IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________
`
`MYLAN PHARMACEUTICALS INC.
`Petitioner,
`
`v.
`
`3M COMPANY
`Patent Owner.
`
`U.S. Patent No. 6,743,413 to Schultz et al.
`Issue Date: June 1, 2004
`Title: Suspension Aerosol Formulations
`
`_____________________
`
`Inter Partes Review No.: IPR2015-_____
`
`
`
`Petition for Inter Partes Review of U.S. Patent No. 6,743,413
`Under 35 U.S.C. §§ 311-319 and 37 C.F.R. §§ 42.1-.80, 42.100-.123
`
`
`
`
`
`
`
`
`
`Mail Stop "PATENT BOARD"
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`
`

`
`I.
`
`II.
`
`Petition for Inter Partes Review of USPN 6,743,413
`
`TABLE OF CONTENTS
`
`INTRODUCTION ........................................................................................... 1
`
`OVERVIEW .................................................................................................... 1
`A.
`The ’413 Patent ..................................................................................... 1
`B.
`The Priority Date of the ’413 Patent ..................................................... 2
`1.
`The Earliest Effective Date for the Claims of the ’413
`Patent is May 4, 1992 .................................................................. 2
`a)
`The ’791 Application Does Not Provide Adequate
`Support for the Claims of the ’413 Patent ........................ 2
`The ’401 Application Does Not Provide Adequate
`Support for Claims of the ’413 Patent .............................. 3
`Applicant Admitted that the Effective Priority Date
`of the ’413 Patent is May 4, 1992 ..................................... 4
`
`b)
`
`c)
`
`III.
`
`STANDING (37 C.F.R. § 42.104(a)); PROCEDURAL
`STATEMENTS ............................................................................................... 5
`
`IV. MANDATORY NOTICES (37 C.F.R. § 42.8(a)(1)) ...................................... 5
`A.
`Each Real Party-In-Interest (37 C.F.R. § 42.8(b)(1)) ........................... 5
`B.
`Notice of Related Matters (37 C.F.R. § 42.8(b)(2)) .............................. 6
`1.
`Judicial Matters Involving the ’413 patent ................................. 6
`2.
`Administrative Matters ............................................................... 6
`Designation of Lead and Back-Up Counsel (37 C.F.R. §
`42.8(b)(3)) ............................................................................................. 6
`D. Notice of Service Information (37 C.F.R. § 42.8(b)(4)) ....................... 7
`
`C.
`
`V.
`
`STATEMENT OF THE PRECISE RELIEF REQUESTED AND THE
`REASONS THEREFOR (37 C.F.R. § 42.22(a)) ............................................ 7
`
`VI. THE ’413 PATENT AND CLAIM CONSTRUCTION ................................. 7
`
`VII. PERSON OF ORDINARY SKILL IN THE ART (“POSA”) &
`STATE OF THE ART ..................................................................................... 8
`
`VIII. IDENTIFICATION OF CHALLENGE (37 C.F.R. § 42.104(b)) ................... 9
`
`IX.
`
`Invalidity analysis ..........................................................................................10
`A.
`The ’011 Publication Anticipates Claims 1-2, 4, 6-7, 10, 12, 14-
`20, and 22-24 .......................................................................................10
`
`i
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`

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`Petition for Inter Partes Review of USPN 6,743,413
`
`Independent Claim 1 .................................................................11
`1.
`Independent Claim 4 .................................................................15
`2.
`Independent Claim 6 .................................................................16
`3.
`Independent Claim 12 ...............................................................18
`4.
`Independent Claim 14 ...............................................................21
`5.
`Independent Claim 17 ...............................................................22
`6.
`Independent Claims 20 and 22 ..................................................23
`7.
`Dependent Claim 2....................................................................25
`8.
`Dependent Claim 7....................................................................25
`9.
`10. Dependent Claim 10 .................................................................26
`11. Dependent Claims 15, 16, 18, 19, 23, and 24 ...........................27
`The Challenged Claims Would Have Been Obvious Given the
`’011 Publication Alone or in Combination .........................................28
`1.
`The Scope and Content of the Prior Art ...................................28
`2.
`Differences Between the Claims and the Prior Art ..................28
`a)
`Claims 1, 2, and 4 Would Have Been Obvious ..............28
`b)
`Claim 3 Would Have Been Obvious ..............................29
`c)
`Claims 5 and 14 Would Have Been Obvious .................31
`d)
`Claim 6 Would Have Been Obvious ..............................33
`e)
`Claim 7 Would Have Been Obvious ..............................34
`f)
`Claims 8-11 Would Have Been Obvious .......................35
`g)
`Claim 12 Would Have Been Obvious ............................36
`h)
`Claim 13 Would Have Been Obvious ............................37
`i)
`Claim 17 Would Have Been Obvious ............................38
`j)
`Claim 20 Would Have Been Obvious ............................38
`k)
`Claims 21 and 22 Would Have Been Obvious ...............39
`l)
`Dependent Claims 15, 16, 18, 19, 23, and 24
`Would Have Been Obvious ............................................39
`The ’333 Publication Anticipates Claims 1-5, 14, and 20-22 .............41
`1.
`Independent Claim 1 .................................................................42
`2.
`Independent Claim 3 .................................................................45
`3.
`Independent Claim 4 .................................................................46
`4.
`Independent Claims 5 and 14 ....................................................47
`5.
`Independent Claims 20, 21, and 22 ...........................................48
`6.
`Dependent Claim 2....................................................................49
`The ’333 Publication Alone or in Combination Renders
`Obvious All of the Challenged Claims of the ’413 Patent ..................50
`1.
`The Base Limitations of Every Claim Would Have Been
`Obvious .....................................................................................50
`
`B.
`
`C.
`
`D.
`
`ii
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`

`
`Petition for Inter Partes Review of USPN 6,743,413
`
`2.
`
`3.
`
`4.
`
`5.
`
`Equipping the Aerosol Canister with a Metering Valve
`Would Have Been Obvious ......................................................52
`Selecting Therapeutically Effective Amounts/Doses
`Would Have Been Obvious ......................................................52
`The Dispersibility/Flocculation Element Would Have
`Been Obvious ............................................................................54
`Selecting a Micronized Drug Particulate, or a Particulate
`Drug wherein 90% or More of the Particles Have a
`Diameter of Less than 10 microns, Would Have Been
`Obvious .....................................................................................55
`Selecting a Formulation that Exhibits Substantially No
`Growth in Particle Size Would Have Been Obvious ................56
`Using Surfactant-Less or Substantially Surfactant-Free
`Formulations for the Treatment of Asthma or COPD
`Would Have Been Obvious ......................................................57
`Objective Indicia of Non-Obviousness ...............................................58
`
`6.
`
`7.
`
`E.
`
`X.
`
`CONCLUSION ..............................................................................................59
`
`
`
`
`
`
`
`
`
`iii
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`

`
`Petition for Inter Partes Review of USPN 6,743,413
`
`TABLE OF AUTHORITIES
`
`Page(s)
`
`
`
`
`CASES
`
`Amneal Pharmaceuticals, LLC v. Supernus Pharmaceuticals, Inc.,
`IPR2013-00368 ................................................................................................... 58
`
`Augustine Med., Inc. v. Gaymar Indus.,
`181 F.3d 1291 (Fed. Cir. 1999) ............................................................................ 4
`
`Celeritas Techs., Ltd. v. Rockwell Int’l Corp.,
`150 F.3d 1354, 47 U.S.P.Q.2d 1516 (Fed. Cir. 1998) ............................... 14, 18
`
`Ecolab, Inc. v. FMC Corp.,
`569 F.3d 1335 (Fed. Cir. 2009) .................................................................... 11, 43
`
`Hoffmann-La Roche Inc. v. Apotex Inc.,
`748 F.3d 1326 (Fed. Cir. 2014) .......................................................................... 58
`
`In re Aller,
`220 F.2d 454 (C.C.P.A. 1955) .......................................................... 31, 33, 35, 54
`
`In re Fulton,
`391 F.3d 1195 (Fed. Cir. 2004) .................................................................... 29, 30
`
`In re Kalm,
`378 F.2d 959 (C.C.P.A. 1967) .......................................................... 28, 50, 51, 52
`
`In re Malagari,
`499 F.2d 1297,1303 (C.C.P.A. 1974) ................................................................. 53
`
`In re Mouttet,
`686 F.3d 1322 (Fed. Cir. 2012) .......................................................................... 29
`
`In re Paulson,
`30 F.3d 1475 (Fed. Cir. 1994) ............................................................................ 10
`
`In re Peterson,
`315 F.3d 1325 (Fed. Cir. 2005) .......................................................................... 53
`
`iv
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`

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`Petition for Inter Partes Review of USPN 6,743,413
`
`In re Woodruff,
`919 F.2d 1575 (Fed. Cir. 1990) .......................................................................... 53
`
`IPXL Holdings, L.L.C. v. Amazon.com, Inc.,
`430 F.3d 1377 (Fed. Cir. 2005) .................................................................... 11, 42
`
`King Pharms., Inc. v. Eon Labs, Inc.,
`616 F.3d 1267 (Fed. Cir. 2010) .................................................................... 26, 27
`
`KSR Int’l Co. v. Teleflex, Inc.,
`550 U.S. 398 (2007) .............................................................................................. 8
`
`Liebel-Flarsheim Co. v. Medrad, Inc.,
`481 F.3d 1371 (Fed. Cir. 2007) .................................................................... 11, 42
`
`Metrics, Inc. v. Senju Pharmaceutical Co., Ltd.,
` IPR2014-01041 .................................................................................................. 31
`
`Newell Cos., Inc. v. Kenney Mfg. Co.,
`864 F.2d 757 (Fed. Cir. 1988) ............................................................................ 58
`
`Pfizer, Inc. v. Apotex, Inc.,
`480 F.3d 1348 (Fed. Cir. 2008) .......................................................................... 58
`
`SkinMedica, Inc. v. Histogen, Inc.,
`727 F.3d 1187 (Fed. Cir. 2013) ...................................................................passim
`
`STATUTES
`
`35 U.S.C. § 102 ........................................................................................................ 10
`
`35 U.S.C. § 102(a) ................................................................................................... 10
`
`35 U.S.C. § 102(b) ...................................................................................... 10, 40, 42
`
`OTHER AUTHORITIES
`
`37 C.F.R. § 42.6(d) .................................................................................................... 9
`
`37 C.F.R. § 42.8(a)(1) ................................................................................................ 5
`
`37 C.F.R. § 42.8(b)(1) ................................................................................................ 5
`
`37 C.F.R. § 42.8(b)(2) ................................................................................................ 6
`
`v
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`

`
`Petition for Inter Partes Review of USPN 6,743,413
`
`37 C.F.R. § 42.8(b)(3) ................................................................................................ 6
`
`37 C.F.R. § 42.8(b)(4) ................................................................................................ 7
`
`37 C.F.R. § 42.10(b) .............................................................................................. 5, 6
`
`37 C.F.R. § 42.22(a) ................................................................................................... 7
`
`37 C.F.R. § 42.63(e) ................................................................................................... 5
`
`37 C.F.R. § 42.100(b) ................................................................................................ 7
`
`37 C.F.R. § 42.104(a) ................................................................................................. 5
`
`37 C.F.R. § 42.104(b) ................................................................................................ 9
`
`37 C.F.R. § 42.106(a) ................................................................................................. 5
`
`vi
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`

`
`Petition for Inter Partes Review of USPN 6,743,413
`
`Exhibit
`#
`
`Petitioner’s Exhibit List
`
`Description
`
`1001
`
`U.S. Patent No. 6,743,413
`
`1002
`
`U.S. Patent Application Ser. No. 07/809,791
`
`1003
`
`U.S. Patent Application Ser. No. 07/810,401
`
`1004
`
`December 8, 1998 Request that an Interference Be Declared
`
`1005
`
`July 30, 2002 Amendment
`
`1006
`
`Declaration of Hugh Smyth
`
`1007
`
`International Patent Application Publication No. WO 1991/004011
`
`1008
`
`RESERVED
`
`1009
`
`U.S. Patent No. 4,866,051
`
`1010
`
`Weir, D.C., et al. “Corticosteroid trials in non-asthmatic chronic
`airflow obstruction: a comparison of oral prednisolone and inhaled
`beclomethasone dipropionate.” 45 Thorax 112 (1990)
`
`1011
`
`International Patent Application Publication No. WO 1990/007333
`
`1012
`
`Curriculum Vitae of Hugh Smyth
`
`1013
`
`RESERVED
`
`1014
`
`1015
`
`Joseph P. Remington, Remington’s Pharmaceutical Sciences 308-17
`(Alfonso R. Gennaro ed., 17 ed. 1985)
`
`G. S. Banker and C. T. Rhodes, Eds., Modern Pharmaceutics,
`Second Edition 341 (Marcel Dekker, Inc., New York 1990)
`
`vii
`
`

`
`Petition for Inter Partes Review of USPN 6,743,413
`
`I.
`
`INTRODUCTION
`
`Mylan Pharmaceuticals Inc. (“Petitioner”) petitions for Inter Partes Review
`
`(“IPR”) seeking cancellation of claims 1-24 (“challenged claims”) of U.S. Patent
`
`No. 6,743,413 to Schultz et al. (“the ’413 patent”) (EX1001), which is owned by 3M
`
`Company (“3M” or “Patent Owner”).
`
`II. OVERVIEW
`
`A. The ’413 Patent
`
`The ’413 patent issued June 1, 2004, from U.S. Appl. No. 08/455,280. The
`
`original priority application was filed in 1991, but the ’413 patent will not expire
`
`until 2021, giving the patentee an almost thirty-year (30) monopoly. The ’413
`
`patent, however, never should have issued as its claims are anticipated and/or
`
`rendered obvious by the prior art. Petitioner files this IPR asking to end Patent
`
`Owner’s wrongful monopoly.
`
`The ’413 patent’s independent, challenged claims are directed to nothing more
`
`than pharmaceutical suspension formulations or apparatuses suitable for aerosol
`
`administration of such formulations. The base limitations of every claim involve
`
`aerosol formulations that contain a: (1) particulate drug; (2) 1,1,1,2-tetrafluoroethane
`
`(HFC-134a) as propellant; and (3) either being surfactant-free or “substantially
`
`surfactant free.”
`
`1
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`

`
`Petition for Inter Partes Review of USPN 6,743,413
`
`B.
`
`The Priority Date of the ’413 Patent
`
`1.
`
`The Earliest Effective Date for the Claims of the ’413 Patent
`is May 4, 1992
`
`The ’413 patent issued from U.S. Application Serial Number 08/455,280 (“the
`
`’280 application”), filed May 31, 1995, which was a divisional application of U.S.
`
`Application Serial Number 07/878,039 (“the ’039 application”) filed May 4, 1992,
`
`now abandoned, which was a continuation-in-part application of commonly
`
`assigned, co-pending applications: U.S. Application Serial Number 07/809,791
`
`(“the ’791 application”) and U.S. Application Serial Number 07/810,401 (“the ’401
`
`application”), both filed December 18, 1991 and both abandoned. (EX1001,
`
`“Related U.S. Application Data”). However, as explained below, the earliest
`
`effective priority date that the ’413 patent should be afforded is May 4, 1992.
`
`a)
`
`The ’791 Application Does Not Provide Adequate
`Support for the Claims of the ’413 Patent
`
`The ’791 application (EX1002), filed December 18, 1991, is directed to
`
`compositions containing albuterol sulfate and 1,1,1,2,3,3,3-heptafluoropropane
`
`(HFC-227) as the propellant. The ’791 application states, “[t]his invention provides
`
`suspension aerosol formulations comprising a therapeutically effective amount of
`
`micronized albuterol sulfate and 1,1,1,2,3,3,3-heptafluoropropane as substantially
`
`the only propellant.” (EX1002, p. 2) (emphasis added). Only three formulations are
`
`described
`
`in
`
`the
`
`’791 application, all of which
`
`include 1,1,1,2,3,3,3-
`
`2
`
`

`
`Petition for Inter Partes Review of USPN 6,743,413
`
`heptafluoropropane as the propellant and albuterol sulfate. (EX1002, pp. 5-6
`
`(Examples 1-3)). Because the ’791 application does not disclose any composition
`
`containing 1,1,1,2-tetrafluoroethane, it does not provide adequate support for the
`
`claimed subject matter of the ’413 patent. PowerOasis, Inc. v. T-Mobile USA, Inc.,
`
`522 F.3d 1299, 1306 (Fed. Cir. 2008).
`
`b)
`
`The ’401 Application Does Not Provide Adequate
`Support for Claims of the ’413 Patent
`
`The ’401 application (EX1003), filed December 18, 1991, is directed to
`
`compositions containing pirbuterol acetate and 1,1,1,2,3,3,3-heptafluoropropane
`
`(HFC-227) as the propellant. The formulation of the ’401 application “is further
`
`characterized in that it is substantially free of perfluorinated surfactant.”
`
`(EX1003, p. 2). All five of the formulations set forth in the ’401 application
`
`include pirbuterol acetate and 1,1,1,2,3,3,3-heptafluoropropane (HFC-227) as the
`
`propellant. (EX1003, pp. 5-8 (Examples 1-5)).
`
`The ’401 application states that “[t]he propellant comprises 1,1,1,2,3,3,3-
`
`heptafluoropropane, preferably as substantially the only propellant. However, one
`
`or more other propellants such as propellant 142b (1-chloro-1,1-difluoroethane),
`
`HFC-134a, and the like can be used, preferably in formulations of the invention
`
`containing ethanol.” (EX1003, p. 9). This disclosure should be interpreted as
`
`encompassing formulations containing HFC-134a in addition to 1,1,1,2,3,3,3-
`
`heptafluoropropane as opposed to in place of 1,1,1,2,3,3,3-heptafluoropropane.
`
`3
`
`

`
`Petition for Inter Partes Review of USPN 6,743,413
`
`Thus, the ’401 application fails to provide adequate support for the claimed
`
`subject matter of the ’413 patent, which recites compositions and apparatuses for
`
`administering compositions “consisting essentially of” HFC-134a as the sole
`
`propellant.
`
`c)
`
`Applicant Admitted that the Effective Priority Date of
`the ’413 Patent is May 4, 1992
`
`The ’280 application, from which the ’413 patent issued, was a divisional of
`
`the ’039 application, which in turn was a continuation-in-part (“CIP”) application of
`
`the ’791 and ’401 applications. Claims in a CIP application are entitled only to the
`
`benefit of priority of an earlier application that has adequate written description
`
`support for the claims at issue. Augustine Med., Inc. v. Gaymar Indus., 181 F.3d
`
`1291, 1302-03 (Fed. Cir. 1999).
`
`On December 8, 1998, during prosecution of the ’280 application, the
`
`Applicant filed a Request that an Interference be Declared. In that document,
`
`Applicant stated, “[a]s demonstrated above claims 1051-115 are fully supported by
`
`the disclosure in the parent application, U.S. Application No. 07/878,039, which was
`
`filed May 4, 1992, and the instant application. Accordingly, the effective priority
`
`date of the present application is May 4, 1992.” (EX1004, Request for Interference
`
`
`1 Claim 105, submitted by Applicants in their Response dated December 8, 1998, is
`
`identical to issued claim 1 of the ’413 patent. (EX1004, p. 1).
`
`4
`
`

`
`Petition for Inter Partes Review of USPN 6,743,413
`
`at p. 22) (emphasis added). Thus, by Applicants’ admission, the ’413 patent claims
`
`are entitled only to an effective filing date of May 4, 1992.
`
`III. STANDING (37 C.F.R. § 42.104(A)); PROCEDURAL STATEMENTS
`
`Petitioner certifies that: (1) the ’413 patent is available for IPR; and (2)
`
`Petitioner is not barred or estopped from requesting IPR of any claim of the ’413
`
`patent on the grounds identified herein. This Petition is filed in accordance with 37
`
`CFR § 42.106(a). Concurrently filed herewith are a Power of Attorney and an
`
`Exhibit List pursuant to § 42.10(b) and § 42.63(e), respectively. The required fee is
`
`paid when filing the Petition and the Office is authorized to charge any fee
`
`deficiencies and credit overpayments to Deposit Acct. No. 160605 (Customer ID
`
`No. 00826).
`
`IV. MANDATORY NOTICES (37 C.F.R. § 42.8(A)(1))
`
`A. Each Real Party-In-Interest (37 C.F.R. § 42.8(b)(1))
`
`The real parties in interest are Mylan Pharmaceuticals, Inc., Mylan, Inc.,
`
`Mylan N.V.,2 and Mylan Pharma U.K. Limited.
`
`
`2 Petitioner identifies Mylan N.V. (“MNV”) as a real party-in-interest (“RPI”) out
`
`of an abundance of caution, due to a pending issue in IPR2015-01069 (an unrelated
`
`proceeding), wherein the petitioner in that proceeding has opposed an allegation that
`
`MNV should have been identified as an RPI. (Paper 12). Petitioner’s identification
`
`5
`
`

`
`Petition for Inter Partes Review of USPN 6,743,413
`
`B. Notice of Related Matters (37 C.F.R. § 42.8(b)(2))
`
`1.
`
`Judicial Matters Involving the ’413 patent
`
`To Petitioner’s knowledge, there are no judicial matters to report.
`
`2.
`
`Administrative Matters
`
`The Public Patent Application Information Retrieval (“Public PAIR”) system
`
`indicates that U.S. Patent No. 7,101,534, which issued September 5, 2006, and U.S.
`
`Patent No. 7,105,152, which issued September 12, 2006, both claim priority to the
`
`’413 patent’s parent application, the ’039 application. Public PAIR further indicates
`
`that all other corresponding U.S. patent applications have been abandoned.
`
`C. Designation of Lead and Back-Up Counsel (37 C.F.R. § 42.8(b)(3))
`
`Lead Counsel
`
`Back-Up Counsel
`
`Jitendra Malik, Ph.D.
`Reg. No. 55823
`ALSTON & BIRD LLP
`4721 Emperor Blvd., Suite 400
`Durham, NC 27703-8580
`jitty.malik@alston.com
`
`
`Robert Caison
`Reg. No. 72939
`ALSTON & BIRD LLP
`101 South Tyron Street, Suite 400.
`Charlotte, NC 28280-4000
`robert.caison@alston.com
`
`
`of MNV as an RPI in the instant proceeding in no way constitutes an admission that
`
`MNV is or was an RPI in any other IPR proceeding.
`
`6
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`

`
`Petition for Inter Partes Review of USPN 6,743,413
`
`D. Notice of Service Information (37 C.F.R. § 42.8(b)(4))
`
`Please direct all correspondence to lead counsel at the above address.
`
`Petitioner
`
`consents
`
`to
`
`email
`
`service
`
`at:
`
`jitty.malik@alston.com
`
`and
`
`robert.caison@alston.com.
`
`V.
`
`STATEMENT OF THE PRECISE RELIEF REQUESTED AND THE
`REASONS THEREFOR (37 C.F.R. § 42.22(A))
`
`Petitioner requests IPR and cancellation of claims 1-24 of the ’413 patent. A
`
`detailed statement of the reasons for the relief requested is set forth below.
`
`VI. THE ’413 PATENT AND CLAIM CONSTRUCTION
`
`The challenged claims must be given their broadest reasonable interpretation
`
`in light of the specification of the ’413 patent. See 37 C.F.R. § 42.100(b). Under
`
`this standard, no terms or phrases require specific construction.3
`
`
`3 The term “substantially free of surfactant”—as found, for example, in claim 5—is
`
`no exception. In a July 30, 2002 amendment, the applicant stated that the term
`
`“substantially free of surfactant” was to be used in a manner consistent with the
`
`specification (EX1005, 7/30/02 amendment, p. 8). The specification includes no
`
`further explanation as to its meaning. As such, “substantially free of surfactant”
`
`should be accorded the definition it would have had to a person of ordinary skill in
`
`the art at the time.
`
`7
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`

`
`Petition for Inter Partes Review of USPN 6,743,413
`
`VII. PERSON OF ORDINARY SKILL IN THE ART (“POSA”) & STATE
`OF THE ART
`
`A POSA is a hypothetical person who is presumed to be aware of all pertinent
`
`art, thinks along conventional wisdom in the art, and is a person of ordinary
`
`creativity. KSR Int’l Co. v. Teleflex, Inc., 550 U.S. 398, 420 (2007). A POSA in the
`
`field of the ’413 patent would have had education and/or experience in particulate
`
`drug formulations and drug delivery via inhalation and knowledge of the scientific
`
`literature in the field.4 Although the education and experience levels may vary, a
`
`POSA would have had at least a bachelor’s degree in pharmacy or chemistry and
`
`work experience in the field of aerosol formulations and aerosol delivery systems
`
`for medications, including working with propellant based systems. A POSA would
`
`also have had experience in the research and/or development of inhalers to
`
`administer various medications, including inhalers directed to the treatment of
`
`asthma and chronic obstructive pulmonary disease (“COPD”). A person holding
`
`only a Bachelor’s degree would be required to have had five to ten years of relevant
`
`work experience to qualify as a POSA, but a person with a more advanced degree,
`
`such as a master’s of science, could qualify as a POSA with fewer years of
`
`
`4 Regardless of which priority date applies, the knowledge of the scientific literature,
`
`common sense, and skill of the POSA would remain the same. (EX1006,
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`Declaration of Hugh Smyth, ¶ 17).
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`Petition for Inter Partes Review of USPN 6,743,413
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`experience. A POSA is not necessarily limited to his or her own skills but also may
`
`work as part of a team and utilize specialized skills of other team members in order
`
`to solve a particular problem.
`
`VIII. IDENTIFICATION OF CHALLENGE (37 C.F.R. § 42.104(B))
`
`IPR of claims 1-24 of the ’413 patent is respectfully requested on the grounds
`
`of unpatentability listed below. Per 37 C.F.R. § 42.6(d), copies of the references are
`
`filed herewith. In support of the proposed grounds for unpatentability, this Petition
`
`includes the declaration of a technical expert, Dr. Hugh Smyth (EX1006), explaining
`
`what the art would have conveyed to a POSA as of the priority date. Dr. Smyth has
`
`offered a declaration from the perspective of a person of ordinary skill.
`
`Reference(s)
`
`WO 91/04011 (EX1007)
`
`WO 90/07333 (EX1011)
`WO 91/04011 (EX1007)
`WO 90/07333 (EX1011)
`WO 91/04011 (EX1007) in view of U.S. Patent
`No. 4,866,051 (EX1009)
`WO 90/07333 (EX1011) in view of U.S. Patent
`No. 4,866,051 (EX1009)
`WO 91/04011 (EX1007) in view of Weir,
`D.C., et al. (EX1010)
`WO 90/07333 (EX1011) in view of Weir,
`D.C., et al. (EX1010)
`
`Basis
`
`§ 102
`
`§ 102
`§ 103
`§ 103
`§ 103
`
`Claims
`Challenged
`
`1-2, 4, 6-7, 10, 12,
`14-20, 22-24
`1-5, 14, 20-22
`1-14, 17, 20-22
`1-14, 17, 20-22
`15, 18, 23
`
`§ 103
`
`15, 18, 23
`
`§ 103
`
`16, 19, 24
`
`§ 103
`
`16, 19, 24
`
`Prior art references, in addition to the primary references listed above, provide
`
`further background in the art, further motivation to combine the teachings of these
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`Petition for Inter Partes Review of USPN 6,743,413
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`references, and/or further support for why a POSA would have a reasonable
`
`expectation of success in combining the teachings of the primary references to arrive
`
`at the formulations and apparatuses suitable for aerosol administrations of such
`
`formulations recited in the challenged claims.
`
`IX.
`
`INVALIDITY ANALYSIS
`
`A. The ’011 Publication Anticipates Claims 1-2, 4, 6-7, 10, 12, 14-20,
`and 22-24
`
`Anticipation under 35 U.S.C. § 102 requires that each and every element of
`
`the claimed invention be disclosed expressly or inherently in a single prior art
`
`reference. See, e.g., In re Paulson, 30 F.3d 1475, 1478-79 (Fed. Cir. 1994).
`
`International Patent Application Publication No. WO 1991/004011 (“the ’011
`
`publication”) (EX1007) anticipates Claims 1-2, 4, 6-7, 10, 12, 14-20, and 22-24 of
`
`the ’413 patent. The ’011 publication, entitled “Medicinal Aerosol Formulations”
`
`published April 4, 1991. Accordingly, the ’011 publication qualifies as a prior art
`
`reference with respect to the ’413 patent under 35 U.S.C. § 102(b), as the earliest
`
`priority date for the ’413 patent is May 4, 1992.5 The ’011 publication discloses
`
`
`5 Even if the ’413 patent is entitled to a filing date of the ’791 or ’401 applications,
`
`the ’011 publication still qualifies as prior art under 35 U.S.C. § 102(a).
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`Petition for Inter Partes Review of USPN 6,743,413
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`medicinal aerosol formulations suitable for pulmonary, nasal, buccal, or topical
`
`administration. (EX1007, p. 1, ll. 1-6).6
`
`1.
`
`Independent Claim 1
`
`Claim 1 recites “[a] pharmaceutical suspension formulation suitable for
`
`aerosol administration consisting essentially of: (i) particulate drug; and (ii) 1,1,1,2-
`
`tetrafluoroethane as propellant, wherein the formulation is further characterized in
`
`that it contains no surfactant.” The phrase “consisting essentially of” signals that a
`
`claim includes the components recited therein and is only open to additional unlisted
`
`ingredients that do not “materially affect the basic and novel properties of the
`
`invention.” Ecolab, Inc. v. FMC Corp., 569 F.3d 1335, 1343 (Fed. Cir. 2009).
`
`The preamble of the ’413 patent states: “[t]he term ‘suspension aerosol
`
`formulation’ as used herein refers to a formulation in which the drug is in particulate
`
`
`6 The ’011 publication was disclosed to the PTO during prosecution of the ’280
`
`application but it was not cited in an Office Action or referred to during prosecution.
`
`Although courts have stated that overcoming the presumption of validity of an issued
`
`patent is more difficult where the PTO has considered the reference, the standard of
`
`proof remains the same. Liebel-Flarsheim Co. v. Medrad, Inc., 481 F.3d 1371 at
`
`1378, 1381 (Fed. Cir. 2007); see also IPXL Holdings, L.L.C. v. Amazon.com, Inc.,
`
`430 F.3d 1377, 1381-83 (Fed. Cir. 2005).
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`Petition for Inter Partes Review of USPN 6,743,413
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`form and is substantially insoluble in the propellant.”
`
` (EX1001, 3:27-29).
`
`Similarly, the ’011 publication states that “[d]esirably the finely divided solid
`
`materials should be substantially insoluble in both the liquefied propellant and
`
`the surface-active agent.” (EX1007, p. 10, ll. 3-5). Moreover, the formulations
`
`described in Example 1 of the ’011 publication are “suitable for aerosol
`
`administration,” as the ’011 publication clearly describes adding the drug to
`
`aluminum aerosol cans and then equipping the cans with an aerosol valve before
`
`adding the propellant, HFC-134a. (EX1007 at p. 12, ll. 18-23). The ’011
`
`publication further states that “[t]his invention relates to medicinal aerosol
`
`formulations and in particular to formulations suitable for pulmonary, nasal,
`
`buccal or topical administration . . . .” (EX1007 at p. 1, ll. 2-5). Thus, the ’011
`
`publication clearly teaches formulations suitable for aerosol administration
`
`containing particulate (i.e., substantially insoluble) drugs. (EX1006, ¶ 35).
`
`Example 1 of the ’011 publication describes the production of seven separate
`
`“control”
`
`pharmaceutical
`
`aerosol
`
`suspension
`
`formulations
`
`containing
`
`1,1,1,2-tetrafluoroethane (Propellant 134a)7 and one of several drugs, without the
`
`
`7 EX1007 at p. 2, ll. 6-11 (“It is disclosed that 1,1,1,2-tetrafluoroethane, hereinafter
`
`referred to as Propellant 134a...”).
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`Petition for Inter Partes Review of USPN 6,743,413
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`use of any surfactant. Relevant portions of Example 1 of the ’011 publication are
`
`reproduced below:
`
`Example 1
`
`The surfactant coated drug was prepared as described
`
`above from micronised drug in dehumidified conditions.
`
`The control comprising the same formulation but omitting
`
`the surfactant was subjected to the same procedure.
`
`69 mg of the coated drug (or control) was added to each of
`
`several 10 ml capacity aluminium aerosol cans.
`
`Polyethylene terephthalate (PET) aerosol containers may
`
`be substituted where appropriate. An aerosol valve was
`
`crimped into place before addition of Pr