Date: 20070528
Citation: 2007
FC 532
Ottawa,
Ontario,
May 28, 2007
PRESENT: The
Honourable Mr. Justice Harrington
Docket: T-1384-04
BETWEEN:
SANOFI-AVENTIS INC. and
SANOFI-AVENTIS DEUTSCHLAND GmbH
Applicants
and
LABORATOIRE RIVA INC. and
THE MINISTER OF HEALTH
Respondents
and
SCHERING CORPORATION
Respondent/Patentee
Docket: T-1888-04
AND
BETWEEN:
SANOFI-AVENTIS INC. and
AVENTIS PHARMA DEUTSCHLAND GmbH
Applicants
and
LABORATOIRE RIVA INC. and
THE MINISTER OF HEALTH
Respondents
AMENDED REASONS FOR ORDERS
[1]
In these
two applications taken pursuant to the Patented Medicines (Notice of
Compliance) Regulations, Sanofi-Aventis seeks orders
prohibiting the Minister from approving, in the form of a Notice of Compliance
(NOC), Laboratoire Riva’s version of Ramipril for use in the treatment of high
blood pressure (hypertension).
[2]
Sanofi-Aventis
was the first to obtain the Minister’s approval and has successfully marketed
Ramipril under the name Altace for many years. Indeed it holds Canadian patent
1,187,087 (‘087) for a process for the preparation of Ramipril and other
compounds and their use in the treatment of high blood pressure. The monopoly
granted by that patent expired in 2002.
[3]
Laboratoire
Riva has persuaded the Minister that its version of Ramipril is
pharmaceutically equivalent and bioequivalent to Altace. However, the Minister
has put Riva-Ramipril on “patent hold” because Sanofi-Aventis submitted four
patents to the Minister which are maintained on his patent list. Riva is
blocked from marketing “Riva-Ramipril” until the expiry of the last of the four
patents in 2018, unless it avails itself of the recourses available to it under
the PM (NOC) Regulations, or otherwise disposes of the patents in a patent
action.
[4]
These
regulations have been intensely litigated and have been considered by the
Supreme Court in such cases as Bristol-Myers Squibb Co. v. Canada (Attorney
General), [2005] 1 S.C.R. 533, 39 C.P.R. (4th) 449 [Biolyse] and Merck Frosst Canada Inc. v.
Canada (Minister of National Health and Welfare), [1998] 2 S.C.R. 193, 80
C.P.R. (3d) 368. More recently, Mr. Justice Hughes recapitulated their history
in Ferring Inc. v. Canada (Minister of Health), 2007 FC 300, [2007] F.C.J.
No. 420 (QL).
[5]
Not
content to wait until the patents expire, Riva served a Notice of Allegation on
Sanofi-Aventis. Insofar as patent 1,341,206 (‘206) (which is owned by the
respondent Schering Corporation but listed by Sanofi-Aventis with its consent),
Riva alleged it to be invalid for a number of reasons, including that there was
no sound basis for predicting it would actually work i.e. fulfil its promise,
when the patent application was filed.
[6]
The three
other patents, all held by Sanofi-Aventis, relate to other uses of Ramipril:
a.
Cardiac
insufficiency – patent 1, 246,457 (‘457);
b.
Cardiac
and vascular hypertrophy and hyperplasia – patent 2,023,089 (‘089); and
c.
Prevention
and therapy of proteinuria, a kidney ailment – patent 2,055,948 (‘948).
Riva alleged that it will not infringe these patents as it
is only seeking approval for and will limit its marketing efforts to the
treatment of high blood pressure.
[7]
Sanofi-Aventis
took up the challenge by applying for the prohibition orders which are before
me. It asserts that the allegations that patent ‘206 is invalid for lack of sound
prediction and other reasons are not justified. With respect to the three “use”
patents, it submits that the Notices of Allegation are insufficiently detailed or
that Riva will infringe by inducing or procuring others to do so at its behest.
[8]
Sanofi-Aventis
(earlier known as Aventis-Pharma) also alleges that Riva is a privy of Pharmascience
Inc. Pharmascience has unsuccessfully alleged in prior NOC proceedings that
patent ‘206 was invalid on the grounds of double patenting (Aventis Pharma
Inc. v. Pharmascience Inc., 2005 FC 340, [2005] 4
F.C.R. 301,
38 C.P.R.
(4th) 441,
Madam Justice Snider [Aventis]; appeal dismissed, 2006 FCA 229, [2007] 2
F.C.R. 103, 53 C.P.R.
(4th) 453,
application for leave denied, [2006] S.C.C.A. No. 362 (QL)). Since
Pharmascience could not relitigate the issue by adding a new ground of
invalidity, i.e. lack of sound prediction, neither can Riva.
[9]
Riva
joined issue with the allegations set out in the applications, and denied that
it was Pharmascience’s privy. In its responding material, and for good measure
by way of a separate motion, it further submitted that since another generic
drug company, Apotex Inc., had alleged in its NOC proceedings that patent ‘206
was invalid for lack of sound prediction, and that that allegation had been
found to be justified, it would be an abuse of process for Sanofi-Aventis to relitigate
the point in these proceedings, even though the parties are not the same (Aventis
Pharma Inc. v. Apotex Inc., 2005 FC 1283, 278 F.T.R.
1, 43 C.P.R.
(4th) 161, Madam
Justice Mactavish [Apotex]; appeal dismissed, 2006 FCA 64, 265 D.L.R. (4th) 308, 46 C.P.R.
(4th) 401 application for leave denied,
[2006] S.C.C.A. No. 136 (QL)).
[10]
After five
days of hearing on the patents, as well as on the privy and abuse of process
issues, and having reviewed the record and the written and oral submissions of
counsel, I find:
a.
Riva is
not privy to Pharmascience and was entitled to allege that patent ‘206 was
invalid for lack of sound prediction;
b.
The allegation
that patent ‘206 is invalid for lack of sound prediction, or otherwise, is not
justified;
c.
The Notices
of Allegation with respect to non-infringement are sufficiently detailed to
satisfy the requirements of the PM (NOC) Regulations;
d.
The
allegations of non-infringement of the cardiac and vascular hypertrophy and hyperplasia, and the prevention and
therapy of proteinuria patents are justified; and
e.
The
application as regards cardiac insufficiency is now moot as that patent has
expired and cannot serve as a basis to prohibit the Minister from issuing an
NOC to Riva.
[11]
I would
have dismissed Riva’s abuse of process motion. It follows that I would have granted
an order prohibiting the Minister from issuing Laboratoire Riva an NOC until
the expiry of patent ‘206 in 2018.
[12]
However,
after I had taken these matters under reserve, the Federal Court of Appeal
handed down its decision in Sanofi-Aventis Canada Inc. v. Novopharm Ltd.,
2007 FCA 163 [Novopharm]. Mr. Justice Sexton found it to be an abuse of
process within the meaning of the PM (NOC) Regulations for a patent holder to
relitigate an allegation of invalidity against a generic, if the allegation had
been held to be well founded in an earlier proceeding against a different
generic. Madam Justice Sharlow concurred, but Mr. Justice Nadon dissented. The
patent at issue was the very same as in this case – patent ‘206.
[13]
I am bound
by that decision, and in light thereof, I will maintain Riva’s motion and dismiss
Sanofi-Aventis’ applications without issuing prohibition orders.
[14]
However, given
that an application for leave to appeal Mr. Justice Sexton’s decision to the
Supreme Court is pending, or that I may have misunderstood the decision or
unduly fettered my discretion, I will set out my reasoning on all issues under
the following headings:
|
|
Paragraphs
|
|
a. History of the proceedings
|
15-20
|
|
b. Are Pharmascience and Riva
privies?
|
21-30
|
|
c. Patent ‘206 – Allegations of
invalidity
|
31-65
|
|
i. Treatment of High Blood
Pressure
|
34-37
|
|
|
ii. Patent Claim
Construction
|
38-39
|
|
|
iii. Skilled Addressee
|
40-46
|
|
|
iv. Sound Prediction and
Lack of Utility
|
47-59
|
|
|
v. “Evergreening”
|
60-65
|
|
|
d. Abuse of process
|
66-86
|
|
e. Allegations of non-infringement
|
87-104
|
|
f. Expired patent ‘457
|
105-106
|
|
g. Costs
|
107
|
|
h. Afterward
|
108
|
HISTORY OF THE PROCEEDINGS
[15]
In June
2004, Riva served Sanofi-Aventis with a Notice of Allegation relating to the
‘457, ‘206 and the ‘089 patents. Sanofi-Aventis responded by filing Federal Court
application T-1384-04 the following month. Laboratoire Riva’s Notice of
Allegation with respect to patent ‘948 was only served in September 2004.
Sanofi-Aventis’ responding Notice of Application to this Court was filed the
next month, under docket number T-1884-04. Subsequently, the cases were ordered
to be heard one after the other.
[16]
The PM
(NOC) Regulations statutorily prohibit the Minister from issuing an NOC for 24
months, or such lesser time as it takes the Court to render a decision. The
matters were set down for hearing in May 2006 before Mr. Justice von
Finckenstein. However, on consent, as reflected in his orders of 5 June 2006,
the hearing was adjourned sine die. The 24-month statutory prohibition
was extended “until a decision [wa]s rendered on the merits in this proceeding
or until a further order of this Court.” The Court adjourned the proceedings so
the parties could wait for the Federal Court of Appeal’s ruling in
Pharmascience’s appeal of the decision of Madam Justice Snider in Aventis,
above. Upon that decision being rendered, a case management conference was held
on 14 July 2006. As a result, the applications were referred to the Office of
the Judicial Administrator for rescheduling. The minutes record that Riva was also
authorized to bring on a motion with respect to abuse of process.
[17]
The two
applications were set down for hearing, one following the other, for five days
in Toronto from April 16 to 20, 2007.
[18]
In the
week preceding the hearing, Riva, out of what it termed an “overabundance of
caution”, filed its abuse of process motion with respect to Sanofi-Aventis’
contention that patent ‘206 was valid because there was a sound basis for
prediction. Since the same point had been raised in Riva’s responding material
in any event, I did not give effect to Sanofi-Aventis’ faint-hearted protest.
[19]
Counsel
pointed out that I could deal with the applications, and the motion, without
having to consider the merits of the invalidity, lack of detailed notice and non-infringement
allegations. If I was satisfied that Riva was Pharmascience’s privy, then Riva
had no standing whatsoever. The applications would be maintained and the abuse
of process motion dismissed. On the other hand, a decision granting the abuse
of process motion would, at the very least, relieve me of the need to consider
the thorny issue of sound prediction.
[20]
It seemed
to me then, and it seems to me now, that I could not have heard the privy issue
and immediately delivered a decision from the bench, or in like manner, dealt
with the abuse of process issue. I would have had to reserve judgment on both,
the net effect being that three or four days which had been set aside for
hearing would have been wasted. I therefore decided to hear all matters at
once.
ARE PHARMASCIENCE AND RIVA PRIVIES?
[21]
The
concept of parties being privy to each other is an offshoot of the principle of
res judicata. The authorities, as they then were, were reviewed by Mr.
Justice Richard, as he then was, in Hoffman-La Roche Ltd. v. Canada (Minister of National Health
and Welfare),
[1997] 2
F.C. 681, 72 C.P.R. (3d) 362. Mr. Justice Richard, deciding in the context of
the PM (NOC) Regulations, referred to the decision of Mr. Justice Dickson, as
he was, in Angle v. Minister of National Revenue, [1975] 2 S.C.R. 248, 47 D.L.R.
(3d) 544, a
tax case, wherein he said that res judicata, a form of estoppel, had two
species. The first, “cause of action estoppel”, precludes a person from
bringing an action against another when that cause of action has already been
decided. The second, “estoppel per rem judicatam”, or “issue estoppel”,
is where, although the cause of action is different, the same point or issue of
fact has already been decided.
[22]
There are
three identities that must be present in res judicata: the object, the
action and the parties. The notion of “privies” deals with identity of parties.
The question is whether two persons legally distinct should be treated as one.
Call one the alter ego or “prête nom” of the other, or call it piercing the
corporate veil; for two corporations to be treated as one there must be a relevant
community or privity of interest between them.
[23]
Riva filed
its Abbreviated New Drug Submission (ANDS) with Health Canada in the spring of 2004. It cross-referenced
its regulatory submission to an earlier one submitted by Pharmascience, who neither
then nor even now has received an NOC (see the decision of Madam Justice Snider
in Aventis, above). Since Pharmascience did not have an NOC it follows
that its version of Ramipril and the product monograph were not publicly
available. This means, as was admitted on cross-examination, that Riva and
Pharmascience had a trade relationship.
[24]
Mostafa
Akbarieh, Riva’s vice-president of Research and Development and Regulatory
Affairs, admitted that its ANDS for Ramipril was not the first submission it filed
which cross-referenced Pharmascience’s submissions. Riva relies on the
information found in the Pharmascience submission and its product monograph
was, and had to be, identical.
[25]
Although
Riva obviously had to have Pharmascience’s permission, Mr. Akbarieh was not
involved in negotiations. He did not know if there was a written agreement in
place with respect to the cross-reference. Although he knew the two
corporations did not have any common employees, he knew nothing of common
shareholding or any other matter which might make the companies related. Riva’s
solicitor refused to undertake to make that information available.
[26]
It is
clear that if the respondent in these applications were Pharmascience, it would
be precluded by “issue estoppel” from relying on the allegations in its NOA. Indeed,
Pharmascience unsuccessfully sought an order that it would be an abuse of
process for Sanofi-Aventis to continue to argue that the ‘206 patent was valid
in the light of the decision of Madam Justice Mactavish in Apotex, above.
In Pharmascience Inc. v. Sanofi-Aventis Canada Inc., 2006 FCA 210,
[2006] F.C.J. No. 933 (QL), Madam Justice Sharlow gave short shrift to that
argument. She pointed out that all Madam Justice Mactavish did was dismiss
Sanofi-Aventis’ application for a prohibition order. That was not a final
determination as to the validity of the’206 patent. Pharmascience had not made
an allegation of invalidity on the basis of lack of sound prediction and so Sanofi-Aventis
could hardly be faulted for failing to respond to an allegation which had not
been made. See also the recent decision of the Federal Court of Appeal in Abbott
Laboratories v. Canada (Minister of Health), 2007 FCA 140.
[27]
However, I
am not satisfied that the facts above and the fact that Riva’s expert, Dr. Christensen,
was first approached by Pharmascience establish that the two parties were
privies. All that has been established is that they have a trade relationship,
and that is not enough (Hoffman-La Roche, above).
[28]
Sanofi-Aventis
has invited the Court to draw an adverse inference from the fact that Mr. Akbarieh,
who signed an affidavit for Riva, was not knowledgeable in that area and that
undertakings were not provided. Mr. Akbarieh was not all-knowing, but certainly
had knowledge with respect to regulatory matters and non-infringement issues.
Cross-examination on an affidavit does not give rise to undertakings. This was
not a discovery of documents and examination for discovery of a corporation
within the meaning of Rules 222 and following of the Federal Courts Rules.
[29]
The point
seems to have been lost that applications, as opposed to actions, are supposed
to be summary in nature. There is nothing summary about proceedings which take
up five days of legal argument! Sanofi-Aventis’ plea of hopelessness and
helplessness does not sit well. Even in applications, Rule 313 provides that
where the Court considers the record of a party to be incomplete, it may order
that more material be filed. If truly relevant, and if so minded, Sanofi-Aventis
could have moved for an order for the production of additional material in the
possession of Riva.
[30]
Sanofi-Aventis
also argues that these proceedings are abusive in that it is the Minister’s
policy not to issue an NOC where a submission cross-references an earlier submission,
unless and until that earlier submission is successful. The application by
Pharmascience was unsuccessful. However, I am not concerned with whatever
policy the Minister may have. What are before me are allegations of invalidity
and non-infringement, no more and no less. If the Minister decides not to issue
an NOC on other grounds, then that decision might be the subject of a separate
judicial review.
PATENT ‘206 – ALLEGATIONS OF INVALIDITY
[31]
Canadian
patent ‘206 has had somewhat of a peculiar history. Schering Corporation
applied for a Canadian patent in October 1981, based on United States priority dates in 1980 and
1981. It covered a genus of compounds known as Angiotensin Converting Enzyme
(ACE) inhibitors that actually included Ramipril, although there was no
specific disclosure of or claim to it. Innovative pharmaceutical companies were
carrying out a great deal of research at that time with respect to ACE
inhibiting compounds, which go to preventing the constriction of blood vessels,
and thereby help to relax blood vessels and lower blood pressure. Due to
protracted conflict proceedings in the patent office, patent ‘206 was only
issued in 2001. Under the Patent Act, as it was before being amended in
1989, and as applicable to patent ‘206, patent ‘206 only expires in 2018, 17
years after issuance.
[32]
Sanofi-Aventis’
patent ‘087 for the preparation of Ramipril and other compounds and their use in
the treatment of high blood pressure was in essence a selection patent, or an
improvement on patent ‘206. The application was filed in November 1982 based
on German priority dates in 1981 and 1982. It was issued in May 1985, and so
expired in 2002.
[33]
Although
the invention covered by patent ‘206 was tied up in the Canadian Patent Office,
it was granted in other jurisdictions, as was Sanofi-Aventis’ Ramipril. The
result was a stand-off in that in those jurisdictions, Schering could not
manufacture Ramipril for fear of infringing patent ‘087, and Sanofi-Aventis
could not manufacture Ramipril for fear of infringing genus patent ‘206. They
had to accommodate each other, which was done by Schering granting
Sanofi-Aventis a worldwide licence to use patent ‘206 insofar as it related to Ramipril.
a. Treatment of High Blood Pressure
[34]
Angiotensin
is a substance which naturally occurs in the body in two forms. Angiotensin I
does not directly affect blood pressure. However, Angiotensin II is a potent
vasoconstrictor, which constricts blood vessels, thereby increasing blood
pressure. Angiotensin II is produced by the action of Angiotensin converting
enzyme on Angiotensin I. It follows that ways and means of inhibiting this
conversion reduce the production of Angiotensin II, thereby reducing blood
pressure.
[35]
ACE is a
member of the class of enzymes known as “Peptidase” which leads to the cleavage
of a peptide or protein into smaller fragments. ACE cleaves Angiotensin I in
such a way that produces Angiotensin II, which is a potent up-regulator of
blood pressure. The value of ACE inhibitors is that they block the cleavage of
Angiotensin I, thus reducing the amount of Angiotensin II in the body.
[36]
In
essence, this is what patent ‘206 is all about. It claims “carboxyalkyl
dipeptides, processes for their production and pharmaceutical compositions
containing them.” According to the Abstract, “disclosed are novel carboxyalkyl
dipeptides which are useful as inhibitors of angiotensinconverting enzyme and as
anti-hypertensive agents… having a particular formula.” Riva also emphasizes
page 24 of the patent which says, “the compounds of this invention has useful
pharmaceutical properties. They are useful in the treatment of high blood
pressure.” The patent makes 13 claims. It is common ground that some, but not
all, could be construed to cover Ramipril. The claim which is narrowest in
scope and which includes Ramipril, and on which validity stands or fails, is
claim 12 which reads:
The compound 1- [N- (1 –
carboethoxy-3-phenylpropyl) – (S) – alanyl] octahydrocyclopenta [b] pyrrole-2
(S) – carboxylic acid and its pharmaceutically acceptable salts thereof.
[37]
This
claim, of course, is incomprehensible to one unskilled in the art. Those who
offered advice to the Court were professors in biochemical pharmacology,
professors of chemistry specialising in the general principles of
stereochemistry and synthesis of compounds containing centres of asymmetry,
professors of medicine and pharmacology, professors in departments of medical
chemistry, and those holding doctorates in the field of organic chemistry and
active in human and animal research.
b. Patent Claim Construction
[38]
Although
much of their focus was on the principle of “sound prediction”, what the
experts said also explained some of the terminology used in the patent.
[39]
The first
step is to determine what the patent discloses and what it promises. Drawing
upon the decisions of the Supreme Court in Free World Trust v. Électro Santé
Inc., [2000] 2 S.C.R. 1024, 9 C.P.R.
(4th) 168
and Whirlpool Corp. v. Camco Inc., [2000] 2 S.C.R. 1067, 9 C.P.R.
(4th) 129,
I set forth my own understanding of what is claimed in a patent in Biovail
Pharmaceuticals Inc. v. Canada (Minister of National Health and Welfare)
(2005), 267 F.T.R. 243, 37 C.P.R. (4th) 487. Not all I said there need be
repeated, but quoting from paragraph 15 thereof:
[…]
a It is a statutory
requirement that the patent contain a specification and end with a claim or
claims "defining distinctly and in explicit terms the subject-matter of
the invention for which an exclusive privilege or property is claimed".
The specification must be sufficiently full, clear, concise and exact "as
to enable any person skilled in the art or science to which it pertains, or to
which it is most closely connected, to make, construct, compound or use
it". (Patent Act, R.S.C. 1985, c. P-4, as amended, s. 27)
b The patent is
notionally addressed to a person skilled in the art or science of the
subject-matter and is to be read as such a person would have read it when it
first became public.
[…]
c The claims are to
be read in an informed and purposive way to permit fairness and predictability
and to define the limits of the monopoly "[I]ngenuity of the patent lies
not in the identification of the desired result but in teaching one particular
means to achieve it. The claims cannot be stretched to allow the patentee to
monopolize anything that achieves the desired result" (Free World Trust,
paras. 31, 32).
[…]
d Yet a patent is
not an ordinary writing. It meets the definition of a "regulation" in
the Interpretation Act, and must be read to assure the attainment of its
objects. "Claims construction is a matter of law for the judge, and he was
quite entitled to adopt a construction of the claims that differed from that
put forward by the parties." (Whirlpool, para. 61.)
c. Skilled Addressee
[40]
There was
surprisingly little debate as to the qualifications of the experts. None was
actually challenged.
[41]
I found
the evidence of Dr. Paul Bartlett, called by Schering, to be particularly
useful. Dr. Bartlett is professor of chemistry emeritus, at the University of California, Berkley. In addition to teaching, he leads
a research group in the field of bio-organic chemistry and synthetic organic
chemistry, the focus of which has been the design, synthesis and evaluation of
biologically active compounds. He has published many articles and is the
inventor or co-inventor of a number of United States patent applications.
[42]
I also
considered the evidence of Dr. Burton Christensen, called by Riva, to be
helpful. Unlike the other experts who spent most of their careers in academia,
after obtaining his Ph.D. in 1956 in the field of organic chemistry from
Harvard, he joined Merck & Co. Inc. in 1956, and was employed in various
positions, including Senior Vice-President chemistry, until his retirement in 1992.
More recently, he has acted as a consultant and co-founded a research company.
He brought to the Court more than 48 years of practical experience in drug development.
[43]
Although
the principles of stereochemistry must be taken into account in determining
whether claim 12 of patent ‘206 claims anything that is useful, which is a
prerequisite of a patent, Schering points out that the broadest claim, claim 1,
has no stereochemistry aspects whatsoever.
[44]
After
having benefited from a tutorial on ACE inhibitors, I find I am able to
construe the patent without any further extrinsic aid, while remaining mindful
of the following words of Mr. Justice Pigeon in Burton Parsons v.
Hewlett-Packard, [1976] 1 S.C.R. 555 at page 563, 17 C.P.R. (2d) 97 at page
104:
While the construction of a patent is for
the Court, like that of any other legal document, it is however to be done on
the basis that the addressee is a man skilled in the art and the knowledge such
a man is expected to possess is to be taken into consideration.
I find that as long as there would be any ACE inhibition or
activity, then the promise of the patent is fulfilled. Dr. Christensen was of
the view that what was disclosed and claimed in the patent had to have some “therapeutic”
use. That word does not appear at page 24 of the patent.
[45]
The
promise was simply that the compounds claimed by the patent would have utility
as both ACE inhibitors and anti-hypertensive agents. More particularly, as
regards claim 12, there was no claim that the compounds would be so effective
as to warrant the issuance of an NOC, or otherwise be commercially viable. As a
practical matter, Dr. Christensen said that he would not waste research time
and money trying to develop something that was not the “best in class”. In
other words, he looked for an improvement on what had already been developed.
I have no doubt that that attitude served him very well in industry, but all
the law requires is that there be some utility. He raised the bar too high.
[46]
Thus, I
have come to the same conclusion as did Madam Justice Mactavish in the Apotex
decision referred to in paragraph 9 hereof. I refer particularly to paragraph
61 and following and paragraph 276 and following of her reasons. Judicial
comity calls for one judge of the same Court to follow another on points of
law, unless of the view that the earlier decision was clearly wrong. My passing
concern was that since we benefited from the advice of different experts, we
might have been reading the patent through different glasses.
d. Sound Prediction and Lack of Utility
[47]
When
Schering applied for the Canadian patent in 1981, it had not actually laboratory
tested the efficacy of any of the eight compounds set out in claim 12. Patent
law did not require it to do so. The Commissioner was entitled to issue a
patent if satisfied there was a sound basis for predicting that each of the
compounds claimed would be useful for the promised purposes. Put another way,
was the promise of the invention a reasonable inference from what the inventors
knew, or should have known, or was it based on mere speculation?
[48]
Claim 12 is
presumed to be valid until it is either proved that at least one of the eight
compounds is not useful, or the Court is satisfied that there was no sound
basis for making the prediction in the first place. Even if it were established
today that all eight compounds fulfilled the promise of the invention, the
patent would still fall if the invention was merely a lucky guess.
[49]
Today we
know that one of the eight compounds, Ramipril, works very well indeed. No laboratory
evidence was properly put before me as to whether the other seven compounds
work or not.
[50]
Although
much of the evidence before me was similar to that before Madam Justice
Mactavish in the Apotex case, the evidence differed sufficiently so that
although she found as a fact that there was no sound basis for predicting the
compounds in claim 12 would be useful, I have come to the opposite conclusion.
The facts relate to stereochemistry. One is not entitled to expect that the
Court knows anything about stereochemistry, so that findings of fact in that
regard come from reliance on expert advice. Madam Justice Mactavish relied on
the opinion of a Dr. Marshall. Dr. Marshall was not before me. I rely particularly
on the evidence of Dr. Bartlett and Dr. Christensen, whose evidence was not
before her.
[51]
The
parties, who are in the pharmaceutical business, know a great deal about
stereochemistry, and the fundamental principles were not in dispute. What was
in dispute was what might be described as “fine tuning”.
[52]
As to relevant
principles of stereochemistry, I can do no better than to refer to paragraphs 25
through 52 of Madam Justice Mactavish’s reasons for judgment.
[53]
I need
only mention that organic molecules are three dimensional. At the heart of the
stereochemistry in this case is the carbon atom, which to be stable must take
four bonds. This linkage may be called a ring. In addition to simple rings
constructed from carbon and hydrogen, organic molecules may also have chains of
atoms connected by double or triple bonds, and additional elements such as
hydrogen, oxygen and sulphur.
[54]
These
three dimensional organic molecules take on different forms. As Dr. Bartlett
explains it, a carbon atom that is substituted with four different groups can
exist in two different forms. These carbon atoms may be called stereocentres or
chiral centres, from the Greek word for hand. As set out in Madam Justice
Mactavish’s decision, these chiral centres may either have an “S” configuration
or an “R” configuration. The importance of the “S” and “R” configurations as
explained by Dr. Bartlett is:
Enzymes are proteins that
catalyze chemical reactions in the living cell, plant, or animal. They do so by
binding the substrate to their active site, catalyzing the
conversion of the substrate to the products of the reaction, and then
allowing the products to dissociate from the active site. An inhibitor
is a molecule that prevents this reaction from occurring, usually by competing
with the substrate for binding to the active site. Inhibitors often bear some
structural resemblance to the substrates with which they compete, but are
themselves incapable of reacting.
[Emphasis in original]
[55]
He went on
to say that long before 1980 it was well known in the field of medical
chemistry that there are distinct subsites of the active sites of peptidase
enzymes; each subsite interacting with a particular segment of the peptide
substrate or part of the inhibitor. It was generally known that for ACE, chiral
centres in the “S” position were more effective than those in the “R” position.
In fact, as mentioned by Madam Justice Mactavish, a paper published by Merck
scientists in 1980 showed that in this context, chiral centres in the “S”
position were 700 times more active (A.A. Patchett et al., “A new class of
angiotensin-converting enzyme inhibitors” (1980) 288 Nature 280 [Merck
article]).
[56]
Following
up on earlier works by Squibb and Merck, the Schering inventors, including Dr.
Elizabeth Smith who filed an affidavit in these proceedings, were exploring
structural variations of the bridgehead rings at the right hand side of the
molecule, as it is usually depicted in diagram form.
[57]
This is
where the evidence before Madam Justice Mactavish and before me diverges. Claim
12 of Schering’s patent has three backbone chiral centres and two bridgehead
chiral centres. It requires two of the three backbone chiral centres to be in
the “S” position. The other three chiral centres may be in either the “S” or
the “R” position.
[58]
Dr.
Marshall, in the affidavit and cross-examination put before Madam Justice
Mactavish, was of the opinion that there would be no activity in the bridgehead
chiral centres invented by Schering, and therefore no sound basis for making a
prediction. However Dr. Christensen admitted that there would be “promiscuity”
or activity in those centres. While Dr. Marshall thought there would be no
activity, Dr. Christensen thought there would not be enough activity. However,
since I, as had Madam Justice Mactavish, construe the patent as only claiming
some activity, the promise was fulfilled.
[59]
In
addition to Dr. Christensen’s admission that there would be activity in the
bridgehead chiral centres, Dr. Bartlett pointed out that although the Merck
article simply reported facts, Merck made promises of activity in its own
patent applications, promises which were very similar to those made by Dr.
Smith and her colleagues. Since the people at Merck were pre-eminent in the
field at that time, I have come to the conclusion that the claims made by Dr.
Smith and her colleagues were not shots in the dark. There was a sound basis
for their prediction. Indeed, patent ‘206 contemplates a 3000-fold difference
in dosages, which more than covers the 700-fold range of activity reported in
the Merck article. The patent also contemplates both oral administration and
injection. Injection may not be popular, but it is a more effective way of
getting medicine into the bloodstream.
e. “Evergreening”
[60]
By the
time the matter came up for hearing, Riva had abandoned some of the grounds it
alleged that patent ‘206 was invalid. However it maintained its allegation with
respect to “evergreening”. Sanofi-Aventis submitted that this was simply a new
term for double patenting. Although I do not think that was Riva’s intent, call
it what you will, it does not justify its allegation that the patent is
invalid.
[61]
Riva’s
argument is that the ‘087 patent claimed Ramipril when made by certain
processes. It was issued in 1985 and expired in 2002. The issuance of patent
‘206 in 2001 in effect perpetuated the monopoly on Ramipril without any new
benefit flowing to the public. The combined effect of the two patents is that a
duopoly beginning in 1985 will run until 2018, some 33 years. The Patent
Act as it was before 1989 only gave a monopoly for 17 years from date of
issuance, while the current version gives a 20-year monopoly from the date of
application.
[62]
Thus there
is, Riva argues, a disproportionate unfairness to the public in that no one else
may make Ramipril under the expired ‘087 patent without infringing patent ‘206.
Expired monopolies should not be perpetuated.
[63]
The delay
in granting patent ‘206 in Canada, but not in other
jurisdictions, worked to Schering’s initial disadvantage. Although
Sanofi-Aventis started paying it a license fee in 1986, it certainly did not
have to do so as far as Canada was concerned. It did so
because it wanted to market Ramipril worldwide, and had to come to grips with
patent ‘206 as granted in other jurisdictions.
[64]
This is
not a case of attempting to patent the same invention twice, or the same patent
holder attempting to add “bells and whistles” onto an existing patent in an
effort to perpetuate the patent list contemplated by the PM (NOC) Regulations.
Ramipril was a “selection” patent out of a known genus.
[65]
The
decision of the Supreme Court in Consolboard Inc. v. MacMillan Bloedel (Sask.)
Ltd., [1981] 1 S.C.R. 504, 56 C.P.R. (2d) 145 is on point. That was a
situation where the Commissioner took the position that a patent had to be
divided in two. The Court held that the patentee could not be prejudiced by
what had happened in the Patent Office. The same applies in this case.
ABUSE OF PROCESS
[66]
Having
found that Riva’s allegations that patent ‘206 was invalid were not justified,
more particularly its allegation with respect to a lack of sound prediction, I
have to consider whether Sanofi-Aventis is precluded from arguing this point in
virtue of the legal doctrine of abuse of process. Like the doctrine of privies,
abuse of process, in this context, is closely related to res judicata.
[67]
Section
6(5)(b) of the PM (NOC) Regulations provides:
|
6(5) In a proceeding in respect of an application
under subsection (1), the court may, on the motion of a second person,
dismiss the application
[…]
(b) on the ground that the application is
redundant, scandalous, frivolous or vexatious or is otherwise an abuse of
process
|
6(5) Lors de l'instance relative à la demande visée au
paragraphe (1), le tribunal peut, sur requête de la seconde personne, rejeter
la demande si, selon le cas :
[…]
b) il conclut qu'elle est inutile, scandaleuse, frivole ou
vexatoire ou constitue autrement un abus de procédure.
|
[68]
Mr.
Justice Sexton’s decision in Novopharm, above, dismissing the appeal
from Madam Justice Tremblay-Lamer’s decision, 2006 FC 1135, drives home the
point that mere litigation, with another party, of a point already decided, can
constitute, without more, an abuse of process, even if it is not clear and
obvious that the application would have failed on the merits. This decision
marks a clear development in the law as applicable in NOC proceedings.
[69]
I
mentioned earlier that were it not for this decision, I would not have found
Sanofi-Aventis’ litigation with respect to sound prediction to be abusive. It
is not necessary to set out those reasons in any detail, as Mr. Justice Sexton
fully addressed the concerns I had, which were that the purpose of NOC applications
is simply to decide whether the Minister should be prohibited from issuing an
NOC, not whether a patent is invalid or would be infringed. An NOC decision
does not even determine the validity of the patent as between the immediate
parties. The jurisprudence, in the main, made it a constituent element of abuse
of process that there be little or no likelihood of success. The issue of sound
prediction is largely one of fact, and the evidence before two judges can well
differ.
[70]
In
addition, I had failed to sufficiently distill the principles of abuse of
process from the facts in the leading case of Toronto (City) v. C.U.P.E., [2003] 3 S.C.R. 77 [C.U.P.E.].
The city fired a recreation instructor after he had been convicted of sexually
assaulting a boy under his supervision. The employee, with the support of his
union, grieved the dismissal. The arbitrator ruled that the criminal
conviction, which had been affirmed on appeal, was not conclusive as to whether
he had actually sexually assaulted the boy. As a matter of public policy it
simply will not do for an arbitrator to question the final decision of a court
of competent jurisdiction. The city would have been put in an impossible
position if it had to rehire a convicted sex felon. Here, there is no possibility
of moral outrage on the part of an informed public.
[71]
In
applying C.U.P.E., above, to NOC proceedings, Mr. Justice Sexton
declared that the old authorities had to be reassessed. He said at paragraphs
35 and 38:
[35] Despite these
authorities, this Court's analysis with respect to abuse of process must now be
informed by the principles enunciated by the Supreme Court of Canada in Toronto
(City) v. C.U.P.E., Local 79, [2003] 3 S.C.R. 77, 2003 SCC 63 ("C.U.P.E.").
In C.U.P.E., Arbour J. provided a thorough explanation of the doctrine
of abuse of process as it relates to attempts by parties to relitigate issues
already adjudicated. She held that relitigation of an issue can constitute
abuse of process and stressed that the key concern motivating the doctrine of
abuse of process is preserving the integrity of the adjudicative process …
[…]
[38] Therefore, despite the
fact that Mactavish J.'s decision would not dictate the outcome of the present
application and consequently, that it is not possible to say that
Sanofi-Aventis has no chance of success, I nevertheless am compelled to hold
that the application in respect of the Novopharm NOA is an abuse of process and
therefore should be dismissed.
[72]
In C.U.P.E.,
above, Madam Justice Arbour noted at paragraph 52 that there would be instances
where relitigation could enhance rather than impeach the integrity of the
judicial system. For example:
(1) when the first proceeding is
tainted by fraud or dishonesty; (2) when fresh, new evidence, previously unavailable,
conclusively impeaches the original results; or (3) when fairness dictates that
the original result should not be binding in the new context.
[73]
Mr.
Justice Sexton was of the view that the very nature of the summary aspect of NOC
applications justifies the court’s refusal to entertain relitigation with
another party. One may proceed in patent infringement or patent invalidity
actions. He said at paragraph 49:
Sanofi-Aventis and Schering also
emphasize that proceedings under the NOC Regulations are of a
preliminary nature and are accompanied by limited procedural safeguards. While
this argument may be sufficient to establish that decisions made in the context
of the NOC Regulations should not be binding on judges adjudicating
actions for patent infringement or declarations of patent invalidity, it does
not change the fact that relitigation by a first person of an issue already
decided against it within the context of the NOC Regulations is
generally not permissible. As I have already said, the possibility of different
judges adjudicating equivalent proceedings concerning the same issue reaching
different results threatens the integrity of the adjudicative process. The
nature of the proceedings does not change this reality.
[74]
As the Novopharm
decision is of prime importance, I gave the parties an opportunity to comment
on its significance. Sanofi-Aventis and Schering submitted that:
a. Mr. Justice Sexton had before
him the Apotex and Novopharm NOAs, but Riva put neither before me.
Consequently, there is insufficient information to allow me to conclude that
the same point is being litigated.
b. The decision of Mr. Justice
Sexton is based on different facts, particularly as to the timing of the
motion;
c. Even if I come to the view
that there is an abuse of process, I have to temper this with fairness. It is
to be recalled that Riva, unlike Apotex, never focussed on the activity, or
lack of same, in the bi-cyclic rings; and
d. I nevertheless still have
discretion under Subsection 6(5) of the PM (NOC) Regulations to hear the
application.
[75]
Although
it may have been better to have Apotex’s NOA formally before me, I think this
is an unduly technical point. A comparison of Riva’s NOA against what Madam
Justice Mactavish took to be the relevant portions of Apotex’s NOA on the lack
of sound prediction point shows no material difference between them. With
respect to claim 12, both allege that apart from Ramipril, the other seven
compounds lack the requisite level of activity to inhibit ACE or the requisite
pharmacological and toxicological properties to have utility, or to be suitable
for the treatment of high blood pressure. Consequently, there is sufficient
information to allow me to conclude that the same point is being litigated.
[76]
I am not
tempted by the timing point. The main distinction between the Novopharm and the
Riva proceedings is that Madam Justice Mactavish’s decision had already been
rendered when Sanofi-Aventis instituted its proceedings against Novopharm. The
proceedings against Riva were already well advanced when that judgment came
out. As I understand it, once a specific allegation of patent invalidity has
been finally found to be justified in the NOC context, as long as the same
allegation and the same patent are in issue in another NOC proceeding, that is
the end of it. It does not matter what the experts said in their affidavits, or
what they might have admitted in cross-examination. The integrity of the
judicial process takes precedence.
[77]
Another
way of looking at it is to determine when relitigation of sound prediction on
Sanofi-Aventis’ part became an abuse of process. It was certainly entitled to
raise the point in its prohibition proceedings as they were filed well before
Madam Justice Mactavish’s decision. Indeed with the 24-month clock running,
both Sanofi-Aventis and Riva had to, from a practical point of view, file
expert evidence, and proceed to cross-examinations.
[78]
Madam
Justice Mactavish’s decision was rendered 20 September, 2005. The appeal
therefrom was dismissed 13 February, 2006. The application for leave to appeal
to the Supreme Court was dismissed 3 August, 2006.
[79]
Sanofi-Aventis’
application was issued in July 2004, and its memorandum of fact and law,
following the various affidavits and cross-examinations, was filed 16 January
2006. Riva first raised abuse of process in its memorandum of fact and law
filed as part of its record on 17 March, 2006.
[80]
Although
Novopharm raised the point by way of motion, before filing its record, Riva
certainly could not have done so before the serving of its affidavits and
cross-examination thereon. Given that the 24-month clock would have been
running, and that the court may or may not have extended the statutory
prohibition against the Minister, I do not take Riva to task for not raising
the point earlier. By the same token, I cannot take Sanofi-Aventis to task for
not abandoning the point. The significance of C.U.P.E., above, in the
NOA context was not generally appreciated before Mr. Justice Sexton’s decision,
which is itself the subject of an application for leave to appeal to the
Supreme Court.
[81]
To
conclude on this point, I do not think that timing is a factor. I must be guided
by the fact that there is now a final decision within the NOC context that
patent ‘206 lacked sound prediction, and a decision of the Federal Court of
Appeal holding that relitigation in and of itself is an abuse of process.
[82]
I do not
think it can be said that the situation is unfair, notwithstanding that the
Minister has been prohibited from issuing Pharmascience an NOA, but not prohibited
from issuing ones to Apotex and Riva (subject to Sanofi-Aventis’ right
of appeal). It is likely that new generics coming along in their wake will
simply have to allege that they will not infringe patent ‘206, because it has
already been held within the NOC context that allegations of invalidity on the
ground of lack of sound prediction were justified. As noted by Mr. Justice
Sexton, Sanofi-Aventis’ obvious remedy would be in rem patent
proceedings
[83]
As stated by
Madame Justice Arbour in C.U.P.E., above, at paragraph 51:
Rather than focus on the motive
or status of the parties, the doctrine of abuse of process concentrates on the
integrity of the adjudicative process. Three preliminary observations are
useful in that respect. First, there can be no assumption that
relitigation will yield a more accurate result than the original
proceeding. Second, if the same result is reached in the subsequent
proceeding, the relitigation will prove to have been a waste of judicial
resources as well as an unnecessary expense for the parties and possibly an
additional hardship for some witnesses. Finally, if the result in the
subsequent proceeding is different from the conclusion reached in the first on
the very same issue, the inconsistency, in and of itself, will undermine the
credibility of the entire judicial process, thereby diminishing its authority,
its credibility and its aim of finality.
[84]
Applying
those observations to the case at bar, there can be no assumption that the
decision in this case would have been more accurate. All that can be said is
that it would have been different, because the explanation of the evidence was
different. The inconsistency in the decisions would undermine the credibility
of the entire judicial process.
[85]
A word of
caution about discretion. Judicial discretion is never at large. When it comes
to res judiata, issue estoppel, collateral attack and abuse of process,
discretion is not to be exercised unless there are peculiar circumstances as
noted above. There are no such circumstances in this case. Furthermore, as will
be seen in the next section hereof, the Court of Appeal has extended the notion
of abuse of process from invalidity to non-infringement.
[86]
Consequently,
Sanofi-Aventis, supported by Schering, is barred from arguing that the
allegation that patent ‘206 is invalid for lack of sound prediction is not
justified.
ALLEGATIONS OF NON-INFRINGEMENT
[87]
When all
is said and done, this was a creative exercise in extreme speculation on the
part of Sanofi-Aventis, both in its effort to pitch the art of persuasion to
the evidentiary requirement of balance of probabilities and to convince me that
the recent decision of the Federal Court of Appeal in Abbott Laboratories v.
Canada (Minister of Health), 2007 FCA 140, [2007] F.C.J. No. 506 (QL), is distinguishable.
[88]
Sanofi-Aventis’
position is that the NOA is insufficient as regards patent ‘089, because the
facts therein alleged do not support a conclusion of non-infringement. In the
alternative, it pleads the allegation is not justified. With respect to patent
‘948, it accepts that the NOA is sufficiently detailed but submits that the
allegation is not justified.
[89]
The
starting point is that Riva is only seeking an NOC for the treatment of hypertension
(high blood pressure). If it obtains an NOC, it will restrict its drug
marketing and sales to that treatment. Indeed, the product monograph approved
by Health Canada limits promotion by the
manufacturer to its content, but this of course does not restrict the use of
Riva Ramipril by physicians, pharmacists and patients. Riva asserts it is only
interested in the old use, not the new uses protected by current patents.
[90]
Since
Riva-Ramipril will work the same way for all uses currently made of Altace, it
is therapeutically equivalent to Altace. Physicians are not typically aware of
the generic product monograph and, in any event, prescribe Ramipril or Altace
based on uses supported by medical literature. These facts are generally
accepted and identify what the parties call off-label use.
[91]
Perhaps
the most important marketplace for generic versions of prescription drugs is in
provincial formularies. The provinces, who underwrite in whole or in part the cost
of drugs prescribed to large segments of the population, attempt to keep costs
down by only indemnifying up to the cost of the least expensive equivalent,
invariably the generic version.
[92]
Thus it
came as no surprise when Mr. Akbarieh testified in cross-examination that Riva
would indeed seek provincial approval. Perhaps the only surprise was that it
intends to limit itself to the Quebec marketplace. Under the “Regulations
respecting the conditions on which manufacturers and wholesales of medications
shall be recognized,” adopted pursuant to an Act Respecting Prescription
Drug Insurance, R.S.Q c. A-29.01 s. 80 as well as the Act itself, the responsible
Quebec Minister draws up a list of medications, the cost of which is covered by
the basic plan. The list indicates generic names, brand names and
manufacturers’ names for each approved medication, the conditions on which they
may be obtained from an accredited manufacturer or wholesaler, and the manner
in which the prices are established.
[93]
Thus,
although Riva must apply to be listed, it is the Quebec Minister who
establishes interchangeability. I find no merit in Sanofi-Aventis’ suggestion
that Riva should have said in its NOA that it would request that
interchangeability be limited to hypertension.
[94]
The NOAs
were sufficiently detailed, and can hardly be said to have taken Sanofi-Aventis
by surprise. It may well be, as Sanofi-Aventis alleges, that provincial
governments, physicians, pharmacists and patients will infringe the patents. If
so, the remedy is to give them notice, and to sue for patent infringement,
notwithstanding that this might be a disastrous business plan. The remedy is
not to prohibit the Minister from allowing the generic onto the marketplace. Furthermore,
drawing on the Manitoba Court of Appeal, and as discussed in the following
paragraphs, a concession by a generic drug company does not constitute an admission
binding on physicians and pharmacists (Astrazeneca Canada Inc. v. Apotex
Inc., 2006 MBCA 21, [2006]
M.J. 38 (QL) at paragraph 55).
[95]
I find no
suspicious circumstances in this case such as were present in Procter &
Gamble Pharmaceuticals Canada, Inc. v. Canada (Minister of Health)
(2002), 20 C.P.R. (4th) 1 (F.C.A.). It can no longer be argued that the mere
presence of the generic drug on the market, coupled with the fact that it could
be used for purposes other than those for which the NOC was obtained,
constitutes infringement of a patent. In Pharmascience Inc. v.
Sanofi-Aventis Canada Inc., referred to in paragraph 8 hereof, this very
issue came up concerning Pharmascience’s use of its proposed Ramipril capsules.
Like Riva, it only sought the Minister’s approval for use in the treatment of
hypertension. Madam Justice Sharlow noted that factual statements made in the
NOA are presumed to be true in the absence of evidence to the contrary. The
evidence in that case, as in this, is that the generic manufacturer only
intended to market its Ramipril capsules for the treatment of hypertension.
[96]
Madam Justice
Sharlow, for the purposes of the appeal before her, assumed, without deciding,
that any patient who took Pharmascience’s Ramipril capsule for a treatment other
than hypertension would infringe the patent. She also assumed, without
deciding, that a prescribing physician or a dispensing pharmacist may be found
to have induced that infringement if he or she prescribes or dispenses for a
use other than in the treatment of hypertension.
[97]
The mere
placing by Riva of its version of Ramipril on the market for use in the
treatment of hypertension cannot, as Madam Justice Sharlow noted at paragraph
35, “without more”, amount to infringement by it. As for the argument that
infringement by someone else would be inevitable, basing herself on Biolyse,
above, she held that the PM (NOC) Regulations were only intended to prevent
infringement by, or infringement induced or procured by, the generic drug
producers, and that the person referred to in the Regulations as they then were
in subparagraph 5(1)(b)(iv), which states that “no claim would be infringed by
the making, constructing, using or selling by that person of the drug,”
meant the generic.
[98]
If there
was any doubt, the Regulations were amended last year to specifically provide
that the Notice of Allegation allege no infringement by the “second person”,
which is limited in context to the generic drug manufacturer. The transitional sections
SOR/2006-242 dated October 5, 2006 provide that the new subsection, which is
subsection 5(1), applies to a “second person” who files a submission prior to
coming into force of the amendments.
[99]
However, I
am satisfied that “person” in the old Regulations and the “second person” in
the new Regulations both refer to the “second person”, the person who filed an
abbreviated new drug submission comparing its drug to that for which an NOC had
already been issued.
[100]
The only
possible basis for suggesting an inducement to infringe is that there is passing
reference in the product monograph, and in some of the articles referred to
therein, concerning contraindications or drug interaction. This does not
constitute infringement. Apparently, this issue needs reassessment on a daily
basis. On April 27, again after judgment was reserved, the Court of Appeal
handed down its decision in Sanofi-Aventis Canada Inc. v. Novopharm Ltd.,
2007 FCA 167. Novapharm had appealed a Federal Court order which had dismissed
its motion to dismiss Sanofi-Aventis’ prohibition application. The basis of the
application was paragraph 6(5)(b) of the PM (NOC) Regulations which allows the
Court to dismiss an application which is “redundant, scandalous, frivolous or
vexatious or is otherwise an abuse of process.” Once again, the drug at issue
in that case was Ramipril. As in this case, Novopharm had only applied for an
NOC for its version of Ramipril to be used in the treatment of hypertension.
The basis of the prohibition proceedings was that there would be an
infringement of Sanofi-Aventis’ other “use” patents by “off label”
prescriptions.
[101] Madam Justice Sharlow said at
paragraph 11:
A generic drug manufacturer may be
implicated in the infringement by others of a claim for a new use of a medicine
if the generic drug manufacturer induces that infringement. Infringement by
inducement may be established, for example, by inferences reasonably drawn from
the contents of the product monograph for the generic drug product, or evidence
relating to the dosage form of the generic product, or its labelling or
marketing. However, an inducement to infringe generally cannot be inferred from
a mere reference to the new use in the product monograph, for example, in the
course of explaining contraindications or drug interactions, or as part of a
list of scientific references.
[102]
The
Motions Judge had dismissed Novopharm’s motion on the grounds that the evidence
was not yet complete and that Sanofi-Aventis should not be deprived of its
opportunity to complete cross-examinations on affidavits. However, Madam Justice
Sharlow went on to note that there was nothing in the product monograph or any
of the other documents in the record that was capable of establishing that
Novopharm would infringe the patents, either directly or by inducing
infringement by others.
[103]
The appeal
was allowed because:
Sanofi does not contend that there is
such evidence, but argues that something might emerge on cross-examination. In
my view, that argument should have been rejected as entirely speculative. Once
the speculative possibility of additional evidence is set aside, it is
inevitable that the prohibition application in this case would fail because
Novopharm’s non-infringement allegation is justified.
[104]
The only
difference in this case is that Riva did not make a similar motion, and that
cross-examinations were completed. Nothing in the cross-examination remotely
suggests that Riva will infringe.
EXPIRED PATENT ‘457
[105]
As stated
earlier in these reasons, although this patent was still in force when Riva
issued its Notice of Allegation, it expired in 2005 and so in accordance with subsection
7(1) of the PM (NOC) Regulations, it cannot serve as a basis for a prohibition
order against the Minister. Nevertheless, Riva submits the patent is still
relevant because Sanofi-Aventis can be liable under section 8 if its
application is withdrawn, discontinued or dismissed. Liability would be based
on any loss suffered during the period beginning on the date the Minister certifies
that the NOC would have been issued had it not been for the Regulations, and
ending on the date of the withdrawal, discontinuance, dismissal or reversal as
the case may be. Nevertheless, the Court may conclude that another starting
date is more appropriate.
[106]
As far as
I am concerned, the point has become moot, and I decline to exercise my
discretion to nevertheless hear it. Section 8 contemplates a separate action in
which the Court may make such order for relief as the circumstances require. An
action has examination of document and examination for discovery mechanisms. Applications
do not. If my decision is not binding, then it is pointless. If it is binding because
of “issue estoppel”, it would be inappropriate to bind the parties on what is a
side issue in the proceedings before me.
COSTS
[107]
Thus, Sanofi-Aventis’
two applications will be dismissed. Schering participated in one in support of
Sanofi-Aventis, but had no interest in the other. Riva’s abuse of process
motion is maintained. Costs may be spoken to. All participating parties agreed that
they should only be addressed once these reasons were issued. In the hope they may
strike an agreement, I extend to 30 days Riva’s delays to bring on a motion. Since
the Minister did not participate, he neither benefits from nor is burdened by
costs.
AFTERWARD
[108]
These
reasons were first issued to the parties on a confidential basis on 17 May
2007. The reasons for that is that a number of the documents in the record were
the subject of confidentiality orders. Consequently, it was appropriate to give
the parties an opportunity to make representations as to whether the public
version of these reasons needed to be vetted to maintain confidentiality. The
parties have informed the Registry that none of the information referred to in
the reasons need be treated as confidential. Consequently, these reasons are as
they were first issued, save that I took the opportunity to correct a slip of
the tongue in paragraph [82].
“Sean Harrington”
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