Sanofi-Aventis U.S. LLC et al v. Eli Lilly and Company

Filing 236

MEMORANDUM OPINION Supplementing the Markman opinion issued by this Court on January 20, 2015, (D.I. 192 ). Signed by Judge Richard G. Andrews on 4/27/2015. (nms)

IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF DELAWARE
SANOFI-AVENTIS U.S. LLC, et al.,
Plaintiffs,
Civil Action No. 14-113-RGA-MPT

v.
ELI LILLY AND COMPANY,
Defendant.

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

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
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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 ofPharmaceutical 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:

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where w+x+y+z is approximately 20, and R is fatty acids present in the following amounts:

CarbonChain
Length
6
8
10
12
14
16
18
18
18

Number of
Double
Bonds
0
0
0
0
0
0
0
1
2
c.

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

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
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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

c.

Percentae:e
:'.S5.0
:'.S 16.0
:'.S 8.0
:'.S6.0
2: 58.0
:'.S 18.0
:'.S4.0

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
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"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.

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