Date: 20090326
Docket: T-1617-07
Citation: 2009 FC 320
Ottawa, Ontario, March 26, 2009
PRESENT: The Honourable Mr. Justice Hughes
BETWEEN:
ELI
LILLY CANADA INC.
Applicant
and
APOTEX INC. and
THE MINISTER OF HEALTH
Respondents
and
ELI LILLY AND COMPANY
Respondent/Patentee
REASONS FOR JUDGMENT AND
JUDGMENT
[1]
This
is a proceeding brought under the provisions of the Patented Medicines
(Notice of Compliance) Regulations, SOR/93-133, as amended (NOC
Regulations). The Applicant is seeking to prohibit the Minister of Health
from issuing a Notice of Compliance to the Respondent Apotex Inc. for a generic
version of the Applicant’s raloxifene hydrochloride medicine until the expiry
of Canadian Letters Patent No. 2,158,399 (the ’399 patent).
[2]
In
a different proceeding heard several days earlier (T-1561-07) the same Applicant
was seeking to prohibit the Minister from issuing a Notice of Compliance to
Novopharm Limited in respect of its generic version of the same drug until the
expiry of the ’399 patent. I dismissed that application with reasons cited as
2009 FC 301. The only issue in that proceeding was the invalidity of the ’399
patent based on anticipation and obviousness. I found that the allegations of
the generic, Novopharm, in regard to that issue and those grounds were
justified, thus the application for prohibition was dismissed. This present
proceeding raises the same allegations together with one other allegation
respecting validity, an allegation of non-infringement and a so-called
“Gillette Defence”.
[3]
For
the reasons that follow, I find that this application is dismissed with costs
to Apotex.
THE PARTIES
[4]
The
Applicant Eli Lilly Canada Inc. (Lilly Canada) has received from the
Minister of Health (Minister) a Notice of Compliance respecting a medicine
containing raloxifene hydrochloride in 60 mg tablet form which medicine the
Applicant markets in Canada under the brand name EVISTA under Drug
Identification Number (DIN) 02239028. This medicine is used in the treatment
and prevention of osteoporosis. This party is referred to as the “first person”
under the NOC Regulations.
[5]
The
Respondent Apotex Inc. (Apotex) sent a Notice of Allegation to Lilly Canada
stating that it intends to market a generic version of the Applicant’s medicine
containing raloxifene hydrochloride and is seeking to obtain a Notice of
Compliance from the Minister to do so by filing an Abbreviated New Drug
Submission (ANDS) in which Lilly Canada’s product has been referenced. This
party is referred to as the “second person” under the NOC Regulations.
[6]
The
Respondent Minister is charged with administering the NOC Regulations
and issuing a Notice of Compliance where appropriate.
[7]
The
Respondent Eli Lilly and Company (Lilly US) is the
patentee of the ’399 patent and has been made a party to these proceedings in
accordance with section 6(4) of the NOC Regulations.
THE PATENT AT ISSUE
[8]
At
issue is Canadian Letters Patent No. 2,158,399 (the ’399 patent). The
application for that patent was filed with the Canadian Patent Office on
September 15, 1995, thus, the patent is governed by the provisions of the Patent
Act, R.S.C. 1985, c. P-4, as they stand following amendments made October
1, 1989. These provisions may be referred to as the new Patent Act.
[9]
The
application for the ’399 patent was laid open for public inspection on March 20,
1996. This becomes an important date in construing the patent. The
application for the patent claims priority from applications filed in the
United States Patent Office on September 19, 1994 and April 26, 1995. The ’399
patent will expire 20 years from the date of filing the application in Canada, that is, on
September 15, 2015. The ’399 patent was issued and granted on March 20, 2001.
That date is not particularly important in these proceedings save to indicate
that the patent has been issued and granted.
[10]
At
page 1 the patent states in the opening paragraph that it is directed to what
is described as a novel, non-solvated crystalline form of a class of chemicals
described by a written formula:
This invention is directed to
a novel pharmaceutical product. More particularly, the invention is directed
to a novel, non-solvated, crystalline form of a
2-aryl-6-hydroxy-3-[4-(2-aminoethoxy) benzoyl] benzo[b]thiophene.
[11]
In
particular the patent deals with a particular member of that class identified by
the formula set out in the second paragraph of page 1:
6-hydroxy-2-(4-hydroxyphenyl)-3-[4-(2-piperidinoethoxy)benzoyl]
benzo[b]-thiophene hydrochloride
[12]
Fortunately,
the patent at the same page, as well as the parties, have used the name raloxifene
hydrochloride or raloxifene HCl in place of the written formula. I will also do
so.
THE EVIDENCE
[13]
The
evidence in this proceeding was provided, as is usual in applications before
this Court, by way of affidavits, exhibits to affidavits, transcripts of
cross-examination and exhibits to those cross-examinations. A Confidentiality
Order was granted in this proceeding.
[14]
The
Applicant filed affidavits from the following witnesses :
·
Jennifer
L. Rotz, Humans Resources Manager for Lilly US. She testifies as to certain
persons being past and present employees of Lilly US and
assignment of patent interests to Lilly US.
·
Dr.
Joel Bernstein, professor of chemistry at Ben-Gurion University of Negev, Beer
Sheva, Israel. He gives
evidence as to crystallization, the ’399 patent and validity issues.
·
Dr.
Leonard J. Chyall, principal in the consulting division of Aptuit Inc., an
independent chemical research and analytical laboratory. He gives evidence as
to certain efforts he made to reproduce Examples 16 and 18 of the ’068 patent.
He provided a further affidavit in response to work conducted by Apotex’s
witness Mr. Buck.
·
Dr.
James Wuest, a professor of chemistry at the Université de Montréal. He gives
evidence as to the ’399 patent, Gillette Defense and validity issues.
[15]
Drs.
Bernstein, Chyall and Wuest were cross-examined. Certain portions of this
evidence were designated as Confidential pursuant to a Confidentiality Order of
this Court issued on November 6, 2007.
[16]
The
Respondent Apotex filed affidavits from the following witnesses:
·
Dr.
Paul Williard, professor of chemistry at Brown University, Rhode
Island.
He gave evidence as to the validity of the ’399 patent and Apotex’s Gillette
Defense.
·
Dr.
Allan W. Rey, Manager, Intellectual Property/Process Research and Development
of Apotex Pharmachem Inc. He testifies as to X-ray powder diffraction (XRPD)
testing and nuclear magnetic resonance (NMR) testing of samples of material
prepared by Mr. Buck.
·
Dr.
Robert A. McClelland, professor of chemistry emeritus of the University of Toronto.
He testifies as to the ’399 patent, validity issues and Apotex’s Gillette
Defence.
·
Johanne
Frosolone, a law clerk employed by Apotex’s solicitors. She exhibits an
exchange of e-mails between Applicant’s counsel and Apotex’s counsel.
·
Matthew
Buck, who was at the time he attempted to replicate some of the asserted prior
art, a chemist with a master’s degree working for Apotex Pharmachem Inc. He
provided a further affidavit in sur-reply. His evidence was the subject of a
motion to strike by the Applicant.
·
Mylene
Rosauro, a secretary in the law firm of Ivor Hughes. She provided a copy of
the Notice of Allegation and copies of documents referred to in that Notice.
[17]
Drs.
Williard, Rey and McClelland and Mr. Buck were cross-examined. Certain
portions of this evidence were designated as Confidential pursuant to the aforesaid
Confidentiality Order.
[18]
The
Minister did not file any evidence nor participate actively in this
proceeding. Lilly US did not participate actively in this proceeding. I
assume that its interests were looked after by Lilly Canada.
[19]
I
endorse the sentiments expressed by Harrington J. of this Court in Lundbeck
Canada Inc. v. Canada (Minister of Health), 2009 FC 146 at paragraph 74
where he wrote that we really do not have evidence by way of actual persons or
even “talking heads” in proceedings such as this, we simply have words on
pieces of paper. Other than in the most exceptional cases, a Court is not in a
position to come to any conclusions as to whether certain witnesses were
evasive, or acted as advocates or acted in other ways urged by counsel so as to
encourage the Court to take a dim view as to demeanour of any other party’s
witnesses. I add my voice to those crying in the wilderness for improvements
in the process.
MOTION TO STRIKE
EVIDENCE
[20]
At
the outset of the hearing of this matter the Applicant brought a motion to
exclude all of the evidence of Apotex’s witness, Matthew Buck and related
evidence of Apotex’s witnesses Williard, Rey, and McClelland. The Notice
respecting this motion was filed about ten days in advance of the hearing.
[21]
The
basis for the motion is set out in the Applicant’s Motion Record and may be
summarized with reference to paragraph 10 of the Grounds for Motion as being:
…the opinion provided by Mr.
Buck are not those of an independent expert witness but rather are influenced
by the continued relationship as an employee of Goodmans LLP (current counsel
of record for Apotex) and his previous employment relationship with Apotex ….
[22]
Buck
furnished two affidavits in this proceeding and was cross-examined. Those
affidavits are directed to experiments conducted by Buck, who states that he
has a Master of Science degree in chemistry, intended to replicate certain procedures
as set out in the prior art, Examples 16 and 18 of the ’068 patent and a “Jones
Article”. The witnesses Williard, Rey and McClelland expressed opinions as to
what they understood were the results of such testing by Buck.
[23]
The
chronology of events is important to the understanding of the motion:
·
August
and September 2005: Buck conducts the testing at issue. The procedure and
analysis are written up in his notebook which is in evidence. The testing was
conducted at the request of a lawyer, Ivor Hughes, acting for Apotex. At this
time Buck was an employee of Apotex Pharmachem Inc., a company related to the
Respondent Apotex.
·
July
20, 2007: Apotex serves its Notice of Allegation on Eli Lilly Canada Inc. No
specific mention is made of Buck’s testing however it is stated in that Notice that
Examples 16 and 18 of the ’068 patent and Jones Article contain sufficient
direction that would lead a person skilled in the art to produce the patented
Raloxifene HCl.
·
September
5, 2007: Eli Lilly Canada Inc. (Applicant) files its Notice of Application thus
commencing these proceedings.
·
February
2008: the Applicant files as part of its evidence in chief an affidavit of Dr.
Chyall stating that he tried to replicate Examples 16 and 18 of the ’068 patent
and could not get them to work.
·
May
2008: Apotex, in response, files an affidavit of Buck showing how, in 2005, he
got Examples 16 to 18 and the Jones article to work. At this point Buck was no
longer an employee of Apotex Pharmaceutics and had become employed by the law firm
of Ivor Hughes. It is to be noted that this law firm has never been a
solicitor of record in these proceedings.
·
In
or about May 2008: Apotex files affidavits of Williard, Rey and McClelland
which, among other things, comment and express opinions upon the testing done
by Buck.
·
August
22, 2008: Prothonotary Tabib makes an Order in these proceedings giving the
Applicant leave to file a reply Affidavit of Dr. Chyall. It is to be noted
that the terms of that Order made no provision that would allow the Applicant a
right to reserve upon any challenge to the Buck affidavit or related comments
in other affidavits.
·
End
of August, 2008: the Applicant files the reply affidavit of Dr. Chyall.
·
Mid-October
2008: Apotex files a Sur-Reply Affidavit of Buck correcting certain
typographical errors and a misnomer in his first affidavit. Counsel for both the
Applicant and Apotex accepted these corrections and agreed that the sur-reply evidence
was not controversial. By this time Buck had again changed jobs and was
employed by Goodmans LLP, the solicitors for Apotex in these proceedings.
·
Late
October 2008: Buck is cross-examined by Applicant’s Counsel.
·
Mid-February
2009: the Applicant serves and files its Notice of Motion in respect of this
matter.
·
March
2, 2009: the hearing of this proceeding commenced with the first matter of
business being the motion to exclude evidence.
[24]
An
examination of each of the affidavits of Buck demonstrates that in neither does
he purport to express any opinion. He simply says that in 2005 he performed
certain laboratory work, he provided his notes and analysis of the compounds
obtained as a result. Nowhere in these affidavits or in the transcript of his
cross-examination is there anything raised in evidence that would lead a
reasonable person to conclude that Buck was biased or that any improper
influence was exerted. The Applicant’s counsel simply relies on Buck’s
employment history with Apotex Pharmachem, then Ivor Hughes, then Goodmans to
make the argument that Buck’s evidence and the related evidence of others ought
to be excluded. The Applicant’s Counsel argues that to perform Examples 16 and
18 of the ’068 patent and the Jones article, Buck must have exercised some expertise
and the results are controversial since Buck seems to have gotten a result and
Chyall says that he could get no result.
[25]
The
Applicant relies on the decision of the Federal Court of Appeal in Cross-Canada
Auto Body Supply (Windsor) Limited v. Hyundai
Auto Canada, 2006 FCA 133 to say that the Court should not receive
evidence from members of the same firm as that of Counsel for a party where
that evidence is controversial. In particular Applicant’s counsel cites
paragraph 7 of the decision of the Court in that case:
7 We should say, in addition, that in our
view it is improper for a solicitor to compromise his independence by acting in
a proceeding in which a member of his firm has given affidavit evidence on a
point of substance. This general principal is well grounded in the various
codes of conduct governing the lawyers of this country, as well as logic. See Canada (Director
of Investigation and Research) v. Irving
Equipment,
[1988] 1 F.C. 27 at para. 9.
[26]
It
must be pointed out, however, that in Hyundai the Court was considering
a motion to remove Counsel and not a motion to exclude evidence.
[27]
More
to the point is my decision in AB Hassle v. Apotex Inc., 2008 FC 184
where each party put in affidavit evidence from members of their law firm in
which affidavits those members clearly stated opinions as well as providing factual
evidence. I stated at paragraphs 45 and 46:
45 I digress at this point to comment
upon the evidence led by the parties on this motion. Rule 82 precludes a
solicitor for a party from furnishing an affidavit and also arguing the matter
without leave. In Cross-Canada Auto Body Supply (Windsor)
Ltd. v. Hyundai Auto Canada, [2005]
F.C.J. No. 1543, 2005 FC 1254, aff'd [2006] F.C.J. No. 539, 2006 FCA 133, this
Court and the Federal Court of Appeal held that it was improper for a solicitor
to argue a case where another member of his firm, a paralegal, filed an
affidavit in support of the position being argued.
46 In
general, the Court does not object to affidavits from members of the firm of
solicitors arguing a motion where the affidavit is restricted to
non-controversial matters such as the furnishing of undisputed documents or
recitation of undisputed facts. However, where such affidavits go further and
include matters that are disputed or controversial or are expressions of
opinion or state of mind, the Court will be reluctant to accept or give weight
to such evidence.
[28]
In
the present proceeding, Apotex’s counsel argues that Buck did not express any
opinion, he simply ran experiments and reported results. Others such as
Williard, Rey and McClelland expressed opinions as to the experiments and
results. Apotex’s counsel says that the circumstance is similar to the
employee who read electrical meters and performed simple calculations in order
to arrive at evidence of electrical power consumption as permitted in evidence
in AlliedSignal Inc. v. DuPont Canada Inc. (1998), 78 C.P.R. (3d) 129
(FC) per Heald D.J. at paragraph 130:
130 Indeed, my overall view of Mr.
Kubitz' testimony is that he was relating his experience as plant engineer at Pottsville to
present his measurements in a useful way to the Court. The fact that Mr. Kubitz
was not called as an expert prevents him from expressing an opinion on his
measurements or drawing inferences from them, but it does not prevent him from
making the type of calculations that he made. His calculations merely allowed
him to express his measurements in kilowatts, a conversion which, for an
electrical engineer, is presumably no more difficult than converting inches to
centimetres. The fact that he relies on his expertise as an electrical engineer
does not mean that he is drawing an inference or expressing an opinion.
[29]
I
drew counsels’ attention to Kirin-Angen Inc. v. Hoffmann-LaRoche Ltd.
(1999), 87 C.P.R. (3d) 1, a decision of Reed J. of the Federal Court where
tests intended to replicate certain scientific tests were run by employees of
the competing litigants. That testing was admitted into evidence and
considered on its merits, for instance at paragraph 63 of her Reasons.
[30]
It
is important to keep focused on what is at issue here. The issue is whether
the Buck evidence and related commentary by others should be struck from the
Record. The reason for arguing that it should be struck is that, because of Buck’s
association with an Apotex related company and later a law firm which does work
for Apotex and lastly with a law firm which is Apotex’s solicitors of record,
Buck’s evidence thus is likely to be prejudiced or biased. Even more so, says
Applicant’s counsel, where the evidence is expert evidence.
[31]
Whether
or not the Buck evidence is expert evidence is subject to debate. Certainly no
average person could do what he did; it required certain skill and experience.
In that regard, I take note of what is said in The New Wigmore-A Treatise on
Evidence, Kaye et al., Aspen Publishers Inc. 2004 at paragraph 7.2:
Tests derived from the
physical and biological sciences and requiring sophisticated laboratory
instruments are uniformly treated as meriting special scrutiny. Radar devices
to measure speed or distance involve sophisticated electronics and fundamental
physics. Spectroscopy, gas chromatography, nuclear magnetic resonance, and
other techniques, in analytical chemistry are impressive, and the machineries
of various forms of imaging in clinical medicine are even more dramatic. It
takes training to understand the underlying theories and technologies.
Physical or chemical tests involving such scientific instrumentation are
paradigms for special scrutiny, for they satisfy all three conditions
identified above.
[32]
The
tests run by Buck are controversial only in that he seemed to get certain prior
art examples to work whereas another person, Dr. Chyall, could not.
[33]
Buck
expresses no opinions, in particular, no opinion as to why his worked and
Chyall’s did not.
[34]
I
dismissed the motion to exclude the Buck evidence and related commentary. I
have done so for several reasons:
a. At the time
that the Applicant sought to put in reply evidence of Chyall and obtained an
Order to do so, it did not raise any objection as to the Buck and related
evidence nor did it seek to reserve its right to do so at the hearing. Instead
the Applicant put in its rebuttal evidence and cross-examined the witness.
This, in my view, constitutes a waiver of any claim to a right to object later.
b. The evidence
is in the record, the Applicant has responded to it. Matters arising from the
evidence have been fully argued. Nobody is taken by surprise.
c. The Buck
evidence, while perhaps it could be cast as expert evidence, is more properly
considered to be evidence from a skilled person, rather than expert person.
The controversy, if any, arises from the interpretation by others as to his
results, not as to the results themselves.
d. Buck’s
connection at the time he did the tests in 2005 was with a company related to
Apotex, not to its solicitors. His later connection to Apotex’s solicitors is
due simply to timing. There is nothing to suggest that any of these
connections caused Buck to be biased or influence the results of his testing
conducted two years earlier.
e. The Applicant
brought its motion very late, after all the Records were filed, written
argument submitted and the matter was to be heard in a few days. The parties
and this Court were committed to a hearing which, under the NOC Regulations
must be disposed of within 24 months from the institution of the proceedings.
The motion appears to be more of an afterthought.
[35]
I
have determined that the evidence shall remain in the Record subject to
scrutiny as to weight.
ISSUES
[36]
At
the outset of the hearing Counsel advised that while the issues of validity and
infringement of the ’399 patent remain, the grounds to be argued in respect of
those issues had been reduced to five:
·
In
respect of validity
o anticipation
o obviousness
o breadth of
the claims.
·
As
a mixed question of validity and infringement a “Gillette defence” was raised
·
Non-infringement
BURDEN OF PROOF
[37]
The
issue as to who bears the burden of proof in NOC proceedings, as to validity of
a patent or infringement of a patent is an issue that I had thought had been
put to rest. Nonetheless the parties in such proceedings continue to argue the
point. It seems that my recent decision in Brystol-Myers Squibb Canada Co.
v. Apotex Inc., 2009 FC 137 has given fresh ammunition to those continually
wishing to stir the pot in this regard. Let me state emphatically that I did
not intend in Brystol-Myers to say or apply any burden different than I
had stated in previous decisions.
[38]
To
be perfectly clear, when it comes to the burden as to invalidity I canvassed
the law, in particular recent Federal Court of Appeal decisions, in Pfizer
Canada Inc. v. Canada (Minister of Health), (2008), 69 C.P.R. (4th)
191, 2008 FC 11 and concluded at paragraph 32:
32 I
do not view the reasoning of the two panels of the Federal Court of Appeal to
be in substantial disagreement. Justice Mosley of this Court reconciled these
decisions in his Reasons in Pfizer Canada Inc. v. Apotex Inc., [2007] F.C.J. No.
1271, 2007 FC 971 at paragraphs 44 to 51. What is required, when issues of
validity of a patent are raised:
1.
The second person, in its Notice of Allegation may raise one or more grounds
for alleging invalidity;
2.
The first person may in its Notice of Application filed with the Court join
issue on any one or more of those grounds;
3.
The second person may lead evidence in the Court proceeding to support the
grounds upon which issue has been joined;
4.
The first person may, at its peril, rely simply upon the presumption of
validity afforded by the Patent Act or, more prudently, adduce its own evidence
as to the grounds of invalidity put in issue.
5.
The Court will weigh the evidence; if the first person relies only on the
presumption, the Court will nonetheless weigh the strength of the evidence led
by the second person. If that evidence is weak or irrelevant the presumption
will prevail. If both parties lead evidence, the Court will weigh all the
evidence and determine the matter on the usual civil balance.
6.
If the evidence weighed in step 5 is evenly balanced (a rare event), the
Applicant (first person) will have failed to prove that the allegation of
invalidity is not justified and will not be entitled to the Order of
prohibition that it seeks.
[39]
I
stated the matter more succinctly in Pfizer Canada Inc. v. Canada (Minister of
Health),
2008 FC 500 at paragraph 12:
12 Here the only issue is
validity. Pharmascience has raised three arguments in that respect. Each of
Pfizer and Pharmascience have led evidence and made submissions as to those
matters. At the end of the day, I must decide the matter on the balance of
probabilities on the evidence that I have and the law as it presently stands.
If, on the evidence, I find that the matter is evenly balanced, I must conclude
that Pfizer has not demonstrated that Pharmascience's allegation is not
justified.
[40]
The
above cases state correctly in my view, the law as to the burden in NOC
proceedings as to invalidity.
[41]
Turning
to infringement the law is well settled that where a generic has alleged
non-infringement, the statements that it makes in that regard in its Notice of
Allegation are presumed to be true. The Applicant (first party) bears the
burden of proof, on the balance of probabilities, to satisfy the Court that the
allegations of non-infringement are not justified; merely to raise the
possibility of infringement is insufficient. The Federal Court of Appeal made
these points quite clearly in its decision in Novopharm Limited v. Pfizer
Canada Inc. (2005), 42 C.P.R. (4th) 97, 2005 FCA 270 at
paragraphs 19, 20 and 24:
19 In Pharmacia Inc. v. Canada (Minister
of National Health and Welfare) (1995), 64 C.P.R. (3d) 450
(F.C.A.), Hugessen J.A. addressed the evidentiary burden placed on a generic
under the Regulations. He adopted the reasons of the trial judge who described
this burden as follows:
... the
grounds that the patentee has for challenging the generic's notice of
allegation should be advanced in the originating notice of motion filed
pursuant to s. 6(1) of the Regulations. ... The generic may then be informed as
to what vexes the patentee and why a prohibition order barring entry should be
issued. Initially, i.e., before the Minister, the generic has raised the issue
of non-infringement. At this stage, before the court, the generic now has the
opportunity to file evidence supporting its detailed statement. In essence,
this is the evidential burden on a respondent.
(see
Pharmacia Inc. v. Canada (Minister of National Health
and Welfare) (1995), 60 C.P.R. (3d) 328 at 339-40
(F.C.T.D.), per Wetston J.)
20 In my view, this statement
remains good law. Where, as here, the NOA is found to be adequate, the legal
burden remains squarely on Pfizer to prove, on a balance of probabilities, that
the allegations in the NOA are unjustified. Novopharm has no evidential burden
to support the allegations in its NOA and detailed statement (see AB Hassle 2
at paragraph 35). Therefore, Novopharm need only file evidence supporting its
detailed statement to counter evidence, if any, submitted by Pfizer in the
course of the prohibition proceedings.
…
24 For whatever reason,
Pfizer relies solely on Dr. Munson's speculations in this proceeding. The law
is well settled that in order to satisfy the legal burden placed on it under
section 6 proceedings, it is insufficient for Pfizer to merely raise the
possibility of infringement (see Glaxo Group Ltd. v. Canada (Minister of
National Health and Welfare) (1998), 80 C.P.R. (3d) 424 (F.C.T.D.)
at paragraph 9). In relying solely on Dr. Munson's evidence, Pfizer has failed
to satisfy its legal burden of proving that Novopharm's NOA is not justified.
EFFECT OF MY EARLIER
DECISION 2009 FC 235
[42]
As
indicated in paragraph 2 of these Reasons, about two weeks before I heard the
present application I heard an application made by the same Applicant
respecting the same ’399 patent but a different generic, Novopharm. I will
refer to this as the Novopharm application. Similar allegations as to
invalidity, namely anticipation and obviousness involving to a large degree the
same prior art, were raised. Here another allegation as to invalidity, breadth
of claims, as well as an allegation of non-infringement and the so-called
Gillette Defence have been raised.
[43]
Both
applications were heard and taken under reserve. I issued my decision,
dismissing the Novopharm application but not until after I heard the present
application. Thus both were under reserve at the same time. I have
endeavoured to decide the Novopharm application without directing my mind to
the present application so that I would not be influenced in one by the other.
[44]
I
am mindful of the instruction given by the Federal Court of Appeal in Sanofi-Aventis
Canada Inc. v. Novpharm Limited, April 23, 2007, 2007 FCA 163 particularly
at paragraph 50, that multiple NOC proceedings even involving different parties
should be avoided where the same patent is involved unless there is different
argument or better evidence. This particular proceeding is peculiar in that
the Novopharm application, heard earlier, was pending at the same time. I
issued the decision in that application before issuing the decision in this
present application so that the element of abuse addressed by the Federal Court
of Appeal in their decision cannot be said to be present here.
[45]
What
can be said to be present here, however is that comity must be addressed.
Justice Barnes of this Court reviewed the matter of comity in Pfizer Canada
Inc. v. Canada (Minister of Health), [2008] 1
F.C.R. 672 at paragraphs 27 to 38. He was affirmed by the Federal Court
Appeal, 2007 FCA 261, 60 C.P.R. (4th) 165. He was dealing
particularly with the matter of construction of the claims of the same patent
that had been previously considered and construed in an earlier application.
[46]
First,
as to construction of the claim of the ’399 patent I find nothing in the Record
in the present case that would require that I construe the claims any differently
than I did in the previous decision. I summarized that construction:
·
Claim
1:
a form of raloxifene hydrochloride having the following characteristics:
- it is crystalline
- it is non-solvated
- it exhibits the particular x-ray diffraction pattern as
set out in Table 1
It
need not be pure.
·
Claim
2:
The form of raloxifene hydrochloride of claim 1 that is at least
95% pure.
·
Claim
3:
The form of raloxifene hydrochloride of claims 1 or 2 which contains less than
5% by weight of chlorobenzene.
·
Claim
4:
The form of raloxifene hydrochloride of claims 1, 2 or 3 which contains less
than 5% by weight of aluminium salts or organoaluminium impurities.
·
Claim
5:
The form of raloxifene hydrochloride of claims 1, 2, 3 or 4 which is
substantially odor free in that it contain less than 3% by weight or mercaptan
or sulphide impurities.
·
Claim
6:
A pharmaceutical formulation containing the form of raloxifene hydrochloride of
any of claim 1 through 5.
·
Claim
7:
The form of raloxifene hydrochloride of any of claims 1 through 5 used as a
pharmaceutical composition.
[47]
The
issues of anticipation and obviousness raised in the earlier proceeding were
based, as to anticipation on the ’068 patent and as to obviousness on the ’068
patent and the Jones Article. The “person skilled in the art’ is the same. Here
I find that Apotex has adequately referred to the Jones Article in its Notice
of Allegation, unlike Novopharm in the earlier proceeding, thus Apotex can rely
not only on the ’068 patent but also the Jones Article, for anticipation. It
doesn’t make much difference; the disclosures in each are essentially the same
except that the Jones Article provides some elemental analysis.
[48]
The
Applicant in the present application relies on the same expert Dr. Bernstein,
who has expressed in the Record in this case the same lack of expertise when it
comes to organic synthesis (question 14 and 245 to 248 on cross-examination).
In the present case the Applicant has also introduced the evidence of Dr.Wuest
who does have some experience in that area. The Applicant also introduced,
this time in reply, the evidence of the experiments conducted by Dr. Chyall.
[49]
Apotex
in the present proceeding did not use any of the same witnesses that Novopharm
did in the earlier proceedings. Apotex introduced testing by Mr. Buck similar
to that conducted by Dr. Ferrari in the earlier proceedings. Mr. Buck’s
material resulting from his testing was subjected to XRPD by Dr.Rey with
results similar to that obtained by Dr. Stradi in the Novopharm proceeding.
Expert evidence from Dr. Williard and Dr. McClelland was introduced by Apotex
which evidence is similar to that of Dr. Tidwell in the Novopharm proceeding.
[50]
Having
carefully reviewed all of this evidence submitted on behalf of each of these
parties, I find no reason to arrive at a result any different from that which I
came to in the Novopharm proceeding. The allegations as to invalidity on the
basis of anticipation, here not only the ’068 patent but also the Jones
Article, and obviousness is justified. There are no differences in the
evidence, or in argument made by counsel sufficient to persuade me to come to a
different conclusion here than that which I concluded earlier.
[51]
I
will, however, provide in these Reasons my detailed consideration of the
matters not raised in Novopharm which are invalidity based on overbreadth,
non-infringement and Gillette Defence.
CLAIMS BROADER
[52]
Apotex
argues that the claims of the ’399 patent are broader in scope than the
invention as disclosed in the patent, thus the claims are invalid. In this
regard it relies on the law as stated by Harrington J. in Biovail
Pharmaceuticals Inc. v. Canada (Minister of National
Health and Welfare) (2005), 37 C.P.R. (4th) 487 at
paragraph 15 (8):
8. To
overclaim is to lose everything. If the inventor underclaims, the court will
not broaden the monopoly in the interests of the "spirit" thereof.
This often, as in this case, results in layers of claims, each limitation
serving as a potential safety net so that if the broadest claims fall, the
monopoly may be saved in part by the more modest claims.
[53]
There
is ample other authority as well to support the proposition that, to be valid,
a claim must not exceed the invention disclosed.
[54]
The
argument that Apotex makes in this regard is essentially a semantic one. It
points to page 1 of the disclosure of the ’399 patent where a statement is made
that, in accordance with the invention, a crystalline form of raloxifene can be
made “free of” for example, chlorobenzene and aluminum contaminants:
In accordance with the present
invention, the Applicants have now discovered that a novel, non-solvated
crystalline form of raloxifene can be produced, free of, for example,
chlorobenzene and aluminum contaminants by the use of a hithereto unknown
synthetic process.
and to page 7 of the
disclosure where it says at lines 14 and 15:
The new process eliminates the
use of aluminum and the use of odorous mercaptans and sulfides
[55]
Going
to the claims, Apotex argues that no claim is directed to a product that is
free from chlorobenzene and aluminum or mercaptans or sulfides. Claim 1 admits
of product that is impure, claim 2 admits of up to 5% by weight of impurity,
claim 3 claims only that the product be “substantially free” of chlorobenzene,
claim 4 that the product be “substantially free” of aluminum salts or
organoaluminum impurities and claim 5 that the product be “substantially” odor
free.
[56]
While
at pages 1 and 7 of the patent it is indicated that the product of the
invention is “free” of unwanted impurities, at pages 3 and 4 the patent
describes a product that is “substantially free” of those impurities and sets
limits for the impurities. At page 4 the patent describes the product as “more
pure” and free of aluminum impurities and odorous solvents:
This non-solvated crystalline
material is more pure than the material produced by the processes described in
the literature. The present material is free of aluminum impurities, as well
as, chlorinated aliphatic hydrocarbon solvents and aromatic solvents. This
non-solvated crystalline form is particularly preferred for use in the
manufacture of pharmaceutical compositions.
[57]
Giving
a fair reading to the description, the promise of the invention is that, by
following the process as described, a raloxifene hydrochloride product is
produced that is “more pure” than the previous products and is free of aluminum
related and odor causing impurities.
[58]
No
claim is restricted to a product that is free from aluminum related or odor
causing impurities. Indeed, in considering anticipation, I have found that the
product as claimed is not different from that disclosed and enabled by the ’068
patent. Had the claims been differently drafted perhaps the matter of
anticipation may have turned out differently. As it is, if there is invention
in getting rid of aluminum and other impurities, that invention is not so
claimed.
[59]
The
allegation that the claims are broader than the invention is justified.
INFRINGEMENT AND
GILLETTE DEFENCE
[60]
Apotex
alleges that its product will be made essentially in the same manner as
described in Examples 16 and 18 of the ’068 patent and in the Jones Article.
No samples of its product have been produced nor has any analysis of its product
been put into evidence. Apotex says it does not have to produce samples since
none were submitted to the Minister. Apotex says the onus in proving
infringement lies with the Applicant.
[61]
The
Applicant in its first Memorandum relies on one point only. It is set out in
paragraph 84 as follows:
84. Apotex’s process for
producing raloxifene hydrochloride includes a recrystallization step which is
different than the ’399 Patent. When dealing with the polymorphic systems any
changes to the purification step will end up with a different polymorph. Dr.
Williard confirmed on cross-examination that changes in the purification can
lead to a different polymorphic material. The differences in Apotex
purification step may lead to a different polymorph than that which is produced
in the ’399 Patent.
[62]
I
have already found as set out in some detail in my Reasons in the Novopharm
application, 2008 FC 301, that while the ’068 patent does not describe by way
of solvation or XRPD the crystalline form of raloxifene hydrochloride produced,
on a civil burden of proof, I am satisfied that it is a non-solvated form
having the XRPD as claimed in the ’399 patent.
[63]
In
order to be consistent with its argument as to validity the Applicant here
argues in paragraph 84 aforesaid, that “any changes” to the process “may lead”
to a different form. On the other hand, Apotex’s expert Dr. McClelland’s
evidence as set out in paragraph 112 of his affidavit is that the Apotex
process “…as a whole follows the ’068 Patent” and that the variations “…are
no more than simple modifications of the procedure for purifying
raloxifene hydrochloride set out in Example 18 of the ’068 patent”. At
paragraph 111 of his Affidavit Dr. McClelland states that such modifications “…would
not impact the final material made.”
[64]
Taking
this evidence into account I find, on the civil burden of proof, that the
Apotex product to be produced in accordance with the process would not be
different from that produced by the ’068 patent process and would fall within
the scope of the claims of the ’399 patent. To that extent, it would
infringe. However since I have found that the product of the ’068 patent
anticipates the product as claimed in the ’399 patent, the claims are not
valid. Therefore, as to Gillette Defence would have it, no valid claim has
been infringed. Apotex’s allegations as to Gillette Defence are justified.
The simple allegation as to non-infringement is not justified.
CONCLUSION AND COSTS
[65]
In
conclusion, I have found Apotex’s allegations as to invalidity of the ’399
patent on the basis of anticipation, obviousness and claims broader to be
justified. Apotex’s allegation as to Gillette Defence is justified. I have
found Apotex’s allegation as to non-infringement not to be justified. As a
result, I would dismiss this Application.
[66]
Apotex
is entitled to costs to be recovered from the Applicant. No costs will be
awarded to or to be paid by either the Minister or Lilly US.
[67]
Apotex
costs are to be assessed in accordance with the middle of Column IV. Two counsel,
a senior and a junior, are allowed for at the hearing and, if in attendance, in
conducting cross-examination. One counsel, a senior, is allowed in defending a
cross-examination. No costs or disbursements are allowable for any other
lawyers, in house or out house counsel, paralegals, students, clerical persons
or any other persons other than the expert witnesses that I shall name whose
evidence was made of record.
[68]
The
fees and disbursements actually paid by Apotex or its solicitors to Dr.
McClelland and Dr. Williard are allowed provided that they are not
disproportionately larger than those charged by the Applicant’s experts. No
fees or disbursements allowed in respect of any other witness.
[69]
As
in some other proceedings of this kind, Apotex raised an allegation in its
Notice of Allegation as to section 53 of the Patent Act, an allegation
that is close to an allegation of fraud. This allegation remained in play at
least until it did not appear in Apotex’s Memorandum of Argument. At the
hearing Apotex’s counsel formally acknowledged that it did not rely on this
allegation. Apotex’s counsel also assured the Court that the format of its
more recent Notices of Allegation was changed to eliminate section 53
allegations. Nonetheless, Apotex’s counsel did not at any early stage in these
proceeding notify the Applicant that it would not rely on section 53, a simple
enough matter that could have been done by a letter. Therefore I will again
direct that the fees and disbursements recoverable by Apotex shall be reduced
by twenty-five percent having regard to the section 53 allegation.
JUDGMENT
FOR THE REASONS
PROVIDED:
THIS COURT ADJUDGES that:
1. The
application is dismissed;
2. Apotex is
entitled to recover its costs from the Applicant in accordance with the Reasons.
"Roger
T. Hughes"
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