`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF NEW JERSEY
`
`C. A. No. 2:17-09105 (SRC-CLW)
`
`SANOFI-AVENTIS U.S. LLC, SANOFI-
`AVENTIS DEUTSCHLAND GMBH, and
`SANOFI WINTHROP INDUSTRIE,
`
`
`Plaintiffs,
`
`
`
`v.
`
`
`MYLAN GMBH, BIOCON LTD., BIOCON
`RESEARCH LTD., BIOCON SDN. BHD.,
`and BIOCON S.A.
`
`
`Defendants.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`PLAINTIFFS’ PRELIMINARY CLAIM CONSTRUCTIONS AND PRELIMINARY
`IDENTIFICATION OF SUPPORTING INTRINSIC AND EXTRINSIC EVIDENCE
`
`Pursuant to Local Patent Rule 4.2 and the Court’s Order (D.I. 23 and D.I. 78), and as
`
`agreed by the parties1, Plaintiffs Sanofi-Aventis U.S. LLC, Sanofi-Aventis Deutschland GMBH,
`
`and Sanofi Winthrop Industrie, (collectively, “Plaintiffs” or “Sanofi”) hereby provide to
`
`Defendant Mylan GmbH ( “Mylan”) and Defendants Biocon Ltd., Biocon Research Ltd., Biocon
`
`Sdn. Bhd., and Biocon S.A. (collectively, “Biocon”) (collectively, “Defendants”) in the attached
`
`Exhibits A-C Plaintiffs’ preliminary claim constructions and preliminary identification of
`
`supporting intrinsic and extrinsic evidence.
`
`These disclosures are based upon information reasonably available to Plaintiffs at this
`
`time and are made without prejudice to Plaintiffs’ right to amend and/or supplement these
`
`disclosures in the future as necessary and appropriate, including as a result of the discovery or
`
`investigation of further information, including Defendants’ supplementation of its non-
`
`
`1 September 5, 2018 e-mail from E. Steiner to R. Vlasis.
`
`
`
`Mylan Exhibit - 1019
`Mylan v. Sanofi
`
`
`
`
`
`infringement contentions and/or invalidity contentions. Plaintiffs may also rely on expert
`
`testimony regarding the person of ordinary skill in the art (“POSITA”) at the time of the
`
`invention to explain the ordinary meaning of any term as it would have been understood by a
`
`POSITA or to describe or elucidate any of these terms, including by presenting a technical
`
`tutorial to the Court. Finally, Plaintiffs reserve the right to offer further intrinsic evidence and
`
`expert testimony and other extrinsic evidence to rebut Defendants’ proposed constructions,
`
`intrinsic evidence, expert testimony, or other extrinsic evidence, if any, offered by Defendants in
`
`support it their claim constructions.
`
`
`
`Dated: September 5, 2018
`
`
`
`
`s/ Liza M. Walsh
`Liza M. Walsh
`Christine I. Gannon
`Katelyn O’Reilly
`Walsh Pizzi O'Reilly Falanga LLP
`One Riverfront Plaza
`1037 Raymond Blvd, Suite 600
`Newark, NJ 07102
`(973) 757-1101
`lwalsh@walsh.law
`cgannon@walsh.law
`koreilly@walsh.law
`Attorneys for Plaintiffs Sanofi-Aventis U.S. LLC,
`Sanofi-Aventis Deutschland GmbH, and Sanofi
`Winthrop Industrie
`
`
`Of Counsel:
`WEIL, GOTSHAL & MANGES LLP
`
`Elizabeth S. Weiswasser
`Anish Desai
`Aaron Pereira
`Anna Dwyer
`Andrew Gesior
`Kathryn Kantha
`767 Fifth Avenue
`New York, New York 10153
`(212) 310-8000
`
`
`
`2
`
`Mylan Exhibit - 1019
`Mylan v. Sanofi
`
`
`
`
`
`elizabeth.weiswasser@weil.com
`anish.desai@weil.com
`aaron.pereira@weil.com
`anna.dwyer@weil.com
`andrew.gesior@weil.com
`kathryn.kantha@weil.com
`
`Robert T. Vlasis III
`Sutton Ansley
`Christopher Pepe
`Matthew Sieger
`2001 M Street NW, Suite 600
`Washington, DC 20036
`(202) 682-7000
`robert.vlasis@weil.com
`sutton.ansley@weil.com
`christopher.pepe@weil.com
`matthew.sieger@weil.com
`
`
`
`
`
`
`3
`
`Mylan Exhibit - 1019
`Mylan v. Sanofi
`
`
`
`
`
`
`
`CERTIFICATE OF SERVICE
`
`I hereby certify that on September 5, 2018, I caused a copy of PLAINTIFFS’
`PRELIMINARY CLAIM CONSTRUCTIONS AND PRELIMINARY IDENTIFICATION OF
`SUPPORTING INTRINSIC AND EXTRINSIC EVIDENCE to be served via email on counsel
`for Defendant.
`
`Dated: September 5, 2018
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`By: s/Anna E. Dwyer
`Anna E. Dwyer
`WEIL, GOTSHAL & MANGES LLP
`767 Fifth Avenue
`New York, New York 10153
`(212) 310-8000
`anna.dwyer@weil.com
`
`
`
`
`
`4
`
`Mylan Exhibit - 1019
`Mylan v. Sanofi
`
`
`
`
`
`Exhibit A
`
`Plaintiffs’ Proposed Preliminary Claim Construction s and Supporting Evidence – U.S. Patent No. 7,476,652
`
`CONSTRUCTION
`
`INTRINSIC
`EVIDENCE
`’652 Patent:
`Abstract, 1:11-15,
`2:23-27; 2:38-41;
`3:41-45; 3:50-56;
`4:7-27, claims 1, 2,
`7, 8, 17-19, 23, 24.
`
`U.S. App. No.
`11/089,777 File
`History: March 25,
`2005 Transmittal of
`New Application
`claims and
`specification at 1, 3,
`5-7; March 21, 2007
`claims and Remarks
`at 6-10; April 25,
`2007 Final Office
`Action at 2-3; July
`25, 2007 claims and
`Remarks at 7-8;
`August 8, 2007 Non-
`Final Office Action
`at 2-3; November 8,
`2007 Remarks at 2-
`7; March 19, 2008
`claims and Remarks
`
`EXTRINSIC
`EVIDENCE
`Memorandum
`Opinion at 4-5,
`Sanofi-Aventis
`U.S. LLC et al. v.
`Eli Lilly and Co.,
`C.A. No. 14-113-
`RGA-MPT (D.
`Del.) (January 20,
`2015, Dkt. 192)
`
`Memorandum
`Opinion at 3-6,
`Sanofi-Aventis
`U.S. LLC et al. v.
`Merck Sharp &
`Dohme Corp.,
`C.A. No. 16-812-
`RGA (D. Del.)
`(January 12, 2018,
`Dkt. 192)
`
`Sanofi may rely on
`expert testimony
`that a POSITA
`during the relevant
`time period would
`have understood
`
`TERM
`
`CLAIM(S)
`
`“at least one
`chemical entity
`chosen from”
`
`ʼ652 patent, claim 1,
`7, 24
`
`
`Plain and ordinary meaning, which a
`POSITA would understand to be “at least
`one chemical compound chosen from.”
`No construction necessary.
`
`
`
`Mylan Exhibit - 1019
`Mylan v. Sanofi
`
`
`
`
`
`TERM
`
`CLAIM(S)
`
`CONSTRUCTION
`
`“chemical entity”
`
`ʼ652 patent, claim 1,
`2, 7, 17, 18, 19, 23,
`24
`
`
`Plain and ordinary meaning, which a
`POSITA would understand to be
`“chemical compound.” No construction
`necessary.
`
`
`
`6
`
`INTRINSIC
`EVIDENCE
`at 8-9; April 15,
`2008 Non-Final
`Office Action at 2-4;
`July 15, 2008 claims
`
`’652 Patent:
`Abstract, 1:11-15,
`2:23-27; 2:38-41;
`3:41-45; 3:50-56;
`4:7-27, claims 1, 2,
`7, 8, 17-19, 23, 24.
`
`U.S. App.
`No.11/089,777 File
`History: March 25,
`2005 Transmittal of
`New Application
`claims and
`specification at 1, 3,
`5-7; March 21, 2007
`claims and Remarks
`at 6-10; April 25,
`
`EXTRINSIC
`EVIDENCE
`this term to have
`the meaning
`assigned to it by
`Sanofi’s proposed
`construction. This
`testimony may be
`provided by one of
`the following
`individuals:
`
`Ralph Tarantino
`George Gokel
`Lee Kirsch
`Bernhardt Trout
`Memorandum
`Opinion at 4-5,
`Sanofi-Aventis
`U.S. LLC et al. v.
`Eli Lilly and Co.,
`C.A. No. 14-113-
`RGA-MPT (D.
`Del.) (January 20,
`2015, Dkt. 192)
`
`Memorandum
`Opinion at 3-6,
`Sanofi-Aventis
`U.S. LLC et al. v.
`Merck Sharp &
`Dohme Corp.,
`C.A. No. 16-812-
`
`Mylan Exhibit - 1019
`Mylan v. Sanofi
`
`
`
`
`
`TERM
`
`CLAIM(S)
`
`CONSTRUCTION
`
`INTRINSIC
`EVIDENCE
`2007Final Office
`Action at 2-3; July
`25, 2007 claims and
`Remarks at 7-8;
`August 8, 2007 Non-
`Final Office Action
`at 2-3; November 8,
`2007 Remarks at 2-
`7; March 19, 2008
`claims and Remarks
`at 8-9; April 15,
`2008 Non-Final
`Office Action at 2-4;
`July 15, 2008
`claims.
`
`“polysorbate”
`
`ʼ652 patent, claim 7,
`24
`
`Partial fatty acid esters of sorbitol and its
`anhydrides copolymerized with
`approximately 20, 5, or 4 moles of
`ethylene oxide for each mole of sorbitol
`and its anhydrides.
`
`’652 Patent: 3:52-
`55; 4:20-25; claims
`7, 24
`
`U.S. App. No.
`11/089,777 File
`History, March
`
`
`
`7
`
`EXTRINSIC
`EVIDENCE
`RGA (D. Del.)
`(January 12, 2018,
`Dkt. 192)
`
`Sanofi may rely on
`expert testimony
`that a POSITA
`during the relevant
`time period would
`have understood
`this term to have
`the meaning
`assigned to it by
`Sanofi’s proposed
`construction. This
`testimony may be
`provided by one of
`the following
`individuals:
`
`Ralph Tarantino
`George Gokel
`Lee Kirsch
`Bernhardt Trout
`Memorandum
`Opinion at 2-3,
`Sanofi-Aventis
`U.S. LLC et al. v.
`Eli Lilly and Co.,
`C.A. No. 14-113-
`RGA-MPT (D.
`
`Mylan Exhibit - 1019
`Mylan v. Sanofi
`
`
`
`
`
`
`
`TERM
`
`CLAIM(S)
`
`CONSTRUCTION
`
`INTRINSIC
`EVIDENCE
`21, 2007
`Amendment, at 5
`
`EXTRINSIC
`EVIDENCE
`Del.) (April 27,
`2015, Dkt. 236)
`
`“polysorbates”
`Handbook of
`Pharmaceutical
`Excipients 417
`(Arthur H. Kibbe
`ed., 3d ed. 2000)
`
`Remington: The
`Science and
`Practice of
`Pharmacy
`(Gennaro ed.,
`20th ed. 2000)
`
`THE MERCK
`INDEX
`(Maryadele J.
`O’Neil et al. eds.,
`13th ed. 1996)
`
`Sanofi may rely on
`expert testimony
`that a POSITA
`during the relevant
`time period would
`have understood
`this term to have
`the meaning
`
`8
`
`Mylan Exhibit - 1019
`Mylan v. Sanofi
`
`
`
`
`
`TERM
`
`CLAIM(S)
`
`CONSTRUCTION
`
`INTRINSIC
`EVIDENCE
`
`“polysorbate 20”
`
`ʼ652 patent, claim 1,
`2, 8, 23
`
`A laurate ester of sorbitol and its
`anhydrides copolymerized with
`approximately 20 moles of ethylene oxide
`for each mole of sorbitol and sorbitol
`anhydrides.
`
`’652 Patent: 3:52-
`55; 5:60-62;
`Examples 1-3,
`claims 1, 8
`
`U.S. App. No.
`11/089,777 File
`History, March 21,
`2007 Amendment at
`5.
`
`EXTRINSIC
`EVIDENCE
`assigned to it by
`Sanofi’s proposed
`construction. This
`testimony may be
`provided by one of
`the following
`individuals:
`
`Ralph Tarantino
`George Gokel
`Lee Kirsch
`Bernhardt Trout
`Memorandum
`Opinion at 4,
`Sanofi-Aventis
`U.S. LLC et al. v.
`Eli Lilly and Co.,
`C.A. No. 14- 113-
`RGA-MPT (D.
`Del.) (April 27,
`2015, Dkt. 236)
`
`“Polysorbate 20“
`The United States
`Pharmacopeia –
`The National
`Formulary (2002)
`
`Remington: The
`Science and
`Practice of
`
`
`
`9
`
`Mylan Exhibit - 1019
`Mylan v. Sanofi
`
`
`
`
`
`TERM
`
`CLAIM(S)
`
`CONSTRUCTION
`
`INTRINSIC
`EVIDENCE
`
`“polysorbate 80”
`
`ʼ652 patent, claim 1 An oleate ester of sorbitol and its
`
`’652 Patent: 3:52-
`
`
`
`10
`
`EXTRINSIC
`EVIDENCE
`Pharmacy
`(Gennaro ed.,
`20th ed. 2000)
`
`Handbook of
`Pharmaceutical
`Excipients 417
`(Arthur H. Kibbe
`ed., 3d ed. 2000)
`
`Sanofi may rely on
`expert testimony
`that a POSITA
`during the relevant
`time period would
`have understood
`this term to have
`the meaning
`assigned to it by
`Sanofi’s proposed
`construction. This
`testimony may be
`provided by one of
`the following
`individuals:
`
`Ralph Tarantino
`George Gokel
`Lee Kirsch
`Bernhardt Trout
`Memorandum
`
`Mylan Exhibit - 1019
`Mylan v. Sanofi
`
`
`
`
`
`
`
`TERM
`
`CLAIM(S)
`
`CONSTRUCTION
`
`anhydrides copolymerized with
`approximately 20 moles of ethylene oxide
`for each mole of sorbitol and sorbitol
`anhydrides.
`
`INTRINSIC
`EVIDENCE
`55; claim 1
`
`U.S. App. No.
`11/089,777 File
`History, March 21,
`2007 Amendment at
`5
`
`EXTRINSIC
`EVIDENCE
`Opinion at 4,
`Sanofi-Aventis
`U.S. LLC et al. v.
`Eli Lilly and Co.,
`C.A. No. 14- 113-
`RGA-MPT
`(D.Del.) (April 27,
`2015, Dkt. 236)
`
`“Polysorbate 80”
`The United States
`Pharmacopeia –
`The National
`Formulary (2002)
`
`Remington: The
`Science and
`Practice of
`Pharmacy
`(Gennaro ed.,
`20th ed. 2000)
`
`Handbook of
`Pharmaceutical
`Excipients 417
`(Arthur H. Kibbe
`ed., 3d ed. 2000)
`
`THE MERCK
`INDEX
`(Maryadele J.
`
`11
`
`Mylan Exhibit - 1019
`Mylan v. Sanofi
`
`
`
`
`
`TERM
`
`CLAIM(S)
`
`CONSTRUCTION
`
`INTRINSIC
`EVIDENCE
`
`ʼ652 patent, claim 8
`
`“the polysorbate is
`present in an
`effective amount
`to prevent
`turbidity”
`
`Plain and ordinary meaning, which a
`POSITA would understand to be “the
`polysorbate 20 is present in an effective
`amount to prevent cloudiness.” No
`construction necessary.
`
`’652 Patent: 3:26-
`31; 5:17-10:67;
`claim 8
`
`
`
`12
`
`EXTRINSIC
`EVIDENCE
`O’Neil et al. eds.,
`13th ed. 1996)
`
`Sanofi may rely on
`expert testimony
`that a POSITA
`during the relevant
`time period would
`have understood
`this term to have
`the meaning
`assigned to it by
`Sanofi’s proposed
`construction. This
`testimony may be
`provided by one of
`the following
`individuals:
`
`Ralph Tarantino
`George Gokel
`Lee Kirsch
`Bernhardt Trout
`Memorandum
`Opinion at 4,
`Sanofi-Aventis
`U.S. LLC et al. v.
`Eli Lilly and Co.,
`C.A. No. 14- 113-
`RGA-MPT
`(D.Del.) (April 27,
`
`Mylan Exhibit - 1019
`Mylan v. Sanofi
`
`
`
`
`
`
`
`TERM
`
`CLAIM(S)
`
`CONSTRUCTION
`
`INTRINSIC
`EVIDENCE
`
`EXTRINSIC
`EVIDENCE
`2015, Dkt. 236)
`
`Sanofi may rely on
`expert testimony
`that a POSITA
`during the relevant
`time period would
`have understood
`this term to have
`the meaning
`assigned to it by
`Sanofi’s proposed
`construction. This
`testimony may be
`provided by one of
`the following
`individuals:
`
`Ralph Tarantino
`George Gokel
`Lee Kirsch
`Bernhardt Trout
`
`
`
`13
`
`Mylan Exhibit - 1019
`Mylan v. Sanofi
`
`
`
`
`
`Exhibit B
`
`Plaintiffs’ Proposed Preliminary Claim Construction s and Supporting Evidence – U.S. Patent No. 7,713,930
`
`CONSTRUCTION
`
`INTRINSIC
`EVIDENCE
`’930 patent:
`Abstract, 1:15-26;
`2:27-31, 2:43-46;
`3:45-49; 3:54-60;
`4:12-33; claims 1,
`14-16
`
`U.S. App. No.
`11/089,777 File
`History: March 25,
`2005 Transmittal of
`New Application
`claims and
`specification at 1, 3,
`5-7; March 21, 2007
`claims and Remarks
`at 6-10; April 25,
`2007 Final Office
`Action at 2-3; July
`25, 2007 claims and
`Remarks at 7-8;
`August 8, 2007 Non-
`Final Office Action
`at 2-3; November 8,
`2007 Remarks at 2-
`7; March 19, 2008
`claims and Remarks
`
`EXTRINSIC
`EVIDENCE
`Memorandum
`Opinion at 4-5,
`Sanofi-Aventis
`U.S. LLC et al. v.
`Eli Lilly and Co.,
`C.A. No. 14-113-
`RGA-MPT
`(D.Del.) (January
`20, 2015, Dkt.
`192)
`
`Memorandum
`Opinion at 3-6,
`Sanofi-Aventis
`U.S. LLC et al. v.
`Merck Sharp &
`Dohme Corp.,
`C.A. No. 16-812-
`RGA (D. Del.)
`(January 12, 2018,
`Dkt. 192)
`
`Sanofi may rely on
`expert testimony
`that a POSITA
`during the relevant
`time period would
`
`TERM
`
`CLAIM(S)
`
`“at least one
`chemical entity
`chosen from”
`
`ʼ930 patent, claim 1
`
`Plain and ordinary meaning, which a
`POSITA would understand to be “at least
`one chemical compound chosen from.”
`No construction necessary.
`
`
`
`14
`
`Mylan Exhibit - 1019
`Mylan v. Sanofi
`
`
`
`
`
`TERM
`
`CLAIM(S)
`
`CONSTRUCTION
`
`“chemical entity”
`
`ʼ930 patent, claim 1,
`14, 15, 16
`
`Plain and ordinary meaning, which a
`POSITA would understand to be
`“chemical compound.” No construction
`necessary.
`
`
`
`15
`
`INTRINSIC
`EVIDENCE
`at 8-9; April 15,
`2008 Non-Final
`Office Action at 2-4;
`July 15, 2008 claims
`
`U.S. App. No.
`12/328,208 File
`History: December
`4, 2008 Transmittal
`of New Application
`claims; June 17,
`2009 Non-Final
`Office Action at 2-4;
`September 16, 2009
`Response at 2
`’930 patent :
`Abstract, 1:15-26;
`2:27-31, 2:43-46;
`3:45-49; 3:54-60;
`4:12-33; claims 1,
`14-16
`
`U.S. App. No.
`11/089,777 File
`History: March 25,
`2005 Transmittal of
`New Application
`claims and
`specification at 1, 3,
`5-7; March 21, 2007
`claims and Remarks
`
`EXTRINSIC
`EVIDENCE
`have understood
`this term to have
`the meaning
`assigned to it by
`Sanofi’s proposed
`construction. This
`testimony may be
`provided by one of
`the following
`individuals:
`
`Ralph Tarantino
`George Gokel
`Lee Kirsch
`Bernhardt Trout
`Memorandum
`Opinion at 4-5,
`Sanofi-Aventis
`U.S. LLC et al. v.
`Eli Lilly and Co.,
`C.A. No. 14-113-
`RGA-MPT (D.
`Del.) (January 20,
`2015, Dkt. 192)
`
`Memorandum
`Opinion at 3-6,
`Sanofi-Aventis
`U.S. LLC et al. v.
`Merck Sharp &
`Dohme Corp.,
`
`Mylan Exhibit - 1019
`Mylan v. Sanofi
`
`
`
`
`
`TERM
`
`CLAIM(S)
`
`CONSTRUCTION
`
`“esters and ethers
`of polyhdric
`alcohols”
`
`ʼ930 patent, claim 1 Chemical compounds in which one or
`more of the hydroxyl groups of a
`polyhydric alcohol instead of being a
`hydroxyl group is an ester (RCOO-X) or
`ether (RC-O-X) group.
`
`
`
`16
`
`INTRINSIC
`EVIDENCE
`at 6-10; April 25,
`2007 Final Office
`Action at 2-3; July
`25, 2007 claims and
`Remarks at 7-8;
`August 8, 2007 Non-
`Final Office Action
`at 2-3; November 8,
`2007 Remarks at 2-
`7; March 19, 2008
`claims and Remarks
`at 8-9; April 15,
`2008 Non-Final
`Office Action at 2-4;
`July 15, 2008 claims
`
`U.S. App. No.
`12/328,208 File
`History: December
`4, 2008 Transmittal
`of New Application
`claims; June 17,
`2009 Non-Final
`Office Action at 2-4;
`September 16, 2009
`Response at 2
`’930 patent: 3:55-60;
`4:23-32; claim 1
`
`U.S. App. No.
`11/089,777 File
`
`EXTRINSIC
`EVIDENCE
`C.A. No. 16-812-
`RGA (D. Del.)
`(January 12, 2018,
`Dkt. 192)
`
`Sanofi may rely on
`expert testimony
`that a POSITA
`during the relevant
`time period would
`have understood
`this term to have
`the meaning
`assigned to it by
`Sanofi’s proposed
`construction. This
`testimony may be
`provided by one of
`the following
`individuals:
`
`Ralph Tarantino
`George Gokel
`Lee Kirsch
`Bernhardt Trout
`
`Memorandum
`Opinion at 5-6,
`Sanofi-Aventis
`U.S. LLC et al. v.
`Eli Lilly and Co.,
`
`Mylan Exhibit - 1019
`Mylan v. Sanofi
`
`
`
`
`
`
`
`TERM
`
`CLAIM(S)
`
`CONSTRUCTION
`
`INTRINSIC
`EVIDENCE
`History, July 25,
`2007 Amendment
`After Final, at 8;
`November 8, 2007
`Reply to Office
`Action, at 2-3
`
`EXTRINSIC
`EVIDENCE
`C.A. No. 14-113-
`RGA-MPT (D.
`Del.) (January 20,
`2015, Dkt. 192)
`
`Frey et al., U.S.
`Patent No.
`8,158,816.
`
`JOHN
`MCMURRAY &
`ROBERT C. FAY,
`CHEMISTRY
`942-79 (Paul F.
`Corey et al. eds.,
`2d ed. 1998)
`
`David Klein,
`ORGANIC
`CHEMISTRY,
`John Wiley &
`Sons (2012), pp.
`622-625, 979-983.
`
`Sanofi may rely on
`expert testimony
`that a POSITA
`during the relevant
`time period would
`have understood
`this term to have
`
`17
`
`Mylan Exhibit - 1019
`Mylan v. Sanofi
`
`
`
`
`
`
`
`
`
`TERM
`
`CLAIM(S)
`
`CONSTRUCTION
`
`INTRINSIC
`EVIDENCE
`
`EXTRINSIC
`EVIDENCE
`the meaning
`assigned to it by
`Sanofi’s proposed
`construction. This
`testimony may be
`provided by one of
`the following
`individuals:
`
`Ralph Tarantino
`George Gokel
`Lee Kirsch
`Bernhardt Trout
`
`
`
`
`
`18
`
`Mylan Exhibit - 1019
`Mylan v. Sanofi
`
`
`
`
`
`TERM
`
`“drive sleeve”
`
`Exhibit C
`
`Plaintiffs’ Proposed Preliminary Claim Construction s and Supporting Evidence –
`U.S. Patent Nos. 8,603,044; 8,679,069; 8,992,486; 9,526,844; 9,604,008
`
`CONSTRUCTION
`
`CLAIM(S)
`
`’069 patent, claim 1
`
`’044 patent, claim 11
`
`’008 patent, claim 1
`
`An essentially tubular component of
`essentially circular cross-section
`releasably connected to the dose dial
`sleeve that drives the piston during dose
`dispensing.
`
`
`INTRINSIC
`EVIDENCE
`’069 Patent: 1:51-
`54, 3:51-62; 6:6-34;
`claim 1
`
`’044 Patent: 1:62-
`65, 4:4-14; 6:27-
`6:55; claims 1, 3,
`11, 13
`
`’008 Patent:
`Abstract; 4:1-5;
`10:15-44; 13:30-67;
`16:25-60; claims 1,
`12
`
`EXTRINSIC
`EVIDENCE
`Memorandum
`Opinion at 10-11,
`Sanofi-Aventis
`U.S. LLC et al. v.
`Eli Lilly and Co.,
`C.A. No. 14-113-
`RGA-MPT
`(D.Del.) (January
`20, 2015, Dkt.
`192)
`
`Memorandum
`Opinion at 1, 14-
`16, Sanofi-Aventis
`U.S. LLC et al. v.
`Merck Sharp &
`Dohme Corp., C.A.
`No. 16-812-RGA
`(D. Del.) (January
`12, 2018, Dkt.
`192);
`
`Sanofi may rely
`on expert
`testimony that a
`POSITA during
`the relevant time
`
`
`
`19
`
`Mylan Exhibit - 1019
`Mylan v. Sanofi
`
`
`
`
`
`TERM
`
`CLAIM(S)
`
`CONSTRUCTION
`
`INTRINSIC
`EVIDENCE
`
`“said housing
`
`The main housing.
`
`’486 patent, claims 1,
`36
`
`’069 patent, claim 1
`
`’044 patent, claim 11
`
`’486 Patent: 5:3-16;
`claims 1, 27
`
`’069 Patent: 4:49-
`62; claim 1
`
`’044 Patent: 5:3-16;
`claims 1, 9, 11, 19
`
`
`
`
`20
`
`EXTRINSIC
`EVIDENCE
`period would have
`understood this
`term to have the
`meaning assigned
`to it by Sanofi’s
`proposed
`construction. This
`testimony may be
`provided by one of
`the following
`individuals:
`
`Alexander Slocum
`Jonathan Posner
`Charles Reinholtz
`Robert Veasey
`Memorandum
`Opinion at 16-17,
`Sanofi-Aventis
`U.S. LLC et al. v.
`Eli Lilly and Co.,
`C.A. No. 14-113-
`RGA-MPT (D.
`Del.) (January 20,
`2015, Dkt. 192)
`
`Sanofi-Aventis
`U.S. LLC et al. v.
`Merck Sharp &
`Dohme Corp.,
`C.A. No. 16-812-
`
`Mylan Exhibit - 1019
`Mylan v. Sanofi
`
`
`
`
`
`TERM
`
`CLAIM(S)
`
`CONSTRUCTION
`
`INTRINSIC
`EVIDENCE
`
`“main housing”
`
`’486 patent, claims 1,
`3, 4, 26, 27, 28, 38, 39
`
`’069 patent, claim 1
`
`’044 patent, claims 11,
`
`An exterior unitary or multipart
`component configured to house, fix,
`protect, guide, and/or engage with one or
`more inner components
`
`’486 patent:
`Abstract,
`1:42-2:3, 3:27-33,
`3:49-55, 4:17-26,
`5:7-32, 5:61-6:3;
`Figs. 1, 2; claims 1,
`
`
`
`21
`
`EXTRINSIC
`EVIDENCE
`RGA (D. Del.)
`(January 29, 2018,
`Dkt. 205)
`
`Sanofi may rely
`on expert
`testimony that a
`POSITA during
`the relevant time
`period would have
`understood this
`term to have the
`meaning assigned
`to it by Sanofi’s
`proposed
`construction. This
`testimony may be
`provided by one of
`the following
`individuals:
`
`Alexander Slocum
`Jonathan Posner
`Charles Reinholtz
`Robert Veasey
`Memorandum
`Opinion at 7-9,
`Sanofi-Aventis
`U.S. LLC et al. v.
`Merck Sharp &
`Dohme Corp.,
`
`Mylan Exhibit - 1019
`Mylan v. Sanofi
`
`
`
`
`
`
`
`TERM
`
`CLAIM(S)
`
`CONSTRUCTION
`
`18, 19
`
`22
`
`INTRINSIC
`EVIDENCE
`3, 4, 26, 27, 28, 31,
`35, 38, 39
`
`’069 patent:
`Abstract, 1:34-2:2,
`3:8-14, 3:29-35,
`3:63-4:5, 4:53-67,
`5:1-11, 5:40-49;
`Figs. 1, 2; claims 1,
`2
`
`’044 patent:
`Abstract, 1:44-2:3,
`3:27-33, 3:49-55,
`4:17-26, 5:7-32,
`5:61-6:3; Figs. 1, 2;
`claims 1, 2, 3, 8, 9,
`10, 11, 20
`
`
`EXTRINSIC
`EVIDENCE
`C.A. No. 16-812-
`RGA (D. Del.)
`(January 12, 2018,
`Dkt. 192)
`
`Sanofi-Aventis
`U.S. LLC et al. v.
`Merck Sharp &
`Dohme Corp.,
`C.A. No. 16-812-
`RGA (D. Del.)
`(January 29, 2018,
`Dkt. 205)
`
`Sanofi may rely
`on expert
`testimony that a
`POSITA during
`the relevant time
`period would have
`understood this
`term to have the
`meaning assigned
`to it by Sanofi’s
`proposed
`construction. This
`testimony may be
`provided by one of
`the following
`individuals:
`
`
`Mylan Exhibit - 1019
`Mylan v. Sanofi
`
`
`
`
`
`TERM
`
`CLAIM(S)
`
`CONSTRUCTION
`
`INTRINSIC
`EVIDENCE
`
`“tubular clutch”
`
`’486 patent, claims 1,
`2, 6, 26
`
`’069 patent, claim 1
`
`’044 patent, claims 11,
`18
`
`A tubular structure that couples and
`decouples a moveable component from
`another component.
`
`’486 Patent: 4:33-
`35; 4:49-5:6; 5:50-
`53; 6:27-44; claims
`1, 2, 6, 7, 8, 10, 19,
`21, 26, 34
`
`’069 Patent: 4:12-
`14; 4:28-41; 4:49-
`52; 5:29-32; 6:6-22;
`claims 1, 3
`
`’044 Patent: 4:33-
`35; 4:49-5:6; 5:50-
`53; 6:27-43; claims
`1, 2, 6, 8, 11, 12, 16,
`18
`
`’008 Patent: 1:60-
`2:7
`
`
`EXTRINSIC
`EVIDENCE
`Alexander Slocum
`Jonathan Posner
`Charles Reinholtz
`Robert Veasey
`Memorandum
`Opinion at 12-13,
`Sanofi-Aventis
`U.S. LLC et al. v.
`Eli Lilly and Co.,
`C.A. No. 14-113-
`RGA-MPT (D.
`Del.) (January 20,
`2015, Dkt. 192);
`
`Sanofi-Aventis
`U.S. LLC et al. v.
`Merck Sharp &
`Dohme Corp.,
`C.A. No. 16-812-
`RGA (D. Del.)
`(January 29, 2018,
`Dkt. 205)
`
`Sanofi may rely
`on expert
`testimony that a
`POSITA during
`the relevant time
`period would have
`understood this
`term to have the
`
`
`
`23
`
`Mylan Exhibit - 1019
`Mylan v. Sanofi
`
`
`
`
`
`TERM
`
`CLAIM(S)
`
`CONSTRUCTION
`
`INTRINSIC
`EVIDENCE
`
`“clutch”
`
`’486 patent, claims 51,
`52, 53, 54, 55, 56, 57
`
`’008 patent, claim 1
`
`’844 patent, claims 23,
`24, 25, 26, 28
`
`A structure that couples and decouples a
`moveable component from another
`component
`
`’486 Patent:4:33-35;
`4:49-5:6; 5:50-53;
`6:27-43; claims 51,
`52, 53, 54, 55, 56,
`57
`
`’008 Patent: 1:60-
`2:7, 4:14-18; 4:62-
`5:20; 8:34-8:52;
`9:36-10:31; 11:57-
`12:4; 12:48-67;
`13:30-41; claims 1,
`10
`
`’844 Patent: 4:42-
`5:9; 5:54-6:54;
`claims 23-26, 28
`
`
`
`
`24
`
`EXTRINSIC
`EVIDENCE
`meaning assigned
`to it by Sanofi’s
`proposed
`construction. This
`testimony may be
`provided by one of
`the following
`individuals:
`
`Alexander Slocum
`Jonathan Posner
`Charles Reinholtz
`Robert Veasey
`Memorandum
`Opinion at 12-13,
`Sanofi-Aventis
`U.S. LLC et al. v.
`Eli Lilly and Co.,
`C.A. No. 14-113-
`RGA-MPT (D.
`Del.) (January 20,
`2015, Dkt. 192)
`
`Sanofi-Aventis
`U.S. LLC et al. v.
`Merck Sharp &
`Dohme Corp.,
`C.A. No. 16-812-
`RGA (D. Del.)
`(January 29, 2018,
`Dkt. 205)
`
`Mylan Exhibit - 1019
`Mylan v. Sanofi
`
`
`
`
`
`TERM
`
`CLAIM(S)
`
`CONSTRUCTION
`
`INTRINSIC
`EVIDENCE
`
`
`
`“driver”
`
`’486 patent, claims 1,
`5, 12, 13
`
`A component releasably connected to the
`dose dial sleeve that drives the piston
`during dose dispensing
`
`
`
`’486 Patent:
`Abstract, 1:50-52;
`4:4-14; 6:28-56;
`claims 1, 5, 9, 12,
`13, 42, 43, 49
`
`
`
`25
`
`EXTRINSIC
`EVIDENCE
`
`
`Sanofi may rely
`on expert
`testimony that a
`POSITA during
`the relevant time
`period would have
`understood this
`term to have the
`meaning assigned
`to it by Sanofi’s
`proposed
`construction. This
`testimony may be
`provided by one of
`the following
`individuals:
`
`Alexander Slocum
`Jonathan Posner
`Charles Reinholtz
`Robert Veasey
`Memorandum
`Opinion at 10-11,
`Sanofi-Aventis
`U.S. LLC et al. v.
`Eli Lilly and Co.,
`C.A. No. 14-113-
`RGA-MPT
`(D.Del.) (January
`20, 2015, Dkt.
`
`Mylan Exhibit - 1019
`Mylan v. Sanofi
`
`
`
`
`
`
`
`TERM
`
`CLAIM(S)
`
`CONSTRUCTION
`
`INTRINSIC
`EVIDENCE
`
`EXTRINSIC
`EVIDENCE
`192)
`
`Memorandum
`Opinion at 1, 14-
`16, Sanofi-Aventis
`U.S. LLC et al. v.
`Merck Sharp &
`Dohme Corp., C.A.
`No. 16-812-RGA
`(D. Del.) (January
`12, 2018, Dkt.
`192);
`
`Sanofi may rely
`on expert
`testimony that a
`POSITA during
`the relevant time
`period would have
`understood this
`term to have the
`meaning assigned
`to it by Sanofi’s
`proposed
`construction. This
`testimony may be
`provided by one of
`the following
`individuals:
`
`Alexander Slocum
`Jonathan Posner
`
`26
`
`Mylan Exhibit - 1019
`Mylan v. Sanofi
`
`
`
`
`
`TERM
`
`CLAIM(S)
`
`CONSTRUCTION
`
`’844 patent, claim 21
`
`“the piston rod and
`the driving member
`are configured to
`rotate relative to one
`another during dose
`dispensing”
`
`Plain and Ordinary Meaning, which a
`POSITA would understand to be “during
`dose dispensing, the piston rod rotates
`while the driving member does not rotate,
`the driving member rotates while the
`piston rod does not rotate, or both rotate at
`different rates and/or directions.”
`
`No construction necessary.
`
`INTRINSIC
`EVIDENCE
`
`’844 Patent: 6:38-
`67; Figure 11;
`Claim 21
`
`“piston rod”
`
`’486 patent, claims 1,
`23, 40
`
`’069 patent, claim 1
`
`’044 patent, claim 11
`
`’008 patent, claims 1,
`
`A rod that engages with the drive
`sleeve/driver/driving member to advance
`the piston during dose dispensing
`
`’486 Patent:
`Abstract; 1:46;
`1:62-65; 3:56-4:14;
`6:28-56; claims 1, 9,
`23, 35, 40
`
`’069 Patent:
`Abstract; 1:36;
`
`
`
`27
`
`EXTRINSIC
`EVIDENCE
`Charles Reinholtz
`Robert Veasey
`Sanofi may rely
`on expert
`testimony that a
`POSITA during
`the relevant time
`period would have
`understood this
`term to have the
`meaning assigned
`to it by Sanofi’s
`proposed
`construction. This
`testimony may be
`provided by one of
`the following
`individuals:
`
`Alexander Slocum
`Jonathan Posner
`Charles Reinholtz
`Robert Veasey
`Memorandum
`Opinion at 16,
`Sanofi-Aventis
`U.S. LLC et al. v.
`Eli Lilly and Co.,
`C.A. No. 14-113-
`RGA-MPT (D.
`Del.) (January 20,
`
`Mylan Exhibit - 1019
`Mylan v. Sanofi
`
`
`
`
`
`TERM
`
`CLAIM(S)
`
`CONSTRUCTION
`
`8, 17
`
`’844 patent, claims 21,
`22
`
`INTRINSIC
`EVIDENCE
`1:51-54; 3:36-60;
`6:6-34; claims 1, 2
`
`’044 Patent:
`Abstract; 1:46;
`1:50-52; 1:62-65;
`4:4-4:14; 6:27-55;
`claims 1, 3, 11, 13
`
`’008 Patent: 1:32-
`36; 4:1-5; 4:19-46;
`7:40-65; 10:15-44;
`13:30-67; claim 1,
`12
`
`’844 Patent:
`Abstract; 1:52; 2:1-
`4; 4:13-23; 6:38-67;
`claims 21, 22
`
`
`“driving member”
`
`’844 patent, claims 21,
`28
`
`A component releasably connected to the
`dose dial sleeve that drives the piston
`during dose dispensing
`
`
`’844 Patent: 1:56-
`58; 4:13-23; 6:38-
`67; claims 1, 21
`
`
`
`28
`
`EXTRINSIC
`EVIDENCE
`2015, Dkt. 192)
`
`Sanofi may rely
`on expert
`testimony that a
`POSITA during
`the relevant time
`period would have
`understood this
`term to have the
`meaning assigned
`to it by Sanofi’s
`proposed
`construction. This
`testimony may be
`provided by one of
`the following
`individuals:
`
`Alexander Slocum
`Jonathan Posner
`Charles Reinholtz
`Robert Veasey
`Memorandum
`Opinion at 10-11,
`Sanofi-Aventis
`U.S. LLC et al. v.
`Eli Lilly and Co.,
`C.A. No. 14-113-
`RGA-MPT (D.
`Del.) (January 20,
`
`Mylan Exhibit - 1019
`Mylan v. Sanofi
`
`
`
`
`
`
`
`TERM
`
`CLAIM(S)
`
`CONSTRUCTION
`
`INTRINSIC
`EVIDENCE
`
`EXTRINSIC
`EVIDENCE
`2015, Dkt. 192)
`
`Memorandum
`Opinion at 1, 14-
`16, Sanofi-Aventis
`U.S. LLC et al. v.
`Merck Sharp &
`Dohme Corp., C.A.
`No. 16-812-RGA
`(D. Del.) (January
`12, 2018, Dkt.
`192);
`
`Sanofi may rely
`on expert
`testimony that a
`POSITA during
`the relevant time
`period would have
`understood this
`term to have the
`meaning assigned
`to it by Sanofi’s
`proposed
`construction. This
`testimony may be
`provided by one of
`the following
`individuals:
`
`Alexander Slocum
`Jonathan Posner
`
`29
`
`Mylan Exhibit - 1019
`Mylan v. Sanofi
`
`
`
`
`
`TERM
`
`CLAIM(S)
`
`CONSTRUCTION
`
`A rib or groove on a first structure that
`engages a corresponding groove or rib on
`a second structure
`
`
`“thread”/“threaded”/
`”threading”
`
`’044 patent, claim 11
`
`’069 patent, claim 1
`
`’486 patent, claim 1
`
`’844 patent, claim 21
`
`’008 patent, claim 1,
`7, 8, 11, 17
`
`INTRINSIC
`EVIDENCE
`
`’044 Patent:
`Abstract; 1:44-2:3,
`2:7-16, 3:49-55,
`3:56-4:3, 4:4-14,
`4:17-26, 5:3-16,
`5:61-6:3, 6:27-34;
`claims 1, 7, 9-11,
`17, 19, 20
`
`’069 Patent:
`Abstract; 1:34-59,
`1;63-2:4, 3:29-47,
`3:51-60, 4:49-62,
`5:40-49, 5:50-56,
`6:6-13; claim 1
`
`’486 patent:
`Abstract, 1:41-2:3,
`4:3-16, 5:7-21,
`5:61-6:11, 6:27-35,
`6:63-65, 7:4-10;
`claims 1, 24, 25, 31,
`43
`
`’844 patent:
`Abstract, 1:53-65,
`3:58-64, 3:65-4:9,
`4:13-23, 4:26-35,
`6:4-13, 6:14-21;
`
`EXTRINSIC
`EVIDENCE
`Charles Reinholtz
`Robert Veasey
`Memorandum
`Opinion at 9-10,
`Sanofi-Aventis
`U.S. LLC et al. v.
`Eli Lilly and Co.,
`C.A. No. 14-113-
`RGA-MPT (D.
`Del.) (January 20,
`2015, Dkt. 192)
`
`Excerpt from The
`Mechanical
`Engineer, dated
`January 5, 1917;
`
`Excerpt from
`Uicker, Matrix
`Methods in the
`Design Analysis
`of Mechanisms
`and Multibody
`Systems,
`Cambridge Univ.
`Press, 2013;
`
`U.S. Patent No.
`8,257,319;
`
`Sanofi may rely
`
`
`
`30
`
`Mylan Exhibit - 1019
`Mylan v. Sanofi
`
`
`
`
`
`TERM
`
`CLAIM(S)
`
`CONSTRUCTION
`
`“clicker”
`
`’044 patent, claim 14,
`15
`
`’486 patent, claims
`14-18, 20
`
`’844 patent, claim 29
`
`A structure that provides audible and/or
`tactile feedback when the dose knob is
`rotated
`
`
`
`31
`
`INTRINSIC
`EVIDENCE
`claim 21
`
`’008 patent:
`Abstract, 2:11-31,
`2:37-44, 2:66-3:27,
`3:28-36, 3:43-67,
`4:6-11, 4:30-37,
`4:40-46, 7:40-65,
`8:1-11; claims 1, 6-
`8, 11, 14-18
`
`’044 Patent: 4:33-
`5:16; 5:50-50;
`claims 14, 15
`
`’486 Patent: 4:33-
`5:16; 5:50-60;
`claims 14, 15, 16,
`17, 18, 19, 20
`
`’844 Patent: 4:42-
`5:26; 5:60-6:3;
`
`EXTRINSIC
`EVIDENCE
`on expert
`testimony that a
`POSITA during
`the relevant time
`period would have
`understood this
`term to have the
`meaning assigned
`to it by Sanofi’s
`proposed
`construction. This
`testimony may be
`provided by one of
`the following
`individuals:
`
`Alexander Slocum
`Jonathan Posner
`Charles Reinholtz
`Robert Veasey
`Sanofi-Aventis
`U.S., LLC, et al. v.
`Mylan GMBH et
`al., C.A. No. 17-
`cv-09105-SRC-
`CLW, Mylan
`Invalidity
`Contentions,
`Cover Document
`at 202-204, 268,
`415-417, 438-440;
`
`Mylan Exhibit - 1019
`Mylan v. Sanofi
`
`
`
`
`
`TERM
`
`CLAIM(S)
`
`CONSTRUCTION
`
`INTRINSIC
`EVIDENCE
`claims 12, 29
`
`“insert”
`
`’486 patent, claims
`38-40
`
`’008 patent, claims 1,
`3
`
`
`Plain and Ordinary Meaning, which a
`POSITA would understand to be “an
`internal structure” as defined in each of
`the claims in which it appears.
`
`E.g.,
`
`’486 patent, claim 38 (“provided at a
`distal end of the main housing”; “secured
`
`’486 Patent: 1:57-
`59; 3:49-55; claims
`38, 39, 40; Fig 1, 3-
`5
`
`’008 Patent: 7:33-
`39; 10:59-67; claims
`1, 3
`
`
`
`
`32
`
`EXTRINSIC
`EVIDENCE
`
`
`Sanofi may rely
`on expert
`testimony that a
`POSITA during
`the relevant time
`period would have
`understood this
`term to have the
`meaning assigned
`to it by Sanofi’s
`proposed
`construction. This
`testimony may be
`provided by one of
`the following
`individuals:
`
`Alexander Slocum
`Jonathan Posner
`Charles Reinholtz
`Robert Veasey
`Sanofi may rely
`on expert
`testimony that a
`POSITA during
`the relevant time
`period would have
`understood this
`term to have the
`meaning assigned
`
`Mylan Exhibit - 1019
`Mylan v. Sanofi
`
`
`
`
`
`TERM
`
`CLAIM(S)
`
`CONSTRUCTION
`
`INTRINSIC
`EVIDENCE
`
`against rotation”), claim 39 (“provided at
`a distal end of the main housing”;
`“secured against longitudinal motion”),
`claim 40 (“an opening extending
`therethrough, such that said piston rod is
`configured to extend through said
`opening”);
`
`’008 patent, claim 1 (“provided in the
`housing, where the insert has a threaded
`circular opening”; “first thread [of the
`piston rod] is engaged with the threaded
`circular opening of the insert”), claim 3
`(“insert is secured in the housing against
`rotational and longitudinal motion”).
`
`No construction necessary.
`
`Plain and Ordinary Meaning, which a
`POSITA would understand to be “a
`structure that holds a referenced structure”
`(e.g., a piston rod holder holds a piston
`rod).
`
`No construction necessary.
`
`’844 Patent: 1:63-
`67; 3:58-4:23; 6:4-
`13; 6:38-67; Claims
`1, 21
`
`“holder”
`
`’844 patent, claim 21
`
`EXTRINSIC
`EVIDENCE
`to it by Sanofi’s
`proposed
`construction. This
`testimony may be
`provided by one of
`the follow