Case 3:14-cv-05499-PGS-LHG Document 36 Filed 06/03/15 Page 1 of 52 PageID: 182
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF NEW JERSEY
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`UNITED THERAPEUTICS CORP.’S AND SANDOZ INC.’S
`JOINT CLAIM CONSTRUCTION AND PREHEARING STATEMENT
`
`
`
`
`
`Civil Action No. 3:14-cv-5499 (PGS)(LHG)
`
`
`
`
`
`
`
`
`
`Defendant.
`
`Pursuant to Local Patent Rule 4.3 and the Scheduling Order [Dkt. No. 22] as amended by
`
`the Court on April 24, 2015 [Dkt No. 31], Plaintiff United Therapeutics Corporation (“UTC”)
`
`and Defendant Sandoz, Inc. (“Sandoz”) jointly file this Joint Claim Construction and Prehearing
`
`Statement, and state as follows:
`
`I. AGREED CLAIM CONSTRUCTIONS (LOCAL PATENT RULE 4.3(A),
` SCHEDULING ORDER ¶ 11(B))
`
`
`The parties reached an agreement on the construction of the following terms in the
`
`asserted claims:
`
`1.
`
`“pharmaceutically acceptable salt” (claims 1 and 9) should be construed as
`“[a] salt which is useful in preparing a pharmaceutical composition that is
`generally safe, non-toxic and neither biologically nor otherwise
`undesirable and includes being useful for veterinary use as well as human
`pharmaceutical use, and which possesses the desired pharmacological
`activity.”
`
`2.
`
`“the product of step (h)” (claims 1 and 9) should be construed as “the
`product of step (b).”
`
`
`
`
`
`
`
`
`
`UNITED THERAPEUTICS
`CORPORATION,
`
`
`
`
`
`Plaintiffs,
`
`
`
`v.
`
`
`SANDOZ, INC.
`
`

`
`Case 3:14-cv-05499-PGS-LHG Document 36 Filed 06/03/15 Page 2 of 52 PageID: 183
`
`
`II.
`
`
`
`
`DISPUTED CLAIM CONSTRUCTIONS (LOCAL PATENT RULE 4.3(B),
`SCHEDULING ORDER ¶ 11(C))
`
`
`
`The parties propose the following constructions for each disputed claim term contained in
`
`the asserted claims of the identified patents-in-suit, and make the following identifications of
`
`evidence in support of their respective constructions. Each party reserves the right to rely upon
`
`evidence identified by the other party.
`
`1.
`
`“product” (claims 1 and 9)
`
`Plaintiff’s Construction
`Plain and ordinary meaning.
`To the extent the Court determines that this
`term requires construction, UTC proposes the
`following:
`“a substance resulting from a chemical
`reaction”
`
`
`Plaintiff’s Evidence
`• U.S. Patent No. 8,497,393 claims 1-22; col.
`7:16-20; col. 7:41-45; col. 17:37-40. UTC-
`Sand-Rem01170057, UTC-Sand-
`Rem01170059, UTC-Sand-Rem01170064-
`66.
`• Amendment and Request for
`Reconsideration dated February 8, 2013.
`SDZ5499 0004846-56.
` Amendments and Reply dated June 5,
`2013. SDZ5499 0004877-90.
`• Notice of Allowance dated June 12, 2013.
`SDZ5499 0004894-99.
`• Webster’s New Collegiate Dictionary
`(1981), Springfield, MA: G. & C. Merriam
`Co., p. 911. UTC_REM_II_000001787.
`• Brown, et.al., CHEMISTRY: THE
`CENTRAL SCIENCE, (9th ed. 2003), p.
`
`•
`
`2
`
`
`Defendant’s Construction
`A chemical composition.
`
`Defendant’s Evidence
`• U.S. Patent No. 8,497,393, SDZ5499
`0004746-60, including but not limited to,
`claims 1-22; col. 7:14-15; col. 7:16-20; col.
`7:41-45; col. 9:19-17:40.
`
`•
`
`’393 patent prosecution history, SDZ5499
`0004761-932, including but not limited to
`01/03/2013 Office Action at p. 2, SDZ
`5499 0004835; Amendment and Request
`for Reconsideration dated February 8,
`2013. SDZ54990004846-56; 5/5/2013
`Office Action at pp. 2-3, SDZ5499
`0004867-68; Amendments and Reply dated
`June 5, 2013. SDZ5499 0004877-90;
`Notice of Allowance dated June 12, 2013.
`SDZ5499 0004894-99.
`
`• WEBSTER’S NEW COLLEGIATE DICTIONARY
`(1981), Springfield, MA: G. & C. Merriam
`Co., p. 911. UTC_REM_II_000001787.
`
`

`
`Case 3:14-cv-05499-PGS-LHG Document 36 Filed 06/03/15 Page 3 of 52 PageID: 184
`
`
`Plaintiff’s Evidence
`G-10. UTC_REM_II_000001762.
`• Suchocki, et. al., CONCEPTUAL
`CHEMISTRY, (2001), p. G-6.
`UTC_REM_II_000001769.
`• Zumdahl, CHEMISTRY (1986), p. A36.
`UTC_REM_II_000001766.
`• Williams, et.al., Asymmetric,
`Stereocontrolled Total Synthesis of
`Paraherquamide A, J. Am. Chem. Soc.
`2003, 125, 12172-178.
`UTC_REM_II_000001741-47.
`• Williams, et.al., Stereocontrolled Total
`Synthesis of (+)-Paraherquamide B, J. Am.
`Chem. Soc. 1996, 118, 557-579.
`UTC_REM_II_000001718-40.
`• Williams, et.al., Synthetic Studies on Et-
`743. Assembly of the Pentacyclic Core and
`a Formal Total Synthesis, J. Org. Chem.
`73.24 (2008): 9594-9600.
`UTC_REM_II_000001748-54.
`• Heathcock, et.al., Further Studies of the
`Daphniphyllum Alkaloid Polycyclization
`Cascade, J. Org. Chem. 66 (2001): 450-
`454. UTC_REM_II_000001670-89.
`• Heathcock, et.al., Daphniphyllum
`Alkaloids. 12. A Proposed Biosynthesis of
`the Pentacyclic Skeleton. Proto-
`Daphniphylline, J. Org. Chem. 57 (1992):
`2554-2566. UTC_REM_II_000001657-69.
`• Buchwald, et.al., An Air-Stable Catalyst
`System for the Conversion of Esters to
`Alcohols, J. Org. Chem. 57 (1992): 3753-
`3755. UTC_REM_II_000001648-50.
`• Buchwald, et.al., A Practical Titanium-
`Catalyzed Synthesis of Bicyclic
`Cyclopentenones and Allylic Amines, J.
`Org. Chem. 61 (1996): 2713-2718.
`UTC_REM_II_000001651-56.
`
`Defendant’s Evidence
`• Brown et al., CHEMISTRY: THE CENTRAL
`SCIENCE, (9th ed. 2003), p. G-10.
`UTC_REM_II_000001762.
`
`• Suchocki et al., CONCEPTUAL CHEMISTRY,
`(2001), p. G-6.
`UTC_REM_II_000001769.
`
`• Zumdahl, CHEMISTRY (1986), p. A36.
`UTC_REM_II_000001766.
`
`• Williams et al., Asymmetric,
`Stereocontrolled Total Synthesis of
`Paraherquamide A, J. AM. CHEM. SOC.
`2003, 125, 12172-178.
`UTC_REM_II_000001741-47.
`
`• Williams et al., Stereocontrolled Total
`Synthesis of (+)-Paraherquamide B, J. AM.
`CHEM. SOC. 1996, 118, 557-579.
`UTC_REM_II_000001718-40.
`
`• Williams et al., Synthetic Studies on Et-
`743. Assembly of the Pentacyclic Core and
`a Formal Total Synthesis, J. ORG. CHEM.
`73.24 (2008): 9594-9600.
`UTC_REM_II_000001748-54.
`
`• Heathcock et al., Further Studies of the
`Daphniphyllum Alkaloid Polycyclization
`Cascade, J. ORG. CHEM. 66 (2001): 450-
`454. UTC_REM_II_000001670-89.
`
`• Heathcock et al., Daphniphyllum Alkaloids.
`12. A Proposed Biosynthesis of the
`Pentacyclic Skeleton. Proto-
`Daphniphylline, J. ORG. CHEM. 57 (1992):
`2554-2566. UTC_REM_II_000001657-69.
`
`• Buchwald et al., An Air-Stable Catalyst
`System for the Conversion of Esters to
`Alcohols, J. ORG. CHEM. 57 (1992): 3753-
`3755. UTC_REM_II_000001648-50.
`
`• Buchwald et al., A Practical Titanium-
`
`3
`
`
`

`
`Case 3:14-cv-05499-PGS-LHG Document 36 Filed 06/03/15 Page 4 of 52 PageID: 185
`
`
`Plaintiff’s Evidence
`• All intrinsic and extrinsic evidence cited for
`this term by Sandoz.
`• Dr. Williams will offer testimony that a
`person of ordinary skill in the art reading
`the term “product” in the context of the
`’393 patent would understand it is used
`according to its plain and ordinary meaning
`or “s substance resulting from a chemical
`reaction.” Dr. Williams will also explain
`why Sandoz’s construction of this term is
`not consistent with the understanding of a
`person of ordinary skill in the art and will
`rebut the testimony of Dr. Heathcock
`regarding this term.
`
`
`Defendant’s Evidence
`Catalyzed Synthesis of Bicyclic
`Cyclopentenones and Allylic Amines, J.
`ORG. CHEM. 61 (1996): 2713-2718.
`UTC_REM_II_000001651-56.
`
`• Dr. Clayton Heathcock will testify that
`Sandoz’s proposed claim construction for
`“product” is consistent with the way this
`term is used in the ’393 patent and is
`consistent with the ordinary and customary
`meaning, as understood by a person of
`ordinary skill in the art around 2007. Dr.
`Heathcock will also rebut the testimony of
`Dr. Williams regarding this term.
`
`2.
`
`“A product comprising a compound of formula I:
`
`
`or a pharmaceutically acceptable salt thereof” (claim 1)
`
`Plaintiff’s Construction
`Plain and ordinary meaning.
`To the extent the Court determines that this
`term requires construction, UTC proposes the
`following:
`“a substance resulting from a chemical reaction
`constituted primarily of formula I:
`
`Defendant’s Construction
`A chemical composition that includes, but is
`not limited to, a compound of formula I, or a
`pharmaceutically acceptable salt thereof, and
`that may also include other non-mentioned
`substances (including impurities), additives, or
`carriers, without limitation as to the types or
`relative amounts thereof.
`
`
`4
`
`
`

`
`Case 3:14-cv-05499-PGS-LHG Document 36 Filed 06/03/15 Page 5 of 52 PageID: 186
`
`
`Plaintiff’s Construction
`
`Defendant’s Construction
`
`
`
`or a pharmaceutically acceptable salt thereof”
`
`
`Plaintiff’s Evidence
`• U.S. Patent No. 8,497,393 claims 1-22; col.
`4:22-26; col. 4:60-col. 5:36; col. 7:16-20;
`col. 7:41-45; col. 17:37-40. UTC-Sand-
`Rem01170057-59, UTC-Sand-
`Rem01170064-66; Abstract; col. 5:38-49;
`col. 7:14-15; col. 8:66-67; col. 14:50-17:36
`at UTC_REM_II_000003354;
`UTC_REM_II_000003358;
`UTC_REM_II_000003359;
`UTC_REM_II_000003362-64;
`UTC_REM_II_000003365.
`• Amendment and Request for
`Reconsideration dated February 8, 2013.
`SDZ5499 0004846-56.
`• Amendments and Reply dated June 5, 2013.
`SDZ5499 0004877-90.
`• Notice of Allowance dated June 12, 2013.
`SDZ5499 0004894-99.
`’305 Patent File History, Amendments and
`Reply dated July 7, 2011, at
`UTC_REM_II_000002032.
`• Webster’s New Collegiate Dictionary
`(1981), Springfield, MA: G. & C. Merriam
`Co., p. 911. UTC_REM_II_000001787.
`• Brown, et.al., CHEMISTRY: THE
`CENTRAL SCIENCE, (9th ed. 2003), p.
`G-10. UTC_REM_II_000001762.
`• Suchocki, et. al., CONCEPTUAL
`
`•
`
`5
`
`
`Defendant’s Evidence
`• U.S. Patent No. 8,497,393, SDZ5499
`0004746-60, including but not limited to,
`claims 1-22; col. 4:22-26; col. 4:60- 5:36;
`col. 7:14-15; col. 7:16-20; col. 7:41-45;
`col. 9:20-23; col. 11:42-13:17; col. 17:26-
`32; col. 17:37-40.
`
`•
`
`’393 patent prosecution history, SDZ5499
`0004761-932, including but not limited to
`Amendment and Request for
`Reconsideration dated February 8, 2013.
`SDZ54990004846-56; Amendments and
`Reply dated June 5, 2013. SDZ5499
`0004877-90; Notice of Allowance dated
`June 12, 2013. SDZ5499 0004894-99.
`
`• WEBSTER’S NEW COLLEGIATE DICTIONARY
`(1981), Springfield, MA: G. & C. Merriam
`Co., p. 911. UTC_REM_II_000001787.
`
`• Brown et al., CHEMISTRY: THE CENTRAL
`SCIENCE, (9th ed. 2003), p. G-10.
`UTC_REM_II_000001762.
`
`• Suchocki et al., CONCEPTUAL CHEMISTRY,
`(2001), p. G-6.
`UTC_REM_II_000001769.
`
`• Zumdahl, CHEMISTRY (1986), p. A36.
`UTC_REM_II_000001766.
`
`• Williams et al., Asymmetric,
`Stereocontrolled Total Synthesis of
`
`

`
`Case 3:14-cv-05499-PGS-LHG Document 36 Filed 06/03/15 Page 6 of 52 PageID: 187
`
`
`Plaintiff’s Evidence
`CHEMISTRY, (2001), p. G-6.
`UTC_REM_II_000001769.
`• Zumdahl, CHEMISTRY (1986), p. A36.
`UTC_REM_II_000001766.
`• Williams, et.al., Asymmetric,
`Stereocontrolled Total Synthesis of
`Paraherquamide A, J. Am. Chem. Soc.
`2003, 125, 12172-178.
`UTC_REM_II_000001741-47.
`• Williams, et.al., Stereocontrolled Total
`Synthesis of (+)-Paraherquamide B, J. Am.
`Chem. Soc. 1996, 118, 557-579.
`UTC_REM_II_000001718-40.
`• Williams, et.al., Synthetic Studies on Et-743.
`Assembly of the Pentacyclic Core and a
`Formal Total Synthesis, J. Org. Chem.
`73.24 (2008): 9594-9600.
`UTC_REM_II_000001748-54.
`• Heathcock, et.al., Further Studies of the
`Daphniphyllum Alkaloid Polycyclization
`Cascade, J. Org. Chem. 66 (2001): 450-
`454. UTC_REM_II_000001670-89.
`• Heathcock, et.al., Daphniphyllum Alkaloids.
`12. A Proposed Biosynthesis of the
`Pentacyclic Skeleton. Proto-
`Daphniphylline, J. Org. Chem. 57 (1992):
`2554-2566. UTC_REM_II_000001657-69.
`• Buchwald, et.al., An Air-Stable Catalyst
`System for the Conversion of Esters to
`Alcohols, J. Org. Chem. 57 (1992): 3753-
`3755. UTC_REM_II_000001648-50.
`• Buchwald, et.al., A Practical Titanium-
`Catalyzed Synthesis of Bicyclic
`Cyclopentenones and Allylic Amines, J.
`Org. Chem. 61 (1996): 2713-2718.
`UTC_REM_II_000001651-56.
`• Aulton, et. al., Aulton’s Pharmaceutics (3rd
`Ed.), Elsevier Ltd. (2007), p. 340-341.
`
`Defendant’s Evidence
`Paraherquamide A, J. AM. CHEM. SOC.
`2003, 125, 12172-178.
`UTC_REM_II_000001741-47.
`
`• Williams et al., Stereocontrolled Total
`Synthesis of (+)-Paraherquamide B, J. AM.
`CHEM. SOC. 1996, 118, 557-579.
`UTC_REM_II_000001718-40.
`
`• Williams et al., Synthetic Studies on Et-
`743. Assembly of the Pentacyclic Core and
`a Formal Total Synthesis, J. ORG. CHEM.
`73.24 (2008): 9594-9600.
`UTC_REM_II_000001748-54.
`
`• Heathcock et al., Further Studies of the
`Daphniphyllum Alkaloid Polycyclization
`Cascade, J. ORG. CHEM. 66 (2001): 450-
`454. UTC_REM_II_000001670-89.
`
`• Heathcock et al., Daphniphyllum Alkaloids.
`12. A Proposed Biosynthesis of the
`Pentacyclic Skeleton. Proto-
`Daphniphylline, J. ORG. CHEM. 57 (1992):
`2554-2566. UTC_REM_II_000001657-69.
`
`• Buchwald et al., An Air-Stable Catalyst
`System for the Conversion of Esters to
`Alcohols, J. ORG. CHEM. 57 (1992): 3753-
`3755. UTC_REM_II_000001648-50.
`
`• Buchwald et al., A Practical Titanium-
`Catalyzed Synthesis of Bicyclic
`Cyclopentenones and Allylic Amines, J.
`ORG. CHEM. 61 (1996): 2713-2718.
`UTC_REM_II_000001651-56
`
`• Aulton et al., AULTON’S PHARMACEUTICS
`(3rd Ed.), Elsevier Ltd. (2007), p. 340-341.
`UTC_REM_II_000001758.
`
`• Haynes et al., Occurrence of
`Pharmaceutically Acceptable Anions and
`Cations in the Cambridge Structural
`Database, J. PHARM. SCI., 94, 10, 2111-21
`
`6
`
`
`

`
`Case 3:14-cv-05499-PGS-LHG Document 36 Filed 06/03/15 Page 7 of 52 PageID: 188
`
`
`Defendant’s Evidence
`(2005). UTC_REM_II_000001690-99.
`
`• Dr. Clayton Heathcock will testify that
`Sandoz’s proposed claim construction for
`“A product comprising a compound of
`formula I:”
`
`
`
`or a pharmaceutically acceptable salt
`thereof” is consistent with the way this
`term is used in the ’393 patent and is
`consistent with the ordinary and customary
`meaning, as understood by a person of
`ordinary skill in the art around 2007. Dr.
`Heathcock will also rebut the testimony of
`Dr. Williams regarding this term.
`
`Plaintiff’s Evidence
`UTC_REM_II_000001758.
`• Haynes, et. al., Occurrence of
`Pharmaceutically Acceptable Anions and
`Cations in the Cambridge Structural
`Database, J.Pharm. Sci., 94, 10, 2111-21
`(2005). UTC_REM_II_000001690-99.
`• All intrinsic and extrinsic evidence cited for
`this term by Sandoz.
`• Dr. Williams will offer testimony that a
`person of ordinary skill in the art reading
`the term “A product comprising a
`compound of formula I:
`
`
`or a pharmaceutically acceptable salt
`thereof” in the context of the ’393 patent
`would understand it is used according to its
`plain and ordinary meaning or “A substance
`resulting from a chemical reaction
`constituted primarily of formula I:
`
`
`or a pharmaceutically acceptable salt thereof.”
`Dr. Williams will also explain why Sandoz’s
`construction of this term is not consistent with
`the understanding of a person of ordinary skill
`in the art and will rebut the testimony of Dr.
`Heathcock regarding this term.
`
`
`
`7
`
`
`

`
`Case 3:14-cv-05499-PGS-LHG Document 36 Filed 06/03/15 Page 8 of 52 PageID: 189
`
`
`3.
`
`“a process comprising” (claim 1)
`
`Plaintiff’s Construction
`Plain and ordinary meaning.
`
`
`
`Plaintiff’s Evidence
`• U.S. Patent No. 8,497,393 claims 1, 9; col.
`4:2-25; 5:37-50. UTC-Sand-Rem01170057,
`UTC-Sand-Rem01170064-65.
`• All intrinsic and extrinsic evidence cited for
`this term by Sandoz.
`• Dr. Williams will offer testimony to rebut
`the testimony of Dr. Heathcock regarding
`this term.
`
`Defendant’s Construction
`A process that includes, but is not limited to,
`the recited process steps, and may include,
`without limitation, any other non-recited steps.
`
`Defendant’s Evidence
`• U.S. Patent No. 8,497,393, SDZ5499
`0004746-60, including but not limited to,
`claims 1, 9; col. 1:65- 3:19, col. 4:2-25,
`col. 5:37-7:13.
`
`• MERRIAM-WEBSTER DICTIONARY HOME
`AND OFFICE EDITION (1998). Springfield,
`MA: Merriam-Webster, Inc., p. 415,
`UTC_REM_II_000001781
`
`• WEBSTER'S NEW COLLEGIATE DICTIONARY
`(1981), p.910, UTC_REM_II_000001786.
`
`• Dr. Clayton Heathcock will testify that
`Sandoz’s proposed claim construction for
`“a process comprising” is consistent with
`the way this term is used in the ’393 patent
`and is consistent with the ordinary and
`customary meaning, as understood by a
`person of ordinary skill in the art around
`2007. Dr. Heathcock will also rebut the
`testimony of Dr. Williams regarding this
`term.
`
`
`
`4.
`
`“an alkylating agent” (claim 1)
`
`Plaintiff’s Construction
`Plain and ordinary meaning.
`To the extent the Court determines that this
`term requires construction, UTC proposes the
`following:
`“a chemical agent capable of transferring a
`carbon-based group to another chemical agent”
`
`Defendant’s Construction
`A reagent that comprises a nitrile substituent,
`that, when used to alkylate a compound of
`structure II, produces a nitrile compound of
`formula III.
`
`
`8
`
`
`

`
`Case 3:14-cv-05499-PGS-LHG Document 36 Filed 06/03/15 Page 9 of 52 PageID: 190
`
`
`Defendant’s Evidence
`• U.S. Patent No. 8,497,393, SDZ5499
`0004746-60, including but not limited to,
`claims 1, 3, 9, 11; col. 2:11-32, col. 8:15-
`19; 7:65-8:46, col. 9:25-10:15, col. 15, col.
`17:28-32.
`
`• WEBSTER’S NEW COLLEGIATE DICTIONARY
`(1981), Springfield, MA: G. & C. Merriam
`Co., p. 29. UTC_REM_II_000001784.
`
`• HAWLEY’S CONDENSED CHEMICAL
`DICTIONARY (14th Ed.), p. 34.
`UTC_REM_II_000001773.
`
`• Loudon, et al., ORGANIC CHEMISTRY, (3rd
`ed. 1995), pp. 454-455.
`UTC_REM_II_000001700-03.
`
`• Dr. Clayton Heathcock will testify that
`Sandoz’s proposed claim construction for
`“an alkylating agent” is consistent with the
`way this term is used in the ‘393 patent and
`is consistent with the ordinary and
`customary meaning, as understood by a
`person of ordinary skill in the art around
`2007. Dr. Heathcock will also rebut the
`testimony of Dr. Williams regarding this
`term.
`
`
`
`Plaintiff’s Evidence
`• U.S. Patent No. 8,497,393 claims 1, 3, 9, 11;
`col. 4:8:15-19; col. 9:25-10:14. UTC-Sand-
`Rem01170057, UTC-Sand-Rem01170060,
`UTC-Sand-Rem01170064-65; col. 1:65-67;
`col. 8:15-19; col. 9:15-23; col. 17:41-46 at
`UTC_REM_II_000003356;
`UTC_REM_II_000003359-60;
`UTC_REM_II_000003364.
`• Webster’s New Collegiate Dictionary
`(1981), Springfield, MA: G. & C. Merriam
`Co., p. 29. UTC_REM_II_000001784.
`• Hawley’s Condensed Chemical Dictionary
`(14th Ed.), p. 34.
`UTC_REM_II_000001773.
`• Loudon, et. al., ORGANIC CHEMISTRY,
`(3rd ed. 1995), pp. 454-455.
`UTC_REM_II_000001700-03.
`• All intrinsic and extrinsic evidence cited for
`this term by Sandoz.
`• Dr. Williams will offer testimony that a
`person of ordinary skill in the art reading the
`term “an alkylating agent” in the context of
`the ’393 patent would understand it is used
`according to its plain and ordinary meaning
`or “a chemical agent capable of transferring
`a carbon-based group to another chemical
`agent.” Dr. Williams will also explain why
`Sandoz’s construction of this term is not
`consistent with the understanding of a
`person of ordinary skill in the art and will
`rebut the testimony of Dr. Heathcock
`regarding this term.
`
`
`
`9
`
`
`

`
`Case 3:14-cv-05499-PGS-LHG Document 36 Filed 06/03/15 Page 10 of 52 PageID: 191
`
`
`5.
`
`“a base B” (claims 1 and 9)
`
`Plaintiff’s Construction
`Plain and ordinary meaning.
`To the extent the Court determines that this
`term requires construction, UTC proposes the
`following:
`“a substance that produces hydroxide ions in
`aqueous solution, a proton acceptor”
`
`
`
`Plaintiff’s Evidence
`• U.S. Patent No. 8,497,393 col. 5:7-36; 9:3-
`5, 15-23; claims 1, 4, 5, 9, 12-14, 17-20.
`UTC-Sand-Rem01170058, UTC-Sand-
`Rem01170060, UTC-Sand-Rem01170064-
`66; col. 9:15-23; col. 17:41-46 at
`UTC_REM_II_000003360;
`UTC_REM_II_000003364.
`
`• Amendment And Reply dated February 8,
`2013, pp. 6-7, 9, prosecution history for
`United States Patent No. 8,497,393.
`UTC_REM_II_000001410-11,
`UTC_REM_II_000001413.
`
`• Brown, et.al., CHEMISTRY: THE
`CENTRAL SCIENCE, (9th ed. 2003), p.
`G-1. UTC_REM_II_000001586.
`
`• March, et. al., MARCH’S ADVANCED
`ORGANIC CHEMISTRY, (5th ed. 2001),
`pp. 327-332. UTC_REM_II_000001589-
`94.
`
`• Rayner-Canham, et. al., DESCRIPTIVE
`INORGANIC CHEMISTRY, (2nd ed.
`1996), pp. 121-134.
`UTC_REM_II_000001597-610.
`
`• Loudon, et. al., ORGANIC CHEMISTRY,
`(3rd ed. 1995), pp. 87-112.
`UTC_REM_II_000001613-38.
`
`10
`
`
`Defendant’s Construction
`A chemical species capable of receiving a
`proton (hydrogen ion, i.e., H ) from the
`product of step (b) to form the positively
`charged conjugate acid HB .
`
`Defendant’s Evidence
`• U.S. Patent No. 8,497,393, SDZ5499
`0004746-60, including but not limited to
`col. 4:37-43, col. 5:7-36; col. 7:65-8:65,
`col. 9:3-5, 15-23; col. 11:42-17:40, claims
`1, 4, 5, 9, 12-14, 17-20.
`
`•
`
`’393 patent prosecution history, SDZ5499
`0004761-932, including but not limited to
`Amendment And Reply dated February 8,
`2013, pp. 6-7, 9-10; 6/5/2013 Response at
`pp. 7-8; Walsh Declaration (SDZ5499
`0004887-89), Notice of Allowability
`(SDZ5499 0004894-99).
`
`• Aulton et al., AULTON’S PHARMACEUTICS
`(3rd Ed.), Elsevier Ltd. (2007), p. 340-341.
`UTC_REM_II_000001758.
`
`• Haynes et al., Occurrence of
`Pharmaceutically Acceptable Anions and
`Cations in the Cambridge Structural
`Database, J. PHARM. SCI., 94, 10, 2111-21
`(2005). UTC_REM_II_000001690-99.
`
`• Brown et al., CHEMISTRY: THE CENTRAL
`SCIENCE, (9th ed. 2003), p. G-1.
`UTC_REM_II_000001586.
`
`• March et al., MARCH’S ADVANCED
`ORGANIC CHEMISTRY, (5th ed. 2001), pp.
`327-332. UTC_REM_II_000001589-1594.
`
`

`
`Case 3:14-cv-05499-PGS-LHG Document 36 Filed 06/03/15 Page 11 of 52 PageID: 192
`
`
`Defendant’s Evidence
`• Rayner-Canham et al., DESCRIPTIVE
`INORGANIC CHEMISTRY, (2nd ed. 1996), pp.
`121-134. UTC_REM_II_000001597-1610.
`
`• Loudon et al., ORGANIC CHEMISTRY, (3rd
`ed. 1995), pp. 87-112.
`UTC_REM_II_000001613-1638.
`
`• Bettelheim et al., INTRODUCTION TO
`GENERAL, ORGANIC & BIOCHEMISTRY (6th
`ed. 2001), p. G-2.
`UTC_REM_II_000001641.
`
`
`
`• Suchocki et al., CONCEPTUAL CHEMISTRY,
`(2001), p. G-1.
`UTC_REM_II_000001644.
`
`• Zumdahl, CHEMISTRY (1986), p. A26.
`UTC_REM_II_000001647.
`
`• MCGRAW-HILL DICTIONARY OF SCIENTIFIC
`AND TECHNICAL TERMS, 6th ed., at p. 203
`(2003) (SDZ5499 0005897).
`
`• U.S. Patent Application Publication No.
`2005/0085540A1 (SDZ5499 0004946-
`5009).
`
`• Jin Li and Kevin K.-C. Liu, Synthetic
`Approaches To The 2002 New Drugs ,
`MINI-REVIEWS IN MEDICINAL CHEMISTRY,
`vol. 4, pp. 207-233 (2004) (SDZ5499
`0005832–5858).
`
`• U.S. Patent No. 4,306,075 (Sandoz-
`Trep0004467-4520).
`
`• Moriarty et al., The Intrmolecular
`Asymmetric Pauson-Khand Cyclization as
`a Novel and General Stereselective Route
`to Benzindene Prostacyclins: Synthesis of
`UT-15 (Treprostinil), J. ORG. CHEM. 2004,
`69, 1890-1902 (Sandoz-Trep0005995-
`
`Plaintiff’s Evidence
`
`
`• Bettelheim, et. al., INTRODUCTION TO
`GENERAL, ORGANIC &
`BIOCHEMISTRY (6th ed. 2001), p. G-2.
`UTC_REM_II_000001641.
`
`• Suchocki, et. al., CONCEPTUAL
`CHEMISTRY, (2001), p. G-1.
`UTC_REM_II_000001644.
`
`• Zumdahl, CHEMISTRY (1986), p. A26.
`UTC_REM_II_000001647.
`
`• Richet, THE PHYSICAL BASIS OF
`THERMODYNAMICS WITH
`APPLICATIONS TO CHEMISTRY
`(2001), p. 285-286.
`UTC_REM_II_000005497-98.
`
`• Aulton, et. al., Aulton’s Pharmaceutics (3rd
`Ed.), Elsevier Ltd. (2007), p. 340-341.
`UTC_REM_II_000001758.
`
`• All intrinsic and extrinsic evidence cited for
`this term by Sandoz.
`• Dr. Williams will offer testimony that a
`person of ordinary skill in the art reading the
`term “a base B” in the context of the ’393
`patent would understand it is used according
`to its plain and ordinary meaning or “a
`substance that produces hydroxide ions in
`aqueous solution, a proton acceptor.” Dr.
`Williams will also explain why Sandoz’s
`construction of this term is not consistent
`with the understanding of a person of
`ordinary skill in the art and will rebut the
`testimony of Dr. Heathcock regarding this
`term.
`
`11
`
`
`

`
`Case 3:14-cv-05499-PGS-LHG Document 36 Filed 06/03/15 Page 12 of 52 PageID: 193
`
`
`Plaintiff’s Evidence
`
`Defendant’s Evidence
`
`6007).
`
`• Streitwieser, A. & Heathcock, C. H.,
`INTRODUCTION TO ORGANIC CHEMISTRY,
`3rd ed. (1985), chapters 2, 4 and 23
`(SDZ5499 0005903-998).
`
`• Dr. Clayton Heathcock will testify that
`Sandoz’s proposed claim construction for
`“a base B” is consistent with the way this
`term is used in the ’393 patent and is
`consistent with the ordinary and customary
`meaning, as understood by a person of
`ordinary skill in the art around 2007. Dr.
`Heathcock will also rebut the testimony of
`Dr. Williams regarding this term.
`
`
`
`6.
`
`“a salt of formula IS
`
`Plaintiff’s Construction
`Plain and ordinary meaning.
`To the extent the Court determines that this
`term requires construction, UTC proposes the
`following:
`“a chemical combination of two ionizable
`components – one acidic and one basic relative
`to each other, with the formula:
`
`” (claim 1)
`
`Defendant’s Construction
`A salt that comprises a conjugate base having
`the formula:
`
`
`and the positively charged conjugate acid
`having the formula HB .
`
`12
`
`
`

`
`Case 3:14-cv-05499-PGS-LHG Document 36 Filed 06/03/15 Page 13 of 52 PageID: 194
`
`
`Plaintiff’s Construction
`
`Defendant’s Construction
`
`”
`
`
`
`Plaintiff’s Evidence
`• U.S. Patent No. 8,497,393 claims 1, 5, and
`19; col. 4:60-5:36; col. 9:2-5. UTC-Sand-
`Rem01170057-58; UTC-Sand-
`Rem01170060, UTC-Sand-Rem01170064-
`66; col. 9:15-23; col. 17:41-46 at
`UTC_REM_II_000003360;
`UTC_REM_II_000003364.
`• Aulton, et. al., Aulton’s Pharmaceutics (3rd
`Ed.), Elsevier Ltd. (2007), p. 340-341.
`UTC_REM_II_000001758.
`• Haynes, et. al., Occurrence of
`Pharmaceutically Acceptable Anions and
`Cations in the Cambridge Structural
`Database, J.Pharm. Sci., 94, 10, 2111-21
`(2005). UTC_REM_II_000001690-99.
`• Richet, THE PHYSICAL BASIS OF
`THERMODYNAMICS WITH
`APPLICATIONS TO CHEMISTRY
`(2001), p. 285-286 at
`UTC_REM_II_000005497-98.
`• All intrinsic and extrinsic evidence cited
`for this term by Sandoz.
`• Dr. Williams will offer testimony that a
`person of ordinary skill in the art reading
`the term “a salt of formula Is:
`
`13
`
`
`Defendant’s Evidence
`• U.S. Patent No. 8,497,393, SDZ5499
`0004746-60, including but not limited to
`claims 1, 5, and 19; col. 4:60-5:36, col.
`7:65-8:65, col. 9:2-5, col.11:42-17:40.
`
`•
`
`’393 patent prosecution history, SDZ5499
`0004761-932, including but not limited to
`2/8/2013 Response at pp. 9-10, 6/5/2013
`Response at pp. 7-8, Walsh Declaration
`(SDZ5499 0004887-89), Notice of
`Allowability (SDZ5499 0004894-99).
`
`• Aulton et al., AULTON’S PHARMACEUTICS
`(3rd Ed.), Elsevier Ltd. (2007), p. 340-341.
`UTC_REM_II_000001758.
`
`• Haynes et al., Occurrence of
`Pharmaceutically Acceptable Anions and
`Cations in the Cambridge Structural
`Database, J. PHARM. SCI., 94, 10, 2111-21
`(2005). UTC_REM_II_000001690-99.
`
`• Brown et al., CHEMISTRY: THE CENTRAL
`SCIENCE, (9th ed. 2003), p. G-1,
`UTC_REM_II_000001586.
`
`• March et al., MARCH’S ADVANCED
`ORGANIC CHEMISTRY, (5th ed. 2001), pp.
`327-332. UTC_REM_II_000001589-1594.
`
`• Rayner-Canham et al., DESCRIPTIVE
`INORGANIC CHEMISTRY, (2nd ed. 1996), pp.
`121-134. UTC_REM_II_000001597-1610.
`
`• Loudon et al., ORGANIC CHEMISTRY, (3rd
`
`

`
`Case 3:14-cv-05499-PGS-LHG Document 36 Filed 06/03/15 Page 14 of 52 PageID: 195
`
`
`Plaintiff’s Evidence
`
`
`in the context of the ’393 patent would
`understand it is used according to its plain and
`ordinary meaning or “a chemical combination
`of two ionizable components – one acidic and
`one basic relative to each other, with the
`formula:
`
`
`Dr. Williams will also explain why Sandoz’s
`construction of this term is not consistent with
`the understanding of a person of ordinary skill
`in the art and will rebut the testimony of Dr.
`Heathcock regarding this term.
`
`14
`
`
`Defendant’s Evidence
`ed. 1995), pp. 87-112.
`UTC_REM_II_000001613-1638.
`
`• Bettelheim et al., INTRODUCTION TO
`GENERAL, ORGANIC & BIOCHEMISTRY (6th
`ed. 2001), p. G-2.
`UTC_REM_II_000001641.
`
`• Suchocki et al., CONCEPTUAL CHEMISTRY,
`(2001), p. G-1. UTC_REM_II_000001644.
`
`• Zumdahl, CHEMISTRY (1986), p. A26.
`UTC_REM_II_000001647.
`
`• MCGRAW-HILL DICTIONARY OF SCIENTIFIC
`AND TECHNICAL TERMS, 6th ed., at p. 203
`(2003) (SDZ5499 0005897).
`
`• U.S. Patent Application Publication No.
`2005/0085540A1 (SDZ5499 0004946-
`5009).
`
`• Jin Li and Kevin K.-C. Liu, Synthetic
`Approaches To The 2002 New Drugs,
`MINI-REVIEWS IN MEDICINAL CHEMISTRY,
`vol. 4, pp. 207-233 (2004) (SDZ5499
`0005832–5858).
`
`• U.S. Patent No. 4,306,075 (Sandoz-
`Trep0004467-4520).
`
`• Moriarty et al., The Intramolecular
`Asymmetric Pauson-Khand Cyclization as
`a Novel and General Stereoselective Route
`to Benzindene Prostacyclins: Synthesis of
`UT-15 (Treprostinil), J. ORG. CHEM. 2004,
`69, 1890-1902 (Sandoz-Trep0005995-
`6007).
`
`• Streitwieser, A. & Heathcock, C. H.,
`INTRODUCTION TO ORGANIC CHEMISTRY,
`3rd ed. (1985), chapters 2, 4 and 23
`(SDZ5499 0005903-998).
`
`• Dr. Clayton Heathcock will testify that
`Sandoz’s proposed claim construction for
`
`

`
`Case 3:14-cv-05499-PGS-LHG Document 36 Filed 06/03/15 Page 15 of 52 PageID: 196
`
`
`Plaintiff’s Evidence
`
`7.
`
`“HB+” (claims 1 and 9)
`
`Plaintiff’s Construction
`Plain and ordinary meaning.
`To the extent the Court determines that this
`term requires construction, UTC proposes the
`following:
`“the cation formed in aqueous solution by base
`B subsequent to reacting base B with the
`product of step (b)”
`
`
`Plaintiff’s Evidence
`• U.S. Patent No. 8,497,393 col. 5:7-36; 9:2-
`5, 15-23; claims 1, 5, 9, 13, 14, 17-20.
`UTC-Sand-Rem01170058, UTC-Sand-
`Rem01170060, UTC-Sand-Rem01170064-
`66; col. 9:15-23; col. 17:41-46 at
`UTC_REM_II_000003360;
`UTC_REM_II_000003364.
`• Amendment And Reply dated February 8,
`2013, pp. 6-7, 9, prosecution history for
`United States Patent No. 8,497,393.
`UTC_REM_II_000001410-11,
`UTC_REM_II_000001413.
`• Brown, et.al., CHEMISTRY: THE
`CENTRAL SCIENCE, (9th ed. 2003), p.
`G-1, G-2. UTC_REM_II_000001586;
`UTC_REM_II_000001761.
`• March, et. al., MARCH’S ADVANCED
`ORGANIC CHEMISTRY, (5th ed. 2001),
`pp. 327-332. UTC_REM_II_000001589-
`
`15
`
`
`Defendant’s Evidence
`this term is consistent with the way this
`term is used in the ’393 patent and is
`consistent with the ordinary and customary
`meaning, as understood by a person of
`ordinary skill in the art around 2007. Dr.
`Heathcock will also rebut the testimony of
`Dr. Williams regarding this term.
`
`Defendant’s Construction
`The positively charged conjugate acid of base
`B formed when base B receives a proton
`(hydrogen ion, i.e., H ) from the product of
`step (b).
`
`Defendant’s Evidence
`• U.S. Patent No. 8,497,393, SDZ5499
`0004746-60, including but not limited to
`claims 1, 5, 9, 13, 14, 17-20; col. 5:7-36;
`7:65-8:65, 9:2-5, 15-23, col.11:42- 17:40.
`
`•
`
`’393 patent prosecution history, SDZ5499
`0004761-932, including but not limited to
`Amendment And Reply dated February 8,
`2013, pp. 6-7, 9-10, 6/5/2013 Response at
`pp. 7-8, Walsh Declaration (SDZ5499
`0004887-89), Notice of Allowability
`(SDZ5499 0004894-99).
`
`• Aulton et al., AULTON’S PHARMACEUTICS
`(3rd Ed.), Elsevier Ltd. (2007), p. 339-341.
`UTC_REM_II_000001757-58.
`
`• Haynes et al., Occurrence of
`Pharmaceutically Acceptable Anions and
`Cations in the Cambridge Structural
`Database, J. PHARM. SCI., 94, 10, 2111-21
`
`

`
`Case 3:14-cv-05499-PGS-LHG Document 36 Filed 06/03/15 Page 16 of 52 PageID: 197
`
`
`Plaintiff’s Evidence
`
`94.
`• Rayner-Canham, et. al., DESCRIPTIVE
`INORGANIC CHEMISTRY, (2nd ed.
`1996), pp. 121-134.
`UTC_REM_II_000001597-610.
`• Loudon, et. al., ORGANIC CHEMISTRY,
`(3rd ed. 1995), pp. 87-112.
`UTC_REM_II_000001613-38.
`• Bettelheim, et. al., INTRODUCTION TO
`GENERAL, ORGANIC &
`BIOCHEMISTRY (6th ed. 2001), p. G-2.
`UTC_REM_II_000001641.
`• Suchocki, et. al., CONCEPTUAL
`CHEMISTRY, (2001), p. G-1.
`UTC_REM_II_000001644.
`• Zumdahl, CHEMISTRY (1986), p. A26.
`UTC_REM_II_000001647.
`• Hawley’s Condensed Chemical Dictionary
`(14th Ed.), p. 221.
`UTC_REM_II_000001774.
`• Aulton, et. al., Aulton’s Pharmaceutics (3rd
`Ed.), Elsevier Ltd. (2007), p. 339-341.
`UTC_REM_II_000001757-58.
`• Richet, THE PHYSICAL BASIS OF
`THERMODYNAMICS WITH
`APPLICATIONS TO CHEMISTRY
`(2001), p. 285-286 at
`UTC_REM_II_000005497-98.
`• All intrinsic and extrinsic evidence cited
`for this term by Sandoz.
`• Dr. Williams will offer testimony that a
`person of ordinary skill in the art reading
`the term “HB+” in the context of the ’393
`patent would understand it is used
`according to its plain and ordinary meaning
`or “the cation formed in aqueous solution
`by base B subsequent to reacting base B
`with the product of step (b).” Dr. Williams
`
`Defendant’s Evidence
`(2005). UTC_REM_II_000001690-99