Date: 20080425
Docket: T-756-06
Citation: 2008 FC 538
Montreal, Quebec, April 25, 2008
PRESENT: The Honourable Mr. Justice Hughes
BETWEEN:
SHIRE BIOCHEM INC., and
CEPHALON INC.
Applicants
and
THE MINISTER OF HEALTH and
APOTEX INC.
Respondents
REASONS FOR JUDGMENT AND JUDGMENT
[1]
This
is an application brought under the provisions of the Patented Medicines
(Notice of Compliance) Regulations, SOR/93-133, as amended (NOC
Regulations) to prohibit the Minister of Health from issuing a Notice of
Compliance to the Respondent Apotex Inc. in respect of Apotex’s application to
market in Canada 100 mg tablets of a drug containing modafinil as the active
medicinal ingredient until the expiry of Canadian Patent No. 2,201,967 (the
’967 patent). For the reasons that follow I find that the application is
dismissed with costs to the Respondent Apotex.
[2]
General Background
[3]
The
Applicant Cephalon Inc. is the owner of the ’967 patent which was issued and
granted to it on December 10, 2002. The application for that patent was filed
in Canada under the
provisions of the Patent Co-operation Treaty (PCT) on April 4, 1997. The
original PCT application was filed in the United States Patent Office on
October 4, 1995 and claimed priority from two United States Patent applications
filed on October 6, 1994. The Canadian application was published on April 18,
1996. Having been filed after October 1989, the “new” provisions of the Patent
Act, R.S.C. 1985, c. P-4 applicable to applications filed after that date
and patents maturing from those applications are applicable to the ’967 patent.
[4]
The
’967 patent contains 28 claims. Claims 1 to 9 are in general directed to a
pharmaceutical composition containing modafinil as the active ingredient.
Claims 10 to 28 are in general directed to the use of that composition in
altering the somnolent state of a mammal.
[5]
The
Applicant Shire Biochem Inc., as a licencee of the Applicant Cephalon, markets
a drug in Canada under the
name ALERTEC for the treatment of sleep-related conditions including narcolepsy.
This product is said to embody the subject matter of one or more claims of the
’967 patent.
[6]
Apotex
wishes to market a generic version of this drug in Canada and, in accordance
with the NOC Regulations, served on Shire a Notice of Allegation by letter
dated March 15, 2006 in which Apotex alleges that the ’967 patent is invalid
on a number of grounds. Apotex does not raise any issue as to
non-infringement.
[7]
The
Applicants filed a Notice of Application for prohibition on May 3, 2006. The
statutory stay for disposition of this matter was extended by Order of the Court
until July 11, 2008. The Applicants challenge the validity of the Notice of
Allegation, alleging that it fails to comply with the NOC Regulations and they challenge
the grounds for invalidity of the ’967 patent raised by Apotex in the Notice of
Allegation.
[8]
The
Applicants further allege that the grounds for invalidity raised by Apotex are
“bewildering” in number and that Apotex has failed to “put into play” several
of those purported grounds. I will deal with these matters when considering the
individual allegations.
GROUNDS FOR INVALIDITY
OF THE PATENT
[9]
Apotex
challenged the validity of the ’967 patent on several grounds. At the hearing
Apotex limited the grounds upon which it challenged the validity of the 967
patent to the following :
·
Lack
of invention
·
Anticipation
·
Obviousness
·
Mere
discovery
·
Lack
of utility
·
Sufficiency
of disclosure
·
Claims
overbroad
[10]
Apotex
dropped several of the challenges to validity made in its Notice of Allegation
namely:
·
Subsection
27(2) of the Patent Act and paragraph 81(c) of the Patent Rules
·
Section
53 of the Patent Act
·
Double
patenting
·
Improper
selection patent
WITNESSES
[11]
The
Applicants filed the affidavit evidence of nine witnesses, six of whom were offered
as experts. The witnesses offered as experts were:
·
Dr.
Diane Boivin – M.D. and Ph.D. in psychiatry, worked with modafinil at the time
the ‘967 patent application was filed as a medical doctor and clinician;
·
Dr.
Joseph Baranski – Ph.D. in psychology who has studied modafinil since the early
1990s;
·
Dr.
Louis Cartilier – Ph.D. in pharmaceutical sciences, specialises in areas
including formulations;
·
Dr.
Eugene Cooper – Ph.D. in physical and theoretical chemistry, specialises in areas
including formulation and particle size;
·
Dr.
James Polli – Ph.D. in pharmaceutics, specialises in areas including
pharmacology and drug delivery;
·
Dr.
David Bugay – Ph.D. in physical chemistry, specializes in areas including physical
and chemical analysis of pharmaceutical compounds, including particle size.
[12]
Recent
jurisprudence of this Court confirms that a party should not seek to adduce the
evidence of more than five expert witnesses in a proceeding without obtaining
leave of the Court. No such leave was sought or obtained here. Apotex raised
no objection and this evidence was tendered before the recent decisions of this
Court in this respect. I will accept the evidence of all these witnesses as
evidence in these proceedings reserving if necessary, as to costs.
[13]
The
Applicants also tendered the affidavit evidence of the following three persons as
fact witnesses:
·
Dr.
Peter Grebow – Ph.D. in chemistry; one of the named inventors of the ’967
Patent;
·
Mr.
Antonio Aveledo – Intellectual Property Advisor at Shire;
·
Ms.
Caroline Deschênes – law student with Ogilvy Renault LLP, the Applicants’
solicitors.
[14]
Drs.
Bugay and Grebow filed reply affidavits in evidence as well as evidence in
chief. All expert and fact witnesses of the Applicants were cross-examined
except Deschênes.
[15]
Apotex
filed the affidavit evidence of five witnesses, four were tendered as experts
and one as a fact witness.
[16]
Tendered
as experts were:
·
Dr.
David Feifel – M.D. and Ph.D. in neurobiology, specialises in areas including the
development of pharmaceuticals to treat psychiatric conditions;
·
Dr.
Sanford Bolton – Ph.D. in
pharmacy, specialises in areas including statistics respecting pharmaceuticals;
·
Dr.
Samuel Yalkowsky – Ph.D. in pharmaceutical chemistry, specialises in areas
including drug formulation;
·
Dr.
Robert Langer – Sc.D. in chemical engineering, specializes in areas including pharmaceutical
chemistry and formulation development.
[17]
All
of the above were cross-examined.
[18]
In
addition, Apotex filed the affidavit evidence of Ines Ferreira, a law clerk as
a fact witness. She was not cross-examined.
[19]
The
Respondent Minister of Health did not submit evidence nor participate actively
in this proceeding.
[20]
At
the end of the hearing I invited Counsel for the parties to make submissions as
to what part of the Record that had been filed as confidential should remain so.
The Court should resist any unnecessary or overbroad claim for confidentiality
since hearings are by their nature public and the jurisprudence in this area is
developing such that an examination of evidence and argument in one case may be
relevant to another. Upon receipt of those submissions I will assess which
aspects of the Record should remain confidential.
CONSTRUCTION OF THE ‘967
PATENT
[21]
As
we have been instructed by the Supreme Court of Canada in Whirlpool Corp. v.
Camco Inc., 2000 SCC 67, [2000] 2 S.C.R. 1067, and often repeated in
proceedings such as this, the Court must first construe the patent claims at
issue before considering issues such as validity and infringement. As
previously noted, the ‘967 patent having been applied for in Canada after
October 1989 is to be governed by the “new” provisions of the Patent Act
and thus is to be construed as of its date of publication, April 18, 1996.
[22]
The
Court, however is not to construe a claim without knowing where the disputes
between the parties lie. To quote Justice Floyd of the England and Wales High
Court (Patent Court) in Qualcomm Incorporated v Nokia Corporation [2008]
EWHC 329 (Pat) at paragraphs 7 to 11, who in turn quoted the late Justice
Pumfrey (as he then was) in Nokia v Interdigital Technology Corporation
[2007] EWHC 3077 (Pat), “it is essential to see where the shoe pinches so that
one can concentrate on the important points.” Justice Floyd also quoted Jacob
L-J. and further stated that, just as is the case in our Courts, construction
is for the Court not expert witnesses save the well known exception as to
technical terms with a special meaning. He raises at paragraph 11 some of the
same concerns that our Court has encountered, particularly in NOC proceedings,
where affidavit evidence is given, that experts will endeavour to put their own
construction on the claims (possibly assisted by lawyers):
7. It is often said that a patent
specification should be construed without reference to the infringement. Yet
one cannot sensibly identify the point of construction without understanding
what it is about the alleged infringement which is said to take it outside the
claims. Pumfrey LJ (sitting at first instance) identified the necessary
process in Nokia v Interdigital Technology Corporation [2007] EWHC 3077 (Pat)
(unreported 21st December 2007), when he said (in another case about mobile
telephone standards):
“Although one construes a
claim ‘as if the defendant had never been born’, in any complex case it is
essential to see where the shoe pinches so that one can concentrate on the
important points. It is important nevertheless that the opportunity thus
presented to construe the document with one eye on the infringement must be
rejected, as far as possible. So when the claim calls for A, and the standard
requires B, the right question is not whether A means B, or covers B, or might
with hindsight be said to be another example of the genus of which B is also a
member, but whether in the context of the specification the skilled man would
appreciate that A in the claim encompassed B.”
8. Jacob LJ was not saying anything
different in Technip France SA’s Patent (2004) RPC 46,
“Although it has often been
said that the question of construction does not depend on the alleged
infringement (“as if we had to construe it before the Defendant was born” per
Lord Esher MR in Nobel v Anderson (1894) 11 RPC 519 at 523), questions of construction seldom
arise in the abstract. That is why in most sensible discussions of the meaning
of language run on the general lines ‘does it mean this, or that, or the
other?’ rather than the open-ended ‘what does it mean’?”
9. It is for the court and not the
witnesses to come to conclusions about what the claim means. Subject to the
well known exception about technical terms with a special meaning, the
construction of a patent is a question of law. So an expert report which seeks
to parse the language of the claim, and opine that a particular ordinary
English word can only in his opinion have a particular meaning is not
admissible, or helpful. Both sides in the present case are guilty of adducing
evidence of this kind.
10. What is both admissible and helpful
expert evidence is something rather different: evidence about the technical
inter-relationship between rival claim meanings and the teaching of the
specification. The expert is well able to assist the Court about the impact of
different assumptions about the correct legal construction of the claim. It
may be that it is only on one construction of the claim that general technical
statements made in the body of the patent about what the invention achieves
will hold good. It is perfectly legitimate for an expert to point that out,
and to give a technical explanation of why, if the rival construction is
adopted, the claim would extend to embodiments which would not achieve the
patent’s technical objective.
11. None of the above requires the
expert to go through the claim and give his definition (wide or narrow) of
every word or phrase in it. The written evidence in the present case suffered
from this excess. Some of the cross examination did as well. It sometimes takes
longer to intervene and stop it than it does to let it happen. It should not
start.
[23]
A
patent is to be construed by the Court in light of the description in the
specification, assisted, where necessary, by expert evidence as to the meaning
of technical terms if they cannot be understood by reading the specification.
This is not intended to open the door for experts to rush in through the portal
of “explanation” to construe the claim themselves. The claims are to be read
through the eyes of a person skilled in the art as of the relevant date which
here is the date of publication, April 18, 1996. The fixing of such date is
often not of any particular concern where the specification is clear and can be
understood. It is only when some particular piece of “common knowledge” has or
has not come into the public domain, such that it would be accepted as part of
the knowledge and understanding of the notional person skilled in the art, that
a meaningful difference in interpretation of the claims might occur.
[24]
In
this instance, for the purpose of interpreting the claims of the ‘967 patent,
there is no significant event put in evidence that occurred after April 18,
1996, that would be relevant in considering claim interpretation.
[25]
The
patent begins by acknowledging that certain things are already known and
constitute, in patent language, prior art. Such an acknowledgment by the
patentee is considered a binding admission as to prior art (see Eli Lilly
Canada Inc. v. Novopharm Ltd., 2007 FC 596 at paragraph 142 and Pfizer
Canada Inc. v. Novopharm Ltd., 2005 FC 1299 at paragraph 78).
[26]
The
description of the ‘967 patent begins at page 1 by letting the reader know that
the patent relates to a chemical known as modafinil which has previously been
successfully tested in humans to treat hypersomnia and narcolepsy. Narcolepsy
is described at pages 1 and 2 to be a sleep disorder. To quote in part:
This invention relates to the acetamide
derivative modafinil.
…
Modafinil has been successfully tested in
humans for treatment of idiopathic hypersomnia and narcolepsy.
…
Narcolepsy is a chronic disorder
characterized by intermittent sleep attacks, persistent, excessive daytime
sleepiness and abnormal rapid eye movement (“REM”) sleep manifestations, such
as sleep-onset REM periods, cataplexy, sleep paralysis and hypnagogic
hallucinations, or both.
[27]
Thus
the reader is told by way of background that modafinil is a known compound with
a known use in treating sleep disorders.
[28]
At
page 3, the alleged invention is summarized. In particular, it is said that the
size of the modafinil particles used in preparing a pharmaceutical composition
is important to the potency and safety of the drug. It says:
Our invention discloses a pharmaceutical
composition comprising modafinil in the form of particles of a defined size,
and the use of such composition. We have discovered that the size of modafinil
particles is important to the potency and safety profile of the drug.
Thus, in a first aspect, the invention
features a pharmaceutical composition comprising a substantially homogeneous
mixture of modafinil particles, wherein at least about 95% of the cumulative
total of modafinil particles in said composition have a diameter of less than
about 200 micrometers and said composition contains between about 50 milligrams
and about 700 milligrams of said modafinil.
[29]
Then
the patent describes a “particle” and illustrates the point with photographic enlargements
at Figures 2 to 5. The particles are not geometrically symmetrical; for
instance, they are not perfect spheres. At page 4, lines 10 to 12, the reader
is told that particle size can be measured by known conventional methods some
of which are described at pages 14 and 15. At page 5, line 29 to page 6, line
16 and at page 12, lines 3 to 15, the reader is told that a particular machine,
a Hiac/Royko was used to measure the size of the particles, and that different
instruments may yield different results.
[30]
Then,
at pages 3, 3a and 4, the patent gives definitions of statistical mathematical
terms “mean”, “median” and “mode” with examples. In part, it says:
As used herein, the term “mean,” when
used in reference to the size of modafinil particles, refers to the sum of the
size measurements of all measurable particles measured divided by the total
number of particles measured.
…
As used herein, the term “median,” when
used in reference to the size of modafinil particles, indicates that about 50%
of all measurable particles measured have a particle size less than the defined
median particle size value.
…
As used herein, the term “mode,” when
used in reference to the size of modafinil particles, indicates the most
frequently-occurring particle size value.
[31]
At
page 4, the patent provides a definition as to the word “about”, a matter
critical to some of the arguments raised in these proceedings. It says at lines
7 to 10:
As used herein, “about” means plus or
minus approximately ten percent of the indicated value, such that “about 20
microns” indicates approximately 18 to 22 microns.
[32]
Continuing
at page 4, the patent discloses preferred ranges of particle sizes using the
“mean”, the “median” and the “mode” ways of describing those sizes. It says:
In accordance with the invention
disclosed herein, the mean particle size for a modafinil particle preferably
ranges from about 2 microns to about 19 microns, more preferably from about 5
microns to about 18 microns, and most preferably from about 10 microns to about
17 microns.
In accordance with the invention
disclosed herein, the median particle size for modafinil preferably ranges from
about 2 microns to about 60 microns, more preferably from about 10 microns to
50 microns, and most preferably from about 20 microns to about 40 microns.
In accordance with the invention
disclosed herein, the mode particle size for modafinil preferably ranges from
about 2 microns to about 60 microns, more preferably from about 10 microns to
about 50 microns, and most preferably from about 20 microns to about 40
microns.
[33]
Continuing
at page 4 and over to page 5, the patent describes that it views the median
measurement to be the most important and that a good indicator of consistency
is a ratio of median to mean of 1:2.50 to 1:0.50 and median to mode of 1:2.50
to 1:0.50 is acceptable and that deviation of less than 25 between the median,
mean and mode is an indication of consistency.
[34]
At
page 5, lines 12 to 28, the patent informs the reader that consistency of
particle size with at least about 95% of the particles under 200 microns, or
better under 190 microns or even better, under 180 microns, is desirable.
[35]
At
page 6, the patent addresses dosage by stating in general terms that “an
effective amount” is that which reduces or eliminates symptoms of a somnolent
state.
“An effective amount”, as used herein, is
an amount of the pharmaceutical composition that is effective for treating a
somnolent or somnolescent state, i.e., an amount of modafinil of a defined particle
size that is able to reduce or eliminate the symptoms of a somnolescent state.
An effective amount of a pharmaceutical composition of the invention is useful
for enhancing alertness, or increasing regularity of sleep rhythms.
[36]
At
page 6 and over to page 7, a definition of “pharmaceutical composition” is
given; it is a medicament comprising modafinil in a defined particle size:
A “pharmaceutical composition” as used
herein, means a medicament for use in treating a mammal that comprises
modafinil of a defined particle size prepared in a manner that is appropriate
for administration to a mammal. A pharmaceutical composition according to the
invention may also, but does not of necessity, include a non-toxic
pharmaceutically acceptable carrier.
[37]
At
lines 5 to 12 of page 7, a preferred dosage range of about 50 mg to 700 mg is
stated:
The pharmaceutical composition of the
invention can contain at least about 50 mg, preferably at least about 100 mg,
or more preferably at least about 200 mg of modafinil having a particle size as
defined above. The pharmaceutical composition preferably contains no more than
about 700 mg; more preferably, no more than about 600 mg; and most preferably,
no more than about 400 mg, of modafinil having a particle size as defined above.
[38]
At
page 8, lines 12 to 15, a statement of “the invention” is provided:
The invention results from our discovery
that the particle size, and the consistency of the particle size, of modafinil
can have a significant effect on its potency and safety profile.
[39]
A
description of the testing of “early” (E) lots with a larger particle size of
modafinil compared to “late” (L) lots follows at page 8 and over to page 9. The
advantages of the particular particle size selected is summarized at page 9,
lines 13 to 23:
Therefore, modafinil particles of a
defined size provide at least two significant and unexpected advantages. First,
potency is increased. A smaller average particle size allows achievement of a
given modafinil plasma concentration at a lower oral dose. Second, with the
knowledge of the importance of particle size on potency, the safety profile of
the drug can be more accurately controlled because dosing with consistent and
defined particle sizes allows for greater reliability in the dosing of the drug
necessary to achieve a desired result.
[40]
At
page 9 to page 11 there follows some detail as to clinical studies in “foreign”
and “United
States”
environments. At page 11, line 25 to page 15, line 4, there is a detailed discussion
of the measurement of particle size of early (E) and late (L) lots of drugs
containing modafinil particles. Arguments as to Table 1 on page 13 were made by
Counsel, particularly the right hand most column “MEDIAN : MEAN : MODE”; these
will be discussed later. At page 13, we see:
Table 1
MODAFINIL
PARTICLE DIAMETER
|
LOT
|
MEAN*
|
MEDIAN*
|
MODE*
|
STD
DEVIATION
BETWEEN
MEAN, MEDIAN, MODE
|
MEDIAN:
MEAN:
MODE
|
|
E-A
|
34.60
+/-
5.21
|
143.65
+/-
3.26
|
176.48
+/-
5.32
|
74.27
|
1 :4.15 :.81
|
|
E-B
|
29.99
+/-
1.09
|
89.10
+/-
4.28
|
78.59
+/-
2.60
|
31.53
|
1 :2.97 :1.13
|
|
E-C
|
28.27
+/-
4.10
|
79.00
+/-
3.78
|
101.00
+/-
40.92
|
37.30
|
2 :2.79 :.78
|
|
E-D
|
22.14
+/-
0.76
|
94.05
+/-
13.75
|
158.63
+/-
63.81
|
68.28
|
1 :4,25 :.59
|
|
L-1
|
21.40
+/-
2.52
|
50.18
+/-
12.57
|
56.56
+/-
22.39
|
18.73
|
1 :2.34 :.89
|
|
L-2
|
18.75
+/-
1.89
|
31.41
+/-
3.57
|
25.31
+/-
1.34
|
6.36
|
1 :1.68 :1.24
|
*n=4; +/- values are standard deviations
Fig. 1 is a graph of particle diameter
versus percent cumulative particles for late Lots L-l, L-2, and for the early
Lots E-A, E-B, E-C, and E-D. The 50 percent cumulative particle size for late Lots
L-l and L-2 was between approximately 30 µm and approximately 50 µm, while the
50 percent cumulative particle size for Lots E-A, E-B, E-C, and E-D was between
approximately 80 µm and approximately 140 µm.
[41]
A
passage identified as VII at page 15 over to page 16 reports the effect of
modafinil particle size on the rate of dissolution of that medicine.
[42]
At
page 16 and over to page 18, a passage identified as VIII provides results of
testing on dogs of modafinil of various particle sizes and the level of the
drug found in the blood plasma of those dogs sampled at various time periods.
This passage, and in particular the results reported at Figure 8 is the subject
of argument of the parties. Figure 8 is reproduced at Annex A so that the
vertical lines occurring at various places on the graph can be seen. They are
discussed variously as “error” bars or as representing statistical levels of
variance. It is important to note that they overlap all the curves so that all
curves are contained within these bars. Figure 8 is discussed at page 17, lines
11 to 20:
Mean plasma modafinil levels in the nine
dogs, at 0 to 36 hours after modafinil administration, are depicted in Fig. 8.
With "small" particles (Lot L-1), the plasma modafinil concentration
peaked at 10 µg/ml. In contrast, with "larger" particles (Lots E-D or
E-B), the plasma modafinil concentration peaked at 8 µg/ml. Thus, the modafinil
having a median particle size of 50.18 µm resulted in a higher peak plasma
concentration than that obtained with the same dose of modafinil administered
in the form of larger particles. …
[43]
At
pages 18 to 19, passage IX describes methods for preparing modafinil in defined
particle sizes using “conventional methods” and those “known in the art”. In
part, it says:
Modafinil and modafinil-related compounds
can be prepared by conventional methods. Methods for preparing modafinil and
modafinil-related compounds appears in the '290 patent. Modafinil of the
particle size defined herein may be obtained by a variety of approaches
utilizing conventional methods, e.g., the methods disclosed in the '290 patent,
and then subjecting the modafinil of undefined particle size to conventional
methods of milling and sieving. Methods for comminution (i.e., the mechanical
process of reducing the size of particles or aggregates) are known to those in
the art.
[44]
Finally,
at pages 19 and 20, in passage X, formulation and administration are discussed.
The dosage range of 50 mg to 700 mg of modafinil is repeated and a variety of
vehicles such as tablets and the like are discussed in general terms.
[45]
The
claims follow. The parties have asserted that all 28 claims must be considered.
Therefor, I have set them out at Annex B. Claims 1 to 9 inclusive are directed
to a pharmaceutical composition. Claims 10 to 28 are directed to use of
modafinil particles. In terms of independent and dependent claims, claim 1 is
an independent claim on which all of claims 2 to 9 depend directly or
indirectly. Claim 10 is independent. Curiously, claim 11 depends on claim 14
which in turn depends on claim 12, and not on claim 10. I inquired of the
parties whether any correction had been made by the Patent Office and I was
told no. Therefor, claim 11 remains dependent on claim 14 thus, indirectly, on
claim 12.
[46]
Claim
12 is an independent claim upon which claims 11, 13 to 17 and 25 to 28 depend
directly or indirectly.
[47]
Claim
18 is an independent claim upon which claims 19 to 21 and 25 to 28 depend.
[48]
Claim
22 is an independent claim upon which claims 23 to 26 and 28 depend directly or
indirectly.
[49]
Claim
27 is an independent claim upon which claim 28 depends.
[50]
These
claims are to be construed against the background established by the
description in the patent. That background is:
·
modafinil
is a known composition
·
modafinil
particles can be made in a variety of sizes using known techniques
·
modafinil
is used in the treatment of sleep disorders including narcolepsy
[51]
The
“invention” is as disclosed at page 8:
… the particle size, and the consistency
of the particle size, of modafinil can have a significant effect on its potency
and safety profile.
[52]
The
“range” of particle sizes can be expressed in terms of mean, median or mode.
[53]
The
mixture should be substantially homogeneous with at least about 95% of the
particles having a diameter of less than about 200 microns, preferably less
than about 190 microns, most preferably less than about 180 microns.
[54]
The
dosage is expressed as “an effective amount” with a range of about 50 mg to
about 700 mg of modafinil indicated.
[55]
Representative
of the claims at issue are claims 1, 10 and 12 which say:
1. A pharmaceutical composition
comprising a substantially homogeneous mixture of modafinil particles, wherein
at least about 95% of the cumulative total of modafinil particles in said
composition have a diameter of less than about 200 micrometers and said
composition contains between 50 milligrams and about 700 milligrams of said
modafinil.
…
10. The use of a substantially
homogeneous mixture of modafinil particles whereof at least about 95% of the
cumulative total of said particles have a diameter of less than about 200
micrometers for the manufacture of a pharmaceutical composition containing
between about 50 mg and about 700 mg of modafinil for use in altering the
somnolent state of a mammal.
…
12. The use of modafinil for the
manufacture of a pharmaceutical composition comprising modafinil particles
having a median particle size of about 2 to about 60 micrometres for use in
altering the somnolent state of a mammal, wherein said composition contains 50
to 700 milligrams of said modafinil particles.
[56]
What
is already known is that pharmaceutical compositions containing modafinil exist
and that they can treat sleep disorders. For the purposes of claim
construction, the essential part of these claims is directed to the particle
size, expressed in a variety of ways such as median, mean and mode, and that
having about 95% at least of those particles under a particular size allows an
“effective amount” of modafinil to be administered. A range of 50 mg to 700 mg
of modafinil is given, this is what the patentee has selected as “an effective
amount” that reduces or eliminates the somnolent state, enhances alertness or
increases regularity of sleep rhythms.
[57]
A
word about dimensions as expressed in the patent and elsewhere. In both the
patent and the prior art, the size of the modafinil particles is often
described using a unit of measurement called the micrometer, which is often
abbreviated to either micron or µm. To put the size of a micrometer in
perspective, one millimetre is the same size as one thousand micrometers.
VALIDITY – BURDEN OF
PROOF
[58]
The
parties did not dwell in argument on the question of burden of proof. I must
decide the matter based on the balance of probabilities. If I find the balance
to be even, then I must find that the Applicants have not displaced the burden
of demonstrating that Apotex’s allegations as to validity such as have been
raised in by the Notice of Allegation, are not justified (to use a double
negative).
VALIDITY - ANTICIPATION
[59]
Apotex
has alleged in its Notice of Allegation, at pages 5 and 6, that the claims of
the ‘967 were anticipated by the earlier publication of an application filed
under the provisions of the Patent Co-Operation Treaty, application number WO94/21371
(WO371). That application was published on September 29, 1994, about a week
before the priority application respecting the ‘967 patent was filed in the
United States Patent Office on October 6, 1994. From the aspect of timeliness,
WO371 is a timely reference.
[60]
The
reference WO371 was published in the French language and while Counsel were apparently
prepared to address the matter in that language, they agreed that an acceptable
English language version of WO371 existed in the form of United States Patent
5,843,347 (US ’347) and, therefore, argument was based on that English language
version.
[61]
Anticipation
is a concept that rests on the requirement as set out in the definition of
“invention” in section 2 of the Patent Act, supra, that an
invention be “new”. The theory behind it is as expressed by the Supreme Court
of Canada in Apotex Inc. v. Wellcome Foundation Ltd., [2002] 4 S.C.R.
153, 2002 SCC 77, at paragraph 37 of their unanimous reasons:
[37] … The public should not be
expected to pay an elevated price in exchange for speculation, or for the
statement of "any mere scientific principle or abstract theorem" (s.
27(3)), or for the "discovery" of things that already exist, or are
obvious. The patent monopoly should be purchased with the hard coinage of new,
ingenious, useful and unobvious disclosures. …
[62]
Therefor,
if the public has been put into possession of the claimed invention by whatever
means, it does not have to pay the price of a monopoly to get it again. The
inquiry thus has to be made as to what the public already has and
compare it with what is claimed as the monopoly in the patent at issue.
[63]
Sometimes
a shortcut is used by asking if the earlier disclosure were to be put into
practice, would it infringe the later claims. This approach was used by the
Federal Court of Appeal in Abbott Laboratories v. Canada (Minister of
Health)
(2006), 56 C.P.R. (4th) 387, 2006 FCA 187, at paragraphs 24 and 25:
[24] The relevant question, in
relation to the claim of the 274 patent for Form 0, is this: Is Form 0 formed in
the process of making Form I or Form II? That is a question of fact, to which
the undisputed answer is yes. A skilled practitioner who makes Form I or II
following the teaching of the prior art inevitably would make Form 0, even if
no steps are taken to stabilize it. The Form 0 might not be recognized, but
that does not matter: see Smithkline Beecham PLC's (Paroxetine
Methanesulfonate) Patent, [2005] UKHL 59, per Lord Hoffman, at paragraph 22:
[...] the matter relied upon
as prior art must disclose subject-matter which, if performed, would
necessarily result in an infringement of the patent. That may be because the
prior art discloses the same invention. In that case there will be no question
that performance of the earlier invention would infringe and usually it will be
apparent to someone who is aware of both the prior art and the patent that it
will do so. But patent infringement does not require that one should be aware
that one is infringing: "whether or not a person is working [an] ...
invention is an objective fact independent of what he knows or thinks about
what he is doing": Merrell Dow Pharmaceuticals Inc v N.H. Norton & Co.
Ltd. [1996] R.P.C. 76, 90. It follows that, whether or not it would be apparent
to anyone at the time, whenever subject-matter described in the prior
disclosure is capable of being performed and is such that, if performed, it
must result in the patent being infringed, the disclosure condition is
satisfied. The flag has been planted, even though the author or maker of the
prior art was not aware that he was doing so.
[25] Because a person who makes Form
I or Form II following the teaching of the prior art inevitably would make Form
0, that person would infringe the 274 patent as surely as Ratiopharm would
infringe it by making the Form II for its product, as it proposes to do, by a
method that results in the creation of Form 0. The situation is aptly described
by the learned authors of Hughes and Woodley on Patents (2nd edition), at page
134 (paraphrasing Rinfret J. in Lightning Fastener Co. v. Colonial Fastener
Co., [1933] S.C.R. 377 at page 381):
[...] what would infringe if
later, anticipates if earlier.
The same thought is expressed as follows
by Jacob L.J. in Technic France S.A.'s Patent, [2004] R.P.C. 919 at paragraph
77:
And yet another way of looking
at the problem is to ask whether what is disclosed [in the prior art] falls
within the claim -- if it had been later would it infringe?
[64]
It
must be recognized however, that this is a simply a shortcut and has limitations
as recognized by Professor Vaver, in his book Intellectual Property Law
(Concord, Ontario: Irwin Law, 1997) at page 133:
A double standard operates here. Courts
give patents a non-literal “purposive” construction when they are testing for
internal validity or trying to catch infringers. When testing prior documents
for novelty, however, they construe them narrowly. The documents are then
subjected to “the closest scrutiny,” and a “weighty burden” is placed on the
challenger. Sauce for the patent goose should perhaps also be sauce for the
prior art gander. Prior documents should be examined purposively as a skilled
reader would read them. This examination should cover obvious equivalents to
described or claimed elements.
[65]
Thus
the same lawyer, who might argue for a generous and broad interpretation of a
patent when seeking infringement, would with equal zeal give the narrowest
possible interpretation to an earlier disclosure. Each document, the prior
disclosure, and the claim at issue, should be given the same, purposive,
interpretation.
[66]
The
matter was expressed this way by the Federal Court of Appeal in Beloit
Canada Ltd. v. Valmet Oy (1986), 8 C.P.R. (3d) 289, at page 297:
… One must, in effect, be able to look at
a prior, single publication and find in it all the information which, for
practical purposes, is needed to produce the claimed invention
without the exercise of any inventive skill. …
[Emphasis
added.]
[67]
The
“claimed invention” must, “for practical purposes” be disclosed
sufficiently in the prior art (use or publication) that no “inventive skill” is
needed to be led to the claimed invention.
[68]
What
is disclosed in this case, in WO371? The first substantive part of the text
(Col. 1 of US ’347) reads as follows:
The present invention relates to a novel
process for the preparation of isolated particles, each of which contains at
least one active ingredient useful in therapeutics, cosmetics, dietetics or
nutrition, by extrusion and then lyophilization.
[69]
The
subject is later more precisely defined (Col. 4 of US ’347):
According to the invention, a process is
recommended for the preparation of particles useful especially in therapeutics,
each particle comprising an excipient forming a matrix and at least one active
ingredient uniformly distributed in the mass of the matrix, said process being
characterized in that it comprises …
[70]
Thus
we are told that the document (in this case it is a patent application but that
is irrelevant, it is the disclosure that is relevant) contains a disclosure as
to how to make particles of a pharmaceutical composition useful in
therapeutics. This is a proper reading of the document so far.
[71]
Examples
are given as to how to prepare these particles. Examples 16 and 17 relate
specifically to modafinil. We know that the applicant in WO371 is Laboratoire
L. Lafon, of France, the same company that licensed the modafinil technology to
the Applicant Cephalon and who the Applicants acknowledge to be the originator
of modafinil. Examples 16 and 17 as disclosed are (Col. 14 of US ’347):
EXAMPLES 16-17
Microbeads of
modafinil
The following
formulations:
______________________________________
Ex. 16 Ex.
17
______________________________________
Modafinil* 100
g 100 g
Sodium
saccharinate 2g 2 g
Dextran 70 10
g 10 g
Tween 80 2
g 2 g
Hydroxypropyl
β-
cyclodextrin 100
g --
Lactose or
mannitol -- 40 g
Xanthan gum 1
g 1 g
Water 200
g 200 g
______________________________________
Note
*particle
size of the modafinil: 2-5 μm are used to prepare microbeads according to
the invention.
Diameter of
the dies: 0.5 mm
Diameter of the
microbeads: 1 mm
[72]
The
reader is told clearly and precisely that the particle size of the modafinil
used is 2-5 μm; that is well below, by up to one hundred fold, the
upper limit of about 200 μm established by claims 1 or 10 and even
within the narrowest range such as in claims 3 or 18 of 2 μm to 19 μm.
[73]
The
Applicants argued that WO371 (US ‘347) did not disclose a “pharmaceutical composition”
as claimed in the ‘967 patent. I reject that argument. WO371 clearly discloses
a composition said to be useful in the therapeutics. As of the date of its
publication, modafinil was well known as the active ingredient in
pharmaceutical compositions used to treat somnolent disorders. The ‘967 patent
itself acknowledges this to be the case.
[74]
The
Applicants further argue that Examples 16 and 17 do not state the purpose to
which the “particles” are to be put. This is really the same as the argument
above, and I reject it. As of the date of publication of WO371, the known
purpose of modafinil was to make pharmaceutical compositions to treat somnolent
disorders. Any person skilled in the art reading Examples 16 and 17 would quite
reasonably expect that that is the purpose for which the “particles” are
prepared.
[75]
The
Applicants further argue that the dosage range of between 50 mg and 700 mg
which is called for directly or indirectly in all the claims is not specified
in Examples 16-17 or anywhere in WO371. This is correct as far as it goes
however, as I have found in construing the claims, this dosage range is not an
essential element of the claim. What is important is, as set out at page 6 of
the patent, that the dosage be in “an effective amount” which is defined as an
amount that reduces or eliminates symptoms of a somnolent state. The evidence
shows that, as of the date of publication of WO371, dosages in the range of 50
mg to 700 mg includes the range of dosages of modafinil commonly given to treat
somnolent disorders. For instance, publications including modafinil product
specifications, at the relevant time before WO371 was published, show that
dosages of 100 mg, 200 mg, up to 600 mg were common and occasionally 700 mg was
reported. There is no “invention” or “essential element” in the range of 50 mg
to 700 mg. The “essential” element of the claims is particle size of modafinil
in a pharmaceutical composition and that is clearly anticipated by Examples
16-17 of WO371.
[76]
Therefore,
I find that the Applicants have, on the balance of probabilities failed to show
that the allegation that the ‘967 patent is invalid because it has been
anticipated by WO371 is not justified. This would be sufficient to dismiss the
application; however, I will examine the other allegations put in issue at the
hearing.
VALIDITY-OBVIOUSNESS
[77]
There
is a difference between the concepts of novelty and obviousness when discussing
the validity of a patent. They have been stated, for instance, by the Federal
Court of Appeal in Rothmans, Benson & Hedges Inc. v. Imperial Tobacco
Ltd. (1993), 47 C.P.R. (3d) 188 at pages 197-199:
"Anticipation" and
"obviousness" are different concepts. In Beloit Canada Ltd. v. Valmet
OY, Hugessen J.A. distinguished them in the following way:
... obviousness is an attack
on a patent based on its lack of inventiveness. The attacker says, in effect,
"Any fool could have done that." Anticipation, or lack of novelty, on
the other hand, in effect assumes that there has been an invention but asserts
that it has been disclosed to the public prior to the application for the
patent. The charge is: "Your invention, though clever, was already
known."
He said about "anticipation":
It will be recalled that
anticipation, or lack of novelty, asserts that the invention has been made
known to the public prior to the relevant time. The inquiry is directed to the
very invention in suit and not, as in the case of obviousness, to the state of
the art and to common general knowledge. Also, as appears from the passage of
the statute quoted above, anticipation must be found in a specific patent or
other published document; it is not enough to pick bits and pieces from a
variety of prior publications and to meld them together so as to come up with
the claimed invention. One must, in effect, be able to look at a prior, single
publication and find in it all the information which, for practical purposes,
is needed to produce the claimed invention without the exercise of any
inventive skill. The prior publication must contain so clear a direction that a
skilled person reading and following it would in every case and without
possibility of error be led to the claimed invention.
[My
emphasis]
He described the test of
"obviousness" in the following way:
The test for obviousness is
not to ask what competent inventors did or would have done to solve the
problem. Inventors are by definition inventive. The classical touchstone for
obviousness is the technician skilled in the art but having no scintilla of
inventiveness or imagination; a paragon of deduction and dexterity, wholly
devoid of intuition; a triumph of the left hemisphere over the right. The
question to be asked is whether this mythical creature (the man in the Clapham
omnibus of patent law) would, in the light of the state of the art and of
common general knowledge as at the claimed date of invention, have come
directly and without difficulty to the solution taught by the patent. It is a
very difficult test to satisfy.
[My
emphasis]
Prior art may be used in the application
of both tests but differently. Fox, Canadian Patent Law and Practice, 4th ed.
(1969) at 136-37, states:
... Prior specifications are
generally used to show anticipation if they disclose exactly and fully what the
patentee has claimed. If such disclosure is not made by the prior specification
and it cannot be used as an anticipation, it may be used as indicating the
state of the art at the time that the patentee made his alleged invention and
as showing that what the patentee did was so slight at contribution to existing
knowledge as to lack the essential element of invention and to be merely
obvious.
[My
emphasis]
Anticipation must therefore be found in a
single document which already gives a skilled person what is claimed and which
teaches it all. In the case of obviousness, however, "the prior art should
be reviewed and its cumulative effect considered". Thus the "mosaic
of extracts".
Both are questions of fact.
[78]
The
first comment to be made is that, with respect to WO371, if something is found
to be lacking in considering anticipation, the gaps are readily filled when
considering obviousness. The document WO371 is one directly relevant to the
pharmaceutical industry and those interested in modafinil. It was published
before the earliest date of invention for the ‘967 patent which is its priority
filing date in the United States. A person skilled in the art would be given
the knowledge that a pharmaceutical composition containing modafinil, a drug
known for treating sleep disorders, could be made using small particulate sizes,
2 μm to 5 μm, of modafinil
[79]
The
common knowledge was that dosage ranges of between 100 mg and 600 mg or even to
700 mg was used. It was known that particle size affected the properties of a
drug, particularly one like modafinil which was known to have low water solubility.
It was known that formulators would adjust particle size to suit the
bioavailability of a drug (e.g. Langer Affidavit, paras. 72 to 159).
[80]
The
Applicants argue that changing particle size was not always known to increase
the benefits of a given drug. In some instances, smaller sizes would be
beneficial, in other instances, not. As stated by in the English courts, the
fact that a number of routes exist does not mean that the alleged inventor is
not obvious.
[81]
Aldous LJ in Lilly Icos LLC v Pfizer Ltd. [2002] EWCA Civ 1, [2002] IP&T 244 at paragraph 57:
"Mr
Young is correct that when considering what is obvious it cannot be assumed
that the skilled person would try every possible permutation or carry out
extensive research (see Hallen Co v Brabantia (UK) Ltd [1991] RPC 195 at 212).
What would have been obvious will depend on all the circumstances. As I said in
Norton Healthcare Ltd v. Beecham Group plc (19 June 1997, unreported) –
'When deciding whether a claimed invention is obvious, it
is often necessary to decide whether a particular avenue of research leading to
the invention was obvious . In such circumstances the extent of the different
avenues of research and the perceived chances of any one of them providing a
successful result can be relevant to the decision whether the invention claimed
was obvious. Whether the subject matter was obvious may depend upon whether it
was obvious to try in the circumstances of that particular case and in those
circumstances it will be necessary to take into account the expectation of
achieving a good result. But that does not mean that in every case the decision
whether a claimed invention was obvious can be determined by deciding whether
there was a reasonable expectation that a person might get a good result from
trying a particular avenue of research. Each case depends upon the invention
and the surrounding facts. No formula should be substituted for the words of
the statute. In every case the Court has to weigh up the evidence and decide
whether the invention was obvious . This is the statutory task.' "
[82]
Laddie J in Brugger v Medic-Aid Ltd. [1996] RPC 635
at 661:
"First a route may still be an obvious one to try even if it is
not possible to be sure that taking it will produce success, or sufficient
success to make it commercially worthwhile. ...Secondly, if a particular route
is an obvious one to take or try, it is not rendered any less obvious from a
technical point of view merely because there are a number, and perhaps a large
number, of other obvious routes as well. If a number of obvious routes exist it
is more or less inevitable that a skilled worker will try some before
others."
[83]
To
the same effect is the finding of the Federal Court of Appeal in the “pink paroxetine”
case: SmithKline Beecham Pharma Inc. v. Apotex Inc., 2002 FCA 216,
aff’g 2001 FCT 770. If there are three ways to make a tablet, wet formulation
and two kinds of dry, and a product turns pink when the wet process is used, it
was obvious that a person skilled in the art would consider a dry process even
if there may be many other factors for the pinkness that may be considered as
well.
[84]
In
SmithKline Beecham, the Trial Judge made the following finding on the
basis of analysis in this respect at paragraph 40:
[40] Having
determined that a wet formulation of paroxetine tablets gives rise to a
"pink hue problem", a problem of significant enough magnitude to
cause a skilled person to seek out at least a partial solution to the problem,
I am satisfied that a logical first step for a person skilled in the art would
be to turn to the alternative formulation methods disclosed by the '060 patent
and to determine whether each or any of those alternative formulation methods
would solve, or at least partially solve, the problem. Such an enquiry would, I
am satisfied, involve no inventive step or skill. It would simply involve
application of the invention taught by the '060 patent.
[85]
At
paragraph 20 of the Court of Appeal’s decision that Court considered the matter
on the basis of “inventive step” or “mechanical skill”. Whether
this is categorized as “anticipation” or “obviousness” is not
relevant. The point is, there is no valid invention:
[20] However,
in this case, the Applications Judge found as a fact that "no inventive
step or skill" was required to arrive at the '637 Patent. In other words,
one could arrive at the '637 Patent "without the aid of inventive genius
but purely by mechanical skill." The instructions for arriving at the
formulation claimed by the '637 Patent are, therefore, clearly and
unmistakeably present in the '060 Patent. The Applications Judge determined
that it is not at all surprising that any person skilled in the art who was
confronted by the "pink hue
problem" would invariably turn to the alternative formulation methods
disclosed by the '060 Patent to arrive at a solution without any inventive
step. Mechanical skill rather than inventive genius is required in order to
apply the '060 Patent to arrive at the '637 Patent. The appellants have not
persuaded me that the Applications Judge erred in his consideration of the
evidence as a whole to arrive at this conclusion. Moreover, the fact that the
'060 Patent contains additional information and instructions not present in the
'637 Patent is immaterial to whether or not one could "look at [the '060
Patent] and find in it all the information which, for practical purposes, is
needed to produce [the '637 Patent] without the exercise of any inventive
skill" (Beloit, supra at 297).
[86]
Here
particle size variation is shown to be something well within the skill and
knowledge of a person skilled in the art. Such a person would be expected to
look at particle size when preparing a drug. No one person should, by a patent
monopoly, deprive such a person of using that skill.
[87]
Thus
I find, on a balance of probabilities, that the Applicants have failed to prove
that Apotex’s allegations of obviousness are not justified. This is a further
ground upon which the application will be dismissed.
VALIDITY-MERE DISCOVERY
[88]
Apotex
argues that the “invention” claimed in the ’967 patent is not an
invention at all but is a “mere discovery”. The world “discovery”
is not found in the Patent Act, but seems to have found its way
into patent language but without a rigorous discussion as to whether a
distinction is to me made between an “invention” and a “mere
discovery”. Section 91(22) of the Constitution Act 1867 (U.K.), 30 &
31 Vict. c. 3, provides that the federal government shall have jurisdiction in
respect of “Patents of Invention and Discovery”, however the Patent
Act, does not address discovery or distinguish between the two.
[89]
Apotex
relies on the decision of Justice Mosley of this Court in Pfizer Canada Ltd.
v. Apotex Inc., 2005 FC 1421, (2005), 43 C.P.R. (4th) 81 at
paras. 150-156. I do not read that decision as creating a new category for
consideration of the validity of a patent. Justice Mosley was simply applying
existing law respecting novelty and obviousness.
[90]
Having
found that the allegations of invalidity in respect of novelty and obviousness
have not been shown not to be not justified (to use a double negative). I see
no need to create precedent for a new category of “mere discovery”.
VALIDTY-UTILITY
[91]
Apotex
argues in respect of utility, that the ’967 patent promises that the claimed
formulation will deliver greater potency and a more predictable safety
profile. It references page 8 lines 12-15 of the patent:
II. The Invention
The invention results from our
discovery that the particle size, and the consistency of the particle size, of
modafinil can have a significant effect on its potency and safety profile.
[92]
However,
Apotex argues that, in fact, modafinil in the particle size range claimed in
the patent is no more potent than previous versions of modafinil and no safer.
[93]
As
to potency, the ’967 patent at pages 16 to 18 discusses studies conducted on
dogs who were fed various dosages of modafinil of particular particle sizes and
the plasma levels measured at various time intervals. The results are
illustrated at Figure 8 (Figure 9 is similar but deals with a metabolite of
modafinil and not modafinil itself). The patent at page 17 lines 24 to 26
states in respect of this study:
These results implicated the
consequences of different particle sizes and the importance of controlling
modafinil particle size
[94]
When
one looks at Figure 8 it is readily apparent that there are a number of
vertical bars on the results plotted on the graph. These bars are referred to
in the evidence as “error” bars or bars reflecting statistical standard
deviation. As to the meaning of this graph and the effect of these bars I
consider that the most important evidence comes from the witnesses Drs. Polli,
Feifel and Cartilier as their expertise lies in this area. Having looked at
all the relevant evidence including in particular that of the witnesses named
above, I am satisfied that the evidence as to Figure 8 and what is said about
it in the ’967 patent can be summarized with reference to questions 627 to 636
and the answers given on Dr. Cartilier’s cross-examination namely that a person
skilled in the art cannot come to any meaningful conclusion from the
information presented:
627 Q. To go back
to Figure 8, are you able to tell me whether there are any statistical
differences in the curves in Figure 8?
A. You
cannot perform a statistical calculation on that. You need the raw data.
628 Q. Okay. So
you cannot—Reading the Patent and looking at this Figure, you cannot tell me,
one way or the other, whether the differences are meaningful?
A. No. I
have plenty of Papers where there are no error bars and where there is a
meaningful message showing differences.
629 Q. Okay. But
--
A. I will
–
630 Q. Sorry. Go
ahead.
A. What I
cannot do is to calculate the statistical test, because I don’t have the data.
631 Q. Right. You
cannot perform a statistical analysis?
A. Yes.
That is correct.
632 Q. And none
was undertaken in the ’967?
A. I don’t
know.
633 Q. Well, you read
it. In the ’967 –
A. In the
’967, I didn’t see –
634 Q. Right. So
at this point, without having that analysis, one cannot conclude whether or not
these differences are meaningful, in the sense that there are statistically
significant differences.
Correct?
A.
Regarding
the statistical aspect, you cannot conclude.
635 Q. Right. So
you cannot conclude whether these differences are meaningful, from a
statistical significance point of view.
Correct?
A.
From
a statistical point of view, I cannot conclude –
636 Q. But more
than “statistical”.
It is
“statistical significant” point of view.
A.
Yes.
From a statistical significant point of view.
B.
[95]
As
to safety, the patent does not expressly address safety except to address
consistency and lower dosages, at page 17:
“These results implicated the
consequences of different particle sizes and the importance of controlling
modafinil particle size. By controlling the particle size, safety concerns can
be addressed. For example, a non-homogenous mixture of modafinil particle
sizes may not provide consistent potency nor avoid undesired fluctuations in
plasma modafinil concentrations; such fluctuations can lead to undesired and
unexpected events. Moreover, the use of modafinil particles having a defined
size is more efficient because a given plasma modafinil concentration can be
achieved at lower oral dosages.”
[96]
The
patent claims express the dosage levels as being between 50 mg and 700 mg. This
range is not lower than the range of dosages previously administered in the
prior art. Previous modafinil products approved for sale in France show that
100 mg tablets were approved with dosages of 2 to 4 tablets daily being
approved, that is, dosages of 200 to 400 mg per day. This is within the
claimed range of the ’967 patent. No demonstrable safety “innovation”
has been shown.
[97]
I
am satisfied, on the evidence, that the Applicants have failed to prove that
Apotex’s allegations that the alleged invention as claimed in the ’967 patent
lacks utility is not justified.
VALIDITY - SUFFICIENCY
[98]
The
Federal Court of Appeal has recently dealt with how an allegation of
sufficiency, in respect of section 27(3) of the Patent Act, it is to be
dealt with. In Pfizer Canada Ltd. v. Ranbaxy Laboratories Limited, 2008
FCA 108 that Court held that sufficiency must be determined having regard to
what is said in the patent itself without regard to extrinsic evidence. Their
conclusion was set out at paragraphs 63 and 64:
[63] The applications judge erred in construing the promise of the
patent and mischaracterized the disclosure requirement under subsection 27(3)
of the Act by asking whether there was sufficient data to substantiate the
promise of the patent. Such an examination exceeds the scope of the provision.
An attack on a selection patent on the basis that there is no data to support
the claimed advantage is certainly relevant for the purposes of validity (most
likely to the question of utility), but it is not relevant with respect to
disclosure under subsection 27(3) of the Act.
[64] The patent must disclose the invention and
how it is made. The 546 patent does this. It also discloses the advantages that
underlie the selection. This, in my view, is the extent of the requirement
under subsection 27(3) of the Act, the purpose of which is to allow a person
skilled in the art to make full use of the invention without having to display
inventive ingenuity.
[99]
Pointing
to decisions such as Cadbury Schweppes Inc. v. FBI Foods Ltd., [1999] 1
S.C.R. 142 at paragraph 46, Apotex argues that:
A patent is a statutory
monopoly which is given in exchange for a full and complete disclosure by the
patentee of his or her invention. The disclosure is the essence of the bargain
between the patentee…and the public.
[100] The argument
made by Apotex at the hearing rested almost entirely on the basis that, having
regard to Table 1 set out at page 13 of the patent and, in particular, the
right hand most column, the data is meaningless. Mathematically it makes no
sense. It purports to assign to the data looking to the left horizontally a
value of 1 to the “median” value then a proportionate value to “mean”
and “mode”. For example, looking at the first entry E-A, the chart says
one thing but calculations show something else:
Median =
143.65 = 1 (chart)
Mean = 34.60 = 4.15 (chart)
0.24 (calculated)
Mode = 176.48 = 0.81 (chart)
1.23 (calculated)
[101] Apotex argues
that these erroneous calculations render the Table and any conclusions as to
median : mean : mode, meaningless. The Applicants argue that a person skilled
in the art would recognize the calculations as erroneous but would appreciate
that the reported data in the other columns is accurate and the data would be
accepted as such.
[102] The
Applicants however raise another point namely that Apotex failed to raise an
argument as to sufficiency of the median: mean: mode column in Table 1 in its
Notice of Allegation and to raise it at the hearing for the first time has not
given the Applicants an opportunity to know the case put against them or to
lead such evidence as they would believe to be appropriate. I agree, this
matter was not clearly raised in the Notice of Allegation and regardless as to
merit or otherwise I find that it is not properly before this Court and cannot
now be raised.
[103] If I am wrong
in this finding, I would have determined on the evidence that I do have on the
matter that the median: mean: mode column of Table 1 is misleading and would
lead a person skilled in the art to doubt the veracity of all data presented in
the Table and any conclusions expressed in the Patent in that regard.
VALIDITY – CLAIMS
OVERBROAD – “ABOUT”
[104] The final
challenge to validity of the ’967 patent made by Apotex at the hearing deals
with the use of the world “about” in the claims. That word appears directly
or indirectly in every one of the 28 claims of the patent. In claim 1 the
world “about” modifies the percentage of particles under a certain size,
it modifies the dimensions of the particle and it modifies the dosage.
[105] In the text
of the disclosure part of the patent, page 4 lines 7-12 the world “about”
is defined:
As used
herein, “about” means plus or minus approximately ten percent of the indicated
value, such that “about 20 microns” indicates approximately 18 to 22 microns.
The size of the particle can be determined, e.g., by the methods provided
below, and by conventional methods known to those of skill in the art.
[106] Apotex argues
that, as a result of this definition, wherever the world “about” occurs
in the claims it means plus or minus approximately ten percent of whatever
value is stated. The Applicants argue that the world “about” as defined
at this place in the patent relates only to particle size and not to other
criteria such as percentage of particles or dosages.
[107] Apotex argues
that, in taking the definition of “about” to apply to the percentage of
particles falling below a stated size in the claim such as “at least about
95%” having a diameter of “less than about 200 micrometers” as it
appears in claim 1 and, by reference, claims 2 to 9, in claim 10, claim 27 and,
by reference, claim 28, would permit a composition (using the 10% definition)
in which at least 85.5% of the cumulative total of modafinil particles has a
particle size of less than 220 micrometers. If this is the case, Apotex argues,
the “early” or “E” lots of modafinil described in the patent as being
previously existing or “prior art” would be within the terms of the
claims.
[108] I agree that
the patent draftsman probably did not pay much attention as to the definition
of the world “about” or how or where that word occurred in the claims.
However, a purposive construction of the patent, reading it fairly, indicates
that “about” being plus or minus ten percent should be limited to
particle size and not other definitions such as percentage or dosage as may
occur in the claims.
[109] Therefore, I
find that this allegation by Apotex is not justified.
CONCLUSION
[110] As a result,
I find that the Applicants have failed, on the balance of probabilities, to
discharge their burden of demonstrating that Apotex’s allegations of invalidity
of the ’967 patent, at least on the grounds of anticipation, obviousness and
utility, are not justified. The application will be dismissed.
COSTS
[111] The
Respondent Apotex has been successful in this application and will be awarded
costs at the usual level in these proceedings, the middle of Column IV. However
Apotex raised in its Notice of Allegation and ultimately did not pursue at the
hearing many allegations as to invalidity including section 53 of the Patent
Act. As discussed in Eli Lilly Canada Inc. v. Apotex Inc., 2008 FC
142, section 53 raises an implication of fraud which if raised and not pursued
should bear a cost penalty. As a result, costs and disbursements taxed and
allowed to Apotex shall be reduced by twenty-five percent.
[112] Costs for two
counsel at the hearing, one senior, one junior may be taxed. Two counsel, if
present, in conducting a cross-examination and one in defending a
cross-examination, will be allowed. No costs are allowed for other lawyers, in
house or out house, or for paralegals.
[113] The fees
taxed for expert witnesses shall not exceed those charged by Apotex’s senior
counsel for the same amount of time.
[114] Photocopying
is allowed at the lesser of $0.25 per page or the actual amount charged.
JUDGMENT
FOR THE REASONS given:
THIS COURT ADJUDGES
that:
1.
The
application is dismissed;
2.
The
Respondent Apotex is entitled to costs to be taxed in accordance with these
Reasons.
"Roger
T. Hughes"
ANNEX A
FIGURE 8
ANNEX B
CLAIMS
1. A
pharmaceutical composition comprising a substantially homogeneous mixture of
modafinil particles, wherein at least about 95% of the cumulative total of
modafinil particles in said composition have a diameter of less than about 200
micrometers and said composition contains between about 50 milligrams and about
700 milligrams of said modafinil.
2. The
composition of claim 1, wherein said particles have a median diameter range of
between about 2 micrometers and about 60 micrometers.
3. The
composition of claim 1, wherein particles have a mean diameter of from about 2
micrometers to about 19 micrometers.
4. The
composition of claim 1, wherein said particles have a mode diameter of from about
2 to about 60 micrometers.
5. The
composition of claim 1, wherein the ratio of the median diameter of said
particles to the mean diameter of said particles is in the range 1:2.50 to
1:0.50.
6. The
composition of claim 1, wherein the ratio of the median diameter of said
particles to the mode diameter of said particles is in the range 1:2.50 to
1:0.50.
7. The
composition of claim 1, wherein said particles have a mean diameter of from about
2 micrometers to about 19 micrometers, a median diameter of from about 2
micrometers to about 60 micrometers, and a mode diameter of from about 2 micrometers
to about 60 micrometers, the ratio of said median diameter to said mode
diameter being in the range 1:2.50 to 1:0.50 and the ratio of said median
diameter to said mean diameter being in the range 1:2.50 to 1:0.50.
8. The
composition of claim 7, wherein the standard deviation of said mean, median and
mode diameters is less than 25 micrometers.
9. The
composition of any one of claims 1 to 9, in a form adapted for oral
administration being a tablet, capsule, powder, pill, liquid suspension or emulsion.
10. The
use of a substantially homogeneous mixture of modafinil particles whereof at
least about 95% of the cumulative total of said particles have a diameter of
less than about 200 micrometers for the manufacture of a pharmaceutical
composition containing between about 50 mg and about 700 mg of modafinil for
use in altering the somnolent state of a mammal.
11. The
use of claim 14, wherein said somnolent state is narcolepsy.
12. The
use of modafinil for the manufacture of a pharmaceutical composition comprising
modafinil particles having a median particle size of about 2 to about 60
micrometres for use in altering the somnolent state of a mammal, wherein said
composition contains 50 to 700 milligrams of said modafinil particles.
13. Used
as claimed in claim 12, wherein particles have a mean diameter of from about 2
micrometers to about 19 micrometers.
14. Used
as claimed in claim 12, wherein said particles have a mode diameter of from
about 2 to about 60 micrometers.
15. Used
as claimed in claim 12, wherein the ratio of the median diameter of said
particles to the mean diameter of said particles is in the range 1:2.50 to
1:0.50.
16. Used
as claimed in claim 12, wherein the ratio of the median diameter of said
particles to the mode diameter of said particles is in the range 1:2.50 to
1:0.50.
17. Used
as claimed in claim 12, wherein said particles have a mean diameter of from
about 2 micrometers to about 19 micrometers, a median diameter of from about 2 micrometers
to about 60 micrometers, and a mode diameter of from about 2 micrometers to
about 60 micrometers, the ratio of said median diameter to said mode diameter
being in the range 1:2.50 to 1:0.50 and the ratio of said median diameter to
said mean diameter being in the range 1:2.50 to 1:0.50.
18. The
use of modafinil for the manufacture of a pharmaceutical composition comprising
modafinil particles having a mean particle size of about 2 to about 19
micrometres for use in allering [sic] the somnolent state of a mammal,
wherein said composition contains 50 to 700 milligrams of said modafinil
particles.
19. Used
as claimed in claim 18, wherein said particles have a mode diameter of from
about 2 to about 60 micrometers.
20. Used
as claimed in claim 18, wherein the ratio of the median diameter of said
particles to the mean diameter of said particles is in the range 1:2.50 to
1:0.50.
21. Used
as claimed in claim 18, wherein the ratio of the median diameter of said
particles to the mode diameter of said particles is in the range 1:2.50 to
1:0.50.
22. The
use of modafinil for the manufacture of a pharmaceutical composition comprising
modafinil particles have [sic] a mode particle size of about 2 to about
60 micrometers for use in altering the somnolent state of a mammal, wherein
said composition contains 50 to 700 milligrams of said modafinil particles.
23. Used
as claimed in claim 22, wherein the ratio of the median of said particles to
the mean diameter of said particles is in the range 1:2.50 to 1:0.50.
24. Used
as claimed in claim 22, wherein the ratio of the median diameter of said
particles to the mode diameter of said particles is in the range 1:2.50 to
1:0.50.
25. Used
as claimed in any one of claims 12 to 24, wherein the standard deviation of
said mean, median and mode diameters is less than 25 micrometers.
26. Used
as claimed in any one of claims 12 to 25, wherein said composition is in a form
adapted for oral administration, said form being a tablet, capsule, powder,
pill, liquid suspension or emulsion.
27. The
use of a substantially homogeneous mixture of modafinil particles whereof at
least about 95% of the cumulative total of said particles have a diameter of
less than about 200 micrometers for the manufacture of a pharmaceutical
composition containing 50 mg to 700 mg of modafinil for use in altering the
somnolent state of a mammal.
28. Use
as claimed in any one of claims 12 to 28, wherein said somnolent state is
narcolepsy.
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