Alcon Canada Inc. v. Apotex Inc., 2014 FC 699, 2014 CF 699, 2014 CarswellNat...
`2014 CarswellNat 2996, 2014 CarswellNat 4494, 2014 FC 699, 2014 CF 699...
`
`2014 FC 699, 2014 CF 699
`Federal Court
`
`Alcon Canada Inc. v. Apotex Inc.
`
`2014 CarswellNat 2996, 2014 CarswellNat 4494,
`2014 FC 699, 2014 CF 699, 122 C.P.R. (4th)
`109, 244 A.C.W.S. (3d) 181, 459 F.T.R. 255
`
`Alcon Canada Inc. and Alcon Research,
`Ltd., Applicants and Apotex Inc. and
`The Minister of Health, Respondents
`
`Catherine M. Kane J.
`
`Heard: May 12-13, 2014
`Judgment: August 8, 2014 *
`Docket: T-1666-12
`
`Proceedings: additional reasons at Alcon Canada Inc. v.
`Apotex Inc. (2014), 2014 CF 794, 2014 CarswellNat 3307,
`2014 CarswellNat 2995, 2014 FC 794, Catherine M. Kane
`J. (F.C.)
`
`Counsel: Gunars Gaikis, Sheldon Hamilton, Tracey Stott,
`for Applicants, Alcon Canada Inc. et al.
`Andrew Brodkin, Dino Clarizio, Jordan Scopa, for
`Respondent, Apotex Inc.
`No one for Minister of Health
`
`Subject: Civil Practice and Procedure; Evidence;
`Intellectual Property; Property
`
`Table of Authorities
`Cases considered by Catherine M. Kane J.:
`Abbott Laboratories v. Canada (Minister of Health)
`(2007), 2007 FCA 153, 2007 CarswellNat 890, 2007
`CAF 153, 361 N.R. 308, 2007 CarswellNat 2377, 59
`C.P.R. (4th) 30 (F.C.A.) — referred to
`Abbott Laboratories v. Canada (Minister of Health)
`(2008), 2008 CF 1359, 71 C.P.R. (4th) 237, 2008
`CarswellNat 5397, 337 F.T.R. 17 (Eng.), [2009] 4
`F.C.R. 401, 2008 FC 1359, 2008 CarswellNat 4573
`(F.C.) — considered
`Abbott Laboratories v. Canada (Minister of Health)
`(2009), 2009 CarswellNat 636, 2009 FCA 94, 73
`C.P.R. (4th) 444, 2009 CAF 94, 387 N.R. 347, 2009
`CarswellNat 2141 (F.C.A.) — referred to
`
`Alcon Canada Inc. v. Cobalt Pharmaceuticals Co. (2014),
`2014 CF 149, 2014 FC 149, 2014 CarswellNat 357,
`117 C.P.R. (4th) 323, 2014 CarswellNat 1661 (F.C.) —
`followed
`Allergan Inc. v. Canada (Minister of Health) (2012), 103
`C.P.R. (4th) 155, 414 F.T.R. 56 (Eng.), 2012 FC 767,
`2012 CarswellNat 2270, 2012 CF 767, 2012 CarswellNat
`3862 (F.C.) — referred to
`Allergan Inc. v. Canada (Minister of Health) (2012), 440
`N.R. 269, 2012 CarswellNat 4583, 2012 FCA 308, 105
`C.P.R. (4th) 371, 2012 CarswellNat 5885, 2012 CAF
`308 (F.C.A.) — referred to
`Apotex Inc. v. Sanofi-Aventis Canada Inc. (2013), 2013
`FCA 186, 2013 CarswellNat 2585, 447 N.R. 313, 114
`C.P.R. (4th) 1 (F.C.A.) — considered
`Apotex Inc. v. Wellcome Foundation Ltd. (2002), 2002
`CarswellNat 3436, 2002 CarswellNat 3437, 2002 SCC
`77, 219 D.L.R. (4th) 660, 21 C.P.R. (4th) 499, 296 N.R.
`130, [2002] 4 S.C.R. 153, 235 F.T.R. 204 (note) (S.C.C.)
`— followed
`Astrazeneca Canada Inc. v. Apotex Inc. (2010), 88
`C.P.R. (4th) 28, (sub nom. AstraZeneca Canada Inc. v.
`Apotex Inc.) 376 F.T.R. 17 (Eng.), 2010 FC 714, 2010
`CarswellNat 2717 (F.C.) — referred to
`Astrazeneca Canada Inc. v. Mylan Pharmaceuticals
`ULC (2011), 2011 FC 1023, 2011 CarswellNat 3401,
`96 C.P.R. (4th) 159, 2011 CF 1023, 2011 CarswellNat
`5092, 396 F.T.R. 162 (Eng.) (F.C.) — followed
`Astrazeneca Canada Inc. v. Mylan Pharmaceuticals
`ULC (2012), 2012 FCA 109, 2012 CarswellNat 979,
`2012 CarswellNat 2008, 101 C.P.R. (4th) 275, 2012
`CAF 109, (sub nom. AstraZeneca Canada Inc. v.
`Mylan Pharmaceuticals ULC) 432 N.R. 292 (F.C.A.) —
`considered
`Consolboard Inc. v. MacMillan Bloedel (Saskatchewan)
`Ltd. (1981), [1981] 1 S.C.R. 504, 56 C.P.R. (2d) 145, 35
`N.R. 390, 122 D.L.R. (3d) 203, 1981 CarswellNat 582F,
`1981 CarswellNat 582 (S.C.C.) — considered
`Eli Lilly Canada Inc. v. Novopharm Ltd. (2009), 346
`F.T.R. 42 (Eng.), 2009 FC 301, 2009 CarswellNat 1479,
`76 C.P.R. (4th) 407 (F.C.) — referred to
`Eli Lilly Canada Inc. v. Novopharm Ltd. (2010), 85
`C.P.R. (4th) 413, [2012] 1 F.C.R. 349, 2010 CarswellNat
`3252, 2010 CAF 197, 405 N.R. 1, 2010 CarswellNat
`2418, 2010 FCA 197 (F.C.A.) — followed
`Fournier Pharma Inc. v. Canada (Minister of Health)
`(2012), 2012 CarswellNat 2278, 2012 FC 741, 413
`F.T.R. 277 (Eng.), 2012 CF 741, 2012 CarswellNat
`3789, 107 C.P.R. (4th) 32 (F.C.) — considered
`
` © 2018 Thomson Reuters. No claim to original U.S. Government Works.
`
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`Santen/Asahi Glass Exhibit 2051
`Micro Labs v. Santen Pharm. and Asahi Glass
`IPR2017-01434
`
`

`

`Alcon Canada Inc. v. Apotex Inc., 2014 FC 699, 2014 CF 699, 2014 CarswellNat...
`2014 CarswellNat 2996, 2014 CarswellNat 4494, 2014 FC 699, 2014 CF 699...
`
`Hoffman-La Roche Ltd. v. Apotex Inc. (2013), 2013 FC
`718, 113 C.P.R. (4th) 1, 2013 CarswellNat 3902, 2013
`CF 718, 2013 CarswellNat 2550 (F.C.) — followed
`I.G. Farbenindustrie A.G.'s Patents, Re (1930), 47 R.P.C.
`289 (Eng. Ch. Div.) — followed
`Lundbeck Canada Inc. v. Canada (Minister of Health)
`(2009), 2009 FC 146, 2009 CarswellNat 467, 343 F.T.R.
`53 (Eng.), 2009 CF 146, 2009 CarswellNat 4883, 73
`C.P.R. (4th) 69 (F.C.) — referred to
`Lundbeck Canada Inc. v. Ratiopharm Inc. (2009), 2009
`CarswellNat 3880, 2009 FC 1102, (sub nom. Lundbeck
`Canada Inc. v. ratiopharm Inc.) 357 F.T.R. 75 (Eng.),
`2009 CarswellNat 5784, 2009 CF 1102, 79 C.P.R. (4th)
`243 (F.C.) — referred to
`Merck & Co. v. Canada (Minister of Health) (2010),
`88 C.P.R. (4th) 98, 375 F.T.R. 121 (Eng.), 2010 FC
`1042, 2010 CarswellNat 3959, 2010 CF 1042, 2010
`CarswellNat 4670 (F.C.) — referred to
`Pfizer Canada Inc. v. Apotex Inc. (2007), 2007
`CarswellNat 43, 2007 FC 26, 59 C.P.R. (4th) 183, 2007
`CF 26, 2007 CarswellNat 5012, 306 F.T.R. 254 (Eng.)
`(F.C.) — considered
`Pfizer Canada Inc. v. Apotex Inc. (2007), 367 N.R. 98,
`2007 CAF 195, 60 C.P.R. (4th) 177, 2007 CarswellNat
`1376, 2007 FCA 195, 2007 CarswellNat 2361 (F.C.A.)
`— referred to
`Pfizer Canada Inc. v. Apotex Inc. (2007), 2007
`CarswellNat 3627, 2007 CarswellNat 3628, 381 N.R.
`399 (note) (S.C.C.) — referred to
`Pfizer Canada Inc. v. Apotex Inc. (2009), [2009] 4 F.C.R.
`223, (sub nom. Apotex Inc. v. Pfizer Canada Inc.) 72
`C.P.R. (4th) 141, 2009 CAF 8, 2009 CarswellNat 1151,
`2009 FCA 8, 2009 CarswellNat 176, 385 N.R. 148
`(F.C.A.) — considered
`Pfizer Canada Inc. v. Canada (Minister of Health)
`(2006), 2006 FCA 214, 2006 CarswellNat 1589, 351
`N.R. 189, 52 C.P.R. (4th) 241, 272 D.L.R. (4th) 756,
`[2007] 2 F.C.R. 137, 2006 CAF 214, 2006 CarswellNat
`2638 (F.C.A.) — considered
`Pfizer Canada Inc. v. Canada (Minister of Health)
`(2007), 60 C.P.R. (4th) 81, 2007 FCA 209, 2007
`CarswellNat 1434, 366 N.R. 347, 2007 CarswellNat
`4252, 2007 CAF 209 (F.C.A.) — referred to
`Pfizer Canada Inc. v. Mylan Pharmaceuticals ULC
`(2014), 2014 CarswellNat 1378, 2014 CF 38, 2014
`CarswellNat 187, 2014 FC 38 (F.C.) — considered
`Pfizer Canada Inc. v. Pharmascience Inc. (2013), 2013
`FC 120, 2013 CarswellNat 177, 2013 CF 120, 2013
`
`CarswellNat 1248, 427 F.T.R. 6 (Eng.), 111 C.P.R. (4th)
`88 (F.C.) — followed
`Pozzoli SpA v. BDMO SA (2007), [2007] F.S.R. 37,
`[2007] EWCA Civ 588 (Eng. C.A.) — followed
`Sanofi-Synthelabo Canada Inc. v. Apotex Inc. (2008),
`2008 SCC 61, 2008 CarswellNat 3844, 2008
`CarswellNat 3845, (sub nom. Apotex Inc. v. Sanofi-
`Synthelabo Canada Inc.) [2008] 3 S.C.R. 265, [2009]
`F.S.R. 7, 69 C.P.R. (4th) 251, 381 N.R. 125, 298 D.L.R.
`(4th) 385 (S.C.C.) — followed
`Schering-Plough Canada Inc. v. Pharmascience Inc.
`(2009), 2009 CarswellNat 5541, 81 C.P.R. (4th) 9, 2009
`CF 1128, 360 F.T.R. 109 (Eng.), 2009 CarswellNat
`4628, 2009 FC 1128 (F.C.) — referred to
`Windsurfing International Inc. v. Tabur Marine (Great
`Britain) Ltd. (1984), [1985] R.P.C. 59 (Eng. C.A.) —
`followed
`Statutes considered:
`Patent Act, R.S.C. 1985, c. P-4
`Generally — referred to
`Tariffs considered:
`Federal Courts Rules, SOR/98-106
`Tariff B, Table, column IV — referred to
`Regulations considered:
`Patent Act, R.S.C. 1985, c. P-4
`Patented Medicines
`(Notice
`Regulations, SOR/93-133
`
`of Compliance)
`
`Generally — referred to
`
`APPLICATION for order prohibiting Minister of Health
`from issuing notice of compliance.
`
`Catherine M. Kane J.:
`
`I. Overview
`
`1      This application is brought under the provisions of the
`Patented Medicines (Notice of Compliance) Regulations,
`SOR/93-133, as amended [NOC Regulations] by Alcon to
`prohibit the Minister of Health from issuing a Notice of
`Compliance to Apotex in respect of its generic product
`(the Apotex product) until the expiry of Canadian Letters
`Patent No 2,129,287 (the '287 Patent) on August 3, 2014.
`
`2           For the reasons that follow, I find that the
`allegations with respect to the invalidity of the claims at
`issue for anticipation and obviousness are justified and the
`allegations with respect to invalidity for lack of utility are
`not justified.
`
` © 2018 Thomson Reuters. No claim to original U.S. Government Works.
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`
`3           The application is dismissed with costs to the
`respondent.
`
`II. Introduction
`
`4           Glaucoma is a disease of the eye resulting in a
`progressive loss of vision due to increased intraocular
`pressure ["IOP"], which is the pressure within the aqueous
`humour of the eye. There is no cure for glaucoma,
`however, it can be managed by reducing IOP. Such
`treatment is ongoing or "chronic" and requires the patient
`to take medication daily, generally for life, to maintain the
`IOP at a reduced level.
`
`5      According to the inventors of the '287, drugs were
`available to treat glaucoma and ocular hypertension prior
`to the invention of the '287, but they had undesirable
`effects.
`
`6      As the experts, Dr deLong and Dr Wolfe, described,
`prostaglandins [PGs] are a large class of biologically
`active chemical compounds with many different roles in
`the body. PGs, and in particular PGF2[alpha] and their
`derivatives, were known to reduce IOP since at least the
`mid 1980s (and Dr deLong suggests as early as 1977).
`
`7      Although naturally occurring prostaglandins were
`known to reduce IOP, there were side effects, particularly
`irritation and hyperemia (blood shot eyes). The goal
`was therefore to develop a compound that reduced IOP
`without the side effects. Synthetic prostaglandins also led
`to side effects, however, various methods may be used to
`reduce or eliminate the side effects.
`
`8           Fluprostenol is a PG, more specifically, a
`synthetic analogue of PGF2[alpha], a naturally occurring
`prostaglandin. Alcon notes that the isopropyl ester of (+)-
`fluprostenol, known as travoprost, is the active ingredient
`in Travatan Z marketed by Alcon for the treatment of
`glaucoma. Apotex seeks to market its own product, Apo-
`Travoprost, also for the treatment of glaucoma.
`
`9      Apotex alleges that it does not infringe the claims
`of the Patent at issue, the '287, because the claims are
`invalid. Apotex alleges that the patent is a selection patent
`from the genus of European Patent Application, (EP 0 364
`417, referred to as the '417), and that it has not lived up
`to its promise of the substantial advantages over the '417
`and specifically that its utility was not demonstrated or
`soundly predicted. Apotex alternatively alleges that if the
`
`'287 is not a selection patent, but a species patent as Alcon
`asserts, then it is not novel as it does only what the '417
`promised, it is anticipated by the '417, and it is obvious.
`
`10           Apotex argues that Alcon cannot characterize
`the '287 as a novel compound with unstated advantages,
`rather than a selection patent, yet rely on its unstated
`advantages to support its novelty. If it is novel then it will
`fail for want of utility because it does not meet its promise.
`
`11           Alcon acknowledges that the '417 application
`discloses a huge genus of compounds, and that travoprost
`is included generically in this genus, but argues that
`the '417 application describes what Alcon refers to as a
`"functional carve out" of compounds that are not useful
`due to their side effects. Fluprostenol (and its esters) was
`carved out, therefore fluprostenol (travoprost) does not
`fall within the '417 and it is not anticipated or obvious
`due to the reference in the '417. Alcon also argues that the
`promised utility of the '287 was soundly predicted.
`
`12           The construction of the claims at issue is not in
`dispute. However, the determination of the allegations of
`invalidity is dependant upon the promise of the patent and
`the inventive concept of the claims, which are in dispute.
`
`III. The Parties
`
`13      The applicant, Alcon, is a "first person" as described
`in the NOC Regulations. It has listed the '287 Patent in
`accordance with the Regulations. Alcon obtained a Notice
`of Compliance [NOC] to sell travoprost, which it does
`under the brand name Travatan Z, from the Minister of
`Health.
`
`14      The applicant, Alcon, is the owner of the '287 Patent
`and this is not contested.
`
`15      The respondent, Apotex, is a "second person" as
`described in the NOC Regulations. In order to sell a generic
`version of travoprost, as Apo-Travoprost, it must receive
`a NOC from the Minister of Health. In accordance with
`the NOC Regulations, Apotex served Alcon with a Notice
`of Allegation [NOA] dated July 25, 2012.
`
`16           In the NOA, Apotex alleges that claims 12, 27,
`35 and 46 of the '287 Patent would not be infringed, and
`that the patent is invalid on the grounds of anticipation,
`obviousness, and lack of utility (alternative). Apotex also
`alleges that it does not infringe any valid claim in making,
`constructing, using or selling its Apotex product.
`
` © 2018 Thomson Reuters. No claim to original U.S. Government Works.
`
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`
`17      The applicant argues that the allegations advanced by
`Apotex do not align with its NOA. This issue is addressed
`later in these reasons.
`
`18           The respondent, the Minister of Health, who
`has various responsibilities under the NOC Regulations,
`including the issuance of an NOC to a "second person"
`such as Apotex, took no active role in these proceedings.
`
`27      The evidence in this proceeding was provided in the
`form of affidavits and transcripts of cross-examinations of
`experts along with their exhibits. All of the experts were
`cross-examined. Each party also submitted as evidence the
`affidavits of law clerks to place documents on the record
`and attest to facts.
`
`28      The evidence on the record includes the following:
`
`IV. The '287 Patent Generally
`
`A. For the applicant, Alcon:
`
`19      Canadian Letters Patent 2,129,287 were applied for
`by an application deemed to be filed with the Canadian
`Patent Office on August 2, 1994. The Patent is therefore
`governed by the provisions of the new Patent Act, RSC
`1985 c P-4, that governs patents applied for after October
`1, 1989.
`
`20      The application was filed under the provisions of
`the Patent Cooperation Treaty [PCT] and claims priority
`from a first application filed in the United States Patent
`Office on August 3, 1993. This is the date upon which the
`issues of anticipation and obviousness will be determined.
`
`21      The date of filing in Canada, August 2, 1994, is the
`date upon which the issue of (utility) sound prediction will
`be determined.
`
`22      The publication date, i.e. the date at which the patent
`was open to the public for inspection, was February 4,
`1995. This is the date that is to be used for the purposes of
`the construction of the claims.
`
`23           The '287 Patent lists the inventors as Paul
`W Zinke, Peter G Klimko, John E Bishop, Verney L
`Sallee, and Louis Desantis Jr, all of the United States of
`America. Only Peter Klimko provided evidence in these
`proceedings.
`
`24      The '287 Patent was issued to Alcon Laboratories
`Inc, US.
`
`25           The term of the '287 Patent, unless declared as
`invalid, will expire 20 years from the date of the filing of
`the application in Canada, which is August 2, 2014.
`
`26      There are 54 claims in the '287 Patent, four of which
`are at issue in this proceeding (Claims 12, 27, 35 and 46).
`The construction of the claims and the inventive concept
`of the patent are addressed below.
`
`V. The Evidence
`
`(1) Kingsley Koo:
`
`29      Kingsley Koo is a law clerk at Alcon's solicitor's
`office. His affidavit attaches a variety of documents,
`such as the '287 patent, Apotex's Notice of Allegation,
`Apotex's prior art references, and the Travatan Z product
`monograph.
`
`(2) Dr Peter Klimko:
`
`30      Dr Peter G Klimko is an inventor on the '287 patent.
`Dr Klimko is a medicinal chemist at Alcon Research, Ltd,
`in Fort Worth, Texas. He has worked at Alcon since 1993,
`after earning his PhD in organic chemistry from Texas
`A&M University in May 1992. He discussed the work
`conducted by Alcon leading to the filing of the '287 patent,
`including biological test results. His affidavit reiterates, to
`a great extent, the contents of the '287 and sets out his role
`in the development of the patent.
`
`(3) Dr Mitchell deLong:
`
`31           Dr deLong is an adjunct professor in the
`department of chemistry at Duke University, and holds
`a PhD in synthetic organic and medicinal chemistry. He
`is vice-president of chemistry at Aerie Pharmaceuticals
`Inc, a company which specializes in the development
`of ocular drugs. Dr deLong has 20 years experience in
`medicinal chemistry with prostaglandins and glaucoma
`treatments. For 13 years, he was a senior scientist at
`Procter & Gamble, from 1992 to 2005, researching the use
`of prostaglandins to treat a variety of illnesses.
`
`32      Dr deLong was called upon by the applicant to review
`the '287 patent and provide an opinion on its construction,
`as well as utility and novelty. His opinion is detailed, and
`sets out the person skilled in the art, prior art, and the
`promise of the patent, among other opinions. He also
`provides a chemistry primer, explaining prostaglandins,
`
` © 2018 Thomson Reuters. No claim to original U.S. Government Works.
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`
`their therapeutic effects, and the type of drug in issue in
`this case.
`
`B. For the respondent, Apotex:
`
`(1) Lisa Ebdon:
`
`33           Lisa Ebdon is a law clerk at the respondent,
`Apotex's, solicitor's office. Her affidavit attaches a variety
`of documents, including Apotex's Notice of Allegation,
`the prior art references, and a copy of the '287 patent.
`
`(2) Dr Manfred Wolff:
`
`34           Dr Manfred E Wolff is a pharmacist and a
`patent agent. He holds a PhD in medicinal chemistry, and
`is currently president and CEO of Intellepharm Inc. Dr
`Wolff was asked to comment on the person skilled in the
`art, and what that person would have understood as the
`subject matter in the '287 patent, as well as the claims
`of the patent. He also examines the state of the art and
`common general knowledge of the skilled person at the
`relevant date, the inventive concept of the '287 patent, and
`the difference between the two. His affidavit focuses on
`anticipation and obviousness. He also commented on the
`evidence of Alcon's experts.
`
`(3) Dr Thomas Mittag:
`
`35           Dr Thomas W Mittag is a professor emeritus
`of ophthalmology and pharmacology at the Mount Sinai
`School of Medicine. Dr Mittag was asked to provide an
`overview of the state of the art as of the relevant date, how
`the patent would have been understood as of February
`4, 1994, as well as to comment on who the skilled person
`is. He also examined the inventive concept of the claims
`of the '287 patent, the differences between the state of
`the art and the inventive concept as of the relevant date,
`and whether the skilled person would have considered
`this routine work or inventive. His affidavit focuses on
`anticipation, obviousness, and utility, in the form of sound
`prediction.
`
`VI. Issues
`
`36           The principal issue is whether to grant an
`Order prohibiting the Minister of Health from granting a
`Notice of Compliance to Apotex for its generic product
`(Apo-Travoprost) until the expiry of the '287 Patent.
`This determination depends upon whether the allegations
`raised by Apotex as to the invalidity of the '287 Patent (and
`non-infringement) are justified.
`
`37      Apotex alleges the '287 patent is invalid on the basis
`of utility, anticipation, and obviousness.
`
`38      The key area of disagreement between the applicant
`and respondent (and from which the other issues depend)
`is the meaning of the patent i.e., what is the promise of the
`patent and what is the inventive concept (of each claim).
`
`39           The parties also disagree on the characterisation
`of the '287 patent as a "selection patent". The applicant,
`Alcon, does not assert that the '287 is a selection patent
`from the genus in the '417; rather, it argues that it is
`a novel compound or invention with a promised utility
`of being useful in the treatment of glaucoma and ocular
`hypertension.
`
`A. Alcon's overall position
`
`is
`  Alcon markets Travatan Z, which
` 
` 
` 
` 
`40
`travoprost, described by Alcon as the isopropyl ester
`of (+)-fluprostenol, structurally a "16-phenoxy" type of
`prostaglandin for the treatment of glaucoma.
`
`41           The claims of the '287 Patent at issue (12, 27,
`35 and 46) relate to pharmaceutically acceptable esters of
`fluprostenol for the treatment of glaucoma.
`
`42      Alcon submits that the claims are valid: they were not
`anticipated by '417 Application; they were not obvious;
`and, the use of fluprostenol esters for the treatment of
`glaucoma was soundly predicted.
`
`43           Alcon submits that the '417 references a huge
`genus of 800 billion compounds, but it only evaluated
`11 compounds and only one of those compounds,
`Compound 4, is a 16-phenoxy (which Alcon submits
`is the most closely related to fluprostenol). This
`evaluation revealed that Compound 4 displayed an
`unacceptable therapeutic profile. Alcon submits that
`the '417 specifically excludes (or "functionally carves
`out") from its invention all non-therapeutically useful
`compounds. Therefore, Compound 4 was not included
`in the '417 and the '287 could not be anticipated by a
`compound which was excluded (or "carved out"). Alcon
`argues that for the same reason, the '287 could not be a
`selection from the '417.
`
`44      Alcon acknowledges that fluprostenol is within the
`huge genus of the '417, but it is not referenced in any way
`in the '417 and was not disclosed.
`
` © 2018 Thomson Reuters. No claim to original U.S. Government Works.
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`45      Alcon submits that the '287 is not obvious because
`a Person of Ordinary Skill in the Art [POSITA] could not
`predict the side effect profile between structurally different
`PGs without testing the usefulness of the fluprostenol
`esters to treat glaucoma. This testing had not been done
`and, therefore, it was not obvious.
`
`52      Alcon submits that Apotex in its NOA asserted that
`the inventive concept was the compounds, compositions
`and uses claimed. But in the alternative, Apotex argues
`that the '287 is a selection patent. Alcon also notes that
`the NOA included other allegations no longer pursued by
`Apotex.
`
`46           Alcon submits that the utility of travoprost was
`soundly predicted, based on the test results of the '287
`combined with the common general knowledge; there was
`a reasonable hypothesis that it would be useful for the
`treatment of glaucoma in humans.
`
`B. Apotex's overall position
`
`47           Apotex submits that the '287 has all the
`hallmarks of a selection patent. The '417 application
`disclosed a genus of compounds all noted as being useful
`in the treatment of glaucoma and IOP with reduced
`side effects. The '287 Patent acknowledges that the '417
`genus included fluprostenol (travoprost). The '287 also
`states that travoprost has substantial advantages over the
`compounds of the '417. Although Alcon does not assert
`that the '287 is a selection from the '417, Apotex submits
`that it appears to be a selection.
`
`48           Apotex submits that while the '287 promises
`substantial advantages over the '417, Alcon could not
`demonstrate these advantages or soundly predict them at
`the time it filed the patent.
`
`49           Apotex argues that Alcon has advanced the
`notion of a "functional carve out" from the '417 and
`proposed a construction of the promise of the patent and
`the inventive concept to avoid the fact that it cannot
`demonstrate the advantages. However, if there are no
`substantial advantages, the '287 is not new and basically
`no different than the '417 - and is anticipated by the '417
`and obvious.
`
`50           Apotex submits that the '287 either fails
`for anticipation and/or obviousness, or if the inventive
`concept and promise is its substantial advantages over the
`'417, it fails for lack of soundly predicted utility.
`
`51      As noted above, the construction of the claims, the
`inventive concept and the promise of the patent will guide
`the analysis of the allegations and must be determined
`first.
`
`VII. The Notice of Allegation
`
`53           Alcon submits that Apotex's memo of argument
`in response to its Notice of Application and Memo is not
`aligned with its Notice of Allegation. Apotex has changed
`its approach and now argues that the '287 must be a
`selection patent, otherwise it would be invalid and, in the
`alternative, that if the '287 is not a selection patent then it
`is anticipated by the '417 and it was obvious.
`
`54           In the present case, the non-alignment of the
`NOA and the memorandum of argument is not an issue.
`Alternative arguments are simply alternatives, and all
`arguments were raised in the NOA, were argued and will
`be addressed. The allegations of anticipation, obviousness
`and inutility will be addressed whether or not the patent
`is a selection.
`
`VIII. Burden
`
`55      The jurisprudence has clearly established who bears
`the burden of proof of the allegations.
`
`56      As a starting point, where the validity of a patent is
`at issue, the patent will be presumed to be valid. However,
`where a generic manufacturer (a second person), in this
`case Apotex, raises allegations of invalidity and adduces
`some evidence capable of establishing the invalidity of the
`patent, the generic is said to put the issue "into play".
`The burden then moves to the brand or applicant (first
`person), in this case, Alcon, to establish on a balance of
`probabilities that all of the allegations of invalidity are
`not justified: see Lundbeck Canada Inc. v. Ratiopharm
`Inc., 2009 FC 1102, [2009] F.C.J. No. 1466 (F.C.); Abbott
`Laboratories v. Canada (Minister of Health), 2007 FCA
`153, [2007] F.C.J. No. 543 (F.C.A.) at paras 9-10; Pfizer
`Canada Inc. v. Canada (Minister of Health), 2007 FCA
`209, [2007] F.C.J. No. 767 (F.C.A.) at para 109; Allergan
`Inc. v. Canada (Minister of Health), 2012 FC 767 (F.C.) at
`para 42 aff'd in the result 2012 FCA 308 (F.C.A.); Pfizer
`Canada Inc. v. Pharmascience Inc., 2013 FC 120, [2013]
`F.C.J. No. 111 (F.C.) at paras 24-27.
`
`57      Justice O'Reilly set out the approach to be followed
`with respect to the burden of proof in Pfizer Canada Inc. v.
`
` © 2018 Thomson Reuters. No claim to original U.S. Government Works.
`
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`Alcon Canada Inc. v. Apotex Inc., 2014 FC 699, 2014 CF 699, 2014 CarswellNat...
`2014 CarswellNat 2996, 2014 CarswellNat 4494, 2014 FC 699, 2014 CF 699...
`
`Apotex Inc., 2007 FC 26, [2007] F.C.J. No. 36 (F.C.) (aff'd
`2007 FCA 195 (F.C.A.), leave to appeal refused 32169
`(November 1, 2007) 2007 CarswellNat 3627 (S.C.C.)) at
`paragraphs 9 and 12, characterizing the burden on the
`respondent as "an 'evidential burden', a burden merely
`to adduce evidence of invalidity". The respondent must
`adduce evidence to give its allegations an air of reality,
`and if it does so, it has put the issues "into play" and the
`presumption of validity no longer applies. The applicant
`must then discharge its legal burden of proof to the
`satisfaction of the court.
`
`58           If the generic (second person, Apotex) does not
`adduce any evidence with respect to a ground of invalidity
`alleged, then the presumption is not rebutted. Similarly,
`if Apotex adduces some evidence but that evidence is
`insufficient to meet its evidential burden or does not have
`an "air of reality", the issues would not be put into play
`and Alcon would continue to rely on the presumption of
`validity to obtain its prohibition order.
`
`59           However, if Apotex presents sufficient evidence
`to give its allegations an air of reality, then the
`presumption of validity is rebutted and the issue becomes
`whether Alcon has established that Apotex's allegations of
`invalidity are unjustified.
`
`60           The brand (first person, Alcon) bears the
`burden with respect to allegations of non- infringement.
`Allegations of non-infringement of specific claims in the
`Notice of Allegation are presumed to be true. Alcon must,
`therefore, demonstrate on a balance of probabilities that
`any allegations of non-infringement are not justified.
`
`61      In the present case, Apotex has raised allegations in
`its NOA and has led sufficient evidence as to the invalidity
`of the Patent on the basis of anticipation, obviousness
`and lack of demonstrated or soundly predicted utility to
`put those issues into play. The applicant, Alcon bears the
`burden of establishing, on a balance of probabilities, that
`these allegations are not justified.
`
`62      Apotex also alleges that it will not infringe claims
`12, 27, 35 and 46.
`
`IX. Person Skilled in the Art
`
`63      As I noted in Hoffman-La Roche Ltd. v. Apotex Inc.,
`2013 FC 718, [2013] F.C.J. No. 844 (F.C.) at paras 65-66:
`
`[65] The person skilled in the art (or person of
`ordinary skill in the art — a "POSITA") provides the
`lens through which the patent is construed and many
`other issues are assessed. As described by Justice
`Hughes in Pfizer Canada Inc v Pharmascience Inc,
`2013 FC 120, [2013] FCJ 111:
`
`28 The person skilled in the art, or as sometimes
`described, the person of ordinary skill in the art
`(POSITA) is the notional person, which may
`include a team of persons, through whose eyes
`a patent is to be construed, the prior art is
`to be considered. This notional person may be
`pertinent to other issues that arise in respect of a
`patent under consideration by the Court.
`
`[66] In Apotex Inc v Sanofi-Aventis, 2011 FC 1486,
`[2011] FCJ 1813, Justice Boivin (as he then was)
`noted:
`
`[64] In assessing the hypothetical POSITA, the
`Court must define the person or group to whom
`the '777 Patent is addressed. This person is
`obviously not a real person. As explained by
`Justice Hughes in Merck & Co v Pharmascience
`Inc., 2010 FC 510, 85 CPR (4th) 179, at para
`42: "[T]hat person is to be unimaginative, but
`that does not mean that the person is slow-witted
`or graduated (if at all) at the bottom of the
`class. Nor is the person the gold medalist who
`graduated at the top of the class. That person
`is the average person in the group. Just as a
`"reasonable man" is expected to be reasonable,
`the POSITA is expected to possess the ordinary
`skill in the art".
`
`[65] The Supreme Court of Canada considered
`such a person in Whirlpool, above, at para 74,
`where Justice Binnie for the Court wrote that
`the POSITA refers to the hypothetical "ordinary
`worker" who is reasonably diligent in keeping up
`with advances in the field to which the patent
`relates.
`
`64           In this case, there is no major dispute as
`to the Person of Ordinary Skill in the Art (POSITA,
`and also referred to as the person of skill or skilled
`person). The applicant and respondent agreed that the
`POSITA (the composite person or team of persons)
`includes a medical doctor specializing in eye diseases,
`
` © 2018 Thomson Reuters. No claim to original U.S. Government Works.
`
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`Alcon Canada Inc. v. Apotex Inc., 2014 FC 699, 2014 CF 699, 2014 CarswellNat...
`2014 CarswellNat 2996, 2014 CarswellNat 4494, 2014 FC 699, 2014 CF 699...
`
`ocular hypertension and glaucoma and persons with
`a background in pharmacology, medicinal chemistry,
`biochemistry or organic chemistry, preferably with a
`degree at the BSc level or higher, and with the ability
`to understand prostaglandin chemistry. Equally such
`a person or persons would have experience or an
`understanding of the pre-clinical evaluation of potential
`drugs in living animals.
`
`65      Alcon's expert noted that if the person has a lower
`degree, they would have relevant practical experience. The
`POSITA would have some experience with prostaglandin
`chemistry and be familiar to some extent with the
`art relating to the potential therapeutic usefulness of
`prostaglandins, including testing models.
`
`X. The '287 Patent in Detail
`
`66      The title of the Patent is the "Use of Cloprostenol,
`Fluprostenol and Their Analogues to Treat Glaucoma
`and Ocular Hypertension".
`
`67