UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`APOTEX, INC.
`Petitioner,
`v.
`
`UCB BIOPHARMA SPRL
`Patent Owner.
`
`U.S. Patent No. 8,633,194 to Fanara et al.
`Case No.: IPR2019-00400
`____________________
`
`REPLY DECLARATION OF DR. PAUL A. LASKAR, PH.D.
`
`Apotex (IPR2019-00400) Ex. 1050 p. 001
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`APOTEX, INC.
`Petitioner,
`v.
`
`UCB BIOPHARMA SPRL
`Patent Owner.
`
`U.S. Patent No. 8,633,194 to Fanara et al.
`Case No.: IPR2019-00400
`____________________
`
`REPLY DECLARATION OF DR. PAUL A. LASKAR, PH.D.
`
`Apotex (IPR2019-00400) Ex. 1050 p. 001
`
`
`
`Declaration of Paul A. Laskar, Ph.D.
`
`Table of Contents
`LIST OF MATERIALS CONSIDERED...................................................... 1
`LEGAL STANDARD .................................................................................. 1
`
`I.
`II.
`
`PERSON OF ORDINARY SKILL IN THE ART (“POSA”) ....................... 2
`III.
`IV. REPLY OPINIONS ..................................................................................... 2
`
`i
`
`Apotex (IPR2019-00400) Ex. 1050 p. 002
`
`
`
`I, Paul A. Laskar, Ph.D., do hereby declare and state as follows:
`
`1.
`
`I am the same Paul A. Laskar that provided the Declaration of Paul A.
`
`Laskar, Ph.D. in connection with this matter. EX1002. I provide this testimony
`
`below:
`
`2.
`
`My Experience and Qualifications are provided in EX1002 and have
`
`not changed since.
`
`3.
`
`I have been retained on behalf of the Petitioner for the above-captioned
`
`inter partes review (“IPR”). I am being compensated for my time in connection with
`
`this IPR at my standard consulting rate, which is $300 per hour for consulting; $375
`
`per hour for deposition and testimony, including preparation; and $125 per hour for
`
`non-working travel time. My compensation does not depend in any way on the
`
`outcome of this IPR.
`
`I.
`
`LIST OF MATERIALS CONSIDERED
`
`4.
`
`In formulating my opinions provided in this Reply Declaration, I have
`
`relied on the materials referenced in this Reply Declaration.
`
`II. LEGAL STANDARD
`
`5.
`
`My understanding of the applicable legal standards are provided in
`
`Declaration of Paul A. Laskar, Ph.D. EX1002.
`
`1
`
`Apotex (IPR2019-00400) Ex. 1050 p. 003
`
`
`
`III. PERSON OF ORDINARY SKILL IN THE ART (“POSA”)
`
`6.
`
`See the Declaration of Paul A. Laskar, Ph.D. in connection with this
`
`matter. EX1002. The opinions in this Reply Declaration are from the perspective
`
`of a POSA as previously defined and applying the same relevant priority date.
`
`IV. REPLY OPINIONS
`
`7.
`
`Although the PTAB gave some guidance on the claim term
`
`“substantially free of bacteria,” I have been informed that all other claims are
`
`governed by the plain and ordinary meaning as understood by a POSA as of the
`
`relevant priority date (i.e., July 14, 2004).
`
`8.
`
`I have reviewed the Deposition transcript of Dr. Niazi. EX1043.
`
`During his deposition, Dr. Niazi offered the following testimony with respect to the
`
`challenged claims:
`
`Q: So you're saying a syrup is excluded within the scope
`of the challenged claims, yes or no?
`A: Just like you mentioned, you know, “comprising” may
`mean that it can include sugar, and it does not limit as
`to how much sugar you can add, therefore, it can be a
`syrup, okay. As long as the product meets the function of
`the specification given in Claim 1, okay, it can include
`sugar also.
`EX1043, 39:16-40:2 (emphasis added); see also 44:17-24.
`
`2
`
`Apotex (IPR2019-00400) Ex. 1050 p. 004
`
`
`
`9.
`
`I agree with Dr. Niazi. All of the challenged claims (i.e., 1-11), read
`
`under the plain and ordinary meaning as understood by a POSA, would include
`
`syrups.
`
`10.
`
`I have reproduced the text of Claim 1 of the ’194 patent below:
`
`1. A liquid pharmaceutical composition comprising (i)
`levocetirizine or a pharmaceutically acceptable salt of
`levocetirizine, and (ii) a preservative mixture consisting
`essentially of a mixture of methyl parahydroxybenzoate
`and propyl parahydroxybenzoate in a ratio of 9/1
`expressed in weight, said mixture being present in an
`amount of more than 0 and up to 0.75 mg/ml of the
`composition, wherein said composition is substantially
`free of bacteria.
`11. Although I am not a lawyer, as explained in the Declaration of Paul A.
`
`Laskar, Ph.D. (EX1002), “comprising” is open ended, i.e., it can include other
`
`components, elements, or steps. The term “consisting essentially of” also appears
`
`in the claim. It is my understanding that the transitional phrase “consisting
`
`essentially of” limits the scope of a claim to the specified materials or steps and those
`
`that do not materially affect the basic and novel characteristic(s) of the claimed
`
`invention. EX1002, ¶44.
`
`3
`
`Apotex (IPR2019-00400) Ex. 1050 p. 005
`
`
`
`12.
`
`Looking at the structure of Claim 1, the “liquid pharmaceutical
`
`composition” includes levocetirizine, which is outside the “consisting essentially of”
`
`recitation, and “said composition is substantially free of bacteria.” Therefore, it is
`
`the composition with all of its components including levocetirizine, methylparaben
`
`and propylparaben that is “substantially free of bacteria.”
`
`13.
`
`I have reviewed the ’194 patent and all the challenged claims from the
`
`perspective of a POSA as of the relevant priority date. Since “comprising” is open-
`
`ended, “comprising” means that the challenged claims can include sugar. Reviewing
`
`the claim language from the perspective of a POSA, there are no limits on any of the
`
`challenged claims as to how much sugar you can add.
`
`14.
`
`Consistent with my analysis, the ’194 patent states that the composition
`
`can include sugars (EX1001, 4:67-5:1) and syrups are a preferred embodiment.
`
`EX1001, 5:25-30.
`
`15. Under its plain and ordinary meaning, a syrup is an “oral solution.” See,
`
`e.g., EX1001 at Claim 4 (“oral solutions”). I understand that Dr. Niazi agrees that
`
`syrups are solutions. EX1043, 177:21-23.
`
`16.
`
`For example, the excerpt from Remington provided in the file history
`
`explains, “[a] solution is a homogenous mixture that is prepared by dissolving a
`
`solid, liquid or gas in another liquid and represents a group of preparations in which
`
`the molecules of the solute or dissolved substance are dispersed among those of the
`
`4
`
`Apotex (IPR2019-00400) Ex. 1050 p. 006
`
`
`
`solvent.” EX1027, p. 18 (emphasis added); EX1048, p. 749.1 This is the plain and
`
`ordinary meaning of a solution.
`
`17.
`
`Remington, on that same page, goes on to explain “syrups are aqueous
`
`solutions containing a sugar.” Id. (emphasis added).
`
`18.
`
`I am aware that on page 749 of Remington, it states under “AQUEOUS
`
`SOLUTIONS”: “The narrower definition in this subsection limits the solvent to
`
`water and excludes those preparations that are sweet and/or viscid in character and
`
`nonaqueous solutions.” Id. To the extent anybody argues that syrups would not be
`
`solutions based on this statement of Remington because syrups are sweet and/or
`
`viscous, for the reasons I explain below, I disagree.
`
`19. At the outset, Remington is characterizing this as a “narrower
`
`definition” limited to a specific subsection of the text. By Remington’s own
`
`admission, it is not the plain and ordinary meaning but a “narrower definition”. As
`
`any college student could state, a solution is “a homogeneous mixture of two or more
`
`substances.” Brown (EX1049), G12 Glossary defining “solution.” The definition
`
`provided in Brown (EX1049) would also represent the plain and ordinary meaning
`
`1 The pages of Remington provided in the Declaration of Fanara may be
`
`difficult to read. Therefore, I have provided reproductions of Remington so that the
`
`reader can more easily read the text. (EX1048).
`
`5
`
`Apotex (IPR2019-00400) Ex. 1050 p. 007
`
`
`
`to a POSA and is consistent with the definition from Remington I provide in ¶16
`
`(supra).
`
`20.
`
`Further, this “narrower definition” of Remington must also be placed
`
`in its proper context. Although not provided in the Fanara declaration, I have
`
`provided the Remington pages that follow page 749. EX1048. If the POSA
`
`continues in the subsection labeled “AQUEOUS SOLUTIONS” (page 749) where
`
`Remington provides its “narrower definition” it contains the following: “Aromatic
`
`Waters,” “Aqueous Acids,” “Diluted Acids,” “Douches,” “Enemas,” “Gargles,”
`
`“Mouthwashes,” “Juices,” “Nasal Solutions,” “Otic Solutions,” and “Irrigation
`
`Solutions.” EX1048, pp. 749-753. Putting aside the fact that Remington’s
`
`“narrower definition” is not the plain and ordinary meaning of a solution (supra
`
`¶¶18-19), syrups are not included under any of the subheadings under “AQUEOUS
`
`SOLUTIONS” (pp. 749-753).
`
`21.
`
`“Syrups” are, however, included in the following Section on page 754
`
`under “SWEET AND OTHER VISCID AQUEOUS SOLUTIONS.” Because of
`
`the nature of the capitation, this a new and standalone section from the previous
`
`section labelled “AQUEOUS SOLUTIONS” (page 749). See generally, EX1048.
`
`22.
`
` Under “SWEET AND OTHER VISCID AQUEOUS SOLUTIONS,”
`
`Remington explains, “Solutions that are sweet or viscid include syrups.” EX1048,
`
`6
`
`Apotex (IPR2019-00400) Ex. 1050 p. 008
`
`
`
`p. 754. Remington further states that “Syrups are concentrated aqueous solutions
`
`of sugar or sugar substitute, with or without flavors and medical substances.” Id.
`
`23.
`
`Consistent with the statements in Remington, Ansel (EX1021) includes
`
`“Syrups” under the chapter entitled “Solutions.” EX1021 at 311.
`
`24.
`
`I understand later during his deposition, Dr. Niazi offered the following
`
`testimony: “[i]f a formulation has any component that serves the purpose of
`
`preserving the formulation against bacterial growth, then they will not be under the
`
`‘consisting essentially of.’ A good example is sugar which is used routinely to
`
`preserve syrups.” EX1043, 254:17-22, see also 253:16-23 (“Q. Does the claimed
`
`preservative mixture in Claim 1 include formulations with other preservatives
`
`besides methylparaben and propylparaben? A. No.”).
`
`25.
`
`In connection with this Reply Declaration, I have been asked to
`
`evaluate which components of Examples 2 or 4 of the ’194 patent, other than
`
`methylparaben and propylparaben, would be considered a preservative.
`
`26.
`
`I understand that Dr. Niazi has taken the position that levocetirizine
`
`preserves the formulation against bacterial growth. EX2034, ¶84 (“A POSA would
`
`understand from this [sic] data that levocetirizine alone is an effective antibacterial
`
`7
`
`Apotex (IPR2019-00400) Ex. 1050 p. 009
`
`
`
`agent”); see also id. at ¶¶83, 85, 189, 200.2, 3 Thus, Dr. Niazi cannot dispute that
`
`levocetirizine would be a preservative in Examples 2 and 4. As stated in paragraph
`
`12 (supra), the “liquid pharmaceutical composition” includes levocetirizine, which
`
`is outside the “consisting essentially of” recitation, and “said composition is
`
`substantially free of bacteria.”
`
`27.
`
`Examples 2 and 4 of the ’194 patent are reproduced below:
`
`2 According to Dr. Niazi, the further inclusion of parabens resulted in meeting
`
`the Pharmacopoeia antimicrobial effectiveness requirements for additional molds
`
`and fungi. EX2034, ¶201.
`
`3 Although this is Dr. Niazi’s view, I do not believe that there are enough
`
`controls to establish this based on the data especially in light of the additional
`
`preservatives (glycerin and/or propylene glycol) included in Examples 2 and 4,
`
`which I discuss later in this declaration. Infra. Dr. Niazi fails to account for these
`
`additional preservatives.
`
`8
`
`Apotex (IPR2019-00400) Ex. 1050 p. 010
`
`
`
`4“
`
`45
`
`5”
`
`55
`
`EXAMPLE 2
`
`.
`.
`.
`.
`.
`.
`Presen’atwe Effect of Levocetrrtzrue
`
`An oral solution and drops containing levocetirizine are
`prepared. The compositions are given in table 4.
`
`.
`
`.
`.
`lrltBLl: 4
`
`chocctirizinc compositions
`
`Oral solution
`
`Drops
`
`Ifl-‘oce’ririzine hydrochloride (mg)
`Maltitol—Lycasin 80—55 ling}
`Glycerine 85% (mg)
`l'ropyleneglycol tmgl
`Sodirun sacclnu‘inatc {rngl
`Tutti li'utti flavour {rugl
`Sodium acetate ting)
`Acetic acid [mg]
`Purified water [mll
`
`[1:]
`40E}
`235.2
`—
`[L5
`0.1 5-
`3.4
`0.5
`ad |
`
`5
`
`294.1
`Flfill
`10
`—
`5.?
`0.53
`art l
`
`EXAMPLE 4
`
`Efficacy ot‘Antirnicrobial Presentation of
`Levoeetirizine Aqueous Solutions by
`p-lrydroxybcnzoatc Esters
`
`Oral solutions and drops containing lcvocctirizinc accord-
`ing to example 2 but also containing mixtures of'p-hydroxy- _.
`benzoate esters (methyl p-hydroxybenzoatefpropyl p-hy-
`droxybenzoate in a ratio of 91’] expressed in weight) are
`prepared. The total amounts ot‘p-hydroxyhenzoate esters are
`0.375 mgfml, 0.75 mgfl'ml and 1.125 mgfml. The eliicaey of
`antimicrobial preservation of these solutions and drops is
`determined according to the European Pharmacopoeia
`(Chap. 5.] 3.). The results ol‘the tests are given in tables 15 to
`20.
`
`9
`
`9 A
`
`potex (IPR2019-00400) EX. 1050 p. 011
`
`Apotex (IPR2019-00400) Ex. 1050 p. 011
`
`
`
`28.
`
`Both the “Oral Solution” and “Oral Drops”, without any distinction,
`
`were used to support UCB’s allegations of unexpected results for all the challenged
`
`claims. Declaration of Fanara EX1027, ¶8-11, Exhibits C and D; EX2034, ¶¶83, 93,
`
`200.
`
`29.
`
`Looking at Examples 2 and 4, both compositions are 1 mL (“ad 1” with
`
`the units, ml, in the left column).
`
`30.
`
`Examples 2 and 4, designated “Oral Solution,” contain 235.2 mg of
`
`85% glycerin,4 (235.2 x 0.85) or 199.92 mg of glycerin per 1 mL of oral solution.
`
`“In oral solutions, glycerin is used as a solvent, sweetening agent, and antimicrobial
`
`preservative, and viscosity-increasing agent.” EX1045, p. 257 (emphasis added).
`
`31.
`
`Thus, Examples 2 and 4 “Oral Solution” contain 19.992 w/v%, or 20
`
`w/v% (rounded off) of glycerin.
`
`32.
`
`Examples 2 and 4, designated “Drops,” contain 294.1 mg of 85%
`
`glycerin and 350 mg of propylene glycol per mL. Therefore, % w/v of glycerin in
`
`the “drops” is 24.9985% or 25% (rounded off), and the % w/v of propylene glycol
`
`is 35%.
`
`33. As explained in Remington, referenced in the file history of the ’194
`
`patent (reproduced below), glycerin and propylene glycol are “common
`
`4 The European spelling is glycerine, the U.S. spelling is glycerin.
`
`10
`
`Apotex (IPR2019-00400) Ex. 1050 p. 012
`
`
`
`preservatives” when used at “typical” concentration levels of 20-30% w/w (glycerin)
`
`and 15-30% w/w (propylene glycol):
`
`EX1027, p. 17 (Table 39-2); see also EX1045, p. 257 (Handbook entry for glycerin
`
`identifying it as an “antimicrobial preservative” under “Functional Category”).
`
`34. A POSA would understand that these “typical” values in Remington
`
`represent when the preservative is used alone, not in combination with other
`
`preservatives. I note that the values in Remington are reported in % w/w. Using the
`
`densities of glycerin (1.2656 g/cm3) and propylene glycol (1.038 g/cm3) reported in
`
`the Handbook (EX1045, p. 258; EX1006, p. 442), 20-30% w/w of glycerin
`
`11
`
`Apotex (IPR2019-00400) Ex. 1050 p. 013
`
`
`
`corresponds to 25 to 38% w/v, and 15 to 30% w/w of propylene glycol corresponds
`
`to 16 to 31% w/v.5
`
`35. While the 20% w/v glycerin in Examples 2 and 4 “Oral Solution” may
`
`be lower than the “typical” values reported in Remington, as noted above, the values
`
`in Remington are for when glycerin is used alone. Example 2 “Oral Solution”
`
`contains the preservative levocetirizine,6 and in the case of Example 4, the additional
`
`inclusion of at least methylparaben and propylparaben. A POSA would expect, at
`
`the very least, when mixed, different preservatives would have an additive effect on
`
`each other because they would work by different mechanisms. Therefore, the 20%
`
`w/v glycerin in Examples 2 and 4 “Oral Solution” would present in an amount that
`
`would make it a preservative.
`
`36.
`
`Furthermore, Remington is not the only source a POSA would consult.
`
`A POSA would have also known that the Handbook reports that glycerin is an
`
`5 There may be some marginal change due to the densities in solution but the
`
`POSA would not consider such a change anything other than trivial and
`
`insignificant.
`
`6 I note that Dr. Niazi has taken the position that “that levocetirizine alone is
`
`an effective antibacterial agent.” EX2034, ¶84.
`
`12
`
`Apotex (IPR2019-00400) Ex. 1050 p. 014
`
`
`
`antimicrobial preservative at concentrations of less than (i.e., “<”) 20% (EX1045,
`
`p. 257):
`
`37.
`
`Therefore, in addition to the points I made in paragraph 35, the
`
`Handbook would inform the POSA that Examples 2 and 4 “Oral Solution” contain
`
`amounts of glycerin in amounts that allow it to function as an antimicrobial
`
`preservative.
`
`38.
`
`Turning to Examples 2 and 4 “Drops”: Examples 2 and 4 “Drops”
`
`contain 25% w/v glycerin and 35% w/v propylene glycol. For the reasons explained
`
`above, Examples 2 and 4 “Drops” contain amounts of glycerin and propylene glycol
`
`that a POSA would know enable them to function as antimicrobial preservatives.7
`
`7 To the extent UCB attempts to argue that 35% w/v propylene glycol is
`
`outside the range reported in Remington and thus it ceases becoming a preservative,
`
`no POSA would accept that. Propylene glycol would not cease becoming a
`
`preservative if you exceed the values reported in Remington.
`
`13
`
`Apotex (IPR2019-00400) Ex. 1050 p. 015
`
`
`
`39.
`
`Therefore, Examples 2 and 4 “Oral Solution” and Examples 2 and 4
`
`“Drops” contain other “component[s] that serves the purpose of preserving the
`
`formulation against bacterial growth.”
`
`40. Along this same vein, the ’194 patent states, “[e]xamples of
`
`preservatives are . . . alcohol”. EX1001, 3:19-26. Although the ’194 patent states
`
`that examples of alcohols are “chlorobutanol, isopropanol, ethanol, . . . , [and]
`
`phenol,” glycerin and propylene glycol fall into the categories of “alcohols” even
`
`though they are not expressly mentioned. The chemical name of glycerin is propane-
`
`1,2,3-triol. EX1045, p. 257. The chemical name of propylene glycol is 1,2-
`
`propanediol. EX1006, p. 442. I have reproduced the structures below:
`
`Glycerin:
`
`EX1045, p. 257.
`
`Propylene glycol:
`
`14
`
`Apotex (IPR2019-00400) Ex. 1050 p. 016
`
`
`
`EX1006, p. 442.
`
`41.
`
`Put simply, Dr. Niazi’s testimony that “[i]f a formulation has any
`
`component that serves the purpose of preserving the formulation against bacterial
`
`growth, then they [sic] will not be under the ‘consisting essentially of’” cannot be
`
`reconciled with the actual formulations of Examples 2 and 4 of the ’194 patent.
`
`42.
`
`Turning next to Example 5 of EP ’203 (EX1004), which is a cetirizine
`
`solution, putting cetirizine, methylparaben and propylparaben aside, none of the
`
`other components of Example 5 would be preservatives.
`
`43.
`
`The complete formulation of Example 5 of EP ’203 is reproduced
`
`below:
`
`EX1004, p. 11.
`
`44.
`
`Remington and the Handbook teach that when propylene glycol’s
`
`concentration exceeds 15% w/v, it becomes effective as an antimicrobial
`
`15
`
`Apotex (IPR2019-00400) Ex. 1050 p. 017
`
`
`
`preservative. EX1027, p. 17 (Table 39-2); EX1006, p. 442. At 2.0 grams per 100
`
`mL (2% w/v) of propylene glycol in EP ’203, the POSA would know this
`
`concentration is well below any level where propylene glycol would be considered
`
`an antimicrobial preservative. Put simply, propylene glycol—when present as only
`
`2.0 grams per (2% w/v) of Example 5 of EP ’203—would not act as a preservative.
`
`45. A POSA would know the only impact of 2% w/v of propylene glycol
`
`would be to a small improvement in the solubility of the parabens so that the
`
`parabens’ preservative activity can be enhanced. EX1024, p. 53 (“co-solvents can
`
`be used to increase the aqueous solubility of methyl and propyl parabens
`
`preservatives and thereby increase their antibacterial activity”) (emphasis added).
`
`46.
`
`In the view of a POSA, a component that only serves to increase the
`
`solubility of the parabens does not materially affect the basic characteristics of the
`
`paraben’s own ability to function as a preservative, or affect the basic characteristics
`
`of any other part of the challenged claims.
`
`47. As to the other components of Example 5, none of the other components
`
`are preservatives, especially at the levels used in Example 5: cyclodextrins, (EX1006
`
`at 165 (“Stabilizing agent, solubilizing agent”); EX2034, ¶113 (same)); polyvinyl
`
`alcohol (EX1006 at 424 (“Coating agent, lubricant, stabilizing agent, viscosity
`
`increasing agent”); EX1004, 3:40-44 (“water soluble polymers”)); sodium acetate
`
`and sodium hydroxide (EX1014 at 240-242 (buffering agents), 1264; EX1004, 3:56-
`
`16
`
`Apotex (IPR2019-00400) Ex. 1050 p. 018
`
`
`
`57 (pH control)). As further proof, none of compounds mentioned in this paragraph
`
`are included Table 39-2 of Remington. EX1027, p. 17 (Table 39-2).
`
`48.
`
`I hereby declare that all statements made herein of my own knowledge
`
`are true and that all statements made on information and belief are believed to be
`
`true; and further that these statements were made with the knowledge that willful
`
`false statements and the like so made are punishable by fine or imprisonment, or
`
`both, under Section 1001 of Title 18 of the United States Code.
`
`Respectfully Submitted,
`
`______________________
`Dr. Paul A. Laskar, Ph.D.
`Date: January 12th, 2020
`
`17
`
`Apotex (IPR2019-00400) Ex. 1050 p. 019
`
`
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