Case 1:14-cv-00113-RGA-MPT Document 236 Filed 04/27/15 Page 1 of 6 PageID #: 6247
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELA WARE
`
`SANOFI-AVENTIS U.S. LLC, et al.,
`
`Plaintiffs,
`
`v.
`
`ELI LILLY AND COMPANY,
`
`Defendant.
`
`Civil Action No. 14-113-RGA-MPT
`
`MEMORANDUM OPINION
`
`Steven J. Balick, Esq., Tiffany Geyer Lydon, Esq., Andrew C. Mayo, Esq., ASHBY &
`GEDDES, Wilmington, DE; Mark A. Perry, Esq., GIBSON, DUNN & CRUTCHER LLP,
`Washington, D.C.; Joseph Evall, Esq. (argued), R. Scott Roe, Esq. (argued), GIBSON, DUNN &
`CRUTCHER LLP, New York, NY; Tracey Davies, Esq. (argued), GIBSON, DUNN &
`CRUTCHER LLP, Dallas, TX; Frederick Brown, Esq., GIBSON, DUNN & CRUTCHER LLP,
`San Francisco, CA; Y. Ernest Hsin, Esq. (argued), GIBSON, DUNN & CRUTCHER LLP, Palo
`Alto, CA.
`
`Attorneys for Plaintiffs Sanofi-Aventis U.S. LLC, et al.
`
`Brian E. Farnan, Esq., Michael J. Farnan, Esq., FARNAN LLP, Wilmington, DE; Bruce M.
`Wexler, Esq. (argued), Joseph M. O'Malley, Jr., Esq., David M. Conca, Esq. (argued), Young
`Park, Esq., Nicholas A. Tymoczko, Esq., PAUL HASTINGS LLP, New York, NY.
`
`Attorneys for Defendant Eli Lilly and Company.
`
`April-;JJ, 2015
`
`
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELA WARE
`
`SANOFI-AVENTIS U.S. LLC, et al.,
`
`Plaintiffs,
`
`v.
`
`ELI LILLY AND COMPANY,
`
`Defendant.
`
`Civil Action No. 14-113-RGA-MPT
`
`MEMORANDUM OPINION
`
`Steven J. Balick, Esq., Tiffany Geyer Lydon, Esq., Andrew C. Mayo, Esq., ASHBY &
`GEDDES, Wilmington, DE; Mark A. Perry, Esq., GIBSON, DUNN & CRUTCHER LLP,
`Washington, D.C.; Joseph Evall, Esq. (argued), R. Scott Roe, Esq. (argued), GIBSON, DUNN &
`CRUTCHER LLP, New York, NY; Tracey Davies, Esq. (argued), GIBSON, DUNN &
`CRUTCHER LLP, Dallas, TX; Frederick Brown, Esq., GIBSON, DUNN & CRUTCHER LLP,
`San Francisco, CA; Y. Ernest Hsin, Esq. (argued), GIBSON, DUNN & CRUTCHER LLP, Palo
`Alto, CA.
`
`Attorneys for Plaintiffs Sanofi-Aventis U.S. LLC, et al.
`
`Brian E. Farnan, Esq., Michael J. Farnan, Esq., FARNAN LLP, Wilmington, DE; Bruce M.
`Wexler, Esq. (argued), Joseph M. O'Malley, Jr., Esq., David M. Conca, Esq. (argued), Young
`Park, Esq., Nicholas A. Tymoczko, Esq., PAUL HASTINGS LLP, New York, NY.
`
`Attorneys for Defendant Eli Lilly and Company.
`
`April-;JJ, 2015
`
`
`
`Case 1:14-cv-00113-RGA-MPT Document 236 Filed 04/27/15 Page 2 of 6 PageID #: 6248
`
`This opinion supplements the Markman opinion issued by this Court on January 20,
`
`2015. (D.I. 192). Knowledge of the prior opinion is presumed. The parties submitted
`
`declarations by expert witnesses on January 16, 2015 (D.I. 189 & 191), and appeared for an
`
`evidentiary hearing on January 23, 2015. (D.I. 198). The following terms are in dispute:
`
`1.
`
`"polysorbate" (' 652 patent: claims 7, 24)
`
`a.
`
`Plaintiffs' proposed construction: Plain and ordinary meaning. If the
`
`Court finds construction is necessary: 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.
`
`b.
`
`Defendant's proposed construction: Compounds with the following
`
`structure:
`
`or
`
`where w+x+y+z is approximately 4, 5, or 20, and where Risa fatty acid.
`
`c.
`
`Court's construction: 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.
`
`The '652 patent has an effective filing date of June 18, 2002, which is the relevant time
`
`period for purposes of claim construction. (D.I. 1-3 at 2). Lilly's expert, Dr. Jerry L. Atwood,
`
`makes clear that "[p ]resented with terms that are ingredients added to a 'pharmaceutical
`
`2
`
`
`
`Case 1:14-cv-00113-RGA-MPT Document 236 Filed 04/27/15 Page 3 of 6 PageID #: 6249
`
`formulation,' a POSA would consult standard pharmaceutical references to ascertain the
`
`meaning of those terms." (D.I. 191 at 9). For this reason, Lilly bases its proposed construction
`
`on the "Structural Formula" of "polysorbates" provided in the Handbook of Pharmaceutical
`
`Excipients (the "Handbook''). (D.I. 138-2 at 39). Lilly, however, relies upon the fourth edition
`
`of the Handbook, which was published in 2003, after the '652 patent's priority date. (Id. at 37).
`
`Sanofi's expert, Dr. Ralph Tarantino, bases Sanofi's proposed construction on the definition of
`
`"polysorbates" provided in the "Applications in Pharmaceutical Formulation or Technology"
`
`section in the third edition of the Handbook, which was published in 2000. (D.I. 189 at 10). The
`
`2000 Handbook defines "polysorbates" as "a series of 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." Handbook of Pharmaceutical Excipients 417 (Arthur H. Kibbe
`
`ed., 3d ed. 2000). The parties' experts agree that a person of ordinary skill in the art would rely
`
`upon the Handbook's definition of "polysorbate," and thus, I adopt the definition provided in the
`
`2000 edition of the Handbook.
`
`2.
`
`"polysorbate 20" ('652 patent: claims 1, 2, 8, 23)
`
`a.
`
`Plaintiffs' proposed construction: Plain and ordinary meaning. If the
`
`Court finds construction is necessary: A polysorbate that is a mixture of fatty acid
`
`(characteristically lauric acid) esters of sorbitol and its anhydrides copolymerized with 20 moles
`
`of ethylene oxide for each mole of sorbitol and its anhydrides.
`
`b.
`
`Defendant's proposed construction: Compounds with the following
`
`structure:
`
`3
`
`
`
`Case 1:14-cv-00113-RGA-MPT Document 236 Filed 04/27/15 Page 4 of 6 PageID #: 6250
`
`where w+x+y+z is approximately 20, and R is fatty acids present in the following amounts:
`
`Carbon-
`Chain
`Length
`6
`8
`10
`12
`14
`16
`18
`18
`18
`
`Number of
`Double
`Bonds
`0
`0
`0
`0
`0
`0
`0
`1
`2
`
`Percentage
`
`:::; 1.0
`:::; 10.0
`:::; 10.0
`40.0-60.0
`14.0-25.00
`7.0-15.0
`:::;7.0
`:::; 11.0
`:::; 3.0
`
`c.
`
`Court's construction: A laurate ester of sorbitol and its anhydrides
`
`copolymerized with approximately 20 moles of ethylene oxide for each mole of sorbitol and
`
`sorbitol anhydrides.
`
`Dr. Atwood recognizes that The United States Pharmacopeia and The National
`
`Formulary (USP-NF) is a "standard pharmaceutical reference[]" and is "widely cited and used in
`
`the pharmaceutical industry." (D.1. 191 at 9). Lilly relies upon the 2014 USP-NF for its
`
`proposed construction of "polysorbate 20," which provides the assay table depicted above. (Id.
`
`at 9-10 ii 34; D.I. 138-2 at 44). Sanofi, on the other hand, cites the 2002 USP-NF, which became
`
`official on January 1, 2002, as the basis for its proposed construction. (D.I. 189 at 12 ii 38 n.11;
`
`D.I. 189-5). The 2002 USP-NF defines "polysorbate 20" as "a laurate ester of sorbitol and its
`
`anhydrides copolymerized with approximately 20 moles of ethylene oxide for each mole of
`
`sorbitol and sorbitol anhydrides." (D.I. 189-5 at 6). A person of ordinary skill in the art as of
`
`4
`
`
`
`Case 1:14-cv-00113-RGA-MPT Document 236 Filed 04/27/15 Page 5 of 6 PageID #: 6251
`
`June 18, 2002 would have used the definition provided in the 2002 USP-NF to understand the
`
`term "polysorbate 20." Therefore, I adopt the definition provided in the 2002 USP-NF.
`
`3.
`
`"polysorbate 80" ('652 patent: claims 1, 2, 8, 23)
`
`a.
`
`Plaintiffs' proposed construction: Plain and ordinary meaning. If the
`
`Court finds construction is necessary: A polysorbate that is a mixture of fatty acid
`
`(characteristically oleic acid) esters of sorbitol and its anhydrides copolymerized with 20 moles
`
`of ethylene oxide for each mole of sorbitol and its anhydrides.
`
`b.
`
`Defendant's proposed construction: Compounds with the following
`
`structure:
`
`where w+x+y+z is approximately 20, and R is fatty acids present in the following amounts:
`
`Fatty Acid
`Myristic acid
`Palmitic acid
`Palmitoleic acid
`Stearic acid
`Oleic acid
`Linoleic acid
`Linolenic acid
`
`Percentae:e
`:'.S5.0
`:'.S 16.0
`:'.S 8.0
`:'.S6.0
`2: 58.0
`:'.S 18.0
`:'.S4.0
`
`c.
`
`Court's construction: An oleate ester of sorbitol and its anhydrides
`
`copolymerized with approximately 20 moles of ethylene oxide for each mole of sorbitol and
`
`sorbitol anhydrides.
`
`Lilly's proposed construction is based on the definition of "polysorbate 80" from the
`
`2014 USP-NF. (D.I. 191 at 11-12 if 38; D.I. 138-2 at 46). The 2002 USP-NF defines
`
`5
`
`
`
`Case 1:14-cv-00113-RGA-MPT Document 236 Filed 04/27/15 Page 6 of 6 PageID #: 6252
`
`"polysorbate 80" as "an oleate ester of sorbitol and its anhydrides copolymerized with
`
`approximately 20 moles of ethylene oxide for each mole of sorbitol and sorbitol anhydrides."
`
`(D.I. 189-5 at 6). A person of ordinary skill in the art as of June 18, 2002 would have used the
`
`definition provided in the 2002 USP-NF to understand the term "polysorbate 80." Therefore, I
`
`adopt the 2002 USP-NF definition.
`
`6
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