The Medicines Company v. Mylan Inc. et al

Filing 309

MEMORANDUM Opinion and Order Signed by the Honorable Amy J. St. Eve on 12/16/2013:Mailed notice(kef, )

IN THE UNITED STATES DISTRICT COURT
NORTHERN DISTRICT OF ILLINOIS
EASTERN DIVISION
THE MEDICINES COMPANY,

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)
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Plaintiff,
v.
MYLAN INC., MYLAN
PHARMACEUTICALS INC., and
BIONICHE PHARMA USA, LLC,
Defendants.

No. 11-cv-1285

MEMORANDUM OPINION AND ORDER
AMY J. ST. EVE, District Court Judge:
On February 23, 2011, Plaintiff The Medicines Company (“TMC”) filed this action
against Defendants Mylan, Inc., Mylan Pharmaceuticals Inc. and Bionche Pharma USA, LLC
alleging infringement of United States Patents Nos. 7,582,727 (the “’727 patent”) and 7,598,343
(the “’343 patent”). (R. 1, Compl.) On June 21, 2013, Defendants moved for summary
judgment of non-infringement or, in the alternative, invalidity. (R. 275, Mot.)
For the following reasons, the Court grants Defendants’ motion for summary judgment of
non-infringement with respect to the ’343 patent but denies it with respect to the ’727 patent.
The Court also denies Defendants’ alternative motion for summary judgment of invalidity with
respect to the ’727 patent. Finally, the Court grants Defendants’ motion for summary judgment
on TMC’s claim for willful infringement.

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BACKGROUND
I.

Northern District of Illinois Local Rule 56.1
“For litigants in the Northern District of Illinois, the Rule 56.1 statement is a critical, and

required, component of a litigant’s response to a motion for summary judgment. The purpose of
the local rule is to make the summary judgment process less burdensome on district courts, by
requiring the parties to nail down the relevant facts and the way they propose to support them.”
Sojka v. Bovis Lend Lease, Inc., 686 F.3d 394, 398 (7th Cir. 2012). Local Rule 56.1 assists the
Court by “organizing the evidence, identifying undisputed facts, and demonstrating precisely
how each side propos[es] to prove a disputed fact with admissible evidence.” Bordelon v.
Chicago Sch. Reform Bd. of Trustees, 233 F.3d 524, 527 (7th Cir. 2000). “The Rule is designed,
in part, to aid the district court, which does not have the advantage of the parties’ familiarity with
the record and often cannot afford to spend time combing the record to locate the relevant
information, in determining whether a trial is necessary.” Delapaz v. Richardson, 634 F.3d 895,
899 (7th Cir. 2011) (internal quotations and citation omitted).
Local Rule 56.1(a)(3) requires the moving party to provide “a statement of material facts
as to which the moving party contends there is no genuine issue.” Cracco v. Vitran Exp., Inc.,
559 F.3d 625, 632 (7th Cir. 2009). The nonmoving party then must file “a response to each
numbered paragraph in the moving party’s statement, including, in the case of any disagreement,
specific references to the affidavits, parts of the record, and other supporting materials relied
upon.” Id. (citing Local Rule 56.1(b)(3)(B)). Pursuant to the Local Rules, the Court will not
consider any additional facts proposed in the nonmoving party’s Local Rule 56.1(b)(3)(B)
response, but must rely on the nonmovant’s Local Rule 56.1(b)(3)(C) statement of additional
facts. See Ciomber v. Cooperative Plus, Inc., 527 F.3d 635, 643-44 (7th Cir. 2008). The Court

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disregards Local Rule 56.1 statements and responses that do not cite to specific portions of the
record or that contain legal argument. See Cracco, 559 F.3d at 632; Cady v. Sheahan, 467 F.3d
1057, 1060 (7th Cir. 2006) (noting that the party’s statement of material facts “did not comply
with Rule 56.1 as it failed to adequately cite the record and was filled with irrelevant
information, legal arguments, and conjecture”); Chicon v. Exelon Generation Co., L.L.C., 401
F.3d 803, 809-10 (7th Cir. 2005) (“A district court does not abuse its discretion when, in
imposing a penalty for a litigant’s non-compliance with Local Rule 56.1, the court chooses to
ignore and not consider the additional facts that a litigant has proposed.”). “When a responding
party’s statement fails to dispute the facts set forth in the moving party’s statement in the manner
dictated by rule, those facts are deemed admitted for purposes of the motion.” Cracco, 559 F.3d
at 632.
II.

Relevant Facts
A.

The Parties and the Court’s Jurisdiction

Plaintiff TMC is a Delaware corporation with its principal place of business in
Parsippany, New Jersey. (R. 277, Mylan L.R. 56.1 Stmt. ¶ 1.) Defendant Mylan Inc. is a
Pennsylvania corporation with its principal place of business in Canonsburg, Pennsylvania. (Id.
¶ 2.) Mylan Inc. wholly owns the other two Defendants in this case—Mylan Pharmaceuticals
Inc. and Bioniche Pharma USA, LLC, now known as Mylan Institutional LLC.1 (Id. ¶¶ 3-4.)
Mylan Pharmaceuticals Inc. is a West Virginia corporation with its principal place of business in
Morgantown, West Virginia. (Id. ¶ 3.) Mylan Institutional LLC’s principal place of business is
in the Northern District of Illinois. (Id. ¶ 4.) The Court has subject matter jurisdiction over

1

Hereinafter, the Court refers to Defendants collectively as “Mylan” unless otherwise noted.

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TMC’s patent claims under 28 U.S.C. §§ 1331 and 1338(a), and venue is proper in this District
pursuant to 28 U.S.C. §§ 1400(b) and 1391(c).
B.

Bivalirudin Final Drug Product

The two patents-in-suit pertain to pharmaceutical formulations of bivalirudin and the
process of making bivalirudin. (Compl. at Ex. A (the ’727 patent) & Ex. B (the ’343 patent);
Mylan L.R. 56.1 Stmt. ¶ 21.) Bivalirudin is the active ingredient in TMC’s Angiomax® drug
product, an injectable anticoagulant used to prevent blood clotting during coronary procedures.
(Mylan L.R. 56.1 Stmt. ¶¶ 9-10; R. 290, TMC Resp. Br. at 3.) TMC has sold Angiomax® since
2001. (Mylan L.R. 56.1 Stmt. ¶ 9.) Before expiration of the patents-in-suit, Mylan submitted
Abbreviated New Drug Application (“ANDA”) No. 202471 to the U.S. Food and Drug
Administration (“FDA”), seeking approval to engage in the commercial manufacture, use, sale,
offer for sale, and/or importation of a generic equivalent to Angiomax®. (Id. ¶ 6.) TMC claims
that Mylan’s ANDA No. 202471 infringes several claims of the patents-in-suit. (Id. ¶¶ 22, 30.)
To create a bivalirudin final drug product, a drug manufacturer first must buy or make the
bivalirudin active pharmaceutical ingredient (“API”) and then perform a compounding process to
adjust the acidity of the bivalirudin API to make the drug suitable for injection in patients. (See
id. ¶ 13.) The compounding process involves three basic steps. (Id.) In the first step, the
bivalirudin API is dissolved into a mannitol solution to form a bivalirudin solution. (Id.) The
resulting bivalirudin solution has a pH level under 3.0, making it too acidic to inject into patients.
(Id. ¶ 14.) Thus, in the second step, the bivalirudin solution is mixed with a pH-adjusting
solution, such as sodium hydroxide, to raise the pH to an acceptable level. (Id. ¶¶ 13-14.) In the
final step, the mannitol solution and the pH-adjusting solution are removed from the mixture to
form the bivalirudin final drug product. (Id. ¶ 13.) During this compounding process, one of the

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amino acids in the bivalirudin API can convert into an aspartate if the pH level becomes too
high. (Id. ¶¶ 11-12, 14, 46.) That conversion forms an impurity in the bivalirudin final drug
product known as Asp9-bivalirudin. (Id. ¶ 12.)
The bivalirudin final drug product is sold in a single-use vial as a sterile freeze-dried
cake. (Id. ¶ 9.) The bivalirudin cake must be reconstituted before injection by adding water to it.
(Id.) Each cake contains 250 milligrams of bivalirudin, 125 milligrams of mannitol (a sugar),
and sodium hydroxide (a base) to adjust the acidity of the drug. (Id.) Each cake also contains
trace amounts of impurities, including Asp9-bivalirudin. (Id. ¶ 12.) High levels of Asp9bivalirudin can negatively affect the stability and shelf-life of the bivalirudin final drug product.
(See ’727 patent at col. 2, ll. 16-19; ’343 patent at col. 2, ll. 16-19.)
Before the inventions in the patents-in-suit, the compounding process used to make the
bivalirudin final drug product resulted in inconsistent and high levels of the Asp9-bivalirudin
impurity. (See TMC Resp. to Mylan L.R. 56.1 Stmt. ¶ 24.) The “old” compounding process
resulted in at least two batches of TMC’s final drug product that failed to meet FDA-approved
specifications regarding the amount of allowable impurities. (Mylan L.R. 56.1 Stmt. ¶ 15.) The
patents-in-suit pertain to an “improved” compounding process that Drs. Gopal Krishna and Gary
Musso2 developed, which reduced the generation of Asp9-bivalirudin impurities and made the
Asp9-bivalirudin impurity levels more consistent across batches. (Mylan L.R. 56.1 Stmt. ¶¶ 24,
46.)

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As the Federal Circuit has noted, “[i]nventions are created by individuals, not corporations.” MBO
Labs., Inc. v. Becton, Dickinson & Co., 474 F.3d 1323, 1326 n.1 (Fed. Cir. 2007). The Court, however,
refers to “TMC” as shorthand for Drs. Krishna and Musso during its discussion of the history of the
patents-in-suit because Drs. Krishna and Musso assigned the inventions in the patents-in-suit to TMC.

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C.

The Patents-In-Suit

TMC filed both patents-in-suit on July 27, 2008. (Id. ¶ 21.) The U.S. Patent and
Trademark Office issued the ’727 patent on September 1, 2009 and the ’343 patent on October 6,
2009. (Id.) Both patents-in-suit shares the same title—“Pharmaceutical Formulations of
Bivalirudin and Processes of Making the Same”—a nearly identical written specification, and a
similar prosecution history. (See id. ¶¶ 21, 33, 58-59.) The ’727 patent is a product patent (see
’727 patent at col. 25-28), whereas the ’343 patent is a product-by-process patent that claims the
same bivalirudin final drug product as the ’727 patent but with additional limitations regarding
the manufacturing process.3 (See ’343 patent at col. 27-28.) Both patents expire no later than
January 27, 2009. (Mylan L.R. 56.1 Stmt. ¶ 21.)
1.

The ’343 Patent

TMC asserts that Mylan has infringed claims 1-3 and 7-11 of the ’343 patent. (Id. ¶ 22.)
Claim 1 is an independent claim, and claims 2-3 and 7-11 depend on claim 1. (Id.) Claim 1
states:
1. Pharmaceutical batches of a drug product comprising bivalirudin (SEQ ID
NO: 1) and a pharmaceutically acceptable carrier, for use as an anticoagulant in a
subject in need thereof, said batches prepared by a compounding process,
comprising:
(i) dissolving bivalirudin in a solvent to form a first solution;
(ii) efficiently mixing a pH-adjusting solution with the first solution to
form a second solution, wherein the pH-adjusting solution comprises a
pH-adjusting solution solvent; and
(iii) removing the solvent and pH-adjusting solution solvent from the
second solution;
3

A “true” product claim defines an invention “in terms of structural characteristics only.” 3-8 Chisum on
Patents § 8.05 (Lexis 2013). A “product-by-process” claim, on the other hand, defines an invention “at
least in part in terms of the method or process by which it is made.” Id. The process terms in a productby-process claim serve as additional limitations in determining infringement. Abbott Labs. v. Sandoz,
Inc., 566 F.3d 1282, 1294 (Fed. Cir. 2009), cert denied 130 S. Ct. 1052 (2010).

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wherein the batches have a pH adjusted by a base, said pH is about 5-6 when
reconstituted in an aqueous solution for injection, and wherein the batches have a
maximum impurity level of Asp9-bivalirudin that does not exceed about 0.6% as
measured by HPLC.
(Id. ¶ 23.)
Each asserted claim in the ’343 patent requires “efficient mixing” as part of the
compounding process. (Id. ¶¶ 22-23; R. 291, TMC L.R. 56.1 Stmt. Add’l Facts ¶ 4.) The ’343
patent specification describes various ways to accomplish efficient mixing (see ’343 patent at
col. 9 l. 34 – col. 11 l. 24), and it contrasts efficient and inefficient mixing conditions through
examples. (See id. at col. 16 l. 15 – col. 25 l. 3.) Example 4, entitled “Effects of Rapidly Adding
pH Adjusting Solution to the Bivalirudin Solution Under Inefficient Mixing Conditions – Large
Scale Study,” describes an example of inefficient mixing (see id. at col. 22 ll. 21-31), while
Example 5, entitled “Effects of Adding pH Adjusting Solution at a Constant Rate and Under
Efficient Mixing Conditions – Large Scale Study,” provides an example of efficient mixing.
(See id. at col. 23 l. 6 – col. 25 l. 3.)
Comparing Examples 4 and 5—as the ’343 patent specification does (see id. at col. 23 l.
56 – col. 25 l. 3)—highlights the differences between “inefficient mixing” (Example 4) and
“efficient mixing” (Example 5). (See Mylan L.R. 56.1 Stmt. ¶ 25); see also Table 1, supra.
First, the examples differ with respect to the rate in which the processes added the pH-adjusting
solution. The “inefficient mixing” process in Example 4 added the pH-adjusting solution to the
bivalirudin solution “either all at once, or rapidly in multiple portions” (’343 patent at col. 22 ll.
37-38; Mylan L.R. 56.1 Stmt. ¶ 26), whereas the “efficient mixing” process in Example 5 added
the pH-adjusting solution “at a controlled rate of 2L/min using a peristaltic pump.” (’343 patent
at col. 23 ll. 21-23; Mylan L.R. 56.1 Stmt. ¶ 29.) Second, the examples differ in the type of
mixers used. The “inefficient mixing” process in Example 4 used two paddle mixers (’343
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patent at col. 22 ll. 39-40; Mylan L.R. 56.1 Stmt. ¶ 26), while the “efficient mixing” process in
Example 5 used one high-shear homogenizer and one paddle mixer. (’343 patent at col. 23 ll.
23-31; Mylan L.R. 56.1 Stmt. ¶ 29.) Third, the examples differ in the rates at which the mixers
operated. In Example 4, both paddle mixers operated at a rate of 400-800 rpm (’343 patent at
col. 22 ll. 41-42; Mylan L.R. 56.1 Stmt. ¶ 26), whereas in Example 5, the high-shear
homogenizer operated at a rate of between 1,000-1,300 rpm and the paddle mixer operated at a
rate of 300-700 rpm. (’343 patent at col. 23 ll. 23-31; Mylan L.R. 56.1 Stmt. ¶ 29.) The volume
and concentration of the mannitol and pH-adjusting solutions, however, are the same in both
examples. (Compare ’343 patent at col. 22 ll. 32-36 with id. at col. 23 ll. 16-20.)
Mixing Conditions

Example 4’s Inefficient
Mixing Conditions

Rate of Base Addition

Added either all at once, or
rapidly in multiple portions

Example 5’s Efficient Mixing
Conditions
Added at a controlled rate of
2L/min

Volume and
Concentration of
Solutions

40 L 0.5 N sodium hydroxide in
a 2.64% w/w mannitol solution

40 L 0.5 N sodium hydroxide in
a 2.64% w/w mannitol solution

Number and Type of
Mixers

Two paddle mixers

One high-shear homogenizer and
one paddle mixer

Mixing Speed

Both paddle mixers operated at
a rate of 400-800 rpm

The homogenizer operated at a
rate of 1000-1300 rpm, and the
paddle mixer operated at a rate
of 300-700 rpm

Table 1.
The ’343 specification summarizes the results of the “inefficient” and “efficient” mixing
processes discussed above. (See ’343 patent at Tbl. 6-9; Mylan L.R. 56.1 Stmt. ¶¶ 27-28.)
Batches produced using “efficient mixing” conditions had a lower mean and maximum level of
Asp9-bivalirudin impurities and a smaller standard deviation relative to the mean than batches
produced using “inefficient mixing.” (See ’343 patent at Tbl. 8-9.); see also Table 2, supra. The

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“efficiently mixed” batches also had a lower mean and maximum reconstitution time4 with a
smaller standard deviation. (Id.)
Example 4 – “Inefficient Mixing”

Example 5 – “Efficient Mixing”

No. of
Batches

Mean ±
SD

Maximum

No. of
Batches

Mean ±
SD

Maximum

Asp9-bivalirudin

87

0.5 ± 0.4

3.6%

24

0.3 ± 0.1

0.6%

Total Impurities

63

1.4 ± 0.5

3.0%

24

1.0 ± 0.4

2.0%

Largest Unknown
Impurity

86

0.3 ± 0.1

0.5%

24

0.2 ± 0.1

0.3%

Reconstitution
time

85

30 ± 12

72 sec.

24

18 ± 6

42 sec.

Table 2.
2.

The ’727 Patent

TMC asserts that Mylan has infringed claims 1-3, 7-10 and 17 of the ’727 patent. (Mylan
L.R. 56.1 Stmt. ¶ 30.) Claim 1 is an independent claim, and the remaining asserted claims
depend on Claim 1. (Id.) Claim 1 states:
Pharmaceutical batches of a drug product comprising bivalirudin (SEQ ID NO: 1)
and a pharmaceutically acceptable carrier for use as an anticoagulant in a subject
in need thereof, wherein the batches have a maximum impurity level of Asp9bivalirudin that does not exceed about 0.6% as measured by HPLC.
(Id. ¶ 30.) Each asserted claim in the ’727 patent contains a limitation requiring the
pharmaceutical batches at issue to have “a maximum impurity level of Asp9-bivalirudin that does
not exceed about 0.6%.” (TMC Resp. to Mylan 56.1 Stmt ¶ 32.)
As mentioned above, the ’727 patent contains a written specification that is nearly
identical to the ’343 patent. (Mylan L.R. 56.1 Stmt. ¶ 33.) The ’727 patent specification

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The “reconstitution time” refers to the amount of time required to prepare the bivalirudin freeze-dried
cake for use by, for example, dissolving it in water or saline. (See R. 291, TMC Resp. to Mylan L.R. 56.1
Stmt. ¶ 9; ’343 patent at col. 12 l.56 – col. 13 l. 6.)

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contains the same description of “efficient mixing” as the ’343 patent and the same set of
examples contrasting “efficient” and “inefficient” mixing conditions. (See ’727 patent at col. 9,
l. 34 – col. 11 l. 30, col. 16 l. 15 – col. 24 l. 35.) Unlike the ’343 patent, however, no claims in
the ’727 patent explicitly refer to “efficient mixing” or any other steps in the bivalirudin
compounding process. (See ’727 patent at col. 25 l. 54 – col. 28 l. 23.)
3.

Prosecution History

In addition to sharing similar specifications, the patents-in-suit also share similar
prosecution histories. During the prosecution of the ’727 patent, TMC’s counsel filed a Petition
to Make Special under the Accelerated Program (“Petition to Make Special”) to have the patent
application examined on an expedited basis. (Mylan L.R. 56.1 Stmt. ¶ 58; 278, Greb Decl. Ex.
19.) The applicants also filed a similarly worded Petition to Make Special with respect to the
’343 patent. (Mylan L.R. 56.1 Stmt. ¶ 53; Greb Decl. Ex. 20.)
In the Petitions to Make Special, the applicants relied both on the use of “efficient
mixing” and the improved characteristics of the Angiomax® drug to distinguish their inventions
from prior art. The applicants, for example, distinguished their invention from the old
compounding process on the basis of efficient mixing: “In the present invention, various
embodiments relate to a less subjective and more consistent process for the mixing of the pHadjusting solution with the bivalirudin solution. This process involves efficiently mixing the pHadjusting solution and the dissolved bivalirudin solution, which is not performed in the
Applicants’ prior compounding process.” (See Greb Decl. Ex. 19 at 3; Greb Decl. Ex. 20 at 3.)5

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See also, e.g., Greb Decl. Ex. 19 at 6 (“The ‘423 application is silent regarding a compounding process
via the addition of a pH-adjusting solution to the bivalirudin solution in a controlled manner with efficient
mixing as to avoid the formation of Asp9-bivalirudin during the compounding stage.”); id. at 9 (“[T]he
EMEA publication discloses that the bivalirudin drug substance is compounded, but does not provide a
disclosure of how the drug substance was compounded . . . . It is important to note that the manufacture of

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The applicants also distinguished the improved Angiomax® drug product from original
Angiomax® on the basis of decreased impurity levels and shorter reconstitution times:
In addition, pharmaceutical batch(es) and pharmaceutical formulation(s) of
bivalirudin formed by the new compounding process are distinguished from the
batches and formulations of bivalirudin formed by the prior compounding
process. The pharmaceutical batch(es) and pharmaceutical formulation(s)
associated with the present compounding process are more consistent and have a
maximum level of Asp9-bivalirudin of about 0.6% w/w (a decrease of about 83%
compared to the batches or formulations made by the prior process), a maximum
reconstitution time of about 42 seconds (a decrease of about 42% compared to the
batches or formulations made from the prior process), and a maximum amount of
total impurities of about 2.0% (a decrease of about 33% compared to the batches
or formulations made by the prior process), for all batches or formulations made
by the new process.
(See Greb Decl. Ex. 19 at 3; Greb Decl. Ex. 20 at 3.)
D.

Mylan’s Bivalirudin ANDA Product

Mylan filed an ANDA seeking FDA approval to engage in the commercial manufacture,
sale, offer for sale and/or importation of a generic equivalent to Angiomax®. (Mylan L.R. 56.1
Stmt. ¶ 6.) Mylan’s ANDA described the finished product specifications for its proposed
bivalirudin product and the compounding process Mylan will use to manufacture it. (Id. ¶¶ 6567.) Mylan’s compounding process adds the pH-adjusting solution to the bivalirudin solution
“all at once,” and mixes the bivalirudin solution with a single paddle mixer operating at a speed
of 200 rpm. (Id. ¶ 68.) The finished product specification in Mylan’s ANDA allows for a
maximum total of 2.0% Asp9-bivalirudin impurities in the proposed bivalirudin final drug
product (1.0% α- Asp9-bivalirudin and 1.0% β- Asp9-bivalirudin). (Id. ¶ 66.)
Mylan submitted an exhibit batch of its proposed bivalirudin product to the FDA in
conjunction with its ANDA. (Id. ¶ 70.) Although the ANDA specifications allow Asp9-

these bivalirudin batches were [sic] not performed using the inventive process of the present invention.”
(emphasis in original)).

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bivalirudin impurities of up to 2.0%, the exhibit batch Mylan submitted had an Asp9-bivalirudin
impurity level of only 0.2%. (TMC L.R. 56.1 Stmt. Add’l Facts ¶ 24.) Mylan’s contract
manufacturer, Biocon Ltd., manufactured the exhibit batch using the same method that Mylan
will use to manufacture the proposed commercial batches, except on a smaller scale. (Mylan
L.R. 56.1 Stmt. ¶ 71.)
After the FDA approved Mylan’s ANDA for filing, Mylan sent notice of the filing to
TMC, the holder of the new drug application for Angiomax® and owner of the patents-in-suit.
(Id. ¶¶ 5-7.) Mylan certified in the notice that (1) it did not believe its proposed bivalirudin
product would infringe the patents-in-suit, and (2) it believed that the patents-in-suit are invalid.
(Id. ¶ 6.) On February 23, 2011, TMC filed this action under the Hatch-Waxman Act, alleging
that the manufacture, sale, and offer for sale of Mylan’s proposed bivalirudin ANDA product
would infringe the patents-in-suit. (R. 1, Compl.)
E.

The Court’s Claim Construction Opinion

On July 30, 2012, the Court held a claim construction hearing to resolve the parties’
disagreements regarding the proper construction of two claim terms: “pharmaceutical batches,”
which appears in the claims of both patents-in-suit, and “efficiently mixing,” which appears only
in the claims of the ’343 patent. (See R. 119, Claim Construction Op. at 4.) Although the
parties’ originally proposed constructions of “pharmaceutical batches” that differed significantly,
the parties ultimately narrowed their dispute during claim construction briefing. (Id. at 8.) By
the claim construction hearing, the parties’ proposed constructions differed in only one respect:
Mylan’s proposal included the phrase “made by a compounding process,” but TMC’s proposal
did not. (Id.) Mylan argued that the addition of the phrase “made by a compounding process”

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was necessary to provide an antecedent basis for the term “said process” that appeared later in
the definition of pharmaceutical batches. (Id. at 9.)
TMC disagreed, contending that “[w]hen viewed in the context of the specification, it is
readily apparent that the phrase ‘made by said process’ refers to the compounding processes
described in the patents-in-suit.” (R. 117, TMC Claim Construction Sur-Reply at 2.) TMC
further argued that if the Court determined that the definition of pharmaceutical batches required
an express antecedent basis, the proper inclusion would be “made by a compounding process of
various embodiments of the present invention,” the verbatim antecedent basis provided in the
specification. (Id. at 4 (emphasis added).) During the claim construction hearing, though, TMC
withdrew its alternate proposal and stated that it “could live with” Mylan’s proposed addition of
“made by a compounding process” if the Court determined an express antecedent basis was
necessary. (7/30/12 Hrg. Tr. 9:15-10:3.)
The Court ultimately construed the disputed terms as follows:
Claim Term or Phrase

Court’s Construction

“pharmaceutical batches”

“[M]ay include a single batch, wherein the
single batch is representative of all
commercial batches (see generally, Manual
of Policies and Procedures, Center for Drug
Evaluation and Research, MAPP 5225.1,
Guidance on the Packaging of Test Batches
at 1) made by a compounding process, and
wherein the levels of, for example, Asp9bivalirudin, total impurities, and largest
unknown impurity, and the reconstitution
time represent levels for all potential
batches made by said process. ‘Batches’
may also include all batches prepared by a
same compounding process.”

“efficiently mix”

“A pH-adjusting solution and the first
solution are mixed not using inefficient
mixing conditions such as described in
Example 4.”
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SUMMARY JUDGMENT STANDARD
Although Federal Circuit precedent governs substantive issues of patent law at issue here,
Seventh Circuit law applies to procedural summary judgment issues. See, e.g., Shum v. Intel
Corp., 633 F.3d 1067, 1076 (Fed. Cir. 2010) (“We review grants of summary judgment . . . under
the law of the regional circuit, since they present procedural issues not unique to patent law.”
(citing Koninklijke Philips Elecs. N.V. v. Cardiac Sci. Operating Co., 590 F.3d 1326, 1332 (Fed.
Cir. 2010))). Summary judgment is appropriate “if the movant shows that there is no genuine
dispute as to any material fact and the movant is entitled to judgment as a matter of law.” Fed.
R. Civ. P. 56(a). A genuine dispute as to any material fact exists if “the evidence is such that a
reasonable jury could return a verdict for the nonmoving party.” Anderson v. Liberty Lobby,
Inc., 477 U.S. 242, 248, 106 S. Ct. 2505, 91 L. Ed. 2d 202 (1986).
In deciding summary judgment motions, “facts must be viewed in the light most
favorable to the nonmoving party only if there is a ‘genuine’ dispute as to those facts.” Scott v.
Harris, 560 U.S. 372, 380, 127 S. Ct. 1769, 167 L. Ed. 2d 686 (2007). The party seeking
summary judgment has the initial burden of establishing that there is no genuine dispute as to
any material fact. See Celotex Corp. v. Catrett, 477 U.S. 317, 323, 106 S. Ct. 2548, 91 L. Ed. 2d
265 (1986). After “a properly supported motion for summary judgment is made, the adverse
party ‘must set forth specific facts showing that there is a genuine issue for trial.’” Anderson,
477 U.S. at 225, 106 S. Ct. 2548, 91 L. Ed. 2d 265 (citation omitted). “[D]istrict courts presiding
over summary judgment proceedings may not weigh conflicting evidence or make credibility
determinations, both of which are the province of the jury.” Omnicare, Inc. v. UnitedHealth
Grp., Inc., 629 F.3d 697, 704-05 (7th Cir. 2011) (internal citations omitted).

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ANALYSIS
Mylan moves for summary judgment of non-infringement or, in the alternative, of
invalidity. Mylan argues that TMC’s infringement claims fail because TMC cannot establish
two elements of the asserted patent claims. (R. 276, Mylan Opening Br. at 12.) First, Mylan
contends that its ANDA compounding process does not use “efficient mixing.” (Id. at 12-20.)
Indeed—Mylan argues—its compounding process is even more inefficient than the examples of
inefficient mixing described in the patents-in-suit. Because “efficient mixing” is an express
limitation of the asserted claims in the ’343 patent, Mylan argues that the Court should grant
summary judgment of non-infringement with respect to the ’343 patent. (Id. at 13-15.)
Additionally, Mylan asserts that summary judgment is also appropriate with respect to the ’727
patent because the term “pharmaceutical batches” incorporates an “efficient mixing” requirement
into the asserted claims in the ’727 patent. (Id. at 15-18.)
Second, Mylan argues that TMC cannot establish that pharmaceutical batches made using
Mylan’s ANDA process will have a maximum impurity level of Asp9-bivalirudin that does not
exceed 0.6%, as the asserted claims of the patents-in-suit require. (Id. at 12, 20-22.) TMC bases
its infringement claim on the Asp9-bivalirudin impurity level of Mylan’s exhibit batch. Mylan
argues that this single batch result fails to create a genuine factual dispute regarding
infringement, and summary judgment of non-infringement is therefore appropriate. (Id.)
In Mylan’s alternative motion based on invalidity, Mylan argues that if the Court
construes the claims of the ’727 patent to encompass both “efficient” and “inefficient” mixing,
then the asserted claims of the ’727 patent are invalid. (Id. at 22-26.) According to Mylan, this
interpretation would render the asserted claims in the ’727 patent invalid on grounds of
anticipation, lack of enablement, and lack of written specification. (Id.)

15

Finally, Mylan seeks summary judgment with respect to TMC’s claim of willful
infringement. (Id. at 26-28.) Mylan argues that the filing of an ANDA alone does not support a
finding of willful infringement, and even if it did, TMC cannot show that Mylan’s actions were
objectively unreasonable. (Id.)
I.

Infringement of the Patents-In-Suit
“To prove literal infringement, the patentee must show that the accused device contains

every limitation in the asserted claims.” Riles v. Shell Exploration & Prod. Co., 298 F.3d 1302,
1308 (Fed. Cir. 2002) (quoting Mas-Hamilton Grp. v. LaGard., Inc., 156 F.3d 1206, 1211 (Fed.
Cir. 1998)). Courts use a two-step analysis to determine whether a product or process literally
infringes a patent. First, the court interprets the claims of the patent to determine their scope and
meaning. Presidio Components, Inc. v. American Tech. Ceramics Corp., 702 F.3d 1351, 1358
(Fed. Cir. 2012); Cybor Corp. v. FAS Techs., Inc., 138 F.3d 1448, 1454 (Fed. Cir. 1998) (en
banc). Next, the fact-finder compares the properly construed claims to the allegedly infringing
product or process. Presidio, 702 F.3d at 1358; Cybor, 138 F.3d at 1454. While the first step is
a question of law for the Court, the second step is a question of fact. ActiveVideo Networks, Inc.
v. Verizon Comm’cns, 694 F.3d 1312, 1319 (Fed. Cir. 2012). “If any claim limitation is absent
from the [product or process], there is no literal infringement as a matter of law.” Cephalon, Inc.
v. Watson Pharms., Inc., 707 F.3d 1330, 1340 (Fed. Cir. 2013).
Under the doctrine of equivalents, “a product or process that does not literally infringe
upon the express terms of a patent claim may nonetheless be found to infringe if there is
‘equivalence’ between the elements of the accused product or process and the claimed elements
of the patented invention.” Voda v. Cordis Corp., 536 F.3d 1311, 1324 (Fed. Cir. 2008) (quoting
Warner-Jenkinson Co. v. Hilton Davis Chem. Co., 520 U.S. 17, 21, 117 S. Ct. 1040, 137 L. Ed.

16

2d 146 (1997)). “To support a finding of infringement under the doctrine of equivalents, a
patentee must provide particularized testimony and linking argument with respect to the
‘function, way, result’ test.” Cephalon, Inc., 707 F.3d at 1340. That is, the patentee must show
that the accused device “performs substantially the same function in substantially the same way
with substantially the same result” as claimed in the patent-in-suit. Energy Transp. Grp., Inc. v.
William Demant Holding A/S, 697 F.3d 1342, 1352 (Fed. Cir. 2012) (quoting Crown Packaging
Tech., Inc. v. Rexam Beverage Can Co., 559 F.3d 1308, 1312 (Fed. Cir. 2009)).
Because the patentee bears the ultimate burden of proving infringement, whether literal
or under the doctrine of equivalents, an accused infringer can prevail on a motion for summary
judgment of non-infringement “either by providing evidence that would preclude a finding of
infringement, or by showing that the evidence on file fails to establish a material issue of fact
essential to the patentee’s case.” Novartis Corp. v. Ben Venue Labs., Inc., 271 F.3d 1043, 1046
(Fed. Cir. 2001). If the accused infringer meets its burden of establishing grounds for summary
judgment, the patentee must then show the existence of a genuine issue of material fact
precluding summary judgment. Anderson, 477 U.S. at 250-51. The patentee “cannot rest on
mere allegations, but must present actual evidence” to avoid summary judgment. Crown
Operations Int’l, Ltd. v. Solutia Inc., 289 F.3d 1367, 1375 (Fed. Cir. 2002) (citing Anderson, 477
U.S. at 248).
Mylan argues that TMC’s infringement claims fail as a matter of law because TMC
cannot prove two elements required by each of the asserted patent claims. First, Mylan argues
that TMC cannot prove Mylan’s compounding process uses “efficient mixing.” (See Mylan
Opening Br. at 11-20.) Second, Mylan argues that TMC cannot prove that pharmaceutical
batches made using Mylan’s compounding process will have a maximum Asp9-bivalirudin

17

impurity level no greater than about 0.6%. (See id. at 20-22.) As explained below, the Court
grants Mylan’s motion for summary judgment of non-infringement with respect to the ’343
patent but denies it with respect to the ‘747 patent.
A.

The ’343 Patent
1.

Mylan’s ANDA Compounding Process Does Not Literally Infringe the
’343 Patent

The Court has construed “efficiently mixing” in the asserted claims of the ’343 patent to
mean that “[a] pH-adjusting solution and the first solution”—i.e., the bivalirudin solution—“are
mixed not using inefficient mixing conditions such as described in Example 4.” (Claim
Construction Order at 30.) Mylan argues that TMC cannot establish infringement of the ’343
patent because Mylan’s compounding process is more inefficient than the “inefficient mixing
conditions” described in Example 4. (Mylan Opening Br. at 14.) The Court agrees.
The ’343 patent contrasts “inefficient” and “efficient” mixing conditions through
examples, most notably Examples 4 and 5. Comparing the “inefficient mixing” conditions in
Example 4 with the “efficient mixing” conditions in Example 5 reveals the mixing conditions
relevant to determining whether a compounding process uses “inefficient” or “efficient” mixing
conditions: the rate at which the pH-adjusting solution is added; the type and number of mixers
used for stirring; and the rate of stirring. (Compare ’343 patent at col. 22 l. 21 – col. 23 l. 4 with
id. at col. 23 l. 6 – col. 23 l. 5.) The “inefficient mixing” process in Example 4 adds the pHadjusting solution to the bivalirudin solution “either all at once, or rapidly in multiple portions”
(’343 patent at col. 22 ll. 37-38; Mylan L.R. 56.1 Stmt. ¶ 26), whereas the “efficient mixing”
process in Example 5 adds the pH-adjusting solution “at a controlled rate of 2L/min using a
peristaltic pump.” (’343 patent at col. 23 ll. 21-23; Mylan L.R. 56.1 Stmt. ¶ 29.) The
“inefficient mixing” process in Example 4 uses two paddle mixers (’343 patent at col. 22 ll. 3918

40; Mylan L.R. 56.1 Stmt. ¶ 26), whereas the “efficient mixing” process in Example 5 uses one
high-shear homogenizer and one paddle mixer. (’343 patent at col. 23 ll. 23-31; Mylan L.R. 56.1
Stmt. ¶ 29.) Furthermore, in Example 4, both paddle mixers operate at a rate of 400-800 rpm
(’343 patent at col. 22 ll. 41-42; Mylan L.R. 56.1 Stmt. ¶ 26), whereas in Example 5, the highshear homogenizer operates at a rate between 1,000-1,300 rpm and the paddle mixer operates at
a rate of 300-700 rpm. (’343 patent at col. 23 ll. 23-31; Mylan L.R. 56.1 Stmt. ¶ 29.)

Mixing Conditions

Example 4’s Inefficient
Mixing Conditions

Rate of Base Addition

Added either all at once, or
rapidly in multiple portions

Example 5’s Efficient Mixing
Conditions
Added at a controlled rate of
2L/min

Volume and
Concentration of
Solutions

40 L 0.5 N sodium hydroxide in
a 2.64% w/w mannitol solution

40 L 0.5 N sodium hydroxide in
a 2.64% w/w mannitol solution

Number and Type of
Mixers

Two paddle mixers

One high-shear homogenizer and
one paddle mixer

Mixing Speed

Both paddle mixers operated at
a rate of 400-800 rpm

The homogenizer operated at a
rate of 1000-1300 rpm, and the
paddle mixer operated at a rate
of 300-700 rpm

Table 1.
No factual disputes exist regarding the steps involved in the compounding processes
described in Example 4 or those in Mylan’s ANDA. (See Mylan L.R. 56.1 Stmt. ¶ 56.) The only
question is whether Mylan’s compounding process is as inefficient (or more inefficient) than the
compounding process described in Example 4 in the ’343 specification. Table 3 compares the
relevant mixing conditions of Example 4 and Mylan’s compounding process.

19

Mixing Conditions

Example 4’s Inefficient
Mixing Conditions

Mylan’s ANDA Compounding
Process
Added all at once

Rate of Base Addition

Added either all at once, or
rapidly in multiple portions

Volume and
Concentration of
Solutions

40 L 0.5 N sodium hydroxide in
a 2.64% w/w mannitol solution

1 L 1.0 N sodium hydroxide (no
mannitol)

Number and Type of
Mixers

Two paddle mixers

One paddle mixer

Mixing Speed

Both paddle mixers operated at
a rate of 400-800 rpm

One mixer operated at 200 rpm

Table 3.
The undisputed facts show that Mylan’s compounding process is more inefficient than
the “inefficient mixing” process described in Example 4. Mylan uses one paddle mixer instead
of two, and its mixer operates at a lower speed than the mixers in Example 4. (See Mylan L.R.
56.1 Stmt. ¶ 68.) Furthermore, while Mylan’s compounding process always adds the pHadjusting solution “all at once” (id.), the process in Example 4 adds the pH-adjusting solution
either all at once or rapidly in multiple portions.
TMC argues that certain differences between Mylan’s compounding process and the
“inefficient mixing” process in Example 4 create a genuine dispute of material fact regarding
whether Mylan practices efficient mixing. (TMC Resp. Br. at 16-18.) Most notably, TMC
argues that the difference in scale between Mylan’s compounding process and the process in
Example 4 creates a factual dispute regarding the efficiency of Mylan’s compounding process.
(Id.) According to TMC, it is easier to efficiently mix a small volume than a large volume, and
thus, Mylan may practice “efficient mixing” despite using fewer paddle mixers and operating
those mixers at lower speeds than in Example 4. (Id. at 16-17.) As TMC’s expert, Dr. Klibanov,
phrased it, “[i]t is much easier to uniformly mix milk into your coffee in an eight-ounce cup than
[in] a two-gallon pot of coffee.” (Id. at 17.)
20

TMC argues that additional differences between Mylan’s process and the process in
Example 4 also affect the efficiency of Mylan’s mixing process. (Id. at 17-18.) Mylan’s
bivalirudin solution contains 3.83% w/w mannitol and its pH-adjusting solution does not contain
any mannitol, whereas Examples 4 uses a 2.64% w/w mannitol in both solutions. (’343 patent,
col. 22-23.) Additionally, Mylan’s process uses 1.0 N sodium hydroxide as its pH-adjusting
solution, while Example 4 uses 0.5 N sodium hydroxide. (Id.) TMC argues that Mylan’s use of
a more concentrated pH-adjusting solution would increase mixing efficiency by minimizing the
formation of “hot spots.” (Id. at 17-18.) According to TMC, these factors, along with the
difference in scale between Mylan’s compounding process and the “inefficient mixing” process
used in Example 4, create a genuine issue of material fact regarding whether Mylan “efficiently
mixes.” (Id. at 18.)
The Court, however, construed the term “efficient mixing” to preclude the use of
“inefficient mixing conditions such as described in Example 4,” not just conditions identical to
those in Example 4. (Claim Construction Op. at 30 (emphasis added).) Moreover, while the
patents-in-suit contain a lengthy discussion about potential ways to achieve “efficient mixing,”
the factors TMC relies on—scale and the concentration of the mannitol and pH-adjusting
solutions used—are not mentioned in that discussion. Volume, sodium hydroxide concentration,
and percentage mannitol, in fact, are held constant between Examples 4 and 5. (Compare ’343
patent at col. 22 l. 21 – col. 23 l. 4 with id. at col. 23 l. 6 – col. 23 l. 5.) The patents-in-suit in no
way indicate that these constants bear on whether mixing conditions are “efficient” or
“inefficient.” This is especially true regarding volume since the volume involved in Example
2—another example of “inefficient mixing” conditions contained in the patent specification—is
more than two magnitudes smaller than the volumes in Examples 4 and 5, yet the patent does not

21

indicate that this difference affected “efficiency” in any way.6 TMC’s argument that the
differences in scale and solution concentrations between Mylan’s compounding process and the
“inefficient mixing” process in Example 4 precludes summary judgment therefore fails.
2.

Mylan Does Not Infringe Under the Doctrine of Equivalents

TMC asserts that even if Mylan’s compounding process does not literally infringe the
’343 patent, it infringes under the doctrine of equivalents. (TMC Resp. Br. at 26.) Under the
doctrine of equivalents, “a product or process that does not literally infringe upon the express
terms of a patent claim may nonetheless be found to infringe if there is ‘equivalence’ between
the elements of the accused product or process and the claimed elements of the patented
invention.” Voda, 536 F.3d at 1324 (quoting Warner-Jenkinson Co., 520 U.S. at 21). To prove
infringement under the doctrine, the patentee must satisfy the “function-way-result” test. That is,
the patentee must show that the accused device “performs substantially the same function in
substantially the same way with substantially the same result.” Energy Transp. Grp., 697 F.3d at
1352 (quoting Crown Packaging Tech., 559 F.3d at 1312).
TMC relies on a declaration from its expert, Dr. Klibanov, dated August 16, 2013, to
support its argument of infringement under the doctrine of equivalents. (TMC Resp. Br. at 2628.) As an initial matter, the Court agrees with Mylan that TMC failed to timely disclose Dr.
Klibanov’s expert opinions regarding the doctrine of equivalents. (See R. 292, Mylan Reply Br.
at 20-23.) On November 19, 2012, the Court set the following expert discovery deadlines:
“Opening expert reports due by 2/8/13. Rebuttal expert reports by 3/8/13. Reply expert reports
6

Mylan also argues that it does not “efficiently mix” because its compounding process is “at least as
inefficient as the other inefficient processes described in the patents-in-suit,” including Example 2.
(Mylan Opening Br. at 14-15.) The Court agrees with TMC that this argument is irrelevant because the
Court’s claim construction specifically refers to Example 4, not to Example 2. (TMC Resp. Br. at 19.)

22

by 4/8/13. All expert discovery shall be completed by 5/8/13.” (R. 173.) TMC served three
expert reports for Dr. Klibanov, totaling over 127 pages, before the close of expert discovery.
(See generally R. 288-2, Dr. Klibanov Opening Expert Report; 288-25, Dr. Klibanov Rebuttal
Expert Report; 288-21, Dr. Klibanov Reply Expert Report.) Dr. Klibanov did not offer any
opinions regarding infringement under the doctrine of equivalents in those reports. In his
opening report, Dr. Klibanov purported to “reserve the right” to address the doctrine of
equivalents in later reports (see Dr. Klibanov Opening Expert Report ¶¶ 92, 162), but he did not
offer any opinions on the doctrine of equivalents until over three months after the close of expert
discovery. (See R. 289, Dr. Klibanov Decl. ¶¶ 43-52.) TMC never requested or received leave
to submit an additional, belated expert report for Dr. Klibanov. The Court, therefore, strikes Dr.
Klibanov’s August 16, 2013 declaration pursuant to Federal Rule of Civil Procedure 37(c)(1).
Even if the Court considered Dr. Klibanov’s belated opinions, moreover, TMC’s claim of
infringement under the doctrine of equivalents fails the second prong of the function/way/result
test. Regardless of whether or not Mylan’s compounding process performs substantially the
same function and achieves substantially the same result as the claimed invention, TMC’s claim
of infringement under the doctrine of equivalents fails because Mylan’s process does not achieve
its results “in substantially the same way” as the invention at issue; that is, Mylan’s ANDA
process does not use “efficient mixing.” TMC argues that “Mylan achieves its low Asp9 result in
substantially the same way as the ’343 patent because, as discussed above, Mylan does not
practice Example 4.” (TMC Resp. Br. at 27.) The Court, however, already has rejected this
argument. (See Part I.A.1, supra.)
Additionally, even if Mylan’s compounding process did meet the function/way/result test,
TMC cannot claim infringement under the doctrine of equivalents because the ’343 patent

23

specification and prosecution history expressly disclaim “inefficient mixing” conditions such as
Example 4 in order to get around anticipation by prior art. See also Retractable Techs., Inc. v.
Becton, Dickinson & Co., 653 F.3d 1296, 1307 (Fed. Cir. 2011) (“It is well settled that when a
specification excludes certain prior art alternatives from the literal scope of the claims and
criticizes those prior art alternatives, the patentee cannot then use the doctrine of equivalents to
capture those alternatives.”) (internal quotation omitted). As discussed above, the ’343 patent
specification explicitly distinguishes between “efficient mixing” conditions, like those in
Example 5, and “inefficient mixing” conditions, like those in Example 4. The “inefficient
mixing” conditions described as Example 4, therefore, are not “substantially similar” to the
“efficient mixing” conditions used in the claimed invention. See Retractable Techs., Inc. 653
F.3d at 1307. Similarly, when arguing for patentability during the prosecution process, TMC
distinguished the prior art references by saying that they utilized “inefficient mixing” conditions,
rather than the “efficient mixing” conditions of the ’343 patent. TMC, therefore, cannot claim
that Mylan’s compounding process, which is more inefficient than the “inefficient mixing”
process in Example 4, is substantially equivalent to the “efficient mixing” process claimed by the
’343 patent. See Loral Fairchild Corp. v. Sony Corp., 181 F.3d 1313, 1322 (Fed. Cir. 1999).
3.

Mylan Did Not Admit That Its Compounding Process Uses “Efficient
Mixing”

TMC next argues that summary judgment of non-infringement is inappropriate because
Mylan admitted that its compounding process uses “efficient mixing.” (TMC Resp. Br. at 5-6,
20.) TMC, however, fails to point to a single admission by Mylan. Rather, TMC relies on
statements that Biocon employees made during the development of Mylan’s exhibit batch.
(TMC Resp. Br. at 5-7, 20; see also R. 288, Fleming Decl. Ex. 7, 11, 28.) Specifically, in one
document, a Biocon employee investigating the cause of a “failed” test batch determined that the
24

high level of Asp9-bivalirudin impurities in the test batch resulted from mixing “without
adequate stirring.”7 (Fleming Decl. Ex. 11 at MYL034579.) According to another document,
Biocon subsequently performed “experiments . . . to identify a better approach for efficient
stirring.” (Fleming Decl. Ex. 7.) A third document states that Biocon manufactured the exhibit
batch Mylan submitted to the FDA using the “better stirring operation” developed through those
experiments. (Fleming Decl. Ex. 28 at BC013418.)
TMC’s reliance on these statements is improper for two reasons. First, “a party may not
rely upon inadmissible hearsay to oppose a motion for summary judgment.” Gunville v. Walker,
583 F.3d 979, 985 (7th Cir. 2009). Federal Rule of Evidence 801(d) “classifies a statement as
nonhearsay if the statement is offered against a particular party and (1) is made by a person
‘authorized by [that] party to make a statement concerning the subject,’ or (2) is made by that
party’s agent ‘concerning a matter within the scope of the agency.’” Carlisle v. Deere & Co.,
576 F.3d 649, 656 (7th Cir. 2009) (quoting Fed. R. Evid. 801(d)(2)(C)-(D)). TMC, however, has
not offered any evidence that Mylan authorized Biocon to make the statements at issue. In
addition, although TMC implies that Biocon was Mylan’s agent and made those statements
within the scope of that agency relationship, TMC offers no evidence to establish this purported
agency relationship between Biocon and Mylan.
Under Illinois law, “[t]he determination of whether a person is an agent or independent
contractor rests upon the facts and circumstances of each case.” Lawlor v. North Am. Corp. of
Ill., 2012 IL 112530, ¶ 44, 368 Ill. Dec. 1, 983 N.E.2d 414 (Ill. 2012). Illinois law provides a

7

Although TMC included full images of the Biocon documents it cited, including the “Biocon” label in
the upper left corner of the documents, in TMC’s additional statement of facts (see TMC L.R. 56.1 Stmt.
of Add’l Facts ¶ 21), the excerpts that appear in the body of TMC’s brief conspicuously, and
misleadingly, omitted the “Biocon” label. (TMC Resp. Br. at 6.)

25

number of factors that courts should consider in determining whether a person qualifies as
another’s agent:
[T]he cardinal consideration is whether that person retains the right to control the
manner of doing the work. . . . Courts should also consider the following factors
in considering the question of whether a person is an agent or independent
contractor: (1) the question of hiring; (2) the right to discharge; (3) the manner of
direction of the servant; (4) the right to terminate the relationship; and (5) the
character of the supervision of the work done. . . . The presence of one or more of
the above facts and indicia are not necessarily conclusive of the issue.
Id. (internal quotations and citations omitted). TMC bears the burden of establishing an agency
relationship. Id. It woefully failed to meet this burden.
In its brief, TMC states that “Mylan contracted with Biocon to do [its] manufacturing
work,” but gives no further explanation of why the Court should attribute Biocon’s statements to
Mylan. (TMC Resp. Br. at 5.) TMC does not even argue—let alone offer evidence—that any of
the factors relevant to an agency determination under Illinois law exist. Thus, TMC provides no
basis for the Court to admit Biocon’s hearsay statements at trial or consider them on summary
judgment. Furthermore, because TMC failed to submit evidence showing an agency relationship
between Mylan and Biocon, even if the Court were to consider the Biocon documents at issue,
the record is insufficient to allow a reasonable jury to attribute Biocon’s statements to Mylan.
Second, even if the Court could attribute Biocon’s statements to Mylan, TMC offers no
evidence that the Biocon employee who authored the documents at issue intended the phrase
“efficient stirring” to take on the specialized meaning in the patents-in-suit. TMC does not even
offer evidence or argument to show that the Biocon employee knew the specialized meaning of
“efficient mixing” contained in the patents-in-suit. Indeed, the Biocon employee’s
interchangeable use of synonymous phrases—“efficient stirring,” “better stirring,” and “adequate
stirring”—suggest that she had used “efficient” in the ordinary sense of the word, not the
technical sense espoused in the patents-in-suit.
26

The Federal Circuit considered a similar issue, albeit at a different stage in the
proceeding, in Rembrandt Vision Technologies, L.P. v. Johnson & Johnson Vision Care, Inc.,
725 F.3d 1377 (Fed. Cir. 2013). In that case, Rembrandt Vision Technologies sued Johnson &
Johnson Vision Care for infringement of its patent pertaining to a “soft gas permeable contact
lens.” Id. at 1379. During claim construction, the district court adopted that parties’ agreed
construction of “soft gas permeable contact lens” to mean “a contact lens having a Hardness
(Shore D) less than five.” Id. Shortly before trial, Rembrandt sought to admit Johnson &
Johnson’s “characterization of its lenses as ‘soft’” as circumstantial evidence of infringement.
Id. at 1382. The district court, however, excluded the evidence from trial because Johnson &
Johnson’s generic characterization of the accused lenses was not probative in light of the court’s
earlier construction of the term “soft.” Id. at 1379. After striking the trial testimony of
Rembrandt’s expert witness under Federal Rule of Civil Procedure 37, the district court entered
judgment as a matter of law for Johnson & Johnson, finding that Rembrandt failed to present
evidence that the accused lenses were “soft.” Id. at 1380. Rembrandt argued on appeal that the
court erred in refusing to consider its circumstantial evidence of infringement. The Federal
Circuit, however, affirmed the judgment of non-infringement, stating that “[g]eneric statements
that the accused lenses are ‘soft’ had the potential to confuse the jury and did not bear on
whether the accused lenses had a Shore D Hardness of less than five.” Id. at 1383 (citing Fed. R.
Evid. 403).
Likewise, Biocon’s generic use of the term “efficient” to describe the stirring method
used in Mylan’s compounding process does not bear on whether Mylan used “efficient mixing,”

27

as defined in the patents-in-suit. Accordingly, TMC has failed to put forward sufficient evidence
to allow a reasonable jury to treat Biocon’s statements as admissions of infringement by Mylan.8
B.

The ’727 Patent Does Not Incorporate an “Efficient Mixing” Process
Limitation

Mylan argues that TMC’s inability to establish that Mylan uses “efficient mixing” also
dooms TMC’s infringement claim under the ’727 patent. (Mylan Opening Br. at 15-18.) Unlike
the ’343 patent, the claims of the ’727 patent do not expressly require the use of “efficient
mixing.” Mylan, however, contends that the Court’s construction of the term “pharmaceutical
batches” incorporates process elements into the asserted claims of the ’727 patent that require the
use of “efficient mixing.” (Id. at 15-16.) Mylan further argues that because TMC disclaimed the
use of “inefficient mixing” in the ’727 patent specification and during patent prosecution, TMC
cannot now argue that the ’727 patent encompasses products generated through the use of
“inefficient mixing.” (Id. at 16-18.)
Claim interpretation is a matter of law for the Court to determine. Markman v. Westview
Instruments, Inc., 52 F.3d 967, 391 (Fed. Cir. 1995) (en banc), aff’d 517 U.S. 370, 116 S. Ct.
1384, 134 L. Ed. 2d 577 (1996); Marine Polymer Techs., Inc. v. HemCon, Inc., 672 F.3d 1350,
1358 (Fed. Cir. 2012). The Court begins its claim construction analysis with the words of the
claims themselves, giving those words their ordinary and customary meaning, i.e., “the meaning
8

On October 3, 2013, TMC filed a motion for leave to file a sur-reply, attaching its proposed sur-reply as
an exhibit. (R. 303.) In TMC’s proposed sur-reply, TMC cited to evidence purportedly showing that a
principal-agent relationship existed between Mylan and Biocon. (Id. at Ex. 1, pp. 2-6.) The Court,
however, denied TMC’s motion for leave to file the proposed sur-reply on October 7, 2013. (R. 306.)
The proposed sur-reply, even if the Court had allowed it, does not change the Court’s opinion regarding
whether the Court can attribute Biocon’s hearsay statements to Mylan. Even if the sur-reply raised
questions of fact regarding whether Biocon is an agent of Mylan, TMC’s argument would still fail
because of the lack of evidence indicating that Biocon used the term “efficient” as the Court construed it
during claim construction. In fact, in her deposition, the Biocon employee who authored the documents
at issue indicated that she had used the phrase “efficient stirring” generically to mean “better stirring,”
“proper stirring,” or “adequate stirring.” (R. 303, TMC Proposed Sur-Reply at 3.) TMC does not present
any evidence contradicting this fact.

28

that the term would have to a person of ordinary skill in the art in question at the time of the
invention.” Phillips v. AWH Corp., 415 F.3d 1303, 1312-13 (Fed. Cir. 2005) (en banc); see also
InterDigital Comm’cns, LLC v. Int’l Trade Comm’n, 690 F.3d 1318, 1333 (Fed. Cir. 2012). The
Federal Circuit teaches that “[i]mportantly, the person of ordinary skill in the art is deemed to
read the claim term not only in the context of the particular claim in which the disputed term
appears, but in the context of the entire patent, including the specification.” Phillips, 415 F.3d at
1313; see also HTC Corp. v. IPCom GmbH & Co., KG, 667 F.3d 1270, 1275 (Fed. Cir. 2012)
(stating that the district court “should have referred to the specification to understand the claims”
(citing Phillips, 415 F.3d at 1315)). Courts also look to the prosecution history of the patent-insuit in interpreting disputed claims. See HTC Corp., 667 F.3d at 1276 (citing Phillips, 415 F.3d
at 1317). Additionally, if necessary, courts may consider “extrinsic evidence,” which consists of
“all evidence external to the patent and prosecution history, including expert and inventor
testimony, dictionaries, and learned treatises,” to help “shed useful light on the relevant art.” See
Phillips, 415 F.3d at 1317 (citations omitted). Extrinsic evidence, however, is “less significant
than the intrinsic record in determining the legally operative meaning of claim language.” Id.
(internal quotations and citation omitted).
In its Claim Construction Order, the Court construed “pharmaceutical batches” as
follows:
“Pharmaceutical batches” may include a single batch, wherein the single batch is
representative of all commercial batches (see generally, Manual of Policies and
Procedures, Center for Drug Evaluation and Research, MAPP 5225.1, Guidance
on the Packaging of Test Batches at 1) made by a compounding process, and
wherein the levels of, for example, Asp9-bivalirudin, total impurities, and largest
unknown impurity, and the reconstitution time represent levels for all potential
batches made by said process. ‘Batches’ may also include all batches prepared by
a same compounding process.

29

(Claim Construction Op. at 11, 30.) The parties disagree regarding whether the phrases “made
by a compounding process,” “made by said process,” and “prepared by a same compounding
process” necessarily incorporate an “efficient mixing” limitation into the asserted claims of the
’727 patent.
1.

Asserted Claims

None of the claims in the ’727 patent expressly refers to an “efficient mixing”
requirement or any other process requirement. While Claim 1 of the ’343 patent expressly
includes certain process limitations, including an “efficient mixing” limitation, those process
limitations are noticeably absent from Claim 1 of the ’727 patent. (Compare ’343 patent at col.
27, ll. 13-31 with ’727 patent at col. 25, ll. 57-64.) Indeed, the lack of process limitations in the
’727 patent is the only difference between the claims in the ’727 patent and those in the ’343
patent. (Compare ’343 patent at col. 27 l. 12 – col. 28 l. 63 with ’727 patent at col. 25 l. 55 – col.
28 l. 24.) TMC argues that incorporating the absent process elements into the ’727 patent’s
claims would “vitiate the distinctions between the ’727 patent’s product claims and the ’343
patent’s product-by-process claims.” (TMC Resp. Br. at 22.)
On the other hand, although the claims in the ’727 patent do not contain any express
process limitations, the definition of “pharmaceutical batches” contained in the specification
repeatedly refers to the use of a compounding process. (See ’727 patent at col. 5, ll. 24-36.)
Specifically, the specification defines a “batch” or “pharmaceutical batch” as follows:
As used here, “batch” or “pharmaceutical batch” refers to material produced by a
single execution of a compounding process of various embodiments of the present
invention. “Batches” or “pharmaceutical batches” as defined herein may include
a single batch, wherein the single batch is representative of all commercial
batches (see generally, Manual of Policies and Procedures, Center for Drug
Evaluation and Research, MAPP 5225.1, Guidance on the Packaging of Test
Batches at 1), and wherein the levels of, for example, Asp9-bivalirudin, total
impurities, and largest unknown impurity, and the reconstitution time represent
30

levels for all potential batches made by said process. “Batches” may also include
all batches prepared by a same compounding process.
(Id. (emphasis added).) During claim construction briefing, TMC even admitted during claim
construction briefing that “[w]hen viewed in the context of the specification, it is readily
apparent that the [definition of ‘pharmaceutical batches’] refers to the compounding processes
described in the patents-in-suit.” (TMC Claim Construction Sur-Reply at 2.)
“Pharmaceutical batch” appears either expressly or by incorporation in every claim of the
’727 patent. (See ’727 patent at col. 25 l. 54 – col. 28 l. 23.) Mylan argues that, as a result, the
asserted claims, when viewed in light of the definition of “pharmaceutical batches,” incorporate
various process limitations, including an “efficient mixing” limitation. (Mylan Reply Br. at 910.)
2.

Patent Specification and Prosecution History

Both parties contend that the ’727 patent specification and its prosecution history lend
support to their respective positions. Mylan argues that the specification and prosecution history
show that “the applicants repeatedly disavowed any compounding process that does not
‘efficiently mix’ the pH-adjusting solution and the bivalirudin solution.” (Mylan Opening Br. at
16-18.) TMC, on the other hand, argues against disavowal, asserting that although the
specification and prosecution history describe preferred embodiments that include “efficient
mixing,” they notably do not mandate the use of “efficient mixing.” (TMC Resp. Br. at 22-25.)
Statements made in the prosecution history of a patent can only amount to a disclaimer if the
applicants “‘clearly and unambiguously’ disavowed claim scope.” See, e.g., Toshiba Corp. v.
Imation Corp., 681 F.3d 1358, 1370 (Fed. Cir. 2012) (citing 3M Innovative Props. Co. v. Avery
Dennison Corp., 350 F.3d 1365, 1370-71 (Fed. Cir. 2003)); Computer Docking Station Corp. v.

31

Dell, Inc., 519 F.3d 1366, 1375 (Fed. Cir. 2008) (“Prosecution disclaimer does not apply to an
ambiguous disavowal.”).
In support of its argument, Mylan points to several purported disclaimers of “inefficient
mixing” conditions in the ’727 patent specification. First, Mylan argues that the contrast
between the “inefficient mixing” conditions used in Example 4 and the “efficient mixing”
conditions used in Example 5 serves as the “focal point” of the ’727 specification. (Mylan
Opening Br. at 16-17.) Second, Mylan points out that no claim in the ’727 patent permits a
maximum Asp9-bivalirudin impurity level above the maximum level of Asp9-bivalirudin
impurities produced using the “efficient mixing” conditions in Example 5. (Mylan Opening Br.
at 16-17.) Third, Mylan notes that the ’727 patent specification attributed the consistently
reduced levels of Asp9-bivalirudin impurities in invention at issue to the use of “efficient
mixing,” and identified “inefficient mixing” conditions as the source of greater levels of Asp9bivalirudin impurities in prior art. (See id. at 17; see also, e.g., ’727 patent at col. 9 ll. 34-35
(“Efficient mixing is characterized by minimizing levels of Asp9-bivalirudin in the compounding
solution.”).) “From this,” Mylan argues, “it is clear that the ‘inefficient mixing’ process of
Example 4 is disclosed as a prior art process that falls outside the scope of the patent claims.”
(Mylan Opening Br. at 17.)
Mylan also cites to purported examples of disclaimer in the prosecution history of the
’727 patent. In the Petition to Make Special for the ’727 patent, the applicants differentiated
between the claimed invention, which the applicants generated using this new “efficient”
compounding process, from original Angiomax® formed using the old “inefficient”
compounding process:
In the present invention, various embodiments relate to a less subjective
and more consistent process for the mixing of the pH-adjusting solution with the
32

bivalirudin solution. This process involves efficiently mixing the pH-adjusting
solution and the dissolved bivalirudin solution, which is not performed in the
Applicants’ prior compounding process.
In addition, pharmaceutical batch(es) and pharmaceutical formulation(s)
of bivalirudin formed by the new compounding process are distinguished from the
batches and formulations of bivalirudin formed by the prior compounding
process. The pharmaceutical batch(es) and pharmaceutical formulation(s)
associated with the present compounding process are more consistent and have a
maximum level of Asp9-bivalirudin of about 0.6% w/w (a decrease of about 83%
compared to the batches or formulations made by the prior process), a maximum
reconstitution time of about 42 seconds (a decrease of about 42% compared to the
batches or formulations made from the prior process), and a maximum amount of
total impurities of about 2.0% (a decrease of about 33% compared to the batches
or formulations made by the prior process), for all batches or formulations made
by the new process.
(Greb Decl. Ex. 19 at 3.)
The applicants expressly noted the absence of “efficient mixing” conditions in
distinguishing the “Tovi” (U.S. Publication No. 20070093423) and “EMEA” (Angiox®) prior art
as well. To distinguish the “Tovi” reference, the applicants stated:
The [Tovi] application is silent regarding a compounding process via the addition
of a pH-adjusting solution to the bivalirudin solution in a controlled manner with
efficient mixing as to avoid the formulation of Asp9-bivalirudin during the
compounding stage. The [Tovi] specification does not state how much Asp9bivalirudin is present in the final formulated unit dosage forms or generated
during the compounding process. Further, the [Tovi] application is silent
regarding the maximum amount of unknown impurity levels and reconstitution
time for the bivalirudin drug product.
(Id. at 6 (emphasis added).) The applicants distinguished the “EMEA” reference on similar
grounds:
[T]he EMEA publication discloses that the bivalirudin drug substance is
compounded, but does not provide a disclosure of how the drug substance was
compounded. The EMEA publication also discloses that over thirty batches have
been prepared. . . . It is important to note that the manufacture of these bivalirudin
batches were [sic] not performed using the inventive process of the present
invention.

33

(Id. at 9 (emphasis in original).) Mylan argues that “[t]hese statements in the ’727 patent
specification and its prosecution history operate as a clear and undeniable waiver of claim
scope[,] [and] TMC cannot now contend that the claims of the ’727 patent encompass the
‘inefficient mixing’ that it expressly disclaimed.” (Mylan Opening Br. at 17-18.)
In opposition, TMC cites various instances in the specification and the prosecution
history where the applicants referred to embodiments of the claimed bivalirudin drug product
without discussing the process used to develop the drug. (TMC Resp. Br. at 22-25.) TMC
points out that although the ’727 specification refers to some embodiments of the claimed
invention as pertaining to a method for preparing pharmaceutical batch(es) or pharmaceutical
formulation(s) of the bivalirudin drug product, it describes other embodiments without reference
to the method of production. (See, e.g., the ’727 patent at col. 1, ll. 24-27 (“Some embodiments
of the present invention are also directed towards a pharmaceutical batch(es) or pharmaceutical
formulation(s) comprising bivalirudin as the active ingredient.”); id. at col. 3 ll. 21-24 (“In
certain embodiments, the pharmaceutical batch(es) or pharmaceutical formulation(s) is
characterized by a maximum impurity level of Asp9-bivalirudin that does not exceed about
0.6%”).) Similarly, in the Petition to Make Special, although the applicants differentiated the
claimed invention from prior art based on the absence of efficient mixing, they also stated that
their new bivalirudin final drug product had lower and more consistent impurity levels and
reconstitution times than prior art. (See, e.g., Greb Decl. Ex. 19 at 6 (“[T]he [Tovi] application is
silent regarding the maximum amount of unknown impurity levels and reconstitution time for the
bivalirudin drug product.”).) Specifically, the applicants distinguished each prior art reference
on the grounds that the prior art did not describe:
(1) pharmaceutical batches of a drug product comprising bivalirudin characterized
by a maximum impurity level of Asp9-bivalirudin not exceeding about 0.6% w/w
34

for all batches; or (2) pharmaceutical batches of a drug product comprising
bivalirudin, characterized by a maximum reconstitution time not exceeding about
42 seconds for all batches.
(Id. at 5-10.)
TMC argues that these repeated references to the physical properties of the new
bivalirudin drug product without respect to the process used to generate it affirm that the ’727
patent is a pure product patent, not a product-by-process patent like the ’343 patent. (TMC Resp.
Br. at 22-25.) TMC contends that the ’727 patent describes preferred embodiments of the
invention that involve “efficient mixing,” but does not require the use of “efficient mixing”
conditions in manufacturing the claimed drug product, like the ’343 patent does. (Id. at 24.)
Thus—TMC argues—the Court should not convert the product claims in the ’727 patent into
process claims. (Id. at 23 (citing Vanguard Prods. Corp. v. Parker Hannifin Corp., 234 F.3d
1370, 1372 (Fed. Cir. 2000)).)
3.

The Court’s Construction

As an initial matter, the Court notes that much of the difficulty inherent in delineating the
scope of the ’727 patent stems from the near identical patent specifications and prosecution
histories for the ’727 and ’343 patents. The patents’ specifications and Petitions to Make Special
give short shrift to the differences between the two patents-in-suit. Instead, the applicants appear
to have copied and pasted full sections from one patent’s specification and Petition into the other
patent’s documents, and then simply changed a few concluding sentences. Based on the totality
of the evidence in the record, however, the Court finds that the ’727 patent does not include an
“efficient mixing” limitation.
The Federal Circuit has repeatedly warned that “[c]ourts must generally take care to
avoid reading process limitations into [a product] claim . . . because the process by which a
product is made is irrelevant to the question of whether that product infringes a pure [product]
35

claim[.]” See AstraZeneca LP v. Breath Ltd., --- Fed. App’x ----, 2013 WL 5813759, at *5 (Fed.
Cir. Oct. 30, 2013) (unpublished opinion) (quoting Baldwin Graphic Sys., Inc. v. Siebert, Inc.,
512 F.3d 1338, 1344 (Fed. Cir. 2008)); Research Corp. Techs., Inc. v. Microsoft Corp., 627 F.3d
859, 873 (Fed. Cir. 2010) (same). Generally, “[t]he method of manufacture, even when cited as
advantageous, does not of itself convert product claims into claims limited to a particular
process . . . . A novel product that meets the criteria of patentability is not limited to the process
by which it is made.” AstraZeneca, 2013 WL 5813759, at *5 (ellipsis in original) (quoting
Vanguard Prods. Corp. v. Parker Hannifin Corp., 234 F.3d 1370, 1372 (Fed. Cir. 2000)).
An applicant, however, may disclaim products created using certain processes if the
applicant “overcomes a rejection against [both] product and process claims by indicating that the
process is necessary to produce the claimed product” and, in doing so, fails to “limit the
disclaimers to [only] the process claims.” Id. (citing Chimie v. PPG Indus., Inc., 402 F.3d 1371,
1384-85 (Fed. Cir. 2005)). Prosecution disclaimer requires “clear and unambiguous disavowal
of claim scope.” Saffran v. Johnson & Johnson, 712 F.3d 549, 559 (Fed. Cir. 2013) (quoting
Storage Tech. Corp. v. Cisco Sys., Inc., 329 F.3d 823, 833 (Fed. Cir. 2003)); Toshiba Corp., 681
F.3d at 1370 (“A statement in the prosecution history can only amount to disclaimer if the
applicant ‘clearly and unambiguously’ disavowed claim scope.”). Accordingly, prosecution
disclaimer does not apply “if the applicant simply describes features of the prior art [but] does
not distinguish the claimed invention based on those features.” Computer Docking Station
Corp., 519 F.3d at 1375 (citing Eolas Techs., Inc. v. Microsoft Corp., 399 F.3d 1325, 1337 (Fed.
Cir. 2005)).
The question for the Court is whether TMC’s purported disavowal of bivalirudin final
drug products manufactured using “inefficient mixing” was sufficiently “clear and

36

unambiguous” to justify reading in an “efficient mixing” limitation into the asserted claims in the
’727 patent. The Court concludes that it was not.
To begin with, the claims of the ’727 patent do not expressly include process limitations,
which weighs against reading process limitations into them. See, e.g., Combined Sys., Inc. v.
Defense Tech. Corp. of Am., 350 F.3d 1207, 1210 (Fed. Cir. 2003) (“[T]he claim construction
inquiry . . . begins and ends in all cases with the actual words of the claim.”). Despite the
similarities between the ’727 and the ’343 patents, the claims of the ’727 patent notably exclude
the process limitations that are present in the claims of the ’343 patent. Furthermore, even
though the applicants submitted nearly identical Petitions to Make Special for the two patents,
they made an effort to differentiate between the product claims in the ’727 patent and the
product-by-process claims in the ’343 patent in the concluding sentence of each section
distinguishing prior art. (Compare Greb. Decl. Ex. 19 at 5-10 with Greb Decl. Ex. 20 at 4-13.)
In the ’727 petition, the applicants concluded each section by stating that the prior art reference
did not describe the improved impurity levels and reconstitution times that characterized the
claimed invention—i.e.,the physical characteristics the invented product at issue—whereas in the
’343 petition, the applicants concluded each section by stating that the new “efficient mixing”
process used to generate the invention at issue distinguished it from prior art. (Compare Greb.
Decl. Ex. 19 at 5-10 with Greb Decl. Ex. 20 at 4-13.) These distinctions between the ’727 and
’343 patents and in their prosecution histories indicate that the ’727 patent is a pure product
patent, cf. Baldwin Graphic Sys., 512 F.3d 1338 (“Claim 1 and its dependent claims . . . are pure
apparatus claims. They have no process limitations[,] [and] . . . are therefore not limited to any
particular process or method of making the claimed [invention.]”), whereas the ’343 patent is a
product-by-process patent. Accordingly, because the applicants’ purported disavowal of

37

bivalirudin final drug products in the prosecution of the ’727 patent is ambiguous, the doctrine of
prosecution disclaimer does not apply. See, e.g., 3M Innovative Props. Co. v. Avery Dennison
Corp., 350 F.3d 1365, 1373 (Fed. Cir. 2003) (finding that remarks made in the prosecution
history did not constitute “the clear and unambiguous disavowal of claim scope that is required
to read a limitation into an expressly defined term”); see also Toshiba Corp., 681 F.3d at 1370;
AstraZeneca LP, 2013 WL 5813759, at *5.
Furthermore, while on first read the definition of “pharmaceutical batches” appears to
incorporate the process elements of “efficient mixing” described in the patent specification into
the ’727 patent’s claims, the definition likely refers to “a compounding process” to distinguish it
from prior art. Asp9-bivalirudin impurities in a bivalirudin final drug product can form at two
steps in the manufacturing process: (1) during the synthesis of the bivalirudin API and (2) during
the compounding process that adjusts the pH level of the bivalirudin API to make it suitable for
injection into patients. (See ’727 patent at col. 2 ll. 8-23.) Prior art, including the “Tovi”
reference, encompassed methods for minimizing the generation of Asp9-bivalirudin impurities
during the synthesis of the bivalirudin API. (See id.; see also Greb Decl. Ex. 19 at 6-7.) By
specifying that a “pharmaceutical batch” consisted of material “produced by . . . a compounding
process of various embodiments of the present invention,” the patent distinguished the properties
of the claimed invention from the properties of bivalirudin APIs generated in prior art. The
“Tovi” prior art, for example, disclosed “the synthetic preparation of bivalirudin”—i.e., the
bivalirudin API—“having not more than 0.5% Asp9-bivalirudin.” (See Greb Decl. Ex. 19 at 6.)
In the Petition to Make Special, the applicants distinguished the “Tovi” prior art on the grounds
that the “Tovi” reference did not state the amount of Asp9-bivalirudin impurities that existed in
the final drug product after it underwent the necessary compounding process. (See id. (“The

38

[Tovi] application does not state how much Asp9-bivalirudin is present in the final formulated
unit dosage forms or generated during the compounding process.”).)
For these reasons, the Court is unpersuaded that the inclusion of the phrase “made by a
compounding process” or similar in the definition of “pharmaceutical batches” incorporates
process elements into the asserted claims of the ’727 patent. The Court, therefore, holds that the
’727 patent does not contain an “efficient mixing” limitation.
C.

Factual Disputes Regarding the Maximum Level of Asp9-Bivalirudin in
Mylan’s Proposed Final Drug Product Preclude Summary Judgment

To prevail on its claim of infringement of the ’727 patent, TMC must prove, among other
things, that the batches made using Mylan’s compounding process will have a maximum
impurity level of Asp9-bivalirudin that does not exceed about 0.6% as measured by HPLC. (’727
patent at Claim 1); see Riles, 298 F.3d at 1308 (“To prove literal infringement, the patentee must
show that the accused device contains every limitation in the asserted claims.” (quoting MasHamilton Grp., 156 F.3d at 1211)). TMC bases its infringement contentions with respect to this
element on the Asp9-bivalirudin impurity level of 0.2% in the exhibit batch Mylan submitted to
the FDA in conjunction with its ANDA. (TMC Resp. Br. at 11-13.) Mylan argues that the
impurity levels in its exhibit batch fail to create a genuine issue of material fact because “a single
batch is insufficient to predict the results of future batches.” (Mylan Opening Br. at 20.)
In an action, like this one, brought under § 271(e)(2)(A) of the Hatch-Waxman Act, the
focus of the infringement inquiry is on “what the ANDA applicant will likely market if its
application is approved, an act that has not yet occurred.” Bayer AG v. Elan Pharm. Res. Corp.,
212 F.3d 1241, 1248 (Fed. Cir. 2000). Thus, the infringement analysis under § 271(e)(2)(A) is
necessarily a “hypothetical inquiry . . . properly grounded in the ANDA application and the
extensive materials typically submitted in its support.” Id. (quoting Glaxo, Inc. v. Novopharm,
39

Ltd., 110 F.3d 1562, 1569 (Fed. Cir. 1997)). “Because drug manufacturers are bound by strict
statutory provisions to sell only those products that comport with the ANDA’s description of the
drug, an ANDA specification defining a proposed generic drug in a way that directly addresses
the issue of infringement will control the infringement inquiry.” Abbott Labs. v. TorPharm, Inc.,
300 F.3d 1367, 1373 (Fed. Cir. 2002); see also Bayer, 212 F.3d at 1249. If, on the other hand,
the ANDA specification does not define the drug in a manner that directly addresses the issue of
infringement, the court may look to evidence outside the ANDA, including sample products
submitted to the FDA, to decide the issue of infringement. Bayer, 212 F.3d at 1250 (citing
Glaxo, 110 F.3d at 1569-70).
Here, Mylan’s ANDA specification, which sets a maximum Asp9-bivalirudin impurity
level of 2.0%, does not “directly address the issue of infringement” because a product with an
Asp9-bivalirudin level of 0.3%, for example, may comply with the ANDA specification and, at
the same time, infringe the claims of the ’727 patent. See Ortho-McNeil Pharm., Inc. v. Kali
Labs., Inc., 482 F. Supp. 2d 478, 501 (D.N.J. 2007) (explaining that a court need not examine
evidence outside the ANDA specification if the scope of the compound described in the ANDA
falls either entirely inside the scope of the patent or entirely outside the scope of the patent), aff’d
in part and vacated in part on other grounds in 344 Fed. App’x 595 (Fed. Cir. 2009). TMC,
therefore, may rely on the exhibit batch Mylan submitted to the FDA to prove infringement. See
Bayer, 212 F.3d at 1250; Glaxo, 110 F.3d at 1569-70.
Even so, Mylan argues that TMC fails to establish a genuine issue of material fact
regarding whether future batches made using Mylan’s ANDA process will infringe the ’727
patent because “[a] single batch result cannot reliably predict the results of future batches.”
(Mylan Opening Br. at 20-22.) Mylan’s argument, however, fails to account for the special

40

nature of the “single batch” at issue here. Because “ANDAs . . . are usually approved based on
data from a single test batch,” the FDA Manual of Policies and Procedures stresses that “[i]t is
critical that all testing be conducted on samples that represent the entire batch and mimic the
product which will be marketed post-approval.” See Manual of Policies and Procedures, Center
for Drug Evaluation and Research, MAP 5225.1, Guidance on the Packaging of Test Batches at
1. Here, Mylan submitted an exhibit batch in conjunction with its ANDA that had an Asp9bivalirudin impurity level of 0.2%, which falls below the maximum level of Asp9-bivalirudin
impurities in the asserted claims. Mylan admits that it will manufacture its proposed commercial
product in the same manner as Biocon manufactured the exhibit batch, except on a larger scale.
(Mylan L.R. 56.1 Stmt. ¶ 71; see also Fleming Decl. Ex. 16 at MYL0000212.) Viewing this
evidence in the light most favorable to TMC and drawing all reasonable inferences in its favor,
the Court finds that TMC has offered sufficient evidence to establish a genuine issue of material
fact, especially in light of the inherently “hypothetical inquiry” involved in an infringement
determination under § 271(e)(2)(A). See Connetics Corp. v. Agis Indus. (1983) Ltd., Civ. No.
05-5038, 2008 U.S. Dist. LEXIS 31646, at *7 (D.N.J. Apr. 14, 2008) (denying summary
judgment of non-infringement where the pH level of one of the several “development batches”
the defendant submitted with its ANDA fell within the claims of the patent-in-suit).
Mylan offers a plethora of evidence in support of its argument that a single exhibit batch
cannot reliably predict the results of future batches, including expert opinions, testimony from
one of the inventors, and data from TMC’s own prior art. (See Mylan Opening Br. at 20-22.)
The Court’s role on summary judgment, however, is not to “weigh the evidence and determine
the truth of the matter but to determine whether there is a genuine issue for trial.” Anderson, 477
U.S. at 249; see also United States v. Funds in Amount of One Hundred Thousand One Hundred

41

& Twenty Dollars ($100,120.00), 730 F.3d 711, 717 (7th Cir. 2013) (“At summary judgment,
whether the movant’s evidence is more persuasive than the evidence of the non-movant is
irrelevant.”). The Court, therefore, denies Mylan’s motion for summary judgment of noninfringement with respect to the ’727 patent.
II.

Invalidity of the ’727 Patent
Mylan moves, in the alternative, for summary judgment of invalidity with respect to the

’727 patent. Mylan argues that if the Court determines that the ’727 patent does not require the
use of “efficient mixing”—which it has—the patent is invalid under 35 U.S.C. § 112, paragraph
1 for lack of enablement and written description.9 Because patents are presumed valid, see 35
U.S.C. § 282, Mylan must prove invalidity by clear and convincing evidence. Microsoft Corp v.
i4i Ltd. P’ship, --- U.S. ----, 131 S. Ct. 2238, 2245, 180 L. Ed. 2d 131 (2011).
The enablement requirement in 35 U.S.C. § 112 mandates that a patent specification
describe “the manner and process of making and using [the invention], in such full, clear,
concise, and exact terms as to enable any person skilled in the art to which it pertains, or with
which it is most nearly connected, to make and use the [invention].” Liebel-Flarsheim Co. v.
Medrad, Inc., 481 F.3d 1371, 1378 (Fed. Cir. 2007) (internal quotations and citation omitted;
alterations in original). To satisfy the enablement requirement, “the specification of a patent
must teach those skilled in the art how to make and use the full scope of the claimed invention
without undue experimentation.” Teva Pharms. USA v. Sandoz, Inc., 723 F.3d 1363, 1370 (Fed.
Cir. 2013); see also AK Steel Corp. v. Sollac & Ugine, 344 F.3d 1234, 1241 (Fed. Cir. 2003)

9

Mylan also argues that if the Court interprets the ’727 patent to encompass batches that “consistently,”
but not always, have maximum Asp9-bivalirudin impurity levels of 0.6%, the ’727 patent is invalid due to
anticipation by TMC’s original Angiomax® product. (Mylan Opening Br. at 22-24.) Neither party has
advanced this interpretation of the ’727 patent. In fact, both have argued against reading “consistently”
into the asserted claims. (See id. at 22; TMC Resp. Br. at 28, 31.) The Court, therefore, does not need to
address this argument.

42

(“[A] patent specification must enable the full scope of a claimed invention.”). “Whether a claim
satisfies the enablement requirement of 35 U.S.C. § 112 is a question of law.” Liebel-Flarsheim,
481 F.3d at 1377.
The closely-related written description requirement of 35 U.S.C. § 112, paragraph 1
“requires a patentee to provide a written description that allows a person of skill in the art to
recognize that the patentee invented what is claimed.” Synthes USA, LLC v. Spinal Kinetics,
Inc., 734 F.3d 1332, 1341 (Fed. Cir. 2013). “[T]he test for sufficiency is whether the disclosure
of the application relied upon reasonably conveys to those skilled in the art that the inventor
ha[d] possession of the claimed subject matter as of the filing date.” Id. (alteration in original).
“The level of detail required to satisfy the written description requirement varies depending on
the nature and scope of the claims and on the complexity and predictability of the relevant
technology.” Id. “Compliance with the written description requirement is a question of fact but
is amenable to summary judgment in cases where no reasonable fact finder could return a verdict
for the non-moving party.” Trading Techs. Int’l, Inc. v. Open E Cry, LLC, 728 F.3d 1309, 1318
(Fed. Cir. 2013) (internal quotations and citation omitted).
According to Mylan, if the ’727 patent encompasses pharmaceutical batches generated
using “inefficient mixing” in addition to batches generated using “efficient mixing,” the patent is
invalid because it fails to enable the full scope of the claimed invention—specifically, batches
generated through “inefficient mixing.” (Mylan Opening Br. at 26.) Mylan further claims that
the ’727 patent fails to satisfy the written description requirement because it does not convey that
the inventors had possession of any embodiment of the invention that used “inefficient” mixing
to achieve the claimed Asp9-bivalirudin levels. (Id.) Mylan’s arguments rest on the faulty
premise that the claims in the ’727 patent speak to process limitations at all.

43

The ’727 patent is a product patent. The invention in the ’727 patent is a bivalirudin drug
product having the characteristics described in the patent, not a bivalirudin drug product made
using a specific process (efficient or otherwise). See Amgen, Inc. v. Hoechst Marion Roussel,
Inc., 314 F.3d 1313, 1329 (Fed. Cir. 2003) (“[P]roduct claims . . . are directed to a structural
entity that is not defined or limited by how it is made.”). As a result, the process used to
generate the claimed drug “is immaterial and ‘legally irrelevant’ . . . and cannot be relied on as a
basis to render the[] . . . claims invalid for lack of enablement.” Johnson & Johnson Vision
Care, Inc. v. CIBA Vision Corp., 648 F. Supp. 2d 1294, 1342-43 (M.D. Fla. 2009); see also
Johns Hopkins Univ. v. CellPro, Inc., 153 F.3d 1342, 1361 (Fed. Cir. 1998) (“[T]he enablement
requirement is met if the description enables any mode of making and using the invention.”
(citation omitted)); Invitrogen Corp. v. Clontech Labs., Inc., 429 F.3d 1052, 1071 (Fed. Cir.
2005) (“Although Clontech’s validity argument might have force had Invitrogen limited its
claims to modified RT by reference to point mutation, Clontech overlooks the fact that the
claims are not limited by the method of achieving the mutation.” Durel Corp. v. Osram Sylvania
Inc., 256 F.3d 1298, 1307 (Fed. Cir. 2001) (“[I]f the patent specification enabled a person of
ordinary skill in the art to make the claimed titanium dioxide coating from a titanium
tetrachloride precursor, it would be irrelevant for purposes of validity if the patent specification
did not enable its preparation from a titanium isopropoxide precursor.”). The Court therefore
rejects Mylan’s argument that the ’727 patent’s failure to describe how to generate the claimed
bivalirudin drug product using “inefficient mixing” renders it invalid.
The Court rejects Mylan’s argument for invalidity due to an inadequate written
description for the same reason. Cf. LizardTech, Inc. v. Earth Resource Mapping, Inc., 424 F.3d
1336, 1345 (Fed. Cir. 2005) (noting that the enablement and written description requirements

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“usually rise and fall together”). The patent need only show that the inventors had possession of
the claimed invention—a bivalirudin drug product having the characteristics described in the
patent—not a bivalirudin drug product generated by “inefficient mixing.” Mylan does not argue
that the patent failed to convey to those skilled in the art that the inventors had possession of a
bivalirudin drug product having, for example, a maximum Asp9-bivalirudin impurity level of
0.6%. Accordingly, the Court rejects Mylan’s argument for invalidity on the grounds of
inadequate written description, and denies Mylan’s motion for summary judgment of invalidity
with respect to the ’727 patent.
III.

TMC’s Claim of Willful Infringement
Finally, Mylan moves for summary judgment with respect to TMC’s willful infringement

claim. (Mylan Opening Br. at 26-28.) In its opening brief, Mylan argued that TMC cannot
prove willful infringement because (1) “the filing of an ANDA alone does not support a finding
of willful infringement” and (2) “TMC cannot show that Mylan’s actions were objectively
unreasonable.” (Mylan Opening Br. at 27.) TMC maintains that Mylan misunderstands its claim
for willful infringement, which TMC bases “on acts that may occur in the future,” not on actions
that Mylan has taken to date. (TMC Resp. Br. at 34.) In other words, TMC claims that Mylan
will willfully infringe the patents-in-suit “if Mylan commercially manufactures, uses, sells, offers
to sell, or imports its generic bivalirudin product in the future.” (Id. (emphasis in original).)
TMC, however, does not cite any authority suggesting that this type of declaratory relief
is appropriate. Nor does TMC cite any facts to warrant this type of declaratory relief.
“Perfunctory and undeveloped arguments, and arguments that are unsupported by pertinent
authority, are waived.” United States v. Hook, 471 F.3d 766, 775 (7th Cir. 2006). The Court,
therefore, grants Mylan’s motion for summary judgment with respect to TMC’s willful

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infringement claim. See Giffney Perret, Inc. v. Matthews, No. 07 C 0869, 2009 WL 792484, at
*16 (N.D. Ill. Mar. 24, 2009) (granting partial summary judgment to the defendant because the
plaintiff’s “undeveloped arguments amount[ed] to a waiver of Plaintiff’s opposition to
Defendants’ motion for summary judgment”).
CONCLUSION
For the reasons explained above, the Court grants Mylan’s motion for summary judgment
of non-infringement with respect to the ’343 patent but denies it with respect to the ’727 patent.
The Court also denies Mylan’s alternative motion for summary judgment as to invalidity of the
’727 patent. Finally, the Court grants Mylan’s motion for summary judgment regarding TMC’s
claim for willful infringement.

Dated: December 16, 2013

ENTERED

______________________________
AMY J. ST. EVE
U.S. District Court Judge

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