Date: 20100426
Docket: T-124-08
Citation: 2010 FC 447
Ottawa,
Ontario, April 26, 2010
PRESENT: The Honourable Madam Justice Heneghan
BETWEEN:
PFIZER CANADA INC. and
PHARMACIA ATKIEBOLAG
Applicants
and
THE MINISTER OF HEALTH and
APOTEX INC.
Respondents
REASONS FOR JUDGMENT AND
JUDGMENT
I. Introduction
[1]
Pfizer
Canada Inc. and Pharmacia Atkiebolag (the “Applicants”) apply pursuant to the Patented
Medicines (Notice of Compliance) Regulations, SOR/93-133 (the “NOC Regulations”)
for an order prohibiting the Minister of
Health from issuing a Notice of Compliance (“NOC”) to Apotex Inc. (“Apotex” or the
“Respondent”), pursuant to section C.08.004 of the Food and Drug Regulations,
C.R.C. 1978, c. 870, until the expiry of Canadian letters patent 1,339,132 (the
“ ‘132 Patent”). The ‘132 Patent is entitled “Prostaglandin Derivatives for
the treatment of glaucoma or Ocular Hypertension”. A patent list pertaining to
50 microgram/ml ophthalmic solution of Latanoprost and referencing the ‘132
Patent was submitted to the Minister of Health (the “Minister”). The Minister
issued Notices of Compliance to Pfizer for the 50 microgram/ml ophthalmic
solution of Latanoprost on various dates, including October 6, 2003. The 50
microgram/ml ophthalmic solution of Latanoprost is marketed in Canada under the
registered trade-mark Xalatan®.
[2]
This
application was commenced following service of a Notice of Allegation (the
“NOA”) dated March 4, 2008 upon the
Applicants. In its NOA, the Respondent alleged that the ‘132 Patent is invalid
on several grounds including anticipation, obviousness, lack of utility, lack
of sound prediction, overbreadth, double patenting and lack of sufficiency. The
Respondent also alleged that it would not infringe the ‘132 Patent by producing
its version of Latanoprost ophthalmic solution, 50 microgram/ml, hereinafter
referred to as “APO-latanoprost”.
[3]
The
Minister of Health (the “Minister”), although a party to this proceeding, is
not actively participating in it.
[4]
Further
to an Order made on April 9, 2010, the statutory injunction granted by the NOC
Regulations was extended until April 26, 2010.
A. The Patent
[5]
The
‘132 Patent application was filed on September 12, 1989. It issued on July 29,
1997. The Patent addresses the use of certain prostaglandin derivatives in the
treatment of glaucoma or ocular hypertension.
[6]
Prostaglandins
are naturally occurring substances found in human and animal tissues that
contain 20 carbon atoms and have a molecular structure called “prostanoic
acid”. The PGF2α is a naturally occurring compound that can be
esterified into PGF2α isopropyl ester, also referred to as PGF2α
–IE. The chemical composition of PGF2α is as follows:
[7]
The
Latanoprost compound is a prostaglandin derivative that has the chemical
formulation of 13,14-dihydro-17-phenyl-18,19,20-trinor PGF2α
isopropyl ester or 13,14-dihydro-17-phenyl-18,19,20-trinor PGF2α
-IE. Its chemical structure is as follows:
[8]
Latanoprost
is made by modifying PGF2α as follows:
i.
removing
the last 3 carbons of the omega chain (“18,19,20-trinor”);
ii.
attaching
a phenyl ring to carbon 17 (“17-phenyl”);
iii.
changing
the double bond to a single bond between carbon 13 and carbon 14
(“13,14-dihydro”); and
iv.
esterifying
the carboxylic acid to an isopropyl ester.
[9]
The
‘132 Patent contains 38 claims; however, only Claims 12, 19, 31, 37 and 38 are
at issue in this proceeding. Broadly speaking, Claim 19 is a compound per se
claim that is dependent on Claim 18. Claims 31, 37 and 38 are use claims. Claim
12 is a narrower use claim and is dependent on Claim 1. The relevant claims
read as follows:
i.
A
therapeutic composition for topical treatment of glaucoma or ocular
hypertension, containing a prostaglandin PGA, PGB, PGD, PGE or PGF in an amount
sufficient to reduce intraocular pressure without causing substantial ocular
irritation and an ophthalmologically compatible vehicle, which the omega chain
of the prostaglandin has the formula:
(13)
(14) (15-24)
C - B
- C - D - R2
wherein
C
is a carbon atom (the number is indicated within parenthesis);
B is a
single bond, a double bond or a triple bond;
D is a chain
with 1-10 carbon atoms, optionally interrupted by hetero atoms O, S, or N, the
substituents on each carbon atom being H, alkyl groups, lower alkyl groups with
1 – 5 carbon atoms, an oxo functionality or a hydroxyl group;
R2
is a ring structure selected from the group consisting of phenyl and phenyl
having at least one substituent, said substituent being selected from C1-C5
alkyl groups, C1-C4 alkoxy groups, trifluoromethyl
groups, C1-C3 aliphatic acylamino groups, nitro groups,
halogen atoms, and phenyl group; or an aromatic heterocyclic group having 5-6
ring atoms, selected from the group consisting of thiazol, imidazole,
pyrrolidine, thiopene and oxazole; or a cycloalkane or a cycloalkene with 3-7
carbon atoms in the ring, optionally substituted with lower alkyl groups with
1-5 carbon atoms.
12. An
ophthalmological composition according to claim 1, wherein the prostaglandin
derivative is 13,14-dihydro-17-phenyl-18,19,20-trinor-PGF2α -isopropylester.
18. 13,14-dihydro-17-phenyl-18,19,20-trinor-PGF2α
-alkyl-ester, in which the alkyl group has 1-10 carbon atoms.
19. Compound
of claim 18, wherein the alkyl group is isopropyl.
31. The
use of 13,14-dihydro-17-phenyl-18, 19,20-trinor-PGF2α -isopropylester
in the treatment of glaucoma or ocular hypertension.
37. The
use of 13,14-dihydro-17-phenyl-18,19,20-trinor- PGF2α -alkyl-ester,
in which the alkyl group has 1-10 carbon atoms for the treatment of glaucoma or
ocular hypertension.
38. The
use of 13,14-dihydro-17-phenyl-18,19,20-trinor- PGF2α -isopropyl-ester
in the treatment of glaucoma or ocular hypertension.
B. The Evidence
[10]
Each
party submitted affidavit evidence from several witnesses, some of whom
provided factual evidence and others who addressed matters of opinion.
i) Applicants’
Witnesses
[11]
Dr.
Wolff is a registered U.S. patent agent and a registered pharmacist
in the State of California, United States of America. He obtained
a Ph.D. degree in Medicinal Chemistry from the University of
California, Berkeley in 1955 and worked as Adjunct Professor of Medicinal
Chemistry at the University of Southern California from 1982 to
2002. He was also a member of the faculty of the Residential School of
Medicinal Chemistry of Drew University in Madison, New Jersey
from 1996 to 2008. He has worked and taught in the fields of medicinal
chemistry drug discovery and drug development, both in the pharmaceutical
industry and the academic world, for more than 40 years.
[12]
Dr.
Wolff’s mandate was to describe the person of skill in the art (“POSITA”),
provide an opinion on the ‘132 Patent, and to review the opinions expressed by
the Respondent’s expert witnesses. He said that around September 12, 1989
there were over 40,000 articles published on prostaglandins. Dr. Wolff said
that most of the articles provided by the Respondent as prior art have nothing
to do with the eye and any teachings on metabolism found in those articles
cannot be transferred to the eye field. He also said that Canadian Patent
No. 1,208,560 entitled “Use of Eicosanoids and Their Derivatives for Treatment
of Ocular Hypertension and Glaucoma” (the “ ‘560 patent”), does
not give the POSITA enough directions to make chemical modifications needed to
get to Latanoprost.
[13]
Discussing
the data found in the ‘132 Patent, he said that using healthy humans gives a
sound basis to expect that the drug would work in glaucoma patients because
there is no reason to expect substantial differences in the side effects seen
between these two groups. He concluded that animal and normal human testing
has been and continues to be the standard step-wise process used to evaluate
almost all drugs.
[14]
Dr.
Robert D. Fechtner is a clinical ophthalmologist practising in New Jersey. He is also
a professor in the Department of Ophthalmology and Visual Science, New Jersey Medical School, University of Medicine
and Dentistry of New Jersey. He has held this position since 2002. He was asked
to provide a basic tutorial on the eye and intraocular pressure (“IOP”),
glaucoma, ocular hypertension and the treatment of those conditions and to
describe the common general knowledge relative to the treatment of ocular
hypertension, glaucoma and prostaglandins as of September 12, 1989.
[15]
Dr.
Fechtner was also asked to describe the qualifications of the POSITA to whom
the ‘132 Patent is addressed and to state his understanding of the ‘132 Patent,
with reference to Claims 12, 19, 31, 37 and 38 as of July 29, 1997. He was also
asked to describe the utility taught by the ‘132 Patent and whether Latanoprost
has utility. He was asked to describe the utility of the ‘132 Patent and
whether Latanoprost exhibits that utility. As well, he was asked to consider
whether the specification of the ‘132 Patent, including Claims 12, 19, 31, 37
and 38 correctly and fully describe, as of July 29, 1997, to the POSITA, the
subject matter of the invention and its operation or use as contemplated by the
inventor. In addition to reviewing relevant documents, including the ‘132
Patent, Dr. Fechtner was asked to review certain affidavits filed by the
Respondent.
[16]
Dr.
Johan W. Stjernschantz of Uppsala, Sweden is one of
the inventors of the ‘132 Patent. He addressed the factual background to the
discovery of Latanoprost, including the history of other efforts that were made
by competitors, seeking the discovery of a drug that would treat glaucoma and
ocular hypertension.
[17]
As
well, Dr. Stjernschantz tendered opinion evidence as to the POSITA as of
September 12, 1989, the concept of obviousness of the invention claimed in the
‘132 Patent having regard to the prior art, the sufficiency of the ‘132 Patent
having regard to the test data in the patent and the evidence tendered by the
Respondent, and the utility of the ‘132 Patent.
[18]
I
note that Dr. Stjernschantz, as one of the inventors of the ‘132 Patent, is
uniquely situated to give evidence about the invention. However, in my opinion,
his evidence is to be cautiously treated in respect of issues of claim
construction and validity since it is almost impossible for a person with an
“interest”, even an intellectual one, to be wholly objective about his own
work. In this regard, I refer to the decision in Emmanuel Simard & Fils
(1983) Inc. v. Raydan Manufacturing Ltd. (2005), 41 C.P.R. (4th)
385 (F.C.).
[19]
Dr.
Kirk M. Maxey is a medicinal chemist with expertise in the area of
prostaglandins with almost 30 years experience in the study and synthesis of
prostaglandins. Although he holds a medical degree, he has never practiced as a
medical doctor. He is the founder and Chairman of the Board of the Cayman Biomedical
Research Institute, a non-profit institute that conducts research in the areas
of rare diseases and genetic defects.
[20]
Dr.
Maxey was asked to give a brief tutorial on prostaglandins. He was also asked
to describe the qualifications of the POSITA and to give his understanding of
the ‘132 Patent, particularly with regard to Claims 12, 19, 31, 37 and 38 as of
July 29, 1997.
[21]
Dr.
Maxey was also asked to consider whether Latanoprost had been disclosed in the
prior art, whether the POSITA would have been led to Latanoprost having regard
to the state of the art as of September 12, 1989 and July 29, 1997 and whether
the claims in issue are broader than the invention made or disclosed in the
‘132 Patent.
[22]
The
affidavit of Dr. Maxey disclosed that not only did his company supply the raw
prostaglandins used by Dr. Stjernschantz’ group, but that no one else had ever
requested the compounds that went into the development of Latanoprost and that
these base chemicals were not in the main catalogue and were difficult to
manufacture.
[23]
Dr.
Maxey said that he was unaware of any company selling modified 17-phenyl
substituted PGF2α as of September 12, 1989. The only people
looking for this product were Dr. Stjernschantz and his team at Pharmacia.
[24]
Dr.
Maxey gave the opinion that Latanoprost was not anticipated by the ‘560 patent
or by NOA Document No. 6 entitled “Effect of Chemical Modifications On The
Metabolic Transformation of Prostaglandins”. This article was published on
December 1, 1976.
[25]
Dr.
Maxey addressed the issue of esterification of the carboxylic acid of PGF2α
and said, in agreement with Dr. Bodor, an expert witness put forward by the
Respondent, that this esterification was known as of September 12, 1989.
However, he testified that it was also known that other positions could
be esterified and sterification was not the solution to the problem of side
effects. He concluded that the choice of the four chemical modifications that
were made by the inventors was “brilliant”.
[26]
Dr.
Arthur H. Neufeld is a Professor of Ophthalmology and the Head of Laboratory
for the Investigation of the Aging Retina at the Northwestern University School
of Medicine. He submitted two affidavits on behalf of the Applicants, the first
sworn on September 11, 2008 and the second sworn on January 15, 2009.
[27]
In
his first affidavit, Dr. Neufeld addressed his mandate to give his
interpretation on the ‘132 Patent and whether the Respondent’s product APO-latanoprost
infringes Claims 12, 19, 31, 37 and 38 of the ‘132 Patent. In his opinion, the
Respondent’s product would infringe the specified claims of the ‘132 Patent.
[28]
In
his second affidavit, Dr. Neufeld said that he had been asked to explain
glaucoma and ocular hypertension and to describe the common general knowledge,
as of September 12, 1989, based on his expertise relative to prostaglandins. He
was also asked to give his “interpretation” of the ‘132 Patent as of July 29,
1997 and to describe the qualifications of the POSITA.
[29]
The
Applicants filed one affidavit of fact, that is the affidavit of Ms. Arshia
Ghani, Regulatory Affairs Associate of Pfizer Canada. She deposed
to the ownership of the ‘132 Patent and the issuance of NOCs over a number of
years, beginning in 1997.
ii) Respondent’s Witnesses
[30]
The
Respondent filed the affidavits of Dr. Nicholas Bodor, Dr. Cheryl Cullen, Dr. Allan
Flach, Dr. Howard Leibowitz, Chrystal Yorke and Ines Ferreira.
[31]
Dr.
Bodor holds a Ph.D. in organic chemistry and has worked in the fields of
pharmochemical research and medical chemistry. He was asked to provide a
summary of prostaglandin development and chemistry as of September 12, 1989, as
well as his opinion as to whether claims of the ‘132 Patent here in issue are
anticipated, by the ‘560 patent and if those claims are obvious.
[32]
Dr.
Bodor summarized the development of prostaglandins as of September 12, 1989. He
also gave a definition of the POSITA. He concluded that that the claims are
obvious and anticipated, in light of the ‘560 patent which he observed would direct
a person skilled in the art to Latanoprost.
[33]
Dr.
Cheryl Cullen is an Associate Professor in the Faculty of Veterinary Medicine
at the University of Calgary, in Calgary,
Alberta.
She was asked to provide comments on the animal models and testing described in
the ‘132 Patent, and whether these models and tests were sufficient to permit
the inventors to predict the behaviour of a new prostaglandin in the treatment
of glaucoma in humans.
[34]
Dr.
Cullen found both the animals and testing insufficient for the purposes of
predicting the behaviour of a new prostaglandin in the treatment of glaucoma in
humans. Her affidavit sets out various criticisms, including criticism of the sample
size and the alleged lack of data.
[35]
Dr.
Allan J. Flach holds a doctorate in pharmacy and a medical degree. He is an
American Board of Ophthalmology certified ophthalmologist and has worked in the
field of ophthalmology for more than 30 years. He has been a tenured professor
within the Department of Ophthalmology at the USCF Medical Center for 23
years. He was asked to provide a history of prostaglandins, to describe the
POSITA and to give his opinion on the animal models and test data found in the
‘132 Patent.
[36]
He
concluded that the animal models used were not sufficiently reliable to predict
the efficacy and toxicity of prostaglandins in humans. He found that the
results of the animal testing could “only provide a general indication of how
the prostaglandins will behave in humans”. He also concluded that the small
number of humans tested was insufficient to support a prediction as to whether
the human response to efficacy or toxicity would be favourable or otherwise.
[37]
Dr.
Howard Leibowitz is a medical doctor with specialized training in
ophthalmology. From 1971 to 2002, he served as the Chairman, Department of
Ophthalmology, Boston University School of Medicine. He has been recognized by
his peers as an expert in external ophthalmic diseases and other diseases. Dr.
Leibowitz was asked to provide his opinion on the POSITA, background
information on glaucoma, the claims of the ‘560 patent, whether the ‘132 Patent
discloses sufficient data and information to support a prediction that Latanoprost
reduces IOP without causing substantial ocular irritation in humans and whether
Latanoprost meets the promise of the patent.
[38]
In
Dr. Leibowitz’ opinion, the ‘132 Patent claims a treatment for glaucoma and
ocular hypertension without substantial ocular irritation and hyperemia. He
expressed the opinion that the ‘560 patent describes and claims “a class of PGE2
and PGF2α eicosanoid (prostaglandin) derivatives, for the
treatment of ocular hypertension without tachyphylaxis”. He expressed the
opinion that the ‘132 Patent did not disclose data or results that show that
Latanoprost has “surprising or unexpected properties” in light of the teachings
of the ‘560 patent. Finally, he rejected the idea that there was a sound
prediction that Latanoprost would “lack” ocular irritation and hyperemia, as
side effects in humans.
[39]
Finally,
the Respondent filed the affidavits of Ms. Chrystal Yorke and Ms. Ines Ferreira.
[40]
Ms.
Yorke, at the time of swearing her affidavit, was an articling law clerk. She
deposed that she attended at the Office of Patented Medicines and Liaison,
Health Canada Therapeutic Products Directorate and obtained documents relating
to the listing of the ‘560 patent on the Patent Register. These documents,
being copies of Form IV Patent List relating to the ‘560 patent, are attached
as exhibits to her affidavit.
[41]
Ms.
Ferreira is a legal assistant with the Solicitors for the Respondent. She
attached, as exhibit “A” to her affidavit, a copy of a “Patent Expiry Report”
for the period January 2003 to December 2003, obtained from the Canadian Patent
Register website. This report notes that the Canadian Patent ‘560 under the
brand name “Xalatan”, using the medicinal ingredient Latanoprost, expired in
July 2003.
[42]
Ms.
Ferreira also attached a copy of the Respondent’s NOA and its Schedules as
exhibit “B”. The Schedules to the NOA include, in Schedule “B", the
documents cited by the Respondent as prior art.
C. The Eye, Glaucoma
and Ocular Hypertension
[43]
The
‘132 Patent deals with an ophthalmic solution for treatment of glaucoma and
ocular hypertension. The eye is a closed sphere that produces a clear fluid
called aqueous humor. Aqueous humor is essential to the functioning of
the eye. It conveys nutrients to the eye and removes waste products and
contaminants from the eye. Drainage of aqueous humor assists in avoiding an
increase in intraocular pressure. Elevated IOP is one of the strongest risk
factors for disorders of the eye, including glaucoma and ocular
hypertension.
[44]
Ocular
hypertension means elevated intraocular hypertension in the absence of damage
to the optic nerve, according to Dr. Fechtner. Glaucoma, according to Dr. Fechtner,
describes a group of disorders that are characterized by damage to the optic
nerve that results in loss of vision if the condition is left untreated.
Elevated intraocular pressure is one of the strongest risk factors for the
development and progression of glaucoma.
[45]
There
is no cure for glaucoma but both this disease and ocular hypertension can be
managed by the reduction of intraocular pressure. According to Dr. Fechtner,
this is the only risk factor of these disorders that can be modified by treatment.
[46]
Two
possible ways of reducing intraocular pressure by the use of drugs are the
reduction in the production of aqueous humor and second, an increase in
the outflow of aqueous humor.
[47]
Successful
treatment of glaucoma by the use of drugs requires a high level of patient
compliance. Therapies with less frequent dosages are preferred by patients and
contribute to patient compliance.
[48]
Tolerance
of the drug regime is another factor that affects patient compliance.
Tolerability of drugs refers to the existence of side effects. Side effects may
be systemic, that is occurring throughout the body or local, that is adverse
effects occurring in and around the eye. Systemic effects of drugs used to
treat glaucoma include worsening of asthma or emphysema. Local side effects
include ocular inflammation, that is within the eye, and irritation, that is
side effects occurring outside the wall of the eye.
[49]
Conjunctival
hyperemia, that is redness of the eye, may also be a local side effect.
Conjunctival hyperemia can be experienced with or without irritation.
[50]
Prior
to the advent of Latanoprost, other drugs were on the market for the treatment
of glaucoma and ocular hypertension. According to the evidence of Dr. Neufeld and
Dr. Fechtner, these drugs included timolol maleate, epinephrine and acetazolamide
which caused side effects, including burning, hyperemia, tingling, and
stomach upset. Further, more serious systemic effects of these drugs were
blood disorders, cardiac arrhythmia, asthma, emphysema and death.
II. Issues
[51]
The
following issues arise from this application:
i.
How
should the claims in issue be construed?
ii.
Will
the Respondent’s drug infringe the ‘132 Patent?
iii.
Are
any of the Respondent’s allegations of invalidity justified, as follows:
(a) double
patenting
(b) anticipation;
(c) obviousness;
(d) lack of
utility;
(e) lack of sound
prediction;
(f) overbreadth.
III. Discussion and Disposition
[52]
The
parties filed a considerable amount of evidence in relation to this
proceeding. I will not refer to all of the evidence contained within the record
but instead will base my conclusions upon that evidence which I found to be
most relevant, credible and reliable. I have not ignored evidence which is not
specifically mentioned.
A. Nature of This Proceeding
[53]
This
application seeks to prohibit the issuance of a NOC to the Respondent for its
product which contains Latanoprost. The Applicants challenge the Respondent’s
NOA on the grounds that the allegations of invalidity of the ‘132 Patent are
not justified.
[54]
A NOC
grants marketing approval for drugs in Canada. It is issued by the Federal Government,
indicating that all requirements have been met pursuant to the Food and Drug
Regulations for the protection of public health and safety. The NOC Regulations
authorize owners of existing patents for pharmaceutical products to file a
“patent list” relative to those products for which they hold a NOC. The NOC
Regulations refer to the person filing such a list as the “first person”. In
this case, the Applicants are the “first person”.
[55]
The
framework of the NOC Regulations allows generic drug manufacturers to rely on
prior approval of related pharmaceutical products in applying for marketing
approval of their generic form of the products. Manufacturers who produce the
same drug may file an application for a NOC that refers to and relies on the
fact that prior approval has been granted for the brand-name version of the
drug. Such a manufacturer is known as the “second person” and that is the
Respondent’s status.
[56]
The NOC
Regulations prohibit the Minister of Health from issuing a NOC until all
relevant product and use patents in the earlier approved medicine, as described
in the patent list, have expired. Consequently, a second person must either
wait until patent expiry before receiving a NOC or it may submit a NOA to the
Minister with its new drug submission.
[57]
The NOC
Regulations require service of the NOA upon the first person. Section 5 sets
out the grounds upon which a NOA is to be based. Briefly, the NOA must assert
either that the first person is not the patentee, that the patent is expired or
invalid, or that it would not be infringed if a NOC were issued.
[58]
Following
service of the NOA, the Minister may issue a NOC to the second person, unless
the first person avails of its right, pursuant to section 6(1) of the NOC
Regulations, to seek an order from the Federal Court prohibiting the Minister
from issuing the NOC. Any such step must be taken by the first person within 45
days after receipt of the NOA and once such a proceeding is commenced, the
issuance of a NOC to the second person is stayed for a maximum period of 24
months.
B. Burden of Proof
[59]
Before
addressing the specific aspects of this case, I will briefly address the
jurisprudence applicable to the burden of proof and the question that must be
answered in a NOC proceeding. It is well-established that the burden of proving
that the second person’s, that is, Apotex’s, allegations are not justified is
on the person seeking the Prohibition Order, Pfizer. Pfizer must establish, on
a balance of probabilities, that Apotex’s allegations are not justified. Apotex
must put its allegations “in play” through its NOA. However, once that has been
done, Pfizer bears the burden of proving that such allegations are not
justified, on a balance of probabilities: see Eli Lilly and Co. v. Nu-Pharm
Inc. (1996), 69 C.P.R. (3d) 1 (F.C.A.), Merck Frosst Canada Inc. v.
Canada (Minister of National Health and Welfare) (1994), 55 C.P.R. (3d) 302
(F.C.A.) and SmithKline Beecham Pharma Inc. v. Apotex Inc., [2001] 4
F.C. 518 (T.D.), aff’d (2002), 291 N.R. 168 (F.C.A.).
[60]
Second,
the Court must determine whether Apotex’s allegations of invalidity are
justified or not. In Pharmacia Inc. v. Canada (Minister of National Health and
Welfare)
(1994), 58 C.P.R. (3d) 209 (F.C.A.) (“Pharmacia”) the Federal Court of
Appeal commented upon the standard to be applied to this type of proceeding, at
page 216:
...these proceedings are not actions for
determining validity or infringement: rather they are proceedings to determine
whether the Minister may issue a notice of compliance. That decision must turn
on whether there are allegations by the generic company sufficiently
substantiated to support a conclusion for administrative purposes (the issue of
a notice of compliance) that the applicant’s patent would not be infringed if
the generic’s product is put on the market…
[61]
In SmithKline,
Justice Gibson considered the evidentiary burden in proceedings under the NOC
Regulations where invalidity of a patent is alleged. At paragraphs 14 to15 he
wrote the following:
Against the foregoing, I conclude that
while an “evidential burden” lies on Apotex to put each of the issues raised in
its notice of allegation “in play”, if it is successful in doing so, the “persuasive
burden” or “legal burden” then lies with SmithKline. Assuming Apotex to be
successful in putting the issue of validity of the ‘637 patent “in play”,
SmithKline is entitled to rely on the presumption of validity of the patent
created by subsection 43(2) of the Act.
The “persuasive burden” or “legal burden”
that lies with SmithKline in the circumstances described in the preceding
paragraph is, however, impacted by the nature of the proceeding here before the
Court. In Merck Frosst Canada Inc. v. Canada (Minister of National Health and
Welfare),
[(1994), 55 C.P.R. (3d) 302 (F.C.A.)] Mr. Justice Hugessen, for the Court,
wrote at pages 319-20:
As I understand the scheme of the
regulations, it is the party moving under s. 6, in this case Merck, which, as
the initiator of the proceedings, has the carriage of the litigation and bears
the initial burden of proof. That burden, as it seems to me, is a difficult one
since it must be to disprove some or all of the allegations in the notice of
allegation which, if left unchallenged, would allow the Minister to issue a
notice of compliance…
…
In this connection, it may be noted
that, while s. 7(2)(b) [of the Regulations] seems to envisage the court making
a declaration of invalidity or non-infringement, it is clear to me that such
declaration could not be given in the course of the s. 6 proceedings
themselves. Those proceedings, after all, are instituted by the patentee and
seek a prohibition against the Minister; since they take the form of a summary
application for judicial review, it is impossible to conceive of them giving
rise to a counterclaim by the respondent seeking such a declaration. Patent
invalidity, like patent infringement, cannot be litigated in this kind of
proceeding.
Thus, the burden on SmithKline is only to
disprove the allegations in the notice of allegation, not to justify
declarations of validity and infringement or conversely to negative claims for
declarations of invalidity and non-infringement.
[62]
The burden
lies on Pfizer, as the Applicants, to refute the allegations set forth by Apotex
in its NOA dated March 4, 2008. Like any plaintiff or applicant, Pfizer has the
overall legal burden of proof. Apotex, as the Respondent, has an obligation to
put the allegations set out in its NOA in play.
[63]
The
present proceeding is a summary proceeding pursuant to the NOC Regulations and
the Federal Court Rules, SOR/98-106 (the “Rules”) governing applications
for judicial review. A finding of invalidity or infringement in the context of
this type of proceeding is not determinative of that issue in any subsequent
action; see Pharmacia at page 216.
Issue 1: Construction of
the ‘132 Patent
[64]
According
to the direction given by the Supreme Court of Canada in its decisions in Whirlpool
Corp. v. Camco Inc. (2000), 9 C.P.R. (4th) 129 (S.C.C.) and Free
World Trust v. Électro Santé Inc. (2000), 9 C.P.R. (4th) 168
(S.C.C.), before addressing the issues of infringement and invalidity, the
Court must first construe the patent.
[65]
Claims
construction must be approached in an informed and purposive manner, with close
regard to the purpose and intent of the authors. Information is to be gained
from the patent as a whole in order to determine the context in which the
claims are to be considered. The role of experts is to provide assistance, if
necessary, relative to the technical meaning of the words and concepts used in
the claims; see Whirlpool at paragraphs 51 and 52. In construing the
claim, the Court should be neither harsh nor benevolent but approach the claim
with a mind willing to understand.
[66]
The
‘132 Patent specification gives an overview of disorders of the eye
derived from elevated IOP, discloses the results if the eye disorder is left
untreated, and defines the formulae to determine IOP levels. The specification
goes on to discuss the current state of the art available at the time the
patent application was filed as well as the available research activity
undertaken in the use of prostaglandins. Finally, the specification discloses
the solution that the invention solves as well as some of the preferred
derivatives and preferred methods of preparing, testing, using and applying the
invention.
[67]
The
‘132 Patent is governed by the provisions of the Patent Act, R.S.C.
1985, c. P-4, (the “Act”). The provisions of the Act that pertain to patents
applied for prior to October 1, 1989, are called “Old Act Patent”. The claims
are to be construed from the date of issue, that is July 29, 1997. The ‘132 is
an “Old Act Patent”.
[68]
The
Applicants and the Respondent made submissions on the issue of claims
construction. The Applicants argued that claims construction should follow the
steps outlined by the Supreme Court of Canada recently in its decision in Sanofi-Synthelabo
Canada Inc. v. Apotex Inc. (2008), 298 D.L.R (4th) 385
(S.C.C.) at para. 76.
[69]
The
Respondent submits that the claim in issue should be construed as addressing
the abolition of side effects in the chronic treatment of glaucoma by the use
of the compound described in Claim 19 of the ‘132 Patent. Further, it argues
that the promise of the patent is chronic use of the compound.
[70]
As
noted earlier, Claims 12, 19, 31, 37 and 38 are in issue in this proceeding.
Broadly speaking, Claim 19 is a compound per se claim. Claims 12, 31, 37
and 38 are use claims, with Claim 12 limited by reference to Claim 1.
[71]
In
Pfizer Canada Inc. v. Canada (Minister of Health), [2009]
F.C.J. No. 1659 (F.C.) (Q.L.), I construed Claims 12, 19, 31, 37 and 38 of the
‘132 Patent, the same claims that are in issue here. I am not persuaded by the
evidence submitted by the Respondent nor by its arguments that the construction
of these claims should differ from what I have already said and my prior
construction will apply here, too.
[72]
Claim
19 reads as follow:
19. Compound
of claim 18, wherein the alkyl group is isopropyl.
[73]
This
claim is for the chemical compound described in Claim 18. Claim 18 reads as
follows:
18.
13,14-dihydro-17-phenyl-18,19,20-trinor-PGF2α
-alkyl-ester, in which the alkyl group has 1-10 carbon atoms.
[74]
I
construe Claim 19, having regard to Claim 18 as being a chemical compound with
isopropyl as the alkyl group. The isopropyl used as the alkyl group has three
carbon atoms.
[75]
Claims
12, 31, 37 and 38 are use claims and I construe them as such. Claim 12 refers
to Claim 1 and accordingly, can be read as follows:
i.
A
therapeutic composition for topical treatment of glaucoma or ocular
hypertension, containing a prostaglandin PGA, PGB, PGD, PGE or PGF in an amount
sufficient to reduce intraocular pressure without causing substantial ocular
irritation and an ophthalmologically compatible vehicle, which the omega chain
of the prostaglandin has the formula:
(13)
(14) (15-24)
C - B
- C - D - R2
wherein
C
is a carbon atom (the number is indicated within parenthesis);
B is a
single bond, a double bond or a triple bond;
D is a chain
with 1-10 carbon atoms, optionally interrupted by hetero atoms O, S, or N, the
substituents on each carbon atom being H, alkyl groups, lower alkyl groups with
1 – 5 carbon atoms, an oxo functionality or a hydroxyl group;
R2
is a ring structure selected from the group consisting of phenyl and phenyl
having at least one substituent, said substituent being selected from C1-C5
alkyl groups, C1-C4 alkoxy groups, trifluoromethyl
groups, C1-C3 aliphatic acylamino groups, nitro groups,
halogen atoms, and phenyl group; or an aromatic heterocyclic group having 5-6
ring atoms, selected from the group consisting of thiazol, imidazole,
pyrrolidine, thiopene and oxazole; or a cycloalkane or a cycloalkene with 3-7
carbon atoms in the ring, optionally substituted with lower alkyl groups with
1-5 carbon atoms.
12. An
ophthalmological composition according to claim 1, wherein the prostaglandin
derivative is 13,14-dihydro-17-phenyl-18,19,20-trinor-PGF2α
-isopropylester.
[76]
The
claim for use in Claim 12 is limited by the reference in Claim 1 to the
reduction of intraocular pressure “without causing substantial ocular
irritation”.
[77]
Claim
31 provides as follows:
31. The
use of 13,14-dihydro-17-phenyl-18, 19,20-trinor-PGF2α
-isopropylester in the treatment of glaucoma or ocular hypertension.
[78]
I
construe this to be a claim for the use of the compound in Claim 19 in the
treatment of glaucoma or ocular hypertension. Glaucoma and ocular hypertension
are disorders of the eye, according to the evidence of the expert witnesses.
[79]
Claim
37 provides as follows:
37. The
use of 13,14-dihydro-17-phenyl-18,19,20-trinor- PGF2α
-alkyl-ester, in which the alkyl group has 1-10 carbon atoms for the treatment
of glaucoma or ocular hypertension.
[80]
I
construe this to be a claim for the use of the compound claimed in Claim 19 for
the treatment of glaucoma or ocular hypertension.
[81]
Claim
38 provides as follows:
38. The
use of 13,14-dihydro-17-phenyl-18,19,20-trinor- PGF2α
-isopropyl-ester in the treatment of glaucoma or ocular hypertension.
[82]
I
construe this to be another claim for the use of the compound claimed in Claim
19 in the treatment of glaucoma or ocular hypertension. It is identical to
Claim 37 with a difference in the spelling of “isopropylester”, a hyphen is
included in Claim 38.
[83]
Since
this is an Old Act Patent, the operative date for claims construction is the
date of issuance of the ‘132 Patent, that is July 29, 1997. In this regard, I
refer to the decision in Janssen-Ortho Inc. v. Novopharm Ltd. (2006),
57 C.P.R. (4th) 6 (F.C.), aff’d (2007), 59 C.P.R. (4th) 116 (F.C.A.), leave
to appeal to S.C.C. refused, [2007] 3 S.C.R. xii.
Issue 2: Infringement
[84]
The
Respondent alleges that its product will not infringe the ‘132 Patent because
the ‘132 Patent claims an old use for an old compound. This kind of allegation
is known as the “Gillette Defence” on the basis of the decision in Gillette
Safety Razor Co. v. Anglo-American Trading Co. Ltd. (1913), 30 R.P.C. 465
(H.L.) at 480 to 481 where the House of Lords said the following:
…The defence that “the alleged
infringement was not novel at the date of the plaintiff’s Letters Patent” is a
good defence in law, and it would sometimes obviate the great length and
expense of Patent cases if the defendant could and would put forth his case in
this form, and thus spare himself the trouble of demonstrating on which horn of
the well-known dilemma the plaintiff had impaled himself, invalidity or
non-infringement.
[85]
The
Gillette Defence has been raised in many cases in Canada but has
rarely been successful. One exception to that trend is the decision in Eli
Lilly Canada Inc. v. Apotex Inc.(2009), 75 C.P.R. (4th) 165 (F.C.),
at paras. 60 to 64, where the Court, per Justice Hughes, found that the product
to be produced by the respondent would not be different from that produced by
the process of a prior art patent and in theory, the respondent would infringe
the patent in issue in the proceedings before him. However, he found that the
product of that earlier patent anticipates the product of the patent in issue
and consequently, the claims in issue were invalid.
[86]
In
my opinion, the availability of the “Gillette Defence” depends upon the
determination of the many allegations of invalidity raised by the Respondent. This
means that if the allegations of anticipation and obviousness fail, this
Gillette Defence must also fail.
[87]
Dr.
Neufeld addressed the issues of infringement on behalf of the Applicants. He
referred to the description of the Respondent’s product as set out in the NOA
as follows:
APO-latanoprost (latanoprost) is an
ophthalmic solution that is meant to be used topically as eyedrops for the reduction
or treatment of IOP in patients that have open-angle glaucoma or ocular
hypertension.
[88]
In
his affidavit, he said that the active pharmacological ingredient in APO-latanoprost
is 13, 14-dihydro-17-phenyl-18,19,20-trinor-PGF2α-isopropyl
ester which is Latanoprost as set out in Claim 19 of the ‘132 Patent.
[89]
Dr.
Neufeld reviewed the five claims of the ‘132 Patent that are in issue and
tendered the opinion that the Respondent’s product will infringe each claim. Claim
12 of the ‘132 Patent claims an ophthalmological composition containing
Latanoprost as described in Claim 19. He also reviewed the use claim in Claims
31, 37 and 38, in comparison with APO-latanoprost, and concluded that the use
claim will be infringed by the Respondent’s product.
[90]
The
disposition of the allegation of non-infringement by the Respondent, then,
depends upon the assessment of the allegations of invalidity that the
Respondent advances.
[91]
The
Regulations that apply here are the ones as they stood prior to the
modifications which came into force on October 5, 2006 since Pfizer’s NOC was
granted before October 5, 2006.
Issue 3: Invalidity
[92]
The Respondent advanced several grounds of
invalidity against the ‘132 Patent, as follows: double patenting, anticipation,
obviousness, lack of utility, lack of sound prediction, overbreadth and lack of
sufficiency.
i) Double
Patenting
[93]
The Respondent alleges that the ‘132 Patent is invalid for double
patenting and refers in this regard to the ‘560 patent. This patent was issued
on July 29, 1986. The ‘560 patent is owned by the Trustees of Columbia
University in the City of New York, New York, United States of America.
[94]
The
‘560 patent is not owned by the Applicants. Further, the claims in the ‘560 patent
are different from those in the ‘132 Patent. In these circumstances, I am not
persuaded that the Respondent has established that the ‘132 Patent is invalid
on the grounds of double patenting.
ii) Anticipation
[95]
Two
distinct requirements must be met in order to prove anticipation, that is disclosure
and enablement. The Supreme Court of Canada addressed these requirements in its
decision in Sanofi. Adopting the approach taken by Lord Hoffmann in the
decision of the House of Lords in Synthon B.V. v. SmithKline Beecham plc,
[2006] 1 All E.R. 685 (H.L.), Mr. Justice Rothstein said the following at paragraph
25 of Sanofi:
He explains that the requirement of prior
disclosure means that the prior patent must disclose subject matter which, if
performed, would necessarily result in infringement of that patent, and states,
at para. 22:
If I may summarise the effect of these
two well-known statements [from General Tire and Hills v. Evans],
the matter relied upon as prior art must disclose subject matter which, if
performed, would necessarily result in an infringement of the patent. . . 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.
When considering the role of the person
skilled in the art in respect of disclosure, the skilled person is “taken to be
trying to understand what the author of the description [in the prior patent]
meant” (para. 32). At this stage, there is no room for trial and error or
experimentation by the skilled person. He is simply reading the prior patent
for the purposes of understanding it.
[96]
Once
the element of disclosure has been addressed, the Supreme Court in Sanofi
instructed that the second step, that is enablement, is to be considered only
if the prior element of disclosure is satisfied. In this regard, I refer to
paragraph 26 of Sanofi where the Supreme Court said the following:
If the disclosure requirement is
satisfied, the second requirement to prove anticipation is “enablement” which
means that the person skilled in the art would have been able to perform the
invention (para. 26). Lord Hoffmann held that the test for enablement for
purposes of anticipation was the same as the test for sufficiency under the
relevant United Kingdom legislation. (Enablement for the
purposes of sufficiency of the patent specification under the Canadian Patent
Act, s. 34(1)(b) of the pre-October 1, 1989 Act, now s. 27(3)(b), is not an
issue to be decided in this case and my analysis of enablement is solely
related to the test for anticipation. The question of whether enablement for
purposes of sufficiency is identical in Canada is better left to another day.)
[97]
In
short, the disclosure requirement is met when a single document discloses
subject matter that, if performed, would necessarily result in infringement. If
there is more than one possible result, there is no disclosure. Further, the
requirement of disclosure is not met when the prior art teaches a broad class
and the invention is for a specific member of that class; see Sanofi, Synthon
and Pfizer Canada Inc. v. Canada (Minister of Health) (2008), 67
C.P.R. (4th) 23 (F.C.A.), at para. 83 (“Pfizer 2008”).
[98]
Any
patent application filed and any patent issuing from it must comply with subsection
27(1) of the Act which outlines the relevant date to assess the state of the
art. In this proceeding, it is two years before the Canadian filing date of
the application. The filing date for the ‘132 Patent is September 12, 1989
under the Act and consequently, anticipation is based on a date on or before
September 12, 1987. Subsection 27(1) of the Act provides:
27. (1)
Subject to this section, any inventor or legal representative of an inventor
of an invention that was
(a)
not known or used by any other person before he invented it,
(b)
not described in any patent or in any publication printed in Canada or in any other country more than two years before
presentation of the
petition
hereunder mentioned, and
(c)
not in public use or on sale in Canada for more than two years prior to his
application in Canada, may, on presentation to the Commissioner of a petition
setting out the facts, in this Act termed the filing in the application, and
on compliance with all other requirements of this Act, obtain a patent
granting to him an exclusive property in the invention.
|
27.
(1) Sous réserve des autres dispositions du présent article, l’auteur de
toute invention ou le représentant légal de l’auteur d’une invention peut,
sur présentation au commissaire d’une pétition exposant les faits, appelée
dans la présente loi le « dépôt de la demande », et en se conformant à toutes
les autres prescriptions de la présente loi, obtenir un brevet qui lui
accorde l’exclusive propriété d’une invention qui n’était pas :
a) connue ou utilisée par une autre
personne avant que lui‑même l’ait faite;
b) décrite dans un brevet ou dans une
publication imprimée au Canada ou dans tout autre pays plus de deux ans avant
la présentation de la pétition ci‑après mentionnée;
c) en usage public ou en vente au
Canada plus de deux ans avant le dépôt de sa demande au Canada.
|
[99]
The
Respondent cited many articles of prior art. All documents with a date on or
before September 12, 1989, the filing date, have been reviewed. No document
listed in the prior art disclosed the chemical composition of Latanoprost as
defined in the ‘132 Patent for the treatment of glaucoma or ocular hypertension
as further discussed below.
[100] In its NOA,
the Respondent referred to several pieces of prior art. Its expert witnesses
addressed some of this prior art, including two articles by E. Granstrom and
the ‘560 patent.
[101] The first
Granstrom article is entitled “Metabolism of 17-phenyl-18,19,20-trinor PGF2α
in the Cynomolgus Monkey and the Human Female”. It was accepted on
December 16, 1974 and published in January 1975; it was NOA Document No. 5. The
second Granstrom article, NOA Document No. 6, was published on December 1, 1976.
[102] The ‘560 patent
was issued on July 26, 1986.
[103] Dr. Bodor
opined that both the Granstrom articles and the ‘560 patent anticipate
Latanoprost. He said that the Granstrom articles described an active species of
Latanoprost, disclosed the benefits of reducing the 13,14-double bond to a
single bond, and demonstrated that the oxidation of the 15-OH position to the
corresponding ketone occurs extremely quickly.
[104] Dr. Bodor and
Dr. Leibowitz took similar stances with respect to the ‘560 patent, saying that
this patent disclosed Latanoprost as having promising therapeutic profiles with
respect to treating ocular hypertension without causing significant side effects
and that isopropyl esters of PGF2α derivatives are the most
preferred.
[105] Dr. Bodor
also addressed other pieces of prior art, that is an article by B.J. Magerlein,
G. L. Bund, F.H. Lincoln and G.A. Youngdale entitled “Synthesis of
17-Phenyl-18,19,20-Trinorprostaglandins”, published in January 1975, NOA
Document No. 3, and an article by Dr. Bito entitled “Comparison Of The Ocular Hypotensive
Efficacy of Eicosanoids and Related Compounds”, published February 1984, NOA
Document No. 17. He offered the opinion that according to the Magerlein article,
a POSITA would know to substitute a phenyl ring onto the omega chain of
a PGF2α prostaglandin
for the purpose of improving its metabolic profile and overall corneal
permeability. The Bito article taught that esters of PGF2α compounds
and derivatives, especially the isopropyl ester, were more readily absorbed in
the body. He expressed the opinion that all the molecular changes in the ‘132
Patent were already known to the POSITA as disclosed in the prior art.
[106] Furthermore, Dr.
Bodor said that the Granstrom article, NOA Document No. 6, disclosed an active
species form of Latanoprost as an observed metabolite.
[107] Dr. Maxey,
Dr. Fechtner and Dr. Neufeld, expert witnesses on behalf of the Applicants,
disagreed with the opinions expressed by the Respondent’s expert witness. Dr.
Maxey considered the opinions regarding the anticipatory effect of NOA Document
Nos. 3 and 17, the Granstrom articles, the ‘560 patent, and other NOA documents.
He said the opinion of both Dr. Bodor with respect to the prior art documents
demonstrate a hindsight approach and further, that many of these documents have
nothing to do with the eye. He said that the Granstrom articles do not disclose
the isopropyl compound and the ‘560 patent does not disclose or enable the
POSITA.
[108] Having regard
to the conflicting evidence given by the expert witnesses for the Applicants
and the Respondent, and having reviewed the documents in question, I am
satisfied that none of the documents relied upon by the Respondent disclose the
chemical composition of Latanoprost as defined in the ‘132 Patent for the
treatment of glaucoma or ocular hypertension. There is not a single prior
publication that discloses all the information that is necessary, for practical
purposes, to perform the claimed invention without the exercise of any
inventive skill.
[109] In the
hearing, the Respondent spent a lot of time addressing the issue of
anticipation by reference to the ‘560 patent. Arguments were made about the
“broad” anticipation afforded by the ‘560 patent. However, the Respondent
advanced refinements on the anticipation argument by submitting that inclusion
of the ‘560 patent on the Form IV Patent list by the Applicants was an
“admission” that the ‘560 patent disclosed Latanoprost and accordingly, that
the ‘560 patent anticipated the ‘132 Patent.
[110] Additionally,
in the hearing, Apotex argued that the only defence of the ‘132 Patent was a selection
patent against the ‘560 patent as the genus patent. The Respondent
amplified the theme of selection patent status of the ‘132 Patent in further
submissions that were made on January 22, 2010 following the decision of Mr.
Justice O’Reilly in Eli Lilly Canada Inc. v. Novopharm Ltd. (2009), 78
C.P.R. (4th) 1 (F.C.). I will first address the Respondent’s
submissions concerning the effect of the inclusion of the ‘560 patent on the
Form IV Patent List filed, at some point, by the Applicants.
[111] The
Respondent’s argument as to the effect on including a drug on the Form IV is
enough to establish invalidity of the subject patent on the grounds of
anticipation. The subject patent here is the ‘132 Patent and the reference is
the ‘560 patent.
[112] Unfortunately,
however, the Respondent cites no jurisprudence in support of its position. In
several decisions, the Federal Court and the Federal Court of Appeal have said
that a challenge to the inclusion of a patent on the Patent List is to be made
by way of a motion pursuant to subsection 6(5) of the Regulations and not by
way of submissions upon an application for a prohibition order. In this regard,
I refer to the decisions in Wyeth Canada v. Ratiopharm Inc. (2007), 58
C.P.R. (4th) 154 (F.C.), aff’d (2007), 60 C.P.R. (4th)
375 (F.C.A.); Ferring Inc. v. Canada (Minister of
Health),
55 C.P.R. (4th) 271 (F.C.) and Solvay Pharma Inc. v. Apotex Inc. (2008),
64 C.P.R. (4th) 246 (F.C.).
[113] While I
understand that the Respondent is not directly challenging the inclusion of the
‘560 patent on Form IV of the Patent List but rather the effect of such
inclusion, I am not prepared to accept the arguments of the Respondent, that
such inclusion is per se evidence of anticipation, in the absence of jurisprudence
in support of that submission.
[114] I turn now to
the Respondent’s submissions about the characterization of the ‘132 Patent as a
selection patent. According to the Respondent, the only defence available to
the Applicants to the allegation of anticipation, was to claim that the ‘132
Patent was a selection patent arising from the genus patent, that is the ‘560 patent.
[115] The
Applicants did not make this assertion but chose to defend against the
allegation of anticipation on other grounds.
[116] In addressing
the decision of Justice O’Reilly in Eli Lilly the Respondent
reviewed the facts. In that case, the innovator drug manufacturer, Eli
Lilly Inc., had unsuccessfully sought a prohibition order in respect of
Canadian Patent No. 2,041,113 (the “ ‘113 patent”). Mr. Justice Hughes, the
applications judge, found that the ‘113 patent was not a valid selection patent
of the ‘1,075,687 (the “ ‘687 patent”). Novopharm began making the drug that
was the subject of the ‘113 patent and Eli Lilly brought an infringement action.
[117] In disposing
of the infringement action, Justice O’Reilly found that the ‘113 patent was not
a valid selection patent selected from the ‘687 patent even if the ‘113 patent
were inventive in the “pharmaceutical sense”. At paragraph 47 of his Reasons,
he said:
As discussed, the earlier ‘687 patent
covered olanzapine, as well as a large number of other related compounds. By
contrast, the ‘113 patent deals with olanzapine alone. In these circumstances,
patent law considers the ‘113 to be a “selection patent”. A selection patent is
valid if it discloses to the public something new and useful in exchange for a
further monopoly on the already-patented compound. In other words, the question
is whether the selected compound truly represents an invention that merits a
separate and free-standing monopoly. An “invention” under s. 2 of the Patent
Act is a “new and useful . . . composition of matter, or any new and useful
improvement in any . . . composition of matter”. Just as with any other kind
of patent, then, a selection patent must disclose an invention. What sets
selection patents somewhat apart is that the inventor must disclose an
invention over and above what was disclosed in the prior patent – the “genus”
patent – covering the selected compound.
[118] Justice
O’Reilly concluded that Eli Lilly had not found unexpected or special qualities
that would justify a fresh monopoly but had only conducted routine testing. The
patent was an invalid selection patent and anticipated by the ‘687 patent.
Since he found that the ‘687 patent was an invalid selection patent, there was
no need to consider the requirements for anticipation or double patenting. The
Court found no inventive step when addressing the issue of obviousness.
[119] The
Respondent argues that a similar analysis and result arise in the present case.
It frames the question as being whether the ‘132 Patent could validly claim Latanoprost
even though the ‘560 patent had disclosed and claimed a genus that includes
Latanoprost.
[120] Apotex argues
that the Eli Lilly decision stands for the proposition that in
addressing anticipation, the Court can conclude that the later patent, here the
‘132 Patent, is not a valid selection patent from the ‘560 patent because it
did not describe an invention, over and above what had been previously
disclosed.
[121] In reply to
the arguments, the Applicants relied on a recent decision of the Court of
Appeal of England and Wales in Dr. Reddy’s Laboratories (UK) Ltd. v. Eli
Lilly and Co. Ltd., [2010] R.P.C. 9 (C.A.) which is an appeal from the dismissal
of an application for revocation of the Eli Lilly patent for the compound olanzapine,
Patent EP No. 0454436 (the “ ‘436 patent”). The challenge to the ‘436 patent
was by reference to a previous British patent 1,533,235 (the “ ‘235 patent”) that
was also owned by Eli Lilly. The ‘235 patent claims a large class of compounds,
not all of which are tested or disclosed in the patent.
[122] The ‘436 patent
claimed a drug for the treatment of schizophrenia. The compound showed
surprising and unexpected properties as compared to other related compounds.
The ‘436 patent disclosed animal and early clinical tests and the results. The
‘235 patent shows 15 examples of the preparation of 15 specific compounds. The
specification did not disclose specific properties or experimental data on any
of the compounds.
[123] The drugs
available on the market for the treatment of schizophrenia, that is clozapine
and chlorpromazine, had severe side effects, for example involuntary movements
of the body or face, chronic distortion of posture, suppression of white blood
cells and even death. Until 1990, it was not known how clozapine worked to
avoid some of the bad side effects found when patients used chlorpromazine.
[124] The ‘436 patent
was attacked for lack of novelty, obviousness and insufficiency as compared to
the ‘235 patent.
[125] The Court
rejected the anticipation attack and concluded that there was no individualized
description or preferred embodiment of olanzapine in the ‘235 patent by which
the skilled person would be able to produce the compound.
[126] In dealing
with the obviousness attack, the Court said that a selection patent must show a
surprising characteristic that is peculiar to the group. It went on to say that
the ‘235 patent was almost useless and no guide to the skilled person for any
particular compound because it gave no reliable basis on the teaching and, or,
use of any compounds found within its very large class.
[127] The Court
also said that the fact that Eli Lilly owns both patents does not change the
principles to be applied in deciding whether the teaching of a more recent
patent is novel and non-obvious over an earlier patent. At paragraph 115, the
Court said:
…The analysis and outcome must be the
same if the 235 patent were claimed and owned by someone wholly unconnected to
Lilly, or indeed if the teaching of 235 was in an article published in an
academic journal…
[128] The
Applicants rely on this recent decision of the U.K. Court of Appeal in response
to the Respondent’s arguments about the Respondent’s reliance on the relevance
and applicability of the recent decision of Justice O’Reilly. They submit that
the decision in Dr. Reddy is consistent with the approach taken by the
Supreme Court of Canada to the issue of obviousness, in Sanofi. In both
instances, the Courts found that the possibility of performing every permutation
of compounds set out in a prior patent is still not enough to show
anticipation. In the present case, the Applicants do not admit that the ‘560 patent
is a genus patent and they do not assert that the ‘132 Patent is a selection
patent.
[129] Indeed, the
Applicants argue that the issue is not before the Court and should not be
entertained. However, insofar as the Respondent raises the issue in the context
of its allegation of anticipation and in view of the Applicants’ substantive
response to the arguments of the Respondent, in the face of recent
jurisprudence, I will consider the submissions of both parties.
[130] I agree with
the position advanced by the Applicants, in response to the merits of the
issue. I note that here, the Applicants are the licensees, not the owners, of
both the ‘132 Patent and the ‘560 patent. The ‘560 patent expired in July 2003
and now forms part of the general prior art.
[131] There is no
evidence in the record before me that the Applicants claim ownership of the
‘560 patent. They did not assert that the ‘132 Patent is a selection patent and
I decline the Respondent’s invitation that I make such a finding. In my
opinion, it is beyond the jurisdiction of this Court to advance an allegation
that has not been made by the parties, that is that the ‘132 Patent is a
selection patent of the ‘560 patent. The jurisprudence is clear that
allegations in a prohibitive proceeding are to be made, in clear terms and in a
timely manner, by the parties. In this regard, I refer to the decision in AB
Hassle v. Canada (Minister of National Health and Welfare) (2000), 7
C.P.R. (4th) 272 (F.C.A.).
[132] I agree with
the Applicants that the decision in Dr. Reddy follows the decision in Sanofi.
The proper approach here is to apply the principles of Sanofi and look
within the ‘560 patent to see if it anticipates the ‘132 Patent, to ask whether
the ‘132 Patent is made obvious by the ‘560 patent and finally, to ask whether
the ‘132 Patent has utility as compared to the ‘560 patent as prior art and as
compared to all other prior art cited by Apotex.
[133] The legal
test to establish anticipation requires the second person to show both
disclosure and enablement in an anticipatory publication. The Court needs to
consider the question of enablement if the prior publication meets the
requirements of disclosure. That threshold has not been met in this case.
[134] The
Respondent has not shown that any prior art anticipates the compound claimed in
Claim 19. It is not necessary for me to discuss the matter of enablement.
iii) Obviousness
[135] In Sanofi,
the Supreme Court of Canada set out the prevailing test for obviousness in Canada. This requires
the Court to consider the following elements:
(a) identify
the skilled person to whom the patent is addressed and the state of the art
known to that person;
(b) identify
the inventive concept in the claims, having regard to the disclosure if the
claims do not expand on that concept;
(c) determine
the differences between what was previously known and the inventive concept in
the claims; and
(d) determine
if those differences would be obvious without the benefit of hindsight.
[136] If the
“obvious to try” test is appropriate, Justice Rothstein in Sanofi
identified four additional but non-exhaustive factors to consider under the
fourth step:
(a) Is
it more or less self-evident that what is being tried ought to work? Are there
an infinite number of identified predictable solutions known to persons skilled
in the art?
(b) What
is the extent, nature and amount of effort required to achieve the invention?
Are routine trials carried out or is the experimentation prolonged and arduous,
such that the trials would not be considered routine?
(c) Is
there a motive provided in the prior art to find the solution the patent
addresses?
(d) What
is the course of conduct followed in arriving at the invention?
(1)
The Person of Ordinary Skill in the Art and the Common General Knowledge
[137] There is
really no dispute between the parties that the POSITA could be a medicinal or
organic chemist or a pharmacologist, holding at least a Bachelor’s degree, with
some familiarity with prostaglandins and the ophthalmological field, as well as
a medical doctor specializing in ophthalmology. The qualifications of the POSITA
were addressed by Dr. Bodor, Dr. Leibowitz, Dr. Flach, Dr. Fechtner, Dr. Wolff
and Dr. Maxey.
[138] The relevant
common general knowledge of the POSITA would include all of the prior art that
was submitted by the Respondent. The experts for both parties agreed that
prostaglandins have the potential to reduce IOP and that reduction of IOP was disclosed
in the prior art. The Applicants point out that the POSITA believed
prostaglandins caused side effects such as hyperemia and irritation in the
eye.
[139] The Respondent
disagreed and alleged that the ‘560 patent discloses no or very little
irritation occurring in the eye. These points were addressed by Dr. Fechtner,
Dr. Flach, Dr. Leibowitz, Dr. Neufeld and Dr. Stjernschantz. The relevant
common general knowledge would include awareness of the types of drugs on the
market at the filing date of the ‘132 Patent, that is September 12, 1989.
[140] The
Applicants repeatedly emphasized on the fact that Dr. Stjernschantz, as one of
the inventors, was awarded the Proctor Medal at the ARVO Conference in 2000. Their
emphasis upon the grant of this award for Dr. Stjernschantz’ work with
prostaglandins, including the invention of Latanoprost, undoubtedly illustrates
achievement and professional respect from peers and others working in the field
of ophthalmology.
[141] However,
receipt of this award per se is not dispositive of the legal issues of
obviousness and utility. These issues are subject to distinct legal tests in Canada. While the
evidence about the Proctor Medal is interesting and forms part of the
background, it is not a determinative answer to the allegations of invalidity
that are in play here.
[142] With respect
to the issue of the relevant common general knowledge of the POSITA, the
Applicants’ experts generally concurred that as of September 12, 1989 for Old
Act Patent that the POSITA would know that there was no available medication
that contained a prostaglandin for the treatment of glaucoma or ocular
hypertension.
[143] At that time,
that is as of September 12, 1989, the state of the art was a drug called timolol
that had to be administered to each eye between two and four times per day for
the rest of a patient’s life since glaucoma is a chronic condition that
requires continuing treatment.
[144] Both Dr.
Neufeld and Dr. Fechtner addressed that point in their affidavits. As well,
timolol causes systemic side effects such as cardio arrhythmia, asthma
and emphysema. There were other drugs on the market, such as acetazolamide, that
were effective in treating glaucoma or ocular hypertension with similar side
effects to timolol, but none contained prostaglandins.
(2)
The Inventive Concept
[145] The
Applicants claim that the inventive concept of the claims in issue is the use
of Latanoprost to reduce IOP in the treatment of glaucoma or ocular
hypertension without causing substantial ocular irritation.
[146] The
Respondent asserts that the inventive concept is the addition of the 17-phenyl
ring. It submits that this was known and consequently cannot be inventive.
[147] I am
persuaded by the evidence of the Applicants, that is the evidence of Dr. Fechtner
and Dr. Maxey. Dr. Fechtner, at paragraphs 113 to 115 of his affidavit, said
that he is satisfied that the ‘132 Patent, in comparison with the prior art,
“correctly and fully” describes the invention. Dr. Maxey, at paragraphs 70 to
74 of his affidavit, said that the POSITA, even a highly skilled POSITA, would
not have been led to Latanoprost.
[148] Prostaglandins,
according to both Dr. Maxey, are naturally occurring molecules and are found in
infinite combinations naturally. Synthetic types can be made with an infinite
number of molecular attachments.
[149] It is either
inconclusive or not clearly shown that prostaglandins, other than Latanoprost
at that time, did not cause substantial ocular irritation to the extent that
another type of prostaglandin was a viable option, except the fact that no other
drug was on the market at that time. None of the affidavits filed on
behalf of both the Applicants and the Respondent conclusively show that there
was another prostaglandin compound ready to be used as a drug on the market
with good patient compliance since the side effects were so high as documented
in the prior art. Pfizer and Apotex agreed that prostaglandins were a promising
area to explore due to the reduction in IOP. However, as of the filing date, the
IOP promise could not be separated from the side effects. More exploration was
needed to conquer side effects and irritation.
[150] As of
September 12, 1989, the general consensus was that prostaglandins were a
promising area to explore in terms of IOP reduction but more work was required,
since the possibility of patient non-compliance was high, due to the side
effects of hyperemia, irritation, burning and other intolerable reactions. The
body of conflicting evidence, for example, NOA Doc. 58 Bito Article
“Prostaglandins, Old Concepts and New Perspectives”, August 1987, NOA Doc. 9
Canadian Patent 986,926 and NOA Doc. 21 Canadian Patent 1,208,560 does
not show that the problem of side effects had been solved.
(3) Differences
Between the “State of the Art” and the Inventive Concept of the Claim.
[151] As of
September 12, 1989, the state of the art would have been the other medicines on
the market that were used to treat glaucoma or ocular hypertension. Those
medicines are timolol, epinephrine, acetazolamide and pilocarpine.
[152] Latanoprost,
a synthetic prostaglandin that was used to treat IOP without substantial ocular
irritation, would be different from the state of the art in September 1989 since
it is the first marketable prostaglandin drug. The side effects of Latanoprost,
in comparison with those of timolol, are less serious since they were
restricted to ocular irritation that is not substantial. In other words, the
side effects did not lead to patient non-compliance.
(4) Are
these steps obvious to the skilled person or do they require a degree of
invention?
(A)
Is it self-evident that what is being tried ought to work?
[153] The evidence
submitted by the witnesses for both parties shows that as of September 12,
1989, those working in the ocular field wanted to find any type of
prostaglandin that would work well enough to be a marketable drug in any area
of medicine. Many people were publishing articles describing experimental and
theoretical data, thereby creating a vast bibliography, numbering in the
thousands of documents about prostaglandins. According to Dr. Maxey, Dr.
Stjernschantz, Dr. Flach, Dr. Bodor and Dr. Neufeld, it was easy to find a
document pointing in one direction and several others that gave different conclusions.
[154] Finally, it
is noteworthy that an almost infinite number of changes can be made to the
natural prostaglandin, in this case the naturally occurring PGF2α . Furthermore,
a POSITA making molecular changes to PGF2α-IE could not
predict the result, since subtle changes in the addition or removal of
molecules from its structure can result in major changes of biological
activity.
[155] On these
grounds, it would not have been obvious that what is being attempted, that is
the chemical structure of Latanoprost, would work.
(B) What is
the extent, nature and amount of effort required to achieve the invention? Are
routine trials conducted or is the experimentation long and arduous, such that
the trial would not be considered routine?
[156] The parties
tendered conflicting evidence on this point. Dr. Stjernschantz, on behalf of
the Applicants, deposed that the synthesis of prostaglandin analogs was
difficult and time-consuming. Experimentation was conducted to find the
modification for PGF2α that would yield the desired
pharmacological benefits. Of course, Dr. Stjernschantz was more experienced than
the POSITA and he had the advantage of having worked with Dr. Bito who was very
prolific and one of the most knowledgeable researchers in this field.
[157] Dr. Bodor,
Dr. Flach and Dr. Cullen, witnesses on behalf of the Respondent, concluded that
Latanoprost was obvious, in light of the prior art. They said that the testing
that was performed was routine and inadequate and they question the
reliability of the data recorded in the ‘132 Patent relative to that testing.
[158] Testing
results shown on pages
18 to 22 and 25 to 29, that is Tables III to VI of the ‘132 Patent disclose
test results on animals and healthy humans where Latanoprost demonstrates how
it works in that it lowers IOP while having minimal irritative effects. The
‘132 Patent discusses why certain animals were used as well as the grading used
to compare compounds. The test results disclose dosage levels and the grading
scale.
[159] Tables III to VI show comparative
tests on Latanoprost and other compounds to determine the required outcomes. More
specifically, the results on page 29 are from a test of Latanoprost in some healthy
human volunteers and show a reduction in IOP over time wherein there is no
reported occurrence of side effects such as hyperemia or ocular irritation as
discussed on page 21. Table III is a compound comparative test to
show the degree of ocular irritation in cats.
[160] Table IV
compares the degree of conjunctival hyperemia for different compounds in
rabbits, Table V compares the IOP reducing effects of different compounds in
monkeys and cats. Table VI uses healthy humans to show IOP reducing effects
for various compounds. The tests were criticized by the Respondent’s expert
witnesses as failing to provide enough “experimental protocols” for the POSITA
to reproduce the experiments.
[161] In spite of
the conflicting opinions from the experts for the Applicants and the
Respondent, I find the evidence adduced by the Applicants to be more
persuasive. I am satisfied from the evidence of Dr. Stjernschantz, in particular
as set out in paragraphs 40 to 44 of his affidavit, that the POSITA following a
similar course of conduct that may encompass routine experimentation, using the
common general knowledge and prior art, and acting in a manner similar to that
followed by Dr. Stjernschantz, would not obtain the same results.
[162] Indeed, a
competitor who performed experiments that were compared to those that had been
performed by Dr. Stjernschantz recorded a different conclusion about the
viability of using synthetic PGF2α compounds. In this regard, I
refer to the paper written by D. F. Woodward et al entitled “Prostaglandin F2α
Effects on Intraocular Pressure Negatively Correlate with FP-Receptor
Stimulation”, published August 1989, NOA document 107.
(C) Is there
a motive in the prior art to find the solution that the patent addresses?
[163] As stated
above, many people wanted to find a marketable drug using prostaglandins for
the treatment of glaucoma and ocular hypertension. Prostaglandins had been
identified by prior art as having great efficiency in the reduction of IOP.
However, prior to the discovery of Latanoprost, the general consensus was that
the irritative effects of prostaglandins could not be adequately removed in
order to provide for a useable product. In my opinion, these considerations
show that there was a motive to find something else.
(D) What is
the course of conduct that was followed in arriving at the invention?
[164] The mixing
and reacting of chemicals was used, along with experimentation on animals and
humans, in order to obtain data for analysis. The results of the testing are
set out in Tables III, IV, V and VI. The tables address testing in cats,
rabbits, monkeys or cats and humans, respectively.
[165] The difference
here, between the Applicants and its competitors, is in the consolidation of
the data, the analysis of the data obtained and the conclusions drawn from the
experimentation which was done.
(5) Conclusion
on Obviousness
[166] I find that Latanoprost
would not have been obvious to the ordinary skilled person. I
conclude that the allegation of obviousness is not justified.
iv) Lack
of Utility
[167] The date for determining
utility for an Old Act Patent is the filing date, that is September 12, 1989.
[168] The
Applicants rely on the evidence of Dr. Neufeld and of Dr. Stjernschantz to
support the claim that the patent has utility. The Respondent relies on allegations
of lack of sound prediction more than on a lack of utility, and depends on the
evidence of Dr. Flach and Dr. Leibowitz in this regard.
[169] The Applicants
refer to the evidence of Dr. Neufeld, Dr. Stjernschantz, Dr. Fechtner and Dr.
Maxey to show that the ‘132 Patent has utility.
[170] The
Applicants’ witnesses, that is Dr. Neufeld and Dr. Stjernschantz, say that
Latanoprost shows a reduction in ocular irritation. As the witnesses assert,
Claim 12 only refers to a reduction of IOP without substantial ocular
irritation. That does not refer to the elimination of all side effects.
[171] Further, the
patent itself shows utility. I refer to pages 7 and 8 where the patent
demonstrates what the invention is, by stating the use for the treatment of
glaucoma or ocular hypertension where the irritating effects are reduced and
treatment is given with 1 or 2 drops per eye.
[172] Example 9 on
page 16 of the ‘132 Patent shows how to prepare Latanoprost. Page 22 of
the patent demonstrates what the invention is by stating that IOP is lowered
with minimal side effects. Page 23 shows the chemical structure of Latanoprost,
again what the invention is.
[173] Pages 18 to 22
and pages 25 to 29 disclose test results on animals and healthy humans. The use
of Latanoprost demonstrated the reduction of IOP with minimal irritative side
effects. Finally, the claims in issue disclose Latanoprost.
[174] The ‘132
Patent demonstrates utility, discloses what the invention is and how it works,
as claimed. Furthermore, the disclosure requirements are met as of the issue
date. Disclosure can be assessed against documents published between September
12, 1989 and July 29, 1997. Dr. Fechtner referred to studies that were done
comparing Latanoprost to timolol and discussing the effectiveness of
Latanoprost. These articles were attached as exhibits to his affidavit.
[175] In the
result, I am satisfied that the ’132 Patent offers the public a useful choice
from what was offered as the state of the art at the time of filing the patent
application and considering the prior art that was available to the POSITA.
v) Lack
of Sound Prediction
[176] The doctrine of
sound prediction was reviewed by the Supreme Court of Canada in Apotex Inc.
v. Wellcome Foundation Ltd., [2002] 4 S.C.R. 153. At paragraph 46, Justice
Binnie said that where the invention is for a new use for an old product, the
utility that is required for patentability must either be demonstrated or a
sound prediction based on the information and expertise then available.
[177] The doctrine
of sound prediction has three elements:
i.
there
must be a factual basis for the prediction;
ii.
the
inventor must have as the date of the patent application a “sound” line of
reasoning from which the desired result can be inferred from the factual basis;
iii.
there
must be proper disclosure.
[178] The date from
which sound prediction is to be considered is the filing date of the patent
application, that is September 12, 1989. In this regard, see Aventis Pharma
Inc. v. Apotex Inc. (2005), 43 C.P.R. (4th) 161 (F.C.), aff’d
(2006), 46 C.P.R. (4th) 401 (F.C.A.).
[179] While I have
found that the ‘132 Patent has utility, I will address the issue of sound
prediction utility because the Respondent has alleged that the ‘132 Patent
fails due to lack of sound prediction.
[180] The date and
the example of the ‘132 Patent provide a sound line of reasoning and
disclosure. Page 16 of the patent discloses how to make Latanoprost. Page 23
shows a diagram of the Latanoprost molecule. Pages 21 to 22 and 29 disclose
test results in healthy humans. Pages 25 to 29 disclose test results where
Latanoprost was tested on animals.
[181] Dr.
Stjernschantz, Dr. Wolff and Dr. Neufeld addressed these tests, while Dr.
Flach, Dr. Leibowitz, Dr. Cullen criticized the test data.
[182] The Applicants’
experts said that the animals used and experiments performed were within the
common models in the 1980s to test ophthalmological drugs. Cats were used to
test for irritation, rabbits to test for hyperemia, healthy humans used to test
IOP and monkeys to test for IOP effects. The POSITA would understand that
normal scientific practices were used, such as using albino rabbits to measure
hyperemia. The patent does not promise with absolute certainty that the
compound will be effective in all patients as the Respondent’s experts allege
should be the case.
[183] Dr. Flach and
Dr. Cullen each criticized the type and quantity of test animals used as well
as the methods of observation utilized. Both stated that utilizing cats and
rabbits in ocular tests does not provide an adequate indication of toxicity in
human subjects.
[184] Dr. Leibowitz
stated that the inventors could not soundly predict that Latanoprost would lack
side effects because the disclosure, as compared to the prostaglandin
derivatives found in the ‘560 patent, does not show a clear and definite trend
that would constitute an unexpected property.
[185] At the
hearing, the Respondent alleged that the ‘132 Patent failed to address the gap
between the single dose studies found within the patent and the fact that the
treatment of glaucoma or ocular hypertension requires chronic use of
medication, i.e. long-term and usually life-time treatments. None of the Respondent’s
experts made reference to this in their affidavits nor did they address this
factor when speaking about the NOA prior art.
[186] I am
satisfied that the evidence tendered by Dr. Wolff and Dr. Neufeld supports the
claim for sound prediction utility.
vi) Overbreadth
[187] The
Respondent argued that the ‘132 Patent is invalid because the claims in issue
are broader than the invention claimed.
[188] The test for
overbreadth is set out in Lowell Manufacturing Co. and Maxwell Ltd. v.
Beatty Bros. Ltd. (1962), 41 C.P.R. 18 (Ex. Ct.), at 66, where the Court
said that “[i]f the claims read fairly on what has been disclosed and
illustrated in the specification and drawing, as they do, they are not wider
than the invention…”.
[189] Relying on
the evidence of Dr. Maxey and Dr. Neufeld, the Applicants submit that the
claims in issue are not broader than the invention disclosed. The Respondent,
relying on the evidence of Dr. Leibowitz, takes the contrary view.
[190] Dr. Leibowitz
said that claims do not include the use for the treatment of humans. He said
Claims 19. 31, 37 and 38 are overbroad because there is no disclosure dealing
with the prevalence of irritation or hyperemia.
[191] However, I
prefer the evidence of the Applicants. The Respondent’s arguments are based
upon the fact that hyperemia was not included in the claims. It was within the
discretion of the inventors of the ‘132 Patent to refrain from making a claim
in relation to hyperemia. The claims in issue are not overbroad because the
inventors decided not to claim a particular benefit.
IV. Conclusion
[192] In my
opinion, the Respondent proceeded in this case upon a mistaken premise. It
urged, from the beginning, that the ‘132 Patent should be construed as
requiring chronic treatment. It argued that, measured against this requirement,
the ‘132 Patent was invalid on several grounds, including overbreadth and lack
of sound prediction. The Respondent, however, was unable to show that its basic
premise was sound. It follows that the arguments founded on that basic premise
did not succeed.
[193] In
conclusion, I am satisfied that the Applicants have demonstrated on a balance
of probabilities that the allegations of invalidity set out by the Respondent
in its NOA dated March 4, 2008 respecting the ‘132 Patent are not justified. It
follows that the Gillette Defence is not available to the Respondent.
[194] Accordingly,
the Applicants are entitled to an Order of Prohibition relative to the ‘132
Patent and an Order will issue in that regard, with costs to the Applicants.
JUDGMENT
THIS COURT
ORDERS AND ADJUDGES that the application for an Order of Prohibition in
respect of the 1,339,132 Patent is granted with costs to the Applicants.
“E. Heneghan”