`
`Date: 20140808
`
`Docket: T-1666-12
`
`Citation: 2014 FC 699
`
`Ottawa, Ontario, August 8, 2014
`
`PRESENT: The Honourable Madam Justice Kane
`
`BETWEEN:
`
`ALCON CANADA INC. and
`ALCON RESEARCH, LTD.
`
`and
`
`APOTEX INC. and
`THE MINISTER OF HEALTH
`
`Applicants
`
`Respondents
`
`PUBLIC JUDGMENT AND REASONS
`(Confidential Judgment and Reasons issued July 15, 2014)
`
`
`
`IPR Page 1/127
`
`Santen/Asahi Glass Exhibit 2027
`Micro Labs v. Santen Pharm. and Asahi Glass
`IPR2017-01434
`
`

`

`
`
`I.
`
`II.
`
`III.
`
`IV.
`
`V.
`
`TABLE OF CONTENTS
`
`Page: 2
`
`Page
`
`OVERVIEW ....................................................................................................................... 4
`
`INTRODUCTION .............................................................................................................. 4
`
`THE PARTIES.................................................................................................................... 6
`
`THE ‘287 PATENT GENERALLY ................................................................................... 7
`
`THE EVIDENCE ................................................................................................................ 9
`
`A.
`
`For the applicant, Alcon: ......................................................................................... 9
`
`(1)
`
`(2)
`
`(3)
`
`Kingsley Koo: ......................................................................................................... 9
`
`Dr Peter Klimko: ..................................................................................................... 9
`
`Dr Mitchell deLong: .............................................................................................. 10
`
`B.
`
`For the respondent, Apotex: .................................................................................. 10
`
`(1)
`
`(2)
`
`(3)
`
`Lisa Ebdon: ........................................................................................................... 10
`
`Dr Manfred Wolff: ................................................................................................ 11
`
`Dr Thomas Mittag: ................................................................................................ 11
`
`VI.
`
`ISSUES ............................................................................................................................. 11
`
`A.
`
`B.
`
`Alcon’s overall position ........................................................................................ 12
`
`Apotex’s overall position ...................................................................................... 14
`
`VII. THE NOTICE OF ALLEGATION .................................................................................. 15
`
`VIII. BURDEN .......................................................................................................................... 16
`
`IX.
`
`X.
`
`XI.
`
`A.
`
`B.
`
`PERSON SKILLED IN THE ART................................................................................... 18
`
`THE ‘287 PATENT IN DETAIL ..................................................................................... 19
`
`CONSTRUCTION OF THE CLAIMS ............................................................................. 33
`
`Jurisprudence and Principles Governing the Construction of a Patent and its
`Claims .................................................................................................................... 33
`
`Claims 12, 27, 35 and 46 ....................................................................................... 34
`
`XII. THE INVENTION ............................................................................................................ 36
`
`Is it a selection patent? .......................................................................................... 36
`
`Jurisprudence and Principles on Selection Patents................................................ 38
`
`The ‘287 is not a selection patent .......................................................................... 43
`
`A.
`
`B.
`
`C.
`
`
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`IPR Page 2/127
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`

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`
`
`Page: 3
`
`XIII.
`
`INVENTIVE CONCEPT .................................................................................................. 45
`
`A.
`
`B.
`
`C.
`
`D.
`
`Alcon’s position..................................................................................................... 45
`
`Apotex’s position................................................................................................... 46
`
`What do the experts say? ....................................................................................... 46
`
`The inventive concept............................................................................................ 48
`
`XIV. UTILITY / SOUND PREDITION .................................................................................... 49
`
`A.
`
`B.
`
`C.
`
`D.
`
`E.
`
`Jurisprudence and Principles on the Promise of the Patent ................................... 50
`
`Alcon’s position..................................................................................................... 53
`
`Apotex’s position................................................................................................... 57
`
`What do the experts say? ....................................................................................... 61
`
`The Promised Utility was Soundly Predicted ........................................................ 66
`
`XV. ANTICIPATION .............................................................................................................. 68
`
`A.
`
`B.
`
`C.
`
`D.
`
`E.
`
`Jurisprudence and Principles on Anticipation ....................................................... 69
`
`Alcon’s position..................................................................................................... 73
`
`Apotex’s position................................................................................................... 80
`
`What do the Experts Say?...................................................................................... 86
`
`The ‘417 anticipates the invention of the ‘287 ...................................................... 92
`
`XVI. OBVIOUSNESS ............................................................................................................... 98
`
`A.
`
`B.
`
`C.
`
`D.
`
`E.
`
`Jurisprudence and Principles on Obviousness..................................................... 100
`
`Alcon’s position................................................................................................... 102
`
`Apotex’s position................................................................................................. 105
`
`What do the Experts say? .................................................................................... 113
`
`The ‘287 was Obvious ......................................................................................... 119
`
`XVII. CONCLUSIONS AND COSTS ..................................................................................... 124
`
`
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`IPR Page 3/127
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`

`

`
`
`I.
`
`OVERVIEW
`
`Page: 4
`
`[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.
`
`[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.
`
`
`
`IPR Page 4/127
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`

`

`
`
`Page: 5
`
`[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 PGF2α 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 PGF2α, 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.
`
`
`
`IPR Page 5/127
`
`

`

`
`
`Page: 6
`
`[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.
`
`
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`IPR Page 6/127
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`

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`
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`Page: 7
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`[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.
`
`[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.
`
`IV.
`
`THE ‘287 PATENT GENERALLY
`
`[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.
`
`
`
`IPR Page 7/127
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`

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`
`
`Page: 8
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`[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.
`
`
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`IPR Page 8/127
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`

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`
`
`V.
`
`THE EVIDENCE
`
`Page: 9
`
`[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:
`
`A.
`
`For the applicant, Alcon:
`
`(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.
`
`
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`IPR Page 9/127
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`

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`Page: 10
`
`(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, 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.
`
`
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`IPR Page 10/127
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`

`

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`Page: 11
`
`(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
`
`
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`IPR Page 11/127
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`

`

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`
`Page: 12
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`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
`
`[40] Alcon markets Travatan Z, which is 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.
`
`
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`IPR Page 12/127
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`Page: 13
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`[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.
`
`[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.
`
`
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`IPR Page 13/127
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`

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`Page: 14
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`[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 differe nt than the ‘417 – and is anticipated by
`
`the ‘417 and obvious.
`
`
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`IPR Page 14/127
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`Page: 15
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`[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
`
`[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.
`
`[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.
`
`
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`IPR Page 15/127
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`VIII. BURDEN
`
`Page: 16
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`[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] FCJ No 1466; Abbott Laboratories v Canada (Minister of Health), 2007 FCA
`
`153, [2007 ] FCJ No 543 at paras 9-10; Pfizer v Canada (Minister of Health), 2007 FCA 209,
`
`[2007] FCJ No 767 at para 109; Allergan Inc v Canada (Minister of Health), 2012 FC 767 at
`
`para 42 aff’d in the result 2012 FCA 308; Pfizer Canada Inc v Pharmascience Inc, 2013 FC 120,
`
`[2013] FCJ No 111 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 Apotex Inc, 2007 FC 26, [2007] FCJ No 36 (aff’d 2007 FCA 195, leave to
`
`appeal refused 32169 (November 1, 2007)) 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
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`
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`IPR Page 16/127
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`Page: 17
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`has put the issues “into play” and the presumption of validity no longer applies. The applicant
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`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.
`
`
`
`IPR Page 17/127
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`

`

`
`
`Page: 18
`
`[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 Limited v Apotex Inc, 2013 FC 718, [2013] FCJ No 844
`
`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:
`
`The person skilled in the art, or as
`28
`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.
`
`In Apotex Inc v Sanofi-Aventis, 2011 FC 1486, [2011] FCJ
`[66]
`1813, Justice Boivin (as he then was) noted:
`
`In assessing the hypothetical POSITA, the
`[64]
`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,
`
`
`
`IPR Page 18/127
`
`

`

`
`
`Page: 19
`
`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, 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] The Patent begins with the Background to the Invention, noting:
`
`
`
`IPR Page 19/127
`
`

`

`
`
`Page: 20
`
`The present invention relates to the treatment of glaucoma and
`ocular hypertension. In particular, the present invention relates to
`the use of cloprostenol, fluprostenol, their analogues and their
`pharmaceutically acceptable salts and esters to treat glaucoma
`and ocular hypertension.
`
`Cloprostenol and fluprostenol, both known compounds, are
`synthetic analogues of PGF2α, a naturally-occurring F-series
`prostaglandin (PG).
`
`[68] The Patent then depicts the chemical structures for PGF2α, cloprostenol and fluprostenol.
`
`[69] The Patent also notes the chemical names for both cloprostenol and fluprostenol, and
`
`notes that both differ from the natural product in that an oxygen atom is embedded within the
`
`lower (omega) chain.
`
`[70] The Background continues at page 2 of the Patent stating:
`
`Naturally-occurring prostaglandins are known to lower
`intraocular pressure (IOP) after topical ocular instillation, but
`generally cause inflammation, as well as surface irritation
`characterized by conjunctival hyperemia and edema. Many
`synthetic prostaglandins have been observed to lower intraocular
`pressure, but such compounds also produce the aforementioned
`side effects. Various methods have been used in attempting to
`overcome the ocular side effects associated with prostaglandins.
`Stjernschantz et al. (EP 364 417 A1) have synthesized derivatives
`or analogues of naturally-occurring prostaglandins in order to
`des