apotex’s allegation of
non-infringement in regard to the ‘615 patent was not justified.
THE DECISION OF THE FEDERAL COURT
A. Burden of Proof
[13]
Heneghan J. first considered the evidentiary
burden of proof applicable in proceedings under the Regulations. Although Pfizer
accepted that it had the legal burden of proving non-infringement, it argued
that with respect to the allegations of invalidity, it was entitled to the
benefit of section 45 of the former Patent Act which creates a
presumption that the patent is valid. As a result, Pfizer argued that the
burden of proof was that of the party challenging the validity of the patent.
[14]
Heneghan
J. rejected Pfizer’s argument. Although, in her view, Apotex had an obligation
to put the allegations of invalidity “in play”, the overall legal burden of
proof was that of Pfizer.
B. Invalidity of the ‘330
Patent
(a) Construction of
the Disputed Claims:
[15]
In order
to assess Apotex’s allegation of invalidity, Heneghan J. first construed claims
3 and 5 of the ’330 patent which were in dispute. Pfizer argued before her that
a purposive construction of the claims would lead to a finding that the ’330
patent disclosed an invention relating to ACE inhibition. Conversely, Apotex argued
that the invention only encompassed those compounds useful in relieving
hypertension and not a broader group of ACE inhibitors, some of which did not
have sufficient inhibition activity to be useful in treating hypertension.
[16]
Heneghan
J. accepted Apotex’s submissions and concluded that the purpose of the
invention disclosed in claims 3 and 5 of the ’330 patent was the use of the
compounds described as active ingredients in medicine for the treatment of
hypertension, not merely the inhibition of ACE activity.
b) Invalidity of the ’330
Patent:
[17]
Heneghan
J. then went on to consider each of Apotex’s specific grounds for alleging
invalidity of the ’330 patent. Only one such allegation succeeded. Heneghan J.
concluded claims 3 and 5 of the ’330 patent were overly broad and, therefore,
that Apotex’s allegation of invalidity was justified.
[18]
Heneghan
J. first considered the argument that the ’330 patent lacked utility. Although
she was not satisfied that the utility of the invention disclosed in the patent
had been demonstrated by the date the patent was applied for, she concluded
that the inventors had been able to soundly predict the utility of the claimed
compounds by that date. Therefore, the inutility argument was rejected.
[19]
Next,
Heneghan J. considered whether the invention was invalid because of
anticipation. Apotex alleged that the Hoechst patent, which gave rise to
conflict proceedings involving the ’330 patent, was anticipatory. The relevant
date for assessing anticipation under the pre-1989 Patent Act was two
years prior to the filing date of the patent at issue (former Patent Act
at s. 27(1)). Since there was no evidence before her that the Hoechst patent
had issued on or before that date, i.e. September 30, 1979, she concluded that
Apotex had not adduced sufficient proof to put the anticipation argument “in
play”.
[20]
Thirdly,
Heneghan J. considered whether the patent was invalid by reason of obviousness
which is assessed at the date of invention. Heneghan J. accepted that the date
of invention was the priority date of October 3, 1980. In her opinion, the
evidence showed that on that date, persons skilled in the art would not have
considered the discovery of quinapril hydrochloride obvious.
[21]
Fourth,
Heneghan J. considered whether claims 3 and 5 of the ’330 patent were broader
than the invention or the disclosure. Apotex argued the disclosure limited the
invention to those stereoisomers with a particular configuration (known as an
“S-configuration”) but that claims 3 and 5 include all stereoisomers and
therefore were overly broad. Heneghan J. accepted Apotex’s argument. She held
that because she had construed claims 3 and 5 as including compounds useful for
treating hypertension and because expert evidence illustrated that the
S-configuration was the optimal configuration for high level ACE inhibition
leading to anti-hypertensive results, the claims encompassing all stereoisomers
were overly broad.
[22]
Finally,
Heneghan J. considered whether the ’330 patent was invalid on the basis of
obvious-type double patenting because it was not patently distinct from the
’615 patent. Heneghan J. rejected this allegation. She was persuaded by the
fact that the ’615 patent had not been involved in the conflict proceedings to
which the ’330 patent was subject.
C. Non-infringement of the ’615
Patent
(a) Adequacy of the NOA:
[23]
Pfizer
argued that the non-infringement allegation in Apotex’s July 18, 2003 NOA was
inadequate because it did not sufficiently describe the entire basis upon which
the allegation rested. The NOA did not allege that ACCUPRIL tablets contained
quinapril magnesium and therefore Pfizer argued that Apotex was precluded from
relying on that allegation in this application.
[24]
Heneghan
J. concluded that the July 18, 2003 NOA partially complied with the legal test
for adequacy. Apotex needed only to address the issue of non-infringement of
claims for the medicine, quinapril hydrochloride, and it was justified in
withholding certain information until a confidentiality order was in place.
However, Heneghan J. concluded the NOA was insufficient in that if Apotex was
alleging that ACCUPRIL contained quinapril magnesium, it should have said so.
Nonetheless, Heneghan J. did not consider this defect fatal and went on to
consider the merits of Apotex’s allegation of non-infringement.
(b) Non-Infringement of
the ’615 Patent:
[25]
Apotex’s
drug, Apo-Quinapril, is allegedly comprised of a substance
called quinapril magnesium. Apotex admits to using a solvated form of quinapril
hydrochloride known as quinapril hydrochloride acetone solvate (“QHAS”) to make
quinapril magnesium.
[26]
In the
Court below, Pfizer argued that claim 1 of the ’615 patent, when properly
construed, encompasses both the solvated and unsolvated forms of quinapril
hydrochloride. Accordingly, because Apotex uses a solvated form of quinapril
hydrochloride, i.e. QHAS, in making ApO Quinapril, it infringes the ’615
patent. Pfizer also argued that Apotex had failed to establish on a balance of
probabilities that there was only quinapril magnesium in its drug product, not
quinapril hydrochloride.
[27]
Apotex, on
the other hand, argued that the medicine in Pfizer’s tablets is quinapril
magnesium, not quinapril hydrochloride, and therefore the ’615 patent is
irrelevant because it does not claim quinapril magnesium. In the alternative,
Apotex argued that the ’615 patent did not encompass QHAS, which it uses in the
production of quinapril magnesium, and therefore the patent was not infringed.
[28]
Heneghan J.
concluded that the appellants had not discharged their burden of showing that
Apotex’s product infringed the ’615 patent. She based her decision on the fact
that although the appellants were provided with a sample of Apotex’s Apo-Quinapril
product, they elected not to test the material to determine its composition. At
paragraph 155 of her Reasons, the Judge said:
[155] In my
opinion, the inability to guarantee the success of a chosen testing process is
no answer to the Applicants’ burden relative to the allegation of
non-infringement. The '615 Patent claims quinapril hydrochloride as the
medicine. The presence of that substance in Apotex's product would amount to
infringement. One means of establishing that presence is testing and according
to the applicants' evidence, no testing was done. In these circumstances, I
conclude that the Applicants have failed to show that the allegation of
non-infringement is not justified.
[29]
Heneghan
J. then went on to hold that it was not necessary for her to decide whether Accupril,
as argued by Apotex, contained quinapril hydrochloride because of her view that
the NOA was insufficient in that regard.
THE ISSUES
[30]
With
respect to the ‘615 patent, the issue is whether the learned Judge erred in
concluding that Pfizer had failed to demonstrate that Apotex’s allegation of
non-infringement was not justified. With respect to the ‘330 patent, the issue
is whether the learned Judge erred in holding that the claims of the ‘330
patent were broader than the invention disclosed. If the Judge erred in that
respect, the issue arises as to whether Pfizer’s application should be upheld
on the basis of Apotex’s allegations of inutility, lack of sound basis to
predict, anticipation, obviousness and double patenting.
THE RELEVANT LEGISLATION
[31]
The
following provisions of the NOC Regulations are relevant to the disposition of
the appeal.
2. In these Regulations,
"claim
for the medicine itself" includes a claim in the patent for the medicine
itself when prepared or produced by the methods or processes of manufacture
particularly described and claimed or by their obvious chemical equivalents;
"claim
for the use of the medicine" means a claim for the use of the medicine
for the diagnosis, treatment, mitigation or prevention of a disease, disorder
or abnormal physical state, or the symptoms thereof;
"court"
means the Federal Court of Canada or any other superior court of competent
jurisdiction;
"expire"
means, in relation to a patent, expire, lapse or terminate by operation of
law;
"first
person" means the person referred to in subsection 4(1);
"medicine"
means a substance intended or capable of being used for the diagnosis,
treatment, mitigation or prevention of a disease, disorder or abnormal
physical state, or the symptoms thereof;
"Minister"
means the Minister of National Health and Welfare;
"notice
of compliance" means a notice issued under section C.08.004 of the Food
and Drug Regulations;
"patent
list" means a list of all patents that is submitted pursuant to section
4;
"register"
means the register maintained by the Minister under section 3.
"second
person" means the person referred to in subsection 5(1) or (1.1), as the
case may be.
…
5. (1) Where a person files or has filed a
submission for a notice of compliance in respect of a drug and compares that
drug with, or makes reference to, another drug for the purpose of
demonstrating bioequivalence on the basis of pharmaceutical and, where
applicable, bioavailability characteristics and that other drug has been
marketed in Canada pursuant to a notice of compliance issued to a first
person and in respect of which a patent list has been submitted, the person
shall, in the submission, with respect to each patent on the register in
respect of the other drug,
(a) state that the person accepts that the notice
of compliance will not issue until the patent expires; or
(b) allege that
(i)
the statement made by the first person pursuant to paragraph 4(2)(c) is
false,
(ii)
the patent has expired,
(iii)
the patent is not valid, or
(iv)
no claim for the medicine itself and no claim for the use of the medicine would
be infringed by the making, constructing, using or selling by that person of
the drug for which the submission for the notice of compliance is filed.
(1.1) Subject to subsection (1.2), where subsection (1) does not apply and
where a person files or has filed a submission for a notice of compliance in
respect of a drug that contains a medicine found in another drug that has
been marketed in Canada pursuant to a notice of compliance issued to a first
person and in respect of which a patent list has been submitted, the person
shall, in the submission, with respect to each patent included on the
register in respect of the other drug containing the medicine, where the drug
has the same route of administration and a comparable strength and dosage
form,
(a) state that the person accepts that the notice
of compliance will not issue until the patent expires; or
(b) allege that
(i)
the statement made by the first person pursuant to paragraph 4(2)(c) is
false,
(ii)
the patent has expired,
(iii)
the patent is not valid, or
(iv)
no claim for the medicine itself and no claim for the use of the medicine
would be infringed by the making, constructing, using or selling by that
person of the drug for which the submission for the notice of compliance is
filed.
…
(3) Where a person makes an allegation pursuant to paragraph (1)(b) or
(1.1)(b) or subsection (2), the person shall
(a) provide a detailed statement of the legal and
factual basis for the allegation;
(b) if the allegation is made under any of
subparagraphs (1)(b)(i) to (iii) or (1.1)(b)(i) to (iii), serve a notice of
the allegation on the first person;
(c) if the allegation is made under subparagraph
(1)(b)(iv) or (1.1)(b)(iv),
(i)
serve on the first person a notice of the allegation relating to the submission
filed under subsection (1) or (1.1) at the time that the person files the
submission or at any time thereafter, and
(ii)
include in the notice of allegation a description of the dosage form,
strength and route of administration of the drug in respect of which the
submission has been filed; and
(d) serve proof of service of the information
referred to in paragraph (b) or (c) on the Minister.
6. (1) A first person may, within 45 days after
being served with a notice of an allegation pursuant to paragraph 5(3)(b) or
(c), apply to a court for an order prohibiting the Minister from issuing a
notice of compliance until after the expiration of a patent that is the
subject of the allegation.
(2) The court shall make an order pursuant to subsection (1) in respect of a
patent that is the subject of one or more allegations if it finds that none
of those allegations is justified.
|
2. Les définitions qui suivent s’appliquent au
présent règlement.
«avis
de conformité» Avis délivré au titre de l’article C.08.004 du Règlement sur
les aliments et drogues. ( notice of compliance )
«expiré»
Se dit du brevet qui est expiré, qui est périmé ou qui a pris fin par l’effet
d’une loi. ( expire )
«liste
de brevets» Liste de brevets soumise aux termes de l’article 4. ( patent list
)
«médicament»
Substance destinée à servir ou pouvant servir au diagnostic, au traitement, à
l’atténuation ou à la prévention d’une maladie, d’un désordre, d’un état
physique anormal, ou de leurs symptômes. ( medicine )
«ministre»
Le ministre de la Santé nationale et du Bien-être social. (Minister )
«première
personne» La personne visée au paragraphe 4(1). ( first person)
«registre»
Le registre tenu par le ministre conformément à l’article 3. (register )
«revendication
pour le médicament en soi» S’entend notamment d’une revendication, dans le
brevet, pour le médicament en soi préparé ou produit selon les modes du
procédé de fabrication décrits en détail et revendiqués ou selon leurs
équivalents chimiques manifestes. ( claim for the medicine itself )
«revendication
pour l’utilisation du médicament» Revendication pour l’utilisation du
médicament aux fins du diagnostic, du traitement, de l’atténuation ou de la
prévention d’une maladie, d’un désordre, d’un état physique anormal, ou de
leurs symptômes. ( claim for the use of the medicine )
«seconde
personne» Selon le cas, la personne visée aux paragraphes 5(1) ou (1.1). (
second person )
«tribunal»
La Cour fédérale du Canada ou tout autre cour supérieure compétente. ( court
)
5 (1) Lorsqu'une personne dépose ou a déposé une
demande d'avis de conformité pour une drogue et la compare, ou fait
référence, à une autre drogue pour en démontrer la bioéquivalence d'après les
caractéristiques pharmaceutiques et, le cas échéant, les caractéristiques en
matière de biodisponibilité, cette autre drogue ayant été commercialisée au
Canada aux termes d'un avis de conformité délivré à la première personne et à
l'égard de laquelle une liste de brevets a été soumise, elle doit inclure dans
la demande, à l'égard de chaque brevet inscrit au registre qui se rapporte à
cette autre drogue :
a) soit une déclaration portant qu'elle accepte
que l'avis de conformité ne sera pas délivré avant l'expiration du brevet;
b) soit une allégation portant que, selon le cas
:
(i)
la déclaration faite par la première personne aux termes de l'alinéa 4(2)c)
est fausse,
(ii)
le brevet est expiré,
(iii)
le brevet n'est pas valide,
(iv)
aucune revendication pour le médicament en soi ni aucune revendication pour
l'utilisation du médicament ne seraient contrefaites advenant l'utilisation,
la fabrication, la construction ou la vente par elle de la drogue faisant
l'objet de la demande d'avis de conformité.
(1.1) Sous réserve du paragraphe (1.2), lorsque le paragraphe (1) ne
s'applique pas, la personne qui dépose ou a déposé une demande d'avis de
conformité pour une drogue contenant un médicament que l'on trouve dans une
autre drogue qui a été commercialisée au Canada par suite de la délivrance
d'un avis de conformité à la première personne et à l'égard de laquelle une
liste de brevets a été soumise doit inclure dans la demande, à l'égard de
chaque brevet inscrit au registre visant cette autre drogue contenant ce
médicament, lorsque celle-ci présente la même voie d'administration et une
forme posologique et une concentration comparables :
a) soit une déclaration portant qu'elle accepte
que l'avis de conformité ne soit pas délivré avant l'expiration du brevet;
b) soit une allégation portant que, selon le cas
:
(i)
la déclaration faite par la première personne aux termes de l'alinéa 4(2)c)
est fausse,
(ii)
le brevet est expiré,
(iii)
le brevet n'est pas valide,
(iv)
aucune revendication pour le médicament en soi ni aucune revendication pour
l'utilisation du médicament ne seraient contrefaites advenant l'utilisation,
la fabrication, la construction ou la vente par elle de la drogue faisant
l'objet de la demande d'avis de conformité.
…
(3) Lorsqu'une personne fait une allégation visée aux alinéas (1)b) ou
(1.1)b) ou au paragraphe (2), elle doit :
a) fournir un énoncé détaillé du droit et des
faits sur lesquels elle se fonde;
b) si l'allégation est faite aux termes de l'un
des sous-alinéas (1)b)(i) à (iii) ou (1.1)b)(i) à (iii), signifier un avis de
l'allégation à la première personne;
c) si l'allégation est faite aux termes des
sous-alinéas (1)b)(iv) ou (1.1)b)(iv) :
(i)
signifier à la première personne un avis de l'allégation relative à la
demande déposée selon les paragraphes (1) ou (1.1), au moment où elle dépose
la demande ou par la suite,
(ii)
insérer dans l'avis d'allégation une description de la forme posologique, de
la concentration et de la voie d'administration de la drogue visée par la
demande;
d) signifier au ministre une preuve de la
signification effectuée conformément aux alinéas b) ou c).
6. (1) La première personne peut, au plus tard
quarante-cinq jours après avoir reçu signification d’un avis d’allégation aux
termes de l’alinéa 5(3)a), demander au tribunal de rendre une ordonnance
interdisant au ministre de délivrer l’avis de conformité avant l’expiration
du brevet en cause.
(2) Le tribunal rend une ordonnance en vertu du paragraphe (1) à l’égard
du brevet visé par une ou plusieurs allégations si elle conclut qu’aucune des
allégations n’est fondée.
|
[32]
Because
the ‘330 patent was filed before October 1, 1989, it is primarily subject to
the provisions of the Patent Act, R.S.C. 1985, c. P-4, as they read
immediately before that date.
27. (1) Subject to this section, any inventor or
legal representative of an inventor of an invention that was
(a) not known or used by any other person before
he invented it,
(b) not described in any patent or in any
publication printed in Canada or in any other country more than two years
before presentation of the petition hereunder mentioned, and
(c) not in public use or on sale in Canada more
than two years prior to his application in Canada,
may,
on presentation to the Commissioner of a petition setting out the facts, in
this Act termed the filing of the application, and on compliance with all
other requirements of this Act, obtain a patent granting to him an exclusive
property in the invention.
…
45. Every patent granted under this Act shall be
issued under the signature of the Commissioner and the seal of the Patent
Office, shall bear on its face the date on which it is granted and issued and
shall thereafter, in the absence of evidence to the contrary, be valid and
avail the grantee and his legal representatives for the term mentioned
therein.
…
61. (1) No patent or claim in a patent shall be
declared invalid or void on the ground that before the invention therein
defined was made by the inventor by whom the patent was applied for, it had
already been known or used by some other person, unless it is established
that,
(a) that other person had, before the date of the
application for the patent, disclosed or used the invention in such a manner
that it had become available to the public;
(b) that other person had, before the issue of
the patent, made an application for patent in Canada on which conflict
proceedings should have been directed; or
(c) that other person had at any time made an
application in Canada which, by virtue of section 28, had the same
force and effect as if it had been filed in Canada before the
issue of the patent and on which conflict proceedings should properly have
been directed had it been so filed.
(2) Notwithstanding section 41, an application for a patent for an invention
for which a patent has already issued under this Act shall be rejected unless
the applicant, within a time to be fixed by the Commissioner, commences an
action to set aside the prior patent, so far as it covers the invention in
question, but if that action is commenced and diligently prosecuted, the
application shall not be deemed to have been abandoned unless the applicant
fails to proceed on it within a reasonable time after the action has been
finally disposed of.
(3) Where the application was filed within one year from the date of the
filing of the application for the prior patent, the provisions of subsection
(1) do not apply to the determination of the respective rights of the parties
to the action.
|
27. (1) Sous réserve des autres dispositions du présent
article, l’auteur de toute invention ou le représentant légal de l’auteur
d’une invention peut, sur présentation au commissaire d’une pétition exposant
les faits, appelée dans la présente loi le « dépôt de la demande »,
et en se conformant à toutes les autres prescriptions de la présente loi,
obtenir un brevet qui lui accorde l’exclusive propriété d’une invention qui
n’était pas :
a) connue ou utilisée par une autre personne
avant que lui-même l’ait faite;
b) décrite dans un brevet ou dans une
publication imprimée au Canada ou dans tout autre pays plus de deux ans avant
la présentation de la pétition ci-après mentionnée;
c) en usage public ou en vente au Canada plus de
deux ans avant le dépôt de sa demande au Canada.
…
45. Tout brevet accordé en vertu de la présente
loi est délivré sous la signature du commissaire et le sceau du Bureau des
brevets. Le brevet porte à sa face la date à laquelle il a été accordé et
délivré, et il est par la suite, sauf preuve contraire, valide et acquis au
titulaire et à ses représentants légaux pour la période y mentionnée.
…
61. (1) Aucun brevet ou aucune revendication
dans un brevet ne peut être déclaré invalide ou nul pour la raison que
l’invention qui y est décrite était déjà connue ou exploitée par une autre
personne avant d’être faite par l’inventeur qui en a demandé le brevet, à
moins qu’il ne soit établi que, selon le cas :
a) cette autre personne avait, avant la date de
la demande du brevet, divulgué ou exploité l’invention de telle manière
qu’elle était devenue accessible au public;
b) cette autre personne avait, avant la
délivrance du brevet, fait une demande pour obtenir au Canada un brevet qui
aurait dû donner lieu à des procédures en cas de conflit;
c) cette autre personne avait à quelque époque
fait au Canada une demande ayant, en vertu de l’article 28, la même force et
le même effet que si elle avait été enregistrée au Canada avant la délivrance
du brevet et pour laquelle des procédures en cas de conflit auraient dû être
régulièrement prises si elle avait été ainsi enregistrée.
(2) Nonobstant l’article 41, une demande de brevet pour une invention à
l’égard de laquelle un brevet a déjà été délivré en vertu de la présente loi
est rejetée, à moins que le demandeur n’intente, dans un délai fixé par le
commissaire, une action pour écarter le brevet antérieur en tant qu’il couvre
l’invention en question. Si pareille action est ainsi commencée et
diligemment poursuivie, la demande n’est pas réputée avoir été abandonnée, à
moins que le demandeur ne néglige de poursuivre sa demande dans un délai
raisonnable après que l’action a été finalement réglée.
(3) Si la demande a été déposée dans le cours de l’année qui suit la date du
dépôt de la demande du brevet antérieur, le paragraphe (1) ne s’applique pas
à la détermination des droits respectifs des parties à cette action.
|
[33]
The current Patent
Act provides for the following transitional provisions:
78.2
(1) Subject
to subsection (3), any matter arising on or after October 1, 1989 in respect
of a patent issued before that date shall be dealt with and disposed of in
accordance with sections 38.1 and 45 and with the provisions of this Act,
other than section 46, as they read immediately before October 1, 1989.
(2)
Subject to subsection (3), any matter arising on or after October 1, 1989 in
respect of a patent issued on or after that date on the basis of an
application filed before that date shall be dealt with and disposed of in
accordance with sections 38.1, 45, 46 and 48.1 to 48.5 and with the
provisions of this Act, other than section 46, as they read immediately
before October 1, 1989.
(3)
The provisions of this Act that apply as provided in subsections (1) and (2)
shall be read subject to any amendments to this Act, other than the
amendments that came into force on October 1, 1989 or October 1, 1996.
|
78.2
(1) Sous réserve du paragraphe (3), la présente loi dans sa version du 30
septembre 1989, à l’exception de l’article 46, s’applique aux affaires
survenant, le 1er octobre 1989 ou par la suite, relativement aux brevets
délivrés avant le 1er octobre 1989. Ces affaires sont également régies par
les articles 38.1 et 45.
(2)
Sous réserve du paragraphe (3), la présente loi dans sa version du 30 septembre
1989, à l’exception de l’article 46, s’applique aux affaires survenant, le
1er octobre 1989 ou par la suite, relativement aux brevets délivrés ce jour
ou par la suite au titre de demandes déposées avant le 1er octobre 1989. Ces
affaires sont également régies par les articles 38.1, 45, 46 et 48.1 à 48.5.
Les
modifications, sauf certaines, sont prises en compte
(3)
Les dispositions visées aux paragraphes (1) et (2) s’appliquent compte tenu
des modifications apportées à la présente loi sauf celles de ces
modifications entrées en vigueur le 1er octobre 1989 et le 1er octobre 1996.
|
ANALYSIS
A. The ‘615 Patent
[34]
I begin
with the ‘615 patent in regard to which Pfizer submits that by reason of her
failure to construe claim 1 thereof, the Judge did not consider its main
submission, i.e. that by making and using QHAS, Apotex will infringe claim 1 of
the patent. More particularly, Pfizer says that in failing to construe claim 1,
the Judge failed to consider whether solvated forms of quinapril hydrochloride
were covered by the patent.
[35]
It is
undeniable that the Judge did not make any attempt to construe claim 1 as she
disposed of the non-infringement issue on the sole basis that Pfizer had failed
to test Apotex’s product. It is now settled law that construction of a patent
must precede a determination of whether there is infringement thereof (see Whirlpool
Corp. v. Camco Inc., [2000] 2 S.C.R. 1067, and Free World Trust v.
Electrosanté Inc., [2000] 2 S.C.R. 1024). It was therefore the Judge’s duty
to construe claim 1 in the light of the expert evidence available to her and to
segregate the non-essential elements of the patent from the essential ones. Thus,
in failing to construe claim 1, the Judge erred in law and, as a result, it
falls upon us to determine the matter de novo.
[36]
Before
turning to that task, it will be useful to briefly examine the principles
governing the construction of patents which were clarified by the Supreme Court
in its recent decisions in Whirlpool, supra and Free World, supra.
[37]
In its
decisions, the Supreme Court endorsed the purposive construction approach to
patents and rejected the “grammatical” or “meticulous verbal analysis” approach
which had prevailed in earlier times. In so concluding, the Court endorsed the
description of “purposive construction” given by Lord Diplock at pages 242 and
243 of his Reasons for a unanimous House of Lords in Catnic Components Ltd.
v. Hill and Smith Ltd., [1982] R.P.C. 183, where His Lordship made the
following remarks:
My Lords, a patent
specification is a unilateral statement by the patentee, in words of his own
choosing, addressed to those likely to have a practical interest in the subject
matter of his invention (i.e. “skilled in the art”), for which he informs them
what he claims to be the essential features of the new product or process for
which the letters patent grant him a monopoly. It is those novel features only
that he claims to be essential that constitute the so-called “pith and marrow”
of the claim. A patent specification should be given a purposive construction
rather than a purely literal one derived from applying to it the kind of
meticulous verbal analysis in which lawyers are too often tempted by their
training to indulge. The question in each case is: whether persons with
practical knowledge and experience of the kind of work in which the invention
was intended to be used, would understand that strict compliance with a
particular descriptive word or phrase appearing in a claim was intended by the
patentee to be an essential requirement of the invention so that any variant
would fall outside the monopoly claimed, even though it could have no material effect
upon the way the invention worked.
[38]
In his
Reasons for a unanimous Supreme Court in Whirlpool, supra, Binnie J.
remarked that although the “purposive construction” approach was introduced
into claims construction by Catnic, supra, it was consistent with
the view expressed by Dickson J. (as he then was) in Consolboard Inc. v.
MacMillan Bloedel (Saskatchewan) Ltd., [1981] S.C.R. 504, where he
said at pages 520 and 521::
We must look to the
whole of the disclosure and the claims to ascertain the nature of the invention
and methods of its performance, (Noranda Mines Limited v. Minerals
Separation North American Corporation, [1950] S.C.R. 36), being neither
benevolent nor harsh, but rather seeking a construction which is reasonable and
fair to both patentee and public. There is no occasion for being too astute or
technical in the matter of objections to either title or specification for, as
Duff C.J.C. said, giving the judgment of the Court in Western Electric
Company, Incorporated, and Northern Electric Company v. Baldwin International
Radio of Canada, [1934] S.C.R. 570, at p. 574, “where the language of the
specification, upon a reasonable view of it, can be so read as to afford the
inventor protection for that which he has actually in good faith invented, the
court, as a rule, will endeavour to give effect to that construction.
[39]
The
principles set forth by the Supreme Court in Whirlpool, supra,. and Free
World,supra, can be summarized as follows:
- The task of the Court is to construe
the claims of the patent with the aid of expert witnesses (Whirlpool
at paragraphs 43, 45 and 57).
- Construction of the claims is not to
be a result-oriented exercise and must be conducted by the Court prior to
its consideration of the issue of infringement (Whirlpool at paragraphs
43 and 49(a)).
- The claims are to be construed as of
the publication date of the patent (Whirlpool at paragraph 42; Free
World at paragraph 44).
- In construing the claims of the
patent, the Court is called upon to determine, on an objective basis, what
a skilled reader would have understood the inventor to mean (Whirlpool,
at paragraph 48; Free World at paragraph 51).
- The claim of the patent which is to
be construed by the Court must be read in the context of the rest of the
specification. I would add to this, however, that reference to the rest of
the specification cannot be used to expand the patentee’s monopoly as
expressed in the claim (Whirlpool at paragraphs 48, 49(f) and 52).
- The expert witnesses are there to
help the Court understand the invention and its context, as well as the
meaning of the terms used in the patent. Needless to say, it is the
Court’s duty to construe the claims and not that of the experts (Whirlpool
at paragraphs 45 and 57).
- In construing the claims, the Court
is to keep in mind that the patent is addressed to the “ordinary person
skilled in the art”, i.e. a hypothetical person possessing the ordinary
skill and knowledge of the particular art to which the invention relates,
and a mind willing to understand a specification that is addressed to him
(Whirlpool at paragraphs 53, 70, 71 and 74).
- The “disclosure” found in the patent
must describe the invention in a sufficiently complete and accurate manner
so to allow the person skilled in the art to construct or use the
invention when the period of monopoly has expired (Whirlpool at
paragraph 42). The resulting construction of the claims should be one
which is “in the interest of fairness both to the patentee and the public”
(Free World at paragraph 50). As a result, the construction of the
claim may lead to an expansion or limitation of the text of the claim. As
Binnie J. said in Free World at paragraph 51:
51. The involvement
in claims construction of the skilled addressee holds out to the patentee the
comfort that the claims will be read in light of the knowledge provided to the
Court by expert evidence on the technical meaning of the terms and concepts
used in the claims. The words chosen by the inventor will be read in the sense
the inventor is presumed to have intended and in a way that is sympathetic to
accomplishment of the inventor’s purpose express or implicit in the text of the
claims. However, if the inventor has misspoken or otherwise created an
unnecessary or troublesome limitation in the claims, it is a self-inflicted wound.
The public is entitled to rely on the words used provided the words used are
interpreted fairly and knowledgeably.
(a) Claim 1 of the ‘615
Patent
[40]
The
parties are in agreement that the only claim of the ‘615 patent which we need be
concerned with in this appeal is claim 1. It reads as follows:
1. A substituted
acyl derivative of 1,2,3,4-tetrahydroisoquinone-3-carboxylic acid in the form
of the (S,S,S) isomer having the following general formula:
where R2 is a
hydrogen atom or a methyl or an ethyl radical, in one of the following acid
salt forms: the hydrochloride, hydrate; the hydrochloride; and the
hydrochloride hemihydrate.
[41]
Although
the word “quinapril” does not appear in claim 1, it is common ground that a
person skilled in the art would understand the claim to describe quinapril in
one of the following acid salt forms: the hydrochloride, hydrate, the
hydrochloride, and the hydrochloride hemihydrate.
[42]
The only
issue which arises from Apotex’s NOA is whether its APO QUINAPRIL tablets
comprise any of the claimed compounds of the ‘615 patent or whether any such
compounds will be made, constructed or used in the manufacture of APO QUINAPRIL
tablets. More particularly, the issue is whether Apotex will infringe claim 1
of the patent by making and using QHAS, a “solvated” form of quinapril
hydrochloride.
[43]
The answer
to this question depends entirely on the construction of claim 1. Specifically,
whether the making, use or constructing of QHAS by Apotex infringes the patent depends
on the meaning of the words “the hydrochloride” found in claim 1.
[44]
Pfizer
submits that a purposive construction of claim 1 leads to the conclusion that
QHAS is covered by the claim. In its submission, a skilled person would
appreciate that quinapril hydrochloride in a solvated form can be substituted
without affecting the working of the invention.
[45]
Apotex
disagrees with Pfizer that QHAS is covered by claim 1 of the ‘615 patent. In
its view, the only solvate covered by claim 1 is water. Apotex further submits
that even if the ‘615 patent covers QHAS, the NOC Regulations only prohibit the
issuance of a NOC if the compounds in the final dosage form of the drug
infringe the claims of the patent. Intermediates used in the production of the
final dosage form, Apotex says, are irrelevant for the purpose of subparagraph
5(1)(b)(iv) of the Regulations. Finally, Apotex argues that even if
intermediates fall within the scope of the Regulations, the appellant still had
to prove that QHAS fell within the definition of “medicine” found in the
Regulations, because subparagraph 6(1)(b)(iv) thereof provides that the
only relevant claims in a prohibition proceeding are those that relate to a
“medicine”. In Apotex’s submission, the appellant has failed to lead such
evidence.
[46]
In order
to make sense of these submissions, a brief overview of the chemistry at issue
will be helpful.
[47]
Molecules
exist in solid states in one of two forms, namely, crystalline (a regular,
repeating lattice patent) or amorphous (i.e., where the molecules have no
discernable pattern). A crystalline form of quinapril hydrochloride has a
crystal lattice structure composed of quinapril molecules and hydrochloride molecules.
[48]
Because of
its shape, a crystalline solid has “holes” in the lattice structure. When these
holes contain liquid, the crystals are called “solvates”. Where the liquid is
water, the solvate is of a special type, i.e. a “hydrate”. When the liquid is
an organic solvent (i.e., other than water), it is either referred to as a
“solvate” or by the name of the solvent, for example, an “acetone solvate”.
Quinapril hydrochloride acetone solvate (“QHAS”) is thus a form of quinapril
hydrochloride with acetone contained in its lattice.
[49]
When a
hydrate contains two molecules of water for every molecule of crystal, it is a
“dehydrate”. When a hydrate contains one molecule of water for every two
molecules of crystal, it is a “hemihydrate”. The term “monohydrate” may be used
when the hydrate contains one molecule of water for every molecule of crystal,
but this can also be referred to simply as a “hydrate”.
[50]
Claim 1 of
the ‘615 patent claims quinapril in a number of acid salt forms, namely the
hydrochloride hydrate, the hydrochloride, and the hydrochloride hemi-hydrate.
The claim does not expressly say whether “solvates” are included by the use of
the words “the hydrochloride”. That is the precise question which must be
answered in construing claim 1. However, before turning to the construction of
the claim, a few words concerning QHAS are in order.
[51]
The
process by which Apotex manufactures its APO QUINAPRIL comprises a number of
steps, two of which are of interest for the present purpose; firstly, the
manufacturing of the drug substance (or active pharmaceutical ingredient) and,
secondly, the manufacturing of the drug product (the making of the active
pharmaceutical ingredient into tablets). More particularly, Apotex’s drug
substance is QHAS which it blends with excipients (inactive ingredients) and
presses into APO QUINAPRIL tablets. Apotex’s Abbreviated New Drug Submission
(“ANDS”) reveals that in making its APO QUINAPRIL tablets, QHAS is converted
into quinapril magnesium, which Apotex refers to as “quinapril hydrochloride
stabilized” or “quinapril 88%”. In its proposed product monograph, Apotex
advises that the active ingredient in its APO QUINAPRIL tablets is quinapril
hydrochloride.
[52]
I now turn
to the construction of claim 1 of the ‘615 patent.
[53]
I start
with the proposition that the claim must be read “purposively” in order to
determine the inventor’s intention. Although it is clear that the words of the
claim must be given effect, reference to the entire specification must be made
so as to provide the context necessary to a proper understanding of the words
used by the inventor.
[54]
To this
first proposition must be added a second one, i.e. that the Court must
identify, with the assistance of a person skilled in the art, those elements of
the claim which the inventor considered essential to his invention. As a
corollary to this proposition, it must be remembered that non-essential elements
are those which can be substituted without having a material effect on the
structure or operation of the invention.
[55]
With those
principles in mind, I now turn to the expert evidence upon which both Pfizer
and Apotex rely for their submissions.
[56]
In support
of its proposed construction of claim 1, Pfizer presented the evidence of Dr.
Gerald S. Brenner, an organic chemist and industrial formulation expert who
spent his entire working life in the pharmaceutical field. From 1961 to 1994,
Dr. Brenner worked for the Merck Research Laboratories in New Jersey and
Pennsylvania, retiring therefrom as Senior Director of Pharmaceutical Research
and Development and Department Head of Pharmaceutical Research with
responsibility for pharmaceutical chemistry, biopharmaceutical chemistry and
formulation development. More particularly, Dr. Brenner was one of those
persons at Merck in charge of formulating “enolapril”, an angiotension-converting
enzyme inhibitor, i.e. an “ACE inhibitor”.
[57]
As he
states in his affidavit of January 14, 2004, Dr. Brenner was asked by Pfizer to
opine regarding, inter alia, Apotex’s allegations that none of the
compounds of the ‘615 patent are being used in the manufacture of its APO-QUINAPRIL
tablets. Dr. Brenner’s answer to that question is that Apotex’s allegations are
“incorrect”. In his view, the reference in claim 1 to quinapril hydrochloride
includes QHAS, the compound used by Apotex in making its APO-QUINAPRIL tablets.
Dr. Brenner’s reasons for so concluding are as follows.
[58]
After a review
of the chemistry at issue, Dr. Brenner turned his attention to Apotex’s ANDS,
which led him to the following remarks:
(i)
Apotex had
submitted an ANDS in respect of its APO-QUINAPRIL tablets;
(ii)
Apotex had
represented to the Minister of Health that the “drug substance” of its ANDS was
QHAS;
(iii)
Quinapril
hydrochloride stabilized or Quinapril 88% was its drug product
[59]
He then
turned to the formulation by Apotex of its APO-QUINAPRIL which he understood to
be that magnesium hydroxide was added to QHAS in a medium of ethanol and water,
that this mixture after stirring and following evaporation, left a solid
mixture of magnesium quinapril and magnesium chloride which Apotex named
Quinapril 88%, or stabilized quinapril hydrochloride, that quinapril 88% was
milled into a powder and dry-mixed with excipients and compressed to form a
tablet, and that the tablet was given a brown-coloured film coating to form
APO-QUINAPRIL.
[60]
With this
information in mind, Dr. Brenner stated his view that in using QHAS to make
APO-QUINAPRIL, Apotex was using the acid salt form of quinapril hydrochloride
which was covered by claim 1 of the patent. This conclusion results from his
understanding of claim 1 which he examined in the light of the specification.
[61]
In Dr.
Brenner’s view, claim 1 of the patent, properly understood by a person skilled
in the art, includes not only all non-hydrated forms of quinapril hydrochloride
(amorphous and crystalline), but all forms solvated with a
pharmaceutically-acceptable organic solvent.
[62]
More
particularly, Dr. Brenner indicates that in attempting to determine the meaning
of the word “hydrochloride”, he had no doubt whatsoever that the inventor had
in mind, at the very least, anhydrous quinapril hydrochloride, i.e. not a
hydrate or, to put in other words, not a crystal form containing water
molecules. He was certain in that view because of the inventor’s use of the
words “hydrochloride hydrate” and “hydrochloride hemihydrate”.
[63]
However,
the use of the word “hydrochloride” did not immediately reveal what forms were
intended to be covered. In Dr. Brenner’s view, the word could possibly include
a non-solvated hydrochloride crystal, a hydrochloride crystallized with an
organic solvent or amorphous hydrochloride.
[64]
In
attempting to ascertain the correct meaning of “hydrochloride”, Dr. Brenner
noted that the inventor had not expressly excluded non-solvated forms of
quinapril hydrochloride and that by reason of the use of the words
“hydrochloride hydrate” and “hydrochloride hemihydrate”, the inventor did not
intend to include in the word “hydrochloride” compounds solvated with water.
[65]
However,
claim 1 of the patent on its face did not, in his view, reveal an intention on
the part of the inventor to exclude solvates. Hence, he turned his attention to
the patent’s disclosure in order to understand whether the inventor intended to
include anhydrous, solvated forms of quinapril hydrochloride. In that regard,
Dr. Brenner took note of that part of the specification which states:
The compounds
of the invention may exist in anhydrous form as well as in solvated, including
hydrated forms. In general, the hydrated forms and the solvated forms with
pharmaceutically acceptable solvents are equivalent to the anhydrous or
unsolvated form for the purposes of the invention.
[66]
This
prompted him to the following remarks: firstly, that the inventor did not
intend to exclude unsolvated of quinapril hydrochloride and, secondly, that he
intended to include solvated forms. In that regard, Dr. Brenner points out that
the inventor makes it clear in the disclosure that his invention can exist in
anhydrous form, as well as in solvated forms, including hydrated, forms. He
further notes that the inventor also makes it clear that the hydrated forms and
the solvated forms are equivalent to anhydrous and unsolvated forms.
[67]
All of
this leads Dr. Brenner to the following conclusion, found at paragraph 25 of
his affidavit of January 14, 2004:
It is my opinion that
when the patentee/inventor used the word “hydrochloride” in claim 1, he
intended to capture quinapril hydrochloride in its organic solvated,
non-hydrated, and amorphous forms.
[Emphasis
added]
[68]
In
concluding as he does, Dr. Brenner adds that he finds comfort in the analysis
that he performed in regard to Canadian patent 1,291,999 (the “ ‘999 patent”)
which shows that the inventors thereof used the word “hydrochloride” with
respect to a claim [claim 1 of the ‘999 patent] clearly intended to cover
quinapril hydrochloride acetonitrile, i.e. quinapril hydrochloride solvated
with acetonitrile.
[69]
In
replying to Dr. Brenner’s evidence, Apotex adduced the evidence of Drs. Robert
S. Langer and Robert A. McClelland, who both disagree with the conclusion
reached by Dr. Brenner. In their view, claim 1 of the ‘615 patent cannot be
read so as to include a solvated form of quinapril hydrochloride.
[70]
I start
with the evidence of Dr. Langer. He obtained his doctorate in chemical
engineering from the Massachusetts Institute of Technology (M.I.T.) in 1974 and
he is presently professor of chemical and biomedical engineering at M.I.T.
[71]
In Dr. Langer’s
opinion, the term “hydrochloride” does not cover organic solvate forms of the
claimed compounds. Specifically, it is his opinion that a person skilled in the
art, reading claim 1 of the ‘615 patent, would not interpret claim 1 to cover
all unspecified organic solvate forms of quinapril hydrochloride, as such a
person would have expected specific organic solvate forms to be listed if the
inventors intended to include organic solvate forms under claim 1. The essence
of Dr. Langer’s reasoning appears at paragraph 25 of his affidavit of May 12,
2004, which I reproduce:
25. Thus, in
my opinion, claim 1 of the ‘615 patent specifies the following three specific
hydrochloride salt forms of compounds from the claimed class that includes
quinapril: (i) the hydrochloride, hydrate, (ii) the hydrochloride and (iii) the
hydrochloride hemihydrate. Based on my reading of the ‘615 patent, I understand
the terms identified as (i) to (iii) above to represent and cover the
following:
(i) hydrochloride, hydrate:
in my opinion, this term as used in claim 1 of the ‘615 patent covers
monohydrate and partially hydrated forms of the claimed compounds such as those
described in Examples 1 through 3 of the ‘615 patent. As I described above, the
compounds described in Examples 1 through 3 of the ‘615 patent were all
referred to as “hydrochloride, hydrate” forms. It is also my opinion that this
term does not cover organic solvate forms of the claimed
compounds.
(ii) hydrochloride
hemihydrate: In my opinion, this term covers hemihydrated (i.e., one water
molecule per two equivalents of drug compound) forms of the claimed compounds
such as the compound described in Example 4 of the ‘615 patent. As I described
above, the compound described in Example 4 of the ‘615 patent was referred to
as a “hydrochloride hemihydrate” form, i.e. C23H26N2O5●HCI●1/2H2O.
It is also my opinion that this term does not cover organic
solvate forms of the claimed compound.
(iii) Hydrochloride:
In my opinion, this term covers anhydrous and unsolvated forms of the claimed
compounds such as those described in Examples 5, 6 and 9 of the ‘615 patent
were all referred to as “hydrochloride” forms; none of these forms were
described to be either hydrated forms or organic solvate forms. Thus, it is my
opinion that this term does not cover organic solvate forms of
the claimed compounds.
[72]
He goes on
to say that the use of the word “the” in lieu of the word “a” to describe the
expressions “hydrochloride, hydrate”, “hydrochloride” and the “hydrochloride hemihydrate”
indicates to the person skilled in the art that specific individual compounds
were being claimed in lieu of a broad class of compounds, such as all
pharmaceutically acceptable organic solvate forms of quinapril hydrochloride.
[73]
Further,
Dr. Langer takes issue with the following statement made by Dr. Brenner found at
paragraph 24 of his January 14, 2004 affidavit in regard to part of the
patent’s disclosure:
The patentee
also expressly advises that the invention may exist in anhydrous form, as well
as in solvated, including hydrated, forms. Further, the patentee advises that
the hydrated forms and the solvated forms are equivalent to anhydrous and
unsolvated forms.
[74]
Dr. Langer
begins by saying that according to his understanding of patent construction, an
invention is disclosed in the patent claim and not in the patent disclosure. He
then indicates that the disclosure may be used “to act as a reference for
definition of terms in the patent claim”. This leads him to conclude that claim
1 discloses only a specific anhydrous and unsolvated form, i.e. the
hydrochloride, and two distinct and specific hydrated forms, i.e. the
hydrochloride, hydrate and the hydrochloride hemihydrate.
[75]
Apotex’s
second expert witness was Dr. McLelland, a professor in the Department of
Chemistry at the University of Toronto, whose particular expertise is in the
field of physical organic chemistry, especially reactive intermediates
generated in nucleophilic substitution and addition reactions, as well as in
the field of biological and medicinal chemistry. In 1970, he was the winner of
the Syntex Award of the Canadian Society for Chemistry for contributions to
medicinal chemistry through research involving biochemical or organic chemical
reaction mechanisms. Since 1974, he has been a Fellow of the Royal Society of
Canada.
[76]
In Dr.
McLelland’s opinion, QHAS does not fall within the scope of claim 1. In his
view, the person skilled in the art would understand claim 1 as referring to
different solid forms of quinapril hydrochloride. Specifically, his view is
that “the hydrochloride” refers to different solid forms only of quinapril
hydrochloride, i.e. with no water or other solvent present.
[77]
The use of
the word “the” with the word “hydrochloride” gives strength to his view, since
there is only one “the hydrochloride”, i.e. the unsolvated HCI acid addition
salt. If the inventors intended to refer to solvated forms, they would,
according to Dr. McLelland have used the words “a hydrochloride” or “the
hydrochlorides”. Further, if the inventors intended, by the use of the words
“the hydrochloride”, to include solvated forms, they would not have felt it
necessary to use the words “the hydrochloride, hydrate” and “the hydrochloride,
hemihydrate”, as these forms would have been covered by the words “the
hydrochlorides”. In addition, Dr. McLelland finds support in the fact that
neither claim 1 nor any of the other claims of the ‘615 patent make reference
to solvated forms other than the hydrate and hemihydrate.
[78]
With
respect to Dr. Brenner’s view concerning claim 1 of the ‘999 patent, Dr.
McLelland, at paragraphs 61 to 63 inclusive of his affidavit, said the
following:
61. In paragraph B26
(with reference to B39 and B40), Dr. Brenner makes reference to the ‘999
patent. In his opinion, the absence of a reference to a solvent in this claim
indicates that the inventors’ use of “hydrochloride” in a claim means that the
term has a broad meaning in the ‘615 patent. I have two comments.
62. The first is
that claim 1 of the ‘999 patent is unambiguous. I say this since this claim
sets out the spacings and intensities in an X-ray diffraction pattern. Only a
particular crystalline form will exhibit such a pattern, and it is not
necessary to indicate that a solvent is present.
63. My second
comment is the same as paragraph 43. If Dr. Brenner is correct, the quinapril
hydrochloride claimed in claim 1 of the “999 patent is also claimed in claim 1
of the ‘615 patent.
[79]
In a
further affidavit sworn September 10, 2004, Dr. Brenner responded to the
affidavits of Drs. Langer and McLelland. First, with respect to Dr. McLelland’s
affidavit, he recalled that part of his first opinion that the inventors of the
‘615 patent had used the word “hydrochloride” in claim 1 of the ‘999 patent,
i.e. a claim clearly intended to cover quinapril hydrochloride acetonitrile and
that the absence therein of a reference to a particular solvent supported his
view of a broad interpretation of the word “hydrochloride” in claim 1 of the
‘615 patent.
[80]
He points
out, correctly, that Dr. McLelland challenged that point of view when he stated
at paragraph 62 of his affidavit that claim 1 of the ‘999 patent was
unambiguous by reason of the fact that it “… sets out the spacings and
intensities in an X-ray diffraction patent. Only a particular crystalline form
will exhibit such a pattern, and it is not necessary to indicate that a solvent
is present.”
[81]
Dr.
Brenner disagrees with Dr. McLelland’s view of the ‘999 patent. More
particularly, he relies on the fact that in some crystalline solvates the
solvent can depart the crystal lattice without affecting the powder diffraction
pattern. As a result, it is possible to have two distinct materials with the
exact same X-ray powder diffraction pattern, “ … one which contains solvent and
the other which does not contain solvent” (paragraph 16 of his affidavit).
[82]
This leads
Dr. Brenner to say that there is therefore no support for Dr. McLelland’s view that
the word “hydrochloride” should be interpreted narrowly, i.e. as referring only
to a specific material. Consequently, Dr. Brenner reiterates his view, as set
out in paragraph 26 of his earlier affidavit, that the inventors of the ‘999
patent must have intended for the word “hydrochloride” found in claim 1 of that
patent to include the hydrochloride acetonitrile solvent.
[83]
Dr.
Brenner then turned to Dr. Langer’s affidavit, with respect to which he opined
that both Dr. Langer and Dr. McLelland had interpreted claim 1 of the ‘615
patent in a perspective different than that which a person of ordinary skill in
the art would have. In his view, their interpretation is inconsistent with how
such a person would understand claim 1 of the ‘615 patent.
[84]
I have
struggled long and hard with these conflicting opinions given by scientists of
repute. However, for the reasons that follow, I conclude that the better view
is that of Dr. Brenner.
[85]
In
considering the evidence of the expert witnesses, i.e. the “ordinary persons
skilled in the art”, it is important to reemphasize that the Supreme Court of
Canada in Whirlpool, supra, and Free World, supra, made it clear
that a patent should be read by an open mind – i.e. a mind not bent on finding
a way to circumvent the inventor’s invention, but one desirous of understanding
the invention – and that in going through the exercise, the skilled reader had
to examine the claim in its context – i.e. the words of the claim were to be
read in the context of the specification. In Free World, supra, at
paragraph 44 of his Reasons, Binnie J. adopted the definition of the “worker
skilled in the art” given by Dr. Fox, found at page 184 of the Canadian Law
and Practice Relating to Letters Patent for Inventions, 4th ed.,
Toronto, Carswell, 1969:
a hypothetical person
possessing the ordinary skill and knowledge of the particular art to which the
invention relates, and a mind willing to understand a specification that is
addressed to him. This hypothetical person has sometimes been equated with the
“reasonable man” used a standard in negligence cases. He is assumed to be a man
who is going to try to achieve success and not one who is looking for
difficulties or seeking failure.
[86]
With these
principles in mind, I now proceed to indicate why I believe that Dr. Brenner’s
understanding of claim 1 is the proper one. I begin by saying that the area of
disagreement between the experts is in respect of the meaning of the word
“hydrochloride” found in claim 1 of the ‘615 patent. More particularly, the
question is whether “hydrochloride” includes only “unsolvated” forms of
quinapril hydrochloride or whether it also includes “solvated” forms thereof.
[87]
As appears
clearly from my review of the opinions given by the experts, Dr. Brenner gave
considerable importance to that part of the specification where the inventors
stated that both the hydrated forms and the solvated forms, with
pharmaceutically acceptable solvents, were equivalent to the unsolvated forms
for the purpose of the invention. Dr. Langer does not agree with Dr. Brenner
that the skilled reader may consider the specification in order to properly
understand the claim at issue. First, he says at paragraph 21 of his affidavit
that he was informed that “[I]f a term is used in a clear and unambiguous
manner in the claim, then the term should be defined based solely on its usage
in the claim itself” and that “if the definition of a term cannot be clearly
and unambiguously determined from a claim, then a patent disclosure should be
consulted to ascertain the definition of the term”. He then says the following
at paragraph 33 of his affidavit:
33. Despite this
[i.e., that the use of the word “the” to describe the hydrochloride indicates
to a skilled person that specific individual compounds are being claimed and
not a broad class of compounds], Dr. Brenner also states in paragraph 24 of his
January 14th Affidavit with respect to the above passage from page 4
of the ‘615 patent that:
The patentee also
expressly advises that the invention may exist in anhydrous form, as well in
solvated, including hydrated, forms. Further, the patentee advises that the
hydrated forms and the solvated forms are equivalent to anhydrous and solvated
forms.
I again disagree with
Dr. Brenner with respect to this point. As I understand it, the invention of a
patent is specifically disclosed in the patent claims, not in the patent disclosures
(noting that patent claims often undergo revision after initial submission of a
patent application). As I also understand it, the patent disclosure can be
utilized to act as a reference for definition of terms in the patent claims. …
[88]
Thus,
according to Dr. Langer, it was wrong of Dr. Brenner to interpret claim 1 of
the ‘615 patent in the light of the specification because claim 1 is clear and
unambiguous. Hence, it is not proper to consider the specification. In my view,
Dr. Langer’s approach is incorrect. In Whirlpool, supra, Binnie J. at
paragraphs 49(e) and 52 made it clear that claims were to be construed in light
of the entire specification in order to enable the reader to properly
understand the claim at issue, bearing in mind that the specification could not
serve as a device to expand the patentee’s monopoly. In expressing this
opinion, Binnie J. referred to the remarks of William L. Hayhurst found in The
Art of Claiming and Reading a Claim, J.F. Anderson editor, Patent Law of
Canada, Scarborough, Ontario, Carswell, 1994, 177, made at page 190, to the
effect that it was often unsafe to conclude that a term in a claim was plain
and unambiguous without having carefully reviewed the specification.
[89]
As a
result of his view regarding the disclosure, Dr. Langer does not give it any
consideration in his attempt to explain the meaning of the word
“hydrochloride”. I find this particularly troubling considering that the
inventors make a clear statement to the effect that quinapril hydrochloride can
exist in solvated and unsolvated forms and that in general, both the hydrated
forms and the solvated forms with pharmaceutically acceptable solvents “are
equivalent to the anhydrous or unsolvated forms for the purposes of the
invention”. From this, I can only conclude that Dr. Langer has not read the
claim with an open mind, a mind willing to attempt to achieve success and not
failure. Consequently, although I am not totally discounting Dr. Langer’s
opinion, I do not give it much weight.
[90]
In any
event, Dr. Langer, like Dr. McLelland, placed considerable importance on the
fact that the word “hydrochloride” was preceded by the word “the”. In their
view, that was a clear indication that the inventors did not intend to claim a
broad class of compounds, such as all pharmaceutically-accepted organic solvate
forms of quinapril hydrochloride, but rather specific individual compounds.
Otherwise, according to Dr. McLelland, the inventors would have used the words
“a hydrochloride” or “the hydrochlorides”. Further, if the word “the
hydrochloride” were meant to include solvated forms, there was no necessity, in
his view, of using the words “the hydrochloride, hydrate” and “the
hydrochloride hemihydrate” as these compounds would have been included in “the
hydrochloride”.
[91]
After very
careful consideration of the evidence given by both Dr. Langer and Dr.
McLelland, I am persuaded that they have not approached claim 1 with an open
mind, a mind willing to attempt to achieve success and not failure. With
respect to Dr. Langer, I have already indicated, at paragraph 86 of these
Reasons, that he deliberately did not consider the disclosure. In the case of
Dr. McLelland, I come to the same conclusion because I do not believe that he
seriously considered the disclosure at page 4 of the patent. In my view,
although he took note of it, for all intents and purposes, he ignored it in
interpreting the claim.
[92]
On the
other hand, I am satisfied that Dr. Brenner did approach claim 1 with an open
mind in that he could not but give serious consideration to the disclosure
which reveals that for the inventors, solvates and hydrates are equivalent to
the anhydrous unsolvated forms of quinapril hydrochloride. With that in mind,
Dr. Brenner read claim 1 and concluded that by the use of the word “hydrochloride”,
the inventors intended to capture quinapril hydrochloride in its organic
solvated, non-hydrated and amorphous forms.
[93]
I am
satisfied that that construction of claim 1, in the light of the disclosure, is
the proper construction. As a result, I conclude that the words “the
hydrochloride” found in claim 1 of the ‘615 patent include solvated forms of
quinapril hydrochloride. Hence, QHAS is covered by claim 1 of the patent.
[94]
I would
add that, in any event, on a purposive construction of claim 1, the extent of
solvation or hydration is not an essential element of the invention. This
conclusion appears to me inevitable, considering that the inventors clearly
stated that hydrated forms and solvated forms with pharmaceutically acceptable
solvents were equivalent to the anhydrous or unsolvated forms.
[95]
In
concluding that Dr. Brenner’s understanding of claim 1 is the correct one, I am
comforted by the fact that Drs. Langer and McLelland’s view leads to the
conclusion that the ‘615 patent teaches a reader how to specifically avoid
infringing claim 1 thereof, i.e. by making a solvated form of quinapril
hydrochloride. That view cannot be characterized as one ensuring the attainment
of the inventor’s intention, nor can it be viewed as a construction arrived at
by a mind willing to understand and attempting to achieve success.
[96]
Apotex
argues that even if QHAS falls within claim 1, it is still entitled to the
issuance of a NOC because the NOC Regulations only prohibit the issuance thereof
by the Minister if the compounds in the final dosage form infringe the claims
of the patent. Apotex says that intermediates used in the production of the
final dosage form, like QHAS, are not relevant for the purpose of subparagraph
5(1)(b)(iv) of the NOC Regulations which, for ease of reference, I again
reproduce:
5. (1) Where a person
files or has filed a submission for a notice of compliance in respect of a
drug and compares that drug with, or makes reference to, another drug for the
purpose of demonstrating bioequivalence on the basis of pharmaceutical and,
where applicable, bioavailability characteristics and that other drug has
been marketed in Canada pursuant to a notice of compliance issued to a first
person and in respect of which a patent list has been submitted, the person
shall, in the submission, with respect to each patent on the register in
respect of the other drug,
(b) allege
that: …
(iv) no claim for the
medicine itself and no claim for the use of the medicine would be infringed
by the making, constructing, using or selling by that person of the drug for
which the submission for the notice of compliance is filed.
|
5 (1) Lorsqu'une
personne dépose ou a déposé une demande d'avis de conformité pour une drogue
et la compare, ou fait référence, à une autre drogue pour en démontrer la
bioéquivalence d'après les caractéristiques pharmaceutiques et, le cas
échéant, les caractéristiques en matière de biodisponibilité, cette autre
drogue ayant été commercialisée au Canada aux termes d'un avis de conformité
délivré à la première personne et à l'égard de laquelle une liste de brevets
a été soumise, elle doit inclure dans la demande, à l'égard de chaque brevet
inscrit au registre qui se rapporte à cette autre drogue :
b) soit une
allégation portant que, selon le cas :
(iv) aucune revendication
pour le médicament en soi ni aucune revendication pour l'utilisation du
médicament ne seraient contrefaites advenant l'utilisation, la fabrication,
la construction ou la vente par elle de la drogue faisant l'objet de la
demande d'avis de conformité.
|
[97]
For this submission,
Apotex relies on two decisions of the Federal Court, namely Abbott
Laboratories v. Canada (Minister of Health), 2005 FC 1093, and Abbott
Laboratories v. Canada (Minister of Health), 2006 FC 120. However, in Abbott
Laboratories v. Canada (Minister of Health), 2006 FCA 187, an appeal from
the earlier Abbott, supra, decision, this Court in interpreting the
words of subparagraph 5(1)(b)(iv) of the NOC Regulations, concluded that
the use of the patented substance at an intermediate stage in the production of
a new drug fell within the subparagraph. At paragraph 16 of her Reasons,
Sharlow J.A. expressed that view as follows:
[16] I must
respectfully disagree with the judge on that point. The phrase "making,
constructing, using or selling" in subparagraph 5(1)(b)(iv) describes a
range of activities that is broader than merely including a patented substance
in the proposed new drug. In my view, that phrase is broad enough to
include the use of the patented substance at an intermediate stage in the
production of the proposed new drug. I reach that conclusion based on
the ordinary and grammatical meaning of the phrase. I see nothing in the
purpose or object of the NOC Regulations that compels a narrower
interpretation.
[Emphasis added]
[98]
Apotex makes a
further argument. It says that even if intermediates fall within the ambit of
subparagraph 5(1)(b)(iv), it is still incumbent upon Pfizer to
demonstrate that QHAS is a “medicine” within
the meaning given to that term by section 2 of the NOC Regulations, i.e. a
“substance intended or capable of being used for the diagnosis, treatment,
mitigation or prevention of a disease, disorder or abnormal physical state or
the symptoms thereof”. Apotex says that Pfizer has not met its burden.
[99]
In my
view, Apotex’s argument is without merit
since its ANDS and the accompanying product monograph for APO-QUINAPRIL clearly
state that QHAS is Apotex’s medicine. Specifically, Apotex
has represented to the Minister of Health that QHAS is its drug substance and
that it is useful in the treatment of hypertension.
[100]
I
therefore conclude that in making and using QHAS, Apotex will infringe claim 1
of the ‘615 patent. I now turn to the ‘330 patent.
B. The ‘330 Patent
(a) Claims Broader
than Invention Disclosed:
[101]
Pfizer
argues that Heneghan J. made a number of errors of law in concluding that
claims 3 and 5 of the ‘330 patent were broader than the invention disclosed.
First, Pfizer says that the Judge erred in misallocating the burden of proof.
Second, it says that she misconstructed the test for “claims broader” in
holding that only the optimal compounds were to be included within the claim.
Third, Pfizer says that the Judge misconstrued the claims and/or the disclosure
of the patent in finding that the claims were for a new use (to treat
hypertension) instead of a new compound.
[102]
The
Judge’s approach to the applicable burden of proof appears at paragraph 53 of
her Reasons, where she says:
[53] The burden
lies on Pfizer, as the Applicant, to refute the allegations set forth by Apotex
in its NOAs dated July 18, 2003 and July 24, 2003. Therefore, like any
plaintiff or applicant, Pfizer has the overall legal burden of proof. Apotex,
as the Respondent, has an obligation to put the allegations set out in its NOAs
“in play”.
[103]
In so concluding,
the Judge relied on Mosley J.’s decision in Jansen-Ortho Inc. v. Novopharm
(2004), 35 C.P.R. (4th) 353, where he held that when a second person
had adduced evidence that was not clearly incapable of establishing allegations
of invalidity, the statutory presumption was countered and could no longer
assist a first person in establishing the validity of its patent.
[104]
In
Pfizer’s view, the correct approach to the burden of proof is that a second
person must lead evidence which proves, on a balance of probabilities, that the
patent is invalid.
[105]
In my
view, the correct test is the one set out by Sharlow J.A. in Bayer Inc. v.
Canada (Minister of National Health and Welfare) (2000), 6 C.P.R. (4th)
285, where at paragraphs 6 and 9, she made the following remarks:
[6] In seeking
to discharge its burden of proving the allegation to be unjustified, Bayer
relied on the statutory presumption of the validity of its patent. Because that
presumption exists, it may be said that Apotex, as the party responding to the
application for a prohibition order, has a burden of proof in this sense: if
Apotex had adduced no evidence that was capable of establishing the invalidity
of the patent, Bayer could have succeeded on the basis of the statutory
presumption alone…
…
[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: Diversified Products Corp. v. Tye-Sil Corp. (1991),
35 C.P.R. (3d) 350 (F.C.A.) at 359. (Bayer at paras. 6, 9)
[106]
That
standard was reiterated by Rothstein J.A. (as he then was), at paragraphs 15
and 16 of his decision in Procter and Gamble Pharmaceuticals Canada Inc. v. Canada (Minister of Health), [2005] 2 F.C.R. 269 (FCA):
[15] … Sharlow
J.A. observed that because of that presumption of validity, the generic, as the
party responding to the application for a prohibition order, has the burden of
proof to displace the presumption.
[16] As to the
standard of proof, at paragraph 9, she wrote:
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...
Therefore, the standard
of proof applicable to proving invalidity has been found to be proof on a
balance of probabilities. …
[107]
More
recently, in Aventis Pharma v. Apotex, 2005 FC
1283 (F.C.), aff’d 2006 FCA 64 (F.C.A.),MacTavish J., relying on Bayer,
supra and Procter and Gamble, supra, explained the applicable burden
of proof as follows:
[77] As the
Applicant in these proceedings, Aventis has the overall burden of establishing
that none of Apotex's allegations are justified. In this case, all of the
issues raised by Apotex in its NOA relate to the validity of the '206 patent.
In the absence of evidence to the contrary, there is a statutory presumption that
a patent is valid: section 45 of the old Patent Act, subsection 43(2) of
the post-1989 Patent Act, R.S.C. 1985, c.P-4.
[78] Relying
upon the presumption of validity, Aventis can thus meet its initial burden
merely by proving the existence of the patent.
[79] Once this
is done, the burden shifts to Apotex to establish that the patent is invalid.
The standard of proof that Apotex is required to satisfy is that of a balance
of probabilities: Bayer v. Canada (Minister of National
Health and Welfare), [2000] F.C.J. No. 464, 6 C.P.R. (4th) 285
(F.C.A.), para. 9.
[108]
In appeal,
this Court affirmed MacTavish J.’s decision and did not take objection to her
understanding of the proper burden of proof, simply saying at paragraph 8 of
its Reasons:
[8] The jurisprudence
of the Federal Court of Appeal clearly establishes that the onus of proof in
NOC proceedings rests on the applicant and is considered on a balance of
probabilities, bearing in mind that on allegations of invalidity, there is a
statutory presumption of validity in favour of the patentee.
[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. …
[111]
I have not
been persuaded that the Judge erred in her understanding of the burden of
proof. She correctly referred to the legal principles enunciated by this Court,
according to which the overall legal or persuasive burden of proof rests upon
the first person, on a balance of probabilities, once the second person has met
its evidentiary burden of adducing evidence sufficient to rebut the presumption
of validity.
[112]
Even if
Pfizer were correct in its submission that the Judge misunderstood the
applicable burden of proof, I am of the opinion that the Judge’s ultimate conclusion
on the issue of whether claims 3 and 5 were overly broad does not depend on her
allocation of the burden of proof.
[113]
Pfizer’s
second submission is that the Judge erred in applying the test for determining
whether claims 3 and 5 of the ‘330 patent were broader than the invention
disclosed. It argues that the Judge erred by failing to consider whether all
claimed stereoisomers were disclosed as being included in the invention and,
instead, erroneously focused on whether the stereoisomers claimed were all
optimal for use in the invention. More specifically, Pfizer argues that all
stereoisomers of the quinapril family of compounds are within the scope of the
invention, as evidenced by the prior art and supported by expert opinion. In
Pfizer’s view, the Judge should have asked herself which stereoisomers were
part of the invention disclosed and which of these were claimed in the patent.
[114]
Apotex submits that Heneghan J. reached the
correct conclusion, in that the disclosure of the ‘330 patent clearly teaches
that the S-configuration is essential for biological activity. The Judge’s
conclusion appears clearly from paragraphs 107 and 108 of her Reasons, where
she says:
[107] … 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.
[108] The aim of
the purposive approach is to give meaning to the claim of a patent. Those
claims which exceed the scope of the invention or the description of the
patent’s specification are invalid; see Farbwerke Hoechst v. Commissioner of
Patents, supra. Accordingly, I am satisfied that the Applicants have failed
to show that the allegation of invalidity, on the basis of overly broad claims,
is not justified.
[115]
It is now
settled law that a patent which claims more than what was invented or disclosed
can be found invalid for being overly broad. As explained in Lovell
Manufacturing Co. and Maxwell Ltd. v. Beatty Brothers Ltd. (1962), 41
C.P.R. 18 (Ex. Ct.) at p. 66:
The other attack was
that the claims were too wide and that they claimed more than had been invented. This
repeats the central them to which I have referred, namely, the contention that
all that had been invented were the specific wringer constructions described in
the specification and that unless the claims were limited in their application
to inventions of the said specific constructions they were too wide and,
therefore, invalid. There is a simple answer to the contention, If the
claims read fairly on what has been disclosed and illustrated in the
specification and drawings, as they do, they are not wider than the invention.
The specific wringer constructions described in the specification are simply
embodiments or illustrations of the invention. The claims embrace them and
might well embrace similar other embodiments or illustrations. There is nothing
in any of the specifications that would limit the claims to one of the specific
wringer constructions or to all of them.
[Emphasis
added]
[116]
The test
referred to by the Trial Judge, i.e. that “… a claim will be considered overly
broad and accordingly, invalid, if it asserts an exclusive property or
privilege in something the inventor did not actually invent; or something that
the inventor did not fully disclose in the patent” (paragraph 99 of the Reasons),
is, in my view, the correct one. However, I cannot but conclude that she did
not apply that test to the evidence before her. In effect, her conclusion
appears to be solely based on her finding that the S-configuration of the
quinapril family of compounds is more effective than the R-configuration for
the relief of hypertension.
[117]
In my
view, the Judge erred in the following respects. First, she erred in treating
as determinative the question of whether or not an invention or parts of an
invention were optimal. Such a consideration is not relevant to the question of
whether claims are overly broad. Second, she misapplied her construction of the
claims to the question of whether they were overly broad. Third, she failed to
recognize that patents for chemical compounds regularly claim, and are
regularly issued for, all stereoisomers. Fourth, she failed to consider the
overwhelming weight of evidence which shows that all stereoisomers fell within
the scope of the invention and that the patent did not claim more than what was
invented. Fifth, she failed to consider the prior art and, in particular, the
fact that the inventors of captopril, enalapril and the Tanabe compound claimed
and disclosed all stereoisomers of the ACE compounds covered by the invention.
[118]
In my
view, these errors are critical and, as a result, it is necessary for this
Court to construe the ‘330 patent. Claims 3 and 5 of the ‘330 patent each refer
to groups of compounds sharing a specific formula, but they are silent as to
the appropriate stereo configuration of these compounds. Apotex argues that the
claims refer unambiguously to all stereoisomers and that it is therefore
improper to resort to the disclosure to assert the scope of the claims. I
cannot agree with that proposition.
[119]
As I
indicated earlier, Binnie J., in Whirlpool, supra, cautioned against too
easily concluding that claims were unambiguous: “[t]erms must be read in
context, and it is therefore unsafe in many instances to conclude that a term
is plain and unambiguous without careful review of the specification” (at
paragraph 52).
[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).
[121]
These
passages from the disclosure led the Judge to conclude that “… the claims of
the ‘330 patent here in issue would be read by a person skilled in the art as
referring to compounds useful for the relief of hypertension” (Heneghan J.’s
Reasons, para. 64).She was not persuaded that the invention was directed to the
broader purpose of ACE inhibition. In my opinion, this conclusion is reasonable
in light of the passage cited above and the overall tenure of the disclosure. At
paragraph 66 of her Reasons, the Judge concluded that the patent claimed “all
possible stereoisomers” of the family of claimed compounds:
[66] … I agree with the submissions of Apotex
on this issue, that the '330 Patent claims a family of compounds with a shared
common structure, that is having three chiral centres, and claiming all
possible stereoisomers thereof. I conclude that the purpose of the inventions
described in claims three (3) and five (5) of the '330 Patent is to use the
described compounds as the active ingredient in medicine for the treatment of
hypertension.
[122]
In construing the disclosure, Heneghan J. only
referred to those parts of the patent quoted above referencing the purpose of
the invention as a treatment for hypertension. Her conclusion that all possible
stereoisomers are claimed apparently arose from the fact that claims 3 and 5
are not limited to specific stereoisomers. However, in my view, it was not
possible for Heneghan J. to construe claims 3 and 5 in accordance with the
teachings of Whirlpool, supra, without interpreting the part of the
disclosure that both parties identify as governing the stereochemistry of the
invention.
[123]
Whether the disclosed invention encompasses all
or a limited set of stereoisomers was a contentious issue between the parties.
In particular, both parties introduced expert evidence providing different
interpretations of the following passage from the disclosure:
…The 1,2,3,4-tetrahydroisoquinoline-3-carboxylic acid
used in this invention has the L(S) configuration. This configuration has been
shown to be required for biological activity, and thus active compounds of the
invention are derived from either L(-) or DL-1,2,3,4-tetrahyudroisoquinoline-3-carboxylic
acid.
Optical and diastereo isomers arising from the
chirality at the centers marked with an asterisk [i.e. all three chiral
centres] in Formula I and racemates and mixtures thereof are within the
scope of this invention. The S-configuration at these centers is preferred.
(’330 patent at 3)
The two paragraphs
are difficult to reconcile. Read together, it appears the patentee is claiming
all stereoisomers within the scope of the invention while acknowledging that
the S-configuration at one of the chiral centres is necessary for the invention
to be useful.
[124]
Pfizer
submitted, on the basis of the evidence of its two experts, that a skilled
reader would have concluded that all stereoisomers were included within the
scope of the invention. Pfizer also argued that Dr. Marshall, Apotex’s expert
on this issue, agreed with its experts during the course of his
cross-examination, when he conceded that the inventors had defined the scope of
the invention to include all stereoisomers.
[125]
I would
describe the invention as a family of chemical compounds with varying levels of
ACE inhibition and varying levels of effectiveness for the relief of
hypertension. Such a construction, which is broader than that of Heneghan J.,
is, in my view, justified. It is not misconstruing the compound claims for use
claims. I do not believe that the Trial Judge mistakenly construed the claims
as use claims by describing the ‘330 patent as referring to compounds “ …
useful for the relief of hypertension” (Reasons of Heneghan J., para. 64). It
appears from the Judge’s decision that she clearly understood the claims to
cover the compounds themselves.
[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 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.
[128]
I would
therefore conclude that Pfizer has met its burden of disproving the allegation
that the ‘330 patent contains overly broad claims. In view of this conclusion,
I must now address the issues of obviousness, anticipation, double patenting and
lack of utility.
(b) Obviousness:
[129]
Apotex
challenges Heneghan J.’s dismissal of its claim that the invention disclosed in
the ‘330 patent was obvious. It says that she erred (i) in accepting Pfizer’s
evidence going to obviousness, even though it assessed the state of knowledge
as of the wrong date; (ii) in considering only whether the creation of
quinapril hydrochloride was obvious, rather than looking to the obviousness of
all of the compounds claimed in the ‘330 patent; and (iii) in failing to take
into
account the fact that two other groups of inventors had
independently invented the subject matter of the ‘330 patent. With respect, I
cannot conclude that Heneghan J.’s holding as to obviousness should be set
aside.
[130]
The Trial
Judge, after reviewing the applicable legal test, reviewed the expert evidence.
She concluded that at the relevant priority date of October 3, 1980, others
skilled in the art would not have known how to create, notice and document the
benefits of the compound quinapril hydrochloride as an anti-hypertensive. On
this basis, she concluded that Pfizer had met its burden of showing that the
allegation of invalidity for obviousness was not justified.
[131]
Pfizer
submits that if the Trial Judge erred, it was in finding that the relevant date
for assessing obviousness was October 3, 1980 (the earliest filing date) and
not June 19, 1980 (which they claim is the date of the conception of the
invention and the articulation of a means of making it).
[132]
There was
evidence adduced by both parties on this issue. Dr. Anderson, Pfizer’s expert,
opined that as of June 19, 1980, only the praline head would have been obvious
to a person of ordinary skill in the art. He did not consider whether it would
have been obvious as of October 3, 1980. Dr. Marshall, for Apotex, was of the
opinion that the disputed claims of the ‘330 patent include within their scope
compounds that were obvious as of June 19, 1980 and October 3, 1980. However,
he admitted on cross-examination that he was not qualified to give an opinion
as to obviousness.
[133]
In my
opinion, the Trial Judge did not commit a reviewable error. She considered and
applied the correct legal test, according to which an invention is obvious if a
person of ordinary skill in the art would, at the claimed date of the
invention, be led “directly and without difficulty to the solution taught by
the patent”. For an allegation of invalidity for obviousness to succeed in the
context of NOC proceedings, sufficient evidence must be adduced to show that
the range of compounds covered by any of the relevant claims would have been
obvious to a person skilled in the art at the time of the invention. Although
the Judge refers only to the obviousness of quinapril hydrochloride, the
compounds covered by the invention are, in my view, closely related to one
another and the evidence does not appear to provide any reason to conclude that
the other compounds would have been more obvious than quinapril hydrochloride.
[134]
It appears
that the Trial Judge considered all of the evidence before her. However, it is
clear that she did not consider Dr. Marshall’s evidence to be very strong and,
upon consideration of that evidence, I cannot but agree with her. There was clear
evidence upon which the Trial Judge could conclude that Pfizer had disproved
the allegation of invalidity for obviousness. This, in my view, is the case
whether a June 19, 1980 or an October 3, 1980 date is used to assess
obviousness. Consequently, I am of the view that the learned Judge, in
concluding as she did, did not commit an overriding and palpable error.
(c) Anticipation:
[135]
Apotex
also challenges Heneghan J.’s dismissal of its allegation that the ‘330 patent
was anticipated. In its NOA, Apotex alleged that the ‘330 patent was
anticipated by the Hoechst patent filed with the Canadian Patent Office before
the ‘330 patent and which gave rise to conflict proceedings.
[136]
The Trial
Judge, after reviewing the parties’ submissions and the applicable legal test,
found that Apotex, in failing to adduce evidence showing that the Hoechst
patent had been filed with the Canadian Patent Office, or had been issued,
before the relevant date of September 30, 1979, had not put the issue “in
play”.
[137]
Apotex
submits that the Trial Judge erred in applying the test of anticipation by
prior publication (paragraph 57(1)(b) of the pre-1989 Patent Act)
instead of the test of anticipation by prior use (subsection 27(1) of the
pre-1989 Patent Act). It relies, as evidence of anticipation by prior
use, on the fact that conflict proceedings were initiated in respect of the Hoechst
patent and the ‘330 patent. Pfizer replies that the existence of conflict
proceedings alone cannot resolve the issue. In any event, Pfizer submits that
these proceedings were ultimately resolved in its favour.
[138]
It appears
from paragraphs 85 and 86 of Heneghan J.’s Reasons that she did apply the
anticipation by prior publication test. In this respect, I find particularly
convincing paragraph 27 of Pfizer’s Reply Memorandum of Fact and Law which
states:
27. Apotex
argues that Justice Heneghan erred by failing to consider s. 27(1)a) of the
Patent Ac, which requires a patent to be “known or used” by any other person
before the inventor invented it. This was not an error. Section 61(1) prevents
a patent from being invalidated on the basis that it was “known or used” unless
it was “disclosed or used … in such manner that it had become available to the public”
or if it was the subject of an application for a patent in Canada on which
“conflict proceedings should have been directed.” Neither of these conditions
are met in this case. There is no evidence that the Hoechst patent application
was known to the public. Moreover, this is not a case in which “conflict
proceedings should have been directed”). Rather, conflict proceedings were
directed, did occur, and the patent ultimately issued to Warner Lambert.
[139]
Even if I
were to agree that the Judge erred in applying the wrong test, this error, in
my opinion, is of no consequence in view of the paucity of the evidence adduced
before Heneghan J. In any event, it is clear that Apotex did not file into
evidence a copy of the Hoechst patent. Thus, Heneghan J. was unable to confirm
the filing or issuance date of that patent. This, in my view, is fatal to
Apotex regardless of whether the correct test is anticipation by prior use or
anticipation by prior publication.
[140]
I
therefore can find no fault in the Judge’s conclusion that Apotex’s allegation
of invalidity for anticipation had not been put “in play”.
(d) Double Patenting:
[141]
Apotex
alleges the ‘330 and ‘615 patents relate to a single invention and do not cover
subject matter which is patently distinct. It therefore submits that the
relevant claims of the ‘330 patent are invalid for double patenting.
[142]
Apotex also
argues that the Judge took into account irrelevant considerations in assessing
whether there had been “obviousness” double patenting between the ‘330 and ‘615
patents. Under this type of double patenting, the second patent will be invalid
if its claims are not “patently distinct” from those in the earlier patent (Whirlpool,
supra, at para. 66).
[143]
The Trial
Judge considered the rule against obviousness double patenting, according to
which the question to be answered is whether the claims of one patent are
patently distinct from those of the other patent(s). She found persuasive the
fact that the ‘330 and ‘615 patents were not placed into conflict. She also
noted that it was the Commissioner of Patents who suggested that a divisional
application be made in respect of the ‘615 patent. On this basis, she concluded
that Pfizer had met its burden of disproving the allegations of invalidity for
double patenting.
[144]
Apotex argues
that the Judge should not have taken into account the fact that the ‘615 had
not been involved in the conflict proceedings with the Hoechst patent. It
further argues that she should not have been persuaded by evidence that the
Commissioner had suggested that divisional application be made in respect of
the ‘615 patent because, in its view, it was the patentee who had requested the
division. Finally, Apotex argues that it submitted uncontroverted evidence that
the compounds claimed in the ‘615 patent did not constitute inventive selection
over the ‘330 patent.
[145]
With
respect to Apotex’s first argument, it was reasonable, in my view, for Heneghan
J. to consider whether the ‘615 patent had been involved in the conflict
proceedings in determining whether there was double patenting. This fact lends
some support to the conclusion that the ‘615 and ‘330 patents do not have the
same scope, at least with respect to the scope of the invention disclosed in
the Hoechst patent. I also find it unlikely that such evidence alone could
dispose of the issue, unless it was shown that all of the subject matter
covered by the Hoechst patent and the ‘330 patent was the same, such that if
the ‘615 patent covered the same subject matter as the ‘330 patent, it would
almost certainly have been involved in the conflict proceedings.
[146]
Of some
persuasiveness is a fact which Apotex points to in its Memorandum of Fact of
Law. At paragraph 87 thereof, in attempting to explain its basis for stating
that the Commissioner did not request the division of the ‘615 patent, Apotex
states:
87. … The
Commissioner initially rejected the issuance of the ‘330 patent on the basis of
double patenting over the ‘615 patent. The Commissioner, however, accepted
Pfizer’s representation that double patenting did not apply as there was a
species/genus relationship between the two patents and thus removed his double
patenting objection.
[147]
This, in
my view, demonstrates that the Commissioner specifically considered the
possibility of double patenting, but was convinced that that was not the case.
[148]
With
respect to Apotex’s allegation that it was the patentee, not the Commissioner,
who requested the division, Apotex points to no evidence supporting that view.
Heneghan J.’s finding that the Commissioner requested the division should
therefore stand.
[149]
In the
end, the application of the test for double patenting to the facts of the case
is a question of mixed fact and law, subject to the overriding and palpable
error standard. Heneghan J. committed no such error. It was reasonable for her,
in my view, to rely on the fact that there were no conflict proceedings
involving the ‘615 patent and that the Commissioner of Patents suggested that
the ‘615 patent be filed as a divisional application. This appears to be the
only evidence which was put before the Judge. Thus, in my opinion, these facts
do not only indicate that the invention claimed in both patents were patently
distinct, but also that the ‘615 patent was a valid selection patent.
(e) Lack of Utility:
[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.
DISPOSITION
[155]
For these
reasons, I would allow the appeal, set aside the order of Heneghan J. and
prohibit the Minister of Health from issuing a NOC to Apotex in respect of APO-QUINAPRIL
until the expiry of the ‘615 and the ‘330 patents. I would allow the appellant
its costs herein and below.
“M. Nadon”
“I
agree.
A.M.
Linden J.A.”
“I
agree.
J.
Edgar Sexton J.A.”