Ferring B v. v. Watson Laboratories, Inc.

United States Court of Appeals
for the Federal Circuit
______________________

FERRING B.V.,
Plaintiff-Appellee,

v.

WATSON LABORATORIES, INC. – FLORIDA,
Defendant-Appellant,

AND

APOTEX, INC., AND APOTEX CORP.,
Defendants.
______________________

2014-1416
______________________

Appeal from the United States District Court for the
District of Nevada in Nos. 3:11-cv-0481-RCJ-VPC, 3:11-
cv-0853-RCJ-VPC, and 2:12-cv-1935-RCJ-VPC, Judge
Robert Clive Jones.
______________________

Decided: August 22, 2014
______________________

PAUL W. BROWNING, Finnegan, Henderson, Farabow,
Garrett & Dunner, LLP, of Washington, DC, argued for
plaintiff-appellee. With him on the brief were JAMES B.
MONROE, JUSTIN J. HASFORD, and MARY E. CHLEBOWSKI.
2 FERRING B.V. v. WATSON LABORATORIES, INC. – FLORIDA

B. JEFFERSON BOGGS, JR., Merchant & Gould P.C., of
Alexandria, Virginia, argued for defendant-appellant.
With him on the brief were MATTHEW L. FEDOWITZ;
CHRISTOPHER J. SORENSON and RACHEL C. HUGHEY, of
Minneapolis, Minnesota.
______________________

Before LOURIE, DYK, and REYNA, Circuit Judges.
LOURIE, Circuit Judge.
Watson Laboratories, Inc. – Florida (“Watson”) ap-
peals from the decisions of the United States District
Court for the District of Nevada (i) holding that the
subject matter of the asserted claims of Ferring B.V.’s
(“Ferring”) U.S. Patents 7,947,739 (the “’739 patent”),
8,022,106 (the “’106 patent”), and 8,273,795 (the “’795
patent”) would not have been obvious under 35 U.S.C.
§ 103, (ii) finding that Watson’s generic tranexamic acid
product infringed those claims under 35 U.S.C. § 271,
consequently (iii) ordering the U.S. Food and Drug Ad-
ministration (“FDA”) to reset the approval date of Wat-
son’s Abbreviated New Drug Application (“ANDA”) 20-
2093 and (iv) permanently enjoining the manufacture,
use, sale, or offer for sale of Watson’s generic product. See
Ferring B.V. v. Watson Labs., Inc. – Fla., No. 11-0481 (D.
Nev. Apr. 14, 2014), ECF No. 524 (“Final Order”); J.A.
325–27. We conclude that the district court did not err in
holding that the subject matter of the claims of Ferring’s
’739, ’106, and ’795 patents would not have been obvious.
However, we conclude that the district court’s judgment
that Watson’s generic product infringed the asserted
claims of Ferring’s patents was not in accordance with
law. Accordingly, we affirm in part, reverse in part, and
vacate both the district court’s resetting order and injunc-
tion.
FERRING B.V. v. WATSON LABORATORIES, INC. – FLORIDA 3

BACKGROUND
Ferring owns the ’739, ’106, and ’795 patents, which
are directed to modified release formulations of trans-4-
(aminomethyl)cyclohexanecarboxylic acid, also known as
tranexamic acid, the active ingredient in the drug mar-
keted as a treatment for heavy menstrual bleeding, or
menorrhagia, under the brand name Lysteda®. The
claims of those patents are drawn to oral dosage forms or
formulations and methods of treating menorrhagia and
require three elements: (1) about 650 mg of tranexamic
acid; (2) a so-called modified release material that com-
prises either about 10% to about 35% or about 5% to
about 50% by weight of the formulation; and (3) a speci-
fied dissolution release rate of the tranexamic acid in
water as measured by a particular United States Phar-
macopeia (“USP”) method. Claim 1 of the ’739 patent is
representative and reads as follows:
1. A tranexamic acid tablet formulation, compris-
ing:
tranexamic acid or a pharmaceutically acceptable
salt thereof; and
a modified release material, wherein the modified
release material comprises a polymer selected
from the group consisting of hydroxyalkylcellu-
loses, alkylcelluloses, cellulose ethers, partial es-
ters thereof, and mixtures thereof;
wherein the modified release material is present
in the formulation in an amount from about 10%
to about 35% by weight of the formulation;
wherein the formulation provides an in-vitro dis-
solution release rate of the tranexamic acid or
pharmaceutically acceptable salt thereof, when
measured by the USP 27 Apparatus Type II
Paddle Method @ 50 RPM in 900 ml water at
37±0.5ºC., of less than about 70% by weight
tranexamic acid or pharmaceutically acceptable
4 FERRING B.V. v. WATSON LABORATORIES, INC. – FLORIDA

salt thereof released at about 45 minutes, and
about 100% by weight tranexamic acid or phar-
maceutically acceptable salt thereof released by
about 120 minutes; and
wherein each tablet of the formulation provides a
dose of about 650 mg of tranexamic acid.
’739 patent col. 69 ll. 46–67. Both claim 1 of the ’106
patent and claim 1 of the ’795 patent are similar but
require a dissolution release rate of tranexamic acid of
less than about 40% at about 15 minutes, less than about
70% at about 45 minutes, and not less than about 50% by
about 90 minutes. ’106 patent col. 69 ll. 8–19; ’795 patent
col. 35 ll. 37–48. Various dependent claims include addi-
tional limitations drawn to amount of tranexamic acid,
amount or type of modified release material, water disso-
lution release rates measured by the USP test, pharma-
cokinetic requirements, and kind of dosage form. For
example, claim 5 of the ’739 patent and claim 19 of the
’106 patent each limit the modified release material to
hydroxypropylmethylcellulose, which is also known as
hypromellose. ’739 patent col. 70 ll. 20–22; ’106 patent
col. 70 ll. 62–64.
It is undisputed that the product Lysteda® is an em-
bodiment of the claims in Ferring’s ’739, ’106, and ’795
patents. J.A. 938. Pursuant to the Hatch-Waxman Act,
21 U.S.C. § 355(b)(1), those patents are listed as refer-
enced to Lysteda® in the FDA’s Approved Drug Products
with Therapeutic Equivalence Evaluations publication
(commonly known as the “Orange Book”). In approving
Lysteda®, the FDA recognized that the drug was intended
for the treatment of a serious or life-threatening disease
or condition that demonstrated the potential to address
unmet medical needs. On that basis, the FDA granted
the Lysteda® New Drug Application (“NDA”) “fast track”
status under 21 U.S.C. § 356(b)(1), which provided for
expedited review. J.A. 18449–63. Lysteda® is the first
FERRING B.V. v. WATSON LABORATORIES, INC. – FLORIDA 5

tranexamic drug approved by the FDA for treating men-
orrhagia in the United States.
Almost a year before the first of Ferring’s patents is-
sued, Watson filed ANDA 20-2093 seeking FDA approval
to market tranexamic acid tablets as generic versions of
Lysteda®. As specified in its ANDA, Watson’s generic
tablets are made of a so-called “core” mixture comprising
650 mg of tranexamic acid and various excipients includ-
ing 6.52% by weight hypromellose, which is described as a
binder. J.A. 13800.
Watson’s initially-filed ANDA specified that the hard-
ness of the cores was 13–20 kp; “kp” is an abbreviation for
kiloponds, which is a measure of hardness compression.
J.A. 13885. In an amendment submitted to the FDA
dated August 29, 2012 and approved December 27, 2012,
Watson modified its ANDA specification to require a core
hardness of 13–17 kp. J.A. 13789, 13912, 13920. The
cores are surrounded by a pH-dependent film coating
comprising various agents including 1.86% Opadry® YS-1-
7006, which itself is a mixture consisting of hypromellose
and polyethylene glycol. J.A. 13800–02, 14074. The film
coating is 2.91% by weight of the total weight of the
composed tablet; it is designed to resist degradation in
water, such as the mouth and the esophagus, but to
dissolve immediately in acidic conditions, such as the
stomach. Id.
Watson maintains that its ANDA contains no specifi-
cation that addresses the manner in which its product
dissolves in water. Appellant’s Br. 24; J.A. 1598, 2080.
However, biobatch data submitted in Watson’s ANDA
demonstrate that the dissolution release rate of tranex-
amic acid from its coated generic 650 mg tablets as meas-
ured by the USP 27 Apparatus Type II Paddle Method at
50 revolutions per minute in 900 mL of water at 37ºC is as
follows: 5% at 15 minutes, 16% at 45 minutes, 29% at 90
minutes, and 37% at 120 minutes. J.A. 14074.
6 FERRING B.V. v. WATSON LABORATORIES, INC. – FLORIDA

In 2011, Watson submitted to Ferring a notice of certi-
fication pursuant to 21 U.S.C. § 355(j)(2)(B)(ii) and 21
C.F.R. § 314.95(c) regarding its proposed generic tranex-
amic acid product as specified in its ANDA. Ferring then
initiated the instant suit, asserting that Watson’s ANDA
submission constituted an act of infringement of claims 1,
4, 5, 8–10, 12, and 13 of the ’739 patent; claims 1, 5–8, 15,
16, 18, 19, and 30–37 of the ’106 patent; and claims 1, 5,
6, and 8–10 of the ’795 patent according to 35 U.S.C.
§ 271(e)(2)(A). * Ferring alleged that both Watson’s un-
coated cores and finished, coated commercial tablets
infringed the asserted patent claims. After receiving FDA
approval of its ANDA on December 27, 2012, Watson
launched its generic tranexamic acid product at risk,
which Ferring did not move to enjoin. J.A. 14848–51.
During discovery, Ferring and Watson each conducted
dissolution testing of samples provided by Watson. Of the
hundreds of coated commercial products tested by the
claimed USP method, only about four individual coated
tablets released more than 50% of their tranexamic acid
at 90 minutes, but none of them released more than about
79% by 120 minutes. J.A. 14218–76, 14751–53, 14768–
69, 18290, 18424, 18427, 18443. The data collected by
both parties showed that, in the majority of the samples
tested, only about 27% to 44% of the tranexamic acid was
released from the individual coated tablets at 90 minutes
and only about 33% to 52% was released at 120 minutes,

* Ferring also sued Apotex, Inc. and Apotex Corp.
(collectively “Apotex”), alleging that Apotex’s ANDA
product consisting of a generic version of Lysteda® would
infringe the same patents at issue here. In the appeal
from that case, 2014-1377, we today affirm the district
court’s judgment that the product specified in both Apo-
tex’s original and amended ANDAs would not infringe the
asserted claims.
FERRING B.V. v. WATSON LABORATORIES, INC. – FLORIDA 7

consistent with the biobatch data reported in Watson’s
ANDA itself. Id.
At trial, Ferring also relied on test data reported in a
Watson document labeled PTX 381 to prove infringement.
Appellee Br. 22; J.A. 991–93, 2003–11. Those data show
dissolution profiles in water of experimental, uncoated
650 mg tranexamic acid cores of various specified hard-
ness, as measured by the USP method, which Watson
recorded in the development of its generic product formu-
lation prior to submitting its ANDA to the FDA. J.A.
1617–19, 2070–72, 14840. The data show that the
amount of tranexamic acid released in Watson’s uncoated
cores with a hardness of 13 kp is 96% at 15 minutes and
100% at 45 minutes; those with a hardness of 16 kp
release 44% at 15 minutes and 95% at 45 minutes; those
with a hardness of 17 kp release 27% at 15 minutes and
71% at 45 minutes; those with a hardness of 18 kp release
35% at 15 minutes and 76% at 45 minutes; and those with
a hardness of 20 kp release 31% at 15 minutes and 77% at
45 minutes. J.A. 14840.
Following a Markman hearing, the district court con-
strued the term “modified release material” to mean “a
material that modifies the release of the active pharma-
ceutical ingredient” in water. Ferring B.V. v. Watson
Labs., Inc. – Fla., No. 11-0481 (D. Nev. Feb. 6, 2013), ECF
No. 295; J.A. 195–96, 204. The court also construed the
term “about” to mean “approximately.” Id.; J.A. 204.
After a bench trial, the court found that the asserted
claims would not have been obvious because “[n]one of the
prior art discusses [a dosage of 650 mg tranexamic acid],
nor does any of the prior art motivate to a higher dosage.
In fact, it motivates just the opposite direction.” J.A.
2308–10. The court also found that both the uncoated
cores of Watson’s generic tranexamic acid product and the
finished, coated commercial tablets with a core hardness
of 17 kp and greater infringed the asserted claims under
8 FERRING B.V. v. WATSON LABORATORIES, INC. – FLORIDA

§ 271(e)(2)(A) and § 271(a). J.A. 2307, 2311, 2315; Final
Order at 1.
On the one hand, the district court considered Wat-
son’s submission of the ANDA itself to be an act of in-
fringement and ostensibly refused to consider all FDA-
approved amendments to the ANDA specification in its
infringement analysis. J.A. 2249–56, 2316. On the other
hand, based on its finding that only uncoated cores or
finished, coated commercial tablets with a core hardness
of 17 kp or greater infringed, the court suggested at the
close of trial that Watson could avoid infringement by
submitting a “change” of its ANDA to the FDA. J.A.
2316–17 (“It looks like, if you avoid or can get away from
the 17 Kp, even as low as 16 with a mandatory, you’re
probably okay.”). Consistent with the court’s suggestion,
Watson filed an amendment to its ANDA on February 11,
2014, further narrowing its specification to require a
hardness range of 13–16.5 kp, which the FDA approved
on March 3, 2014. J.A. 243–46, 255–57.
The district court nevertheless issued a final judg-
ment permanently enjoining the manufacture, use, sale,
or offer for sale of Watson’s generic tranexamic acid
product. Final Order at 1–2. The court further ordered
the FDA to reset the approval date of Watson’s ANDA 20-
2093 pursuant to § 271(e)(4)(A) to a date no earlier than
the expiration of Ferring’s asserted patents, viz., March 4,
2025. Id. at 2.
Watson appealed. We have jurisdiction pursuant to
28 U.S.C. § 1295(a)(1). On Watson’s motion, we stayed
the district court’s resetting order and injunction pending
disposition of the appeal.
DISCUSSION
This appeal raises questions of validity and infringe-
ment, but, unlike most such appeals, does not challenge
the district court’s claim construction. As we find no
FERRING B.V. v. WATSON LABORATORIES, INC. – FLORIDA 9

reason to disturb the district court’s claim construction in
this case, we will proceed directly to the issues raised.
I
We first address Watson’s argument that the district
court erred by failing to hold the asserted claims invalid
for obviousness under § 103.
Following a bench trial, we review the district court’s
conclusions of law without deference and its findings of
fact for clear error. Golden Blount, Inc. v. Robert H.
Peterson Co., 365 F.3d 1054, 1058 (Fed. Cir. 2004). A
factual finding is clearly erroneous if, despite some sup-
porting evidence, we are left with the definite and firm
conviction that a mistake has been made. United States
v. U.S. Gypsum Co., 333 U.S. 364, 395 (1948); Alza Corp.
v. Mylan Labs., Inc., 464 F.3d 1286, 1289 (Fed. Cir. 2006).
Watson contends that each limitation of Ferring’s
claims was disclosed or suggested in the prior art. Wat-
son relies on a July 27, 2000 report by the European
Agency for the Evaluation of Medicinal Products Commit-
tee for Proprietary Medicinal Products (“EMA report”)
that evaluates the safety and efficacy of a 500 mg tranex-
amic acid product comprising the excipient hydroxypro-
pylcellulose, which was indicated throughout Europe for
the treatment of menorrhagia. J.A. 13629–37. According
to Watson, it would have been obvious to increase the
amount of tranexamic acid to 650 mg and to package the
drug in a modified oral dosage form because U.S. Patent
5,858,411 of Nakagami described tranexamic acid as one
of many medicinal ingredients that could be used with
proposed sustained release granular preparations con-
taining binders such as hydroxypropylcellulose and
hypromellose. Ferring responds that there were no
disclosures in the prior art that either taught or suggested
650 mg tranexamic acid formulations containing modified
release materials with specified dissolution limitations,
and that the prior art actually taught away from using
10 FERRING B.V. v. WATSON LABORATORIES, INC. – FLORIDA

such a high dose. Ferring also argues that secondary
considerations support the district court’s conclusion of
nonobviousness.
We agree with Ferring and the district court that
Watson failed to prove that the subject matter of the
asserted claims would have been obvious under § 103. A
claim is invalid for obviousness if, to one of ordinary skill
in the pertinent art, “the differences between the subject
matter sought to be patented and the prior art are such
that the subject matter as a whole would have been
obvious at the time the invention was made.” 35 U.S.C.
§ 103(a) (2006); KSR Int’l Co. v. Teleflex Inc., 550 U.S.
398, 406–07 (2007). Obviousness is a legal conclusion
based on underlying factual findings, including: (1) the
scope and content of the prior art; (2) the level of ordinary
skill in the pertinent art; (3) the differences between the
claimed invention and the prior art; and (4) objective
evidence such as commercial success, long-felt but un-
solved need, and the failure of others. Graham v. John
Deere Co., 383 U.S. 1, 17–18 (1966). Furthermore, pa-
tents are presumed to be valid, and overcoming that
presumption requires clear and convincing evidence. 35
U.S.C. § 282; Microsoft Corp. v. i4i Ltd., 564 U.S. __, 131
S. Ct. 2238, 2242 (2011).
In this case, the cited prior art references neither set
forth the limitations required by the asserted claims, nor
provided any reason or motivation to combine those
teachings to derive the claimed formulations with specific
dissolution profiles. Accordingly, the asserted claims
have not been shown to be invalid under § 103.
First, the references disclose 500 mg tranexamic acid
formulations, but no higher tablet strengths, and particu-
larly not the claimed 650 mg formulation. The EMA
report upon which Watson relies specifically notes that an
increased dose of tranexamic acid results in a concomitant
dose-dependent increase in gastrointestinal side effects.
FERRING B.V. v. WATSON LABORATORIES, INC. – FLORIDA 11

J.A. 13631, 13635. Secondly, the references do not dis-
close the claimed amounts of modified release polymers.
The EMA report merely recites hydoxypropylcellulose, a
species of hydroxyalkylcellulose, among a list of a dozen
other excipients, but does not specify an amount present
in the formulation of that polymer or any other inactive
ingredient. J.A. 13636. Nakagami likewise lists tranex-
amic acid as one of more than eight orally dosable medici-
nal ingredients suitable for a sustained-release granular
preparation, but teaches that binders such as hydroxy-
propylcellulose and hypromellose may only be added in an
amount from 1% to 5% by weight of the preparation, and
does not teach any example of a tranexamic acid formula-
tion. J.A. 14481–82. Third, Watson did not identify any
prior art references disclosing the critical dissolution
limitations of the patented claims, but merely asserted in
a conclusory manner that those limitations would have
been obvious or could have been predicted while failing to
address why one of ordinary skill in the art would choose
the specific release profiles claimed. Moreover, support-
ing evidence demonstrated that there was a long-felt and
unmet need for a treatment for menorrhagia that avoided
adverse events, as the FDA recognized in granting “fast
track” status under 21 U.S.C. § 356(b)(1) to the NDA
covering Lysteda®, which is the undisputed commercial
embodiment of Ferring’s asserted claims. See J.A. 13879,
18449–63.
In view of the foregoing, we therefore affirm the dis-
trict court’s holding that Watson failed to prove by clear
and convincing evidence that the asserted claims of
Ferring’s ’739, ’106, and ’795 patents are invalid as obvi-
ous under § 103.
II
We next address the district court’s holdings that
Watson’s ANDA submission and generic tranexamic acid
product infringed the asserted claims.
12 FERRING B.V. v. WATSON LABORATORIES, INC. – FLORIDA

Watson argues that the district court erred in finding
infringement because the accused products do not meet
the claimed in vitro dissolution release rate profile.
Watson contends that its finished, commercial tablets
with the pH-dependent coating dissolve far slower in
water than the limitations set forth in the asserted
claims. Watson asserts that the data showing dissolution
rates of uncoated cores with different levels of hardness
compression reported in document PTX 381 fall within
the experimental use privilege afforded by 35 U.S.C.
§ 271(e)(1) for developmental work done to support an
ANDA application. Watson further asserts that the
accused products do not have the claimed amount of
modified release material.
In response, Ferring maintains that both Watson’s
uncoated cores and coated tablets infringe the asserted
claims because they both contain the requisite amount of
a modified release material and because they both meet
the claimed dissolution limitations. Ferring argues that
Watson’s ANDA specifies that a blend of polymers and
other inactive ingredients, including hypromellose, makes
up 32.87–34.83% of the accused tablets and asserts that
the ANDA describes how Watson chose the type and
amount of such inactive ingredients in its uncoated cores
“such that they would release the tranexamic acid
‘[n]either too fast [n]or too slow.’” Appellee Br. 33 (citing
J.A. 972–83, 13880–82) (alterations in original).
Infringement is a question of fact that we review for
clear error. Amgen Inc. v. Hoechst Marion Roussel, Inc.,
314 F.3d 1313, 1339 (Fed. Cir. 2003). Under the Hatch-
Waxman framework, the filing of an ANDA constitutes an
“artificial” act of infringement for purposes of creating
case or controversy jurisdiction. 35 U.S.C. § 271(e)(2)(A);
Eli Lilly & Co. v. Medtronic, Inc., 496 U.S. 661, 676
(1990); Glaxo, Inc. v. Novopharm, Ltd., 110 F.3d 1562,
1569 (Fed. Cir. 1997). The district court here thus erred
to the extent that it read § 271(e) to mean that Watson’s
FERRING B.V. v. WATSON LABORATORIES, INC. – FLORIDA 13

act of filing an ANDA, by itself, established infringement
sufficient to preclude consideration of the ANDA specifi-
cation and any amendments before the FDA. The filing
only constituted a technical act of infringement for juris-
dictional purposes. J.A. 2192–93, 2248–56, 2316. As we
have explained, once jurisdiction is established, the
ultimate infringement inquiry provoked by such filing is
focused on a comparison of the asserted patent claims
against the product that is likely to be sold following
ANDA approval and determined by traditional patent law
principles. Warner-Lambert Co. v. Apotex Corp., 316 F.3d
1348, 1365 (Fed. Cir. 2003); Abbott Labs. v. TorPharm,
Inc., 300 F.3d 1367, 1373 (Fed. Cir. 2002); Bristol-Myers
Squibb Co. v. Royce Labs., Inc., 69 F.3d 1130, 1135 (Fed.
Cir. 1995). “The plain language of [§ 271(e)(2)(A)] does
not alter a patentee’s burden of proving infringement” by
a preponderance of the evidence, and we have rejected
shifting that burden to the accused infringer to disprove
infringement. Glaxo, 110 F.3d at 1567–68.
The infringement determination is thus based on con-
sideration of all the relevant evidence, and “[b]ecause
drug manufacturers are bound by strict statutory provi-
sions to sell only those products that comport with the
ANDA’s description of the drug,” the ANDA itself domi-
nates the analysis. Abbott, 300 F.3d at 1373; see also
Alcon Research Ltd. v. Barr Labs., 745 F.3d 1180, 1186–
87 (Fed. Cir. 2014). In some cases, the ANDA specifica-
tion directly resolves the infringement question because it
defines a proposed generic product in a manner that
either meets the limitations of an asserted patent claim or
is outside the scope of such a claim. See Sunovion Pharm.
v. Teva Pharm. USA, Inc., 731 F.3d 1271, 1279–80 (Fed.
Cir. 2013) (proposed generic product infringed because the
ANDA specification described an amount of stereoisomer
within the scope of the asserted patent claim); Bayer AG
v. Elan Pharm. Research Corp., 212 F.3d 1241, 1248–50
(Fed. Cir. 2000) (proposed generic product did not infringe
14 FERRING B.V. v. WATSON LABORATORIES, INC. – FLORIDA

because the ANDA specification required a surface area
outside of the range claimed by the asserted patent). In
cases in which the ANDA specification does not resolve
the infringement question in the first instance, we have
endorsed the district court’s reference to relevant evi-
dence, including biobatch data and actual samples of the
proposed generic composition that the ANDA filer had
submitted to the FDA. See Glaxo, 110 F.3d at 1569
(proposed generic product did not infringe because the
ANDA specified only one crystalline form with certain
purity, but did not reveal whether a different crystalline
form claimed by the asserted patents would be present at
all).
This case is more like Glaxo than either Sunovion or
Bayer because Watson’s ANDA specification does not
itself resolve the question of infringement. There is no
specification that calls for measuring the dissolution of its
finished, coated commercial product in water; but silence
does not answer the question of infringement. The focus
that both Ferring and the district court thus gave to
infringement by the uncoated cores of Watson’s generic
product is misplaced. The infringement evaluation is
concerned only with the final, coated commercial tranex-
amic acid tablets for which Watson sought and was grant-
ed FDA approval to market as a generic version of a
treatment of menorrhagia. Id. Watson cannot sell the
uncoated cores alone because it would not comply with its
ANDA specification; to do so would be to sell both an
unapproved and adulterated drug in violation of the law.
See J.A. 1465.
The independent claims of the ’106 and ’795 patents
require “not less than about 50% by weight of the tranex-
amic acid or pharmaceutically acceptable salt thereof
released at about 90 minutes.” ’106 patent col. 69 ll. 16–
19; ’795 patent col. 35 ll. 47–48. The independent claim of
the ’739 patent requires “about 100% by weight tranexam-
ic acid or a pharmaceutically acceptable salt thereof
FERRING B.V. v. WATSON LABORATORIES, INC. – FLORIDA 15

released by about 120 minutes.” ’739 patent col. 69 ll. 63–
65. The dissolution data collected by both parties during
discovery showed that, in an overwhelming majority of
the samples tested by the claimed USP method, only
about 27% to 44% of the tranexamic acid was released
from the individual coated tablets at 90 minutes and only
about 33% to 52% was released at 120 minutes, consistent
with the biobatch data reported in Watson’s ANDA itself.
J.A. 14074, 14218–76, 14751–53, 14768–69, 18290, 18424,
18427, 18443. These data show the samples to be outside
the scope of the asserted claims. Of the hundreds of
coated commercial products tested, only about four indi-
vidual tablets released more than 50% of their tranexamic
acid at 90 minutes, and none of those released more than
about 79% by 120 minutes. Id.
Ferring’s argument that Watson’s own expert conced-
ed in deposition testimony that those results showed that
Watson’s coated tablets met the dissolution limitations of
the asserted claims conveniently ignores that the same
expert also testified at trial that those outliers were not
representative of Watson’s ANDA product. Appellee Br.
43; J.A. 1694–95, 17611–15. The expert, who personally
oversaw the testing and specifically observed the dissolu-
tion tests at issue, testified that “there was something
incomplete about the coating. It lacked coating integrity.
The coating on the tablet sort of came apart and opened
up. It was very atypical and aberrant relative to all of the
other 176 tablets that were examined.” J.A. 1694–95. We
accordingly do not agree with Ferring or the district court
that reliance on such anomalies proves infringement by a
preponderance of the evidence in this case. See In re
Omeprazole Patent Litig., 84 F. App’x 76, 83 (Fed. Cir.
2003) (“For infringement, the record need only reflect
proof by preponderant evidence.”).
Furthermore, the district court in fact found that
Watson’s accused products would not infringe at a core
hardness level of less than 17 kp. When all materials are
16 FERRING B.V. v. WATSON LABORATORIES, INC. – FLORIDA

considered, including amendments, there is no support for
the district court’s inconsistent finding of infringement
under either § 271(e) or § 271(a) because there was no
evidence that Watson either did or will manufacture, use,
or sell any commercial products with a core hardness of
17 kp or greater. J.A. 1408, 1435, 1464, 2317, 14186.
Pursuant to the amendment suggested by the district
court at the close of trial, Watson’s FDA-approved ANDA
specification now only permits it to make, use, and sell
tablets with cores that have a hardness of 13–16.5 kp.
J.A. 243–46, 255–57.
Ferring acknowledges that the only other data on
which it relied at trial and on appeal to prove infringe-
ment was Watson’s own internal project document labeled
PTX 381. Appellee Br. 22. That document reported
dissolution profiles in water of experimental, uncoated
tranexamic acid cores of specified hardness, as measured
by the USP method, which Watson recorded in the devel-
opment of its generic product formulation prior to submit-
ting its ANDA to the FDA. J.A. 991–93, 1617–19, 2003–
11, 2070–72. Those data show that 95% to 100% of the
tranexamic acid is released at 45 minutes from uncoated
cores compressed to a hardness of 13 kp and 16 kp but
that cores with a hardness of 17 kp or greater release 71%
to 77% of the tranexamic acid at 45 minutes. J.A. 14840.
And it was on that basis that the district court found that
both the uncoated cores of Watson’s generic tranexamic
acid product and the final, coated commercial tablets with
a core hardness of 17 kp and greater infringed Ferring’s
asserted claims, which require that less than about 70%
of the tranexamic acid to be released at about 45 minutes.
J.A. 2307–17. But Watson’s PTX 381 document is not
relevant to the question of infringement because it does
not provide any data for the dissolution release rate of
tranexamic acid from Watson’s finished, coated commer-
cial tablets. The data in PTX 381 therefore were not
evidence that Watson’s ANDA product would infringe the
FERRING B.V. v. WATSON LABORATORIES, INC. – FLORIDA 17

asserted claims. Thus, although those data were not part
of the ANDA, either as filed or as finally approved, we
need not address the applicability to them of the experi-
mental use provision of § 271(e)(1).
The asserted independent claims also require that the
accused product contain a certain amount of “modified
release material,” ranging from about 5% to about 50% by
weight of the formulation in the ’795 patent and about
10% to about 35% by weight of the formulation in the ’106
and ’739 patents. ’795 patent col. 35 ll. 31–33; ’106 patent
col. 69 ll. 5–7; ’739 patent col. 69 ll. 54–56. The district
court construed the term “modified release material” to
mean “a material that modifies the release of the active
pharmaceutical ingredient.” Ferring B.V. v. Watson
Labs., Inc. – Fla., No. 11-0481 (D. Nev. Feb. 6, 2013), ECF
No. 295; J.A. 195–96, 204. But under that construction,
which we do not disturb, just because a certain material
can modify release of the active pharmaceutical ingredi-
ent tranexamic acid, does not necessarily mean that it
actually does. Experts for both parties agreed that testing
is required to measure whether a particular excipient
actually functions to modify the release of tranexamic
acid in a given formulation and therefore qualify as a
modified release material. J.A. 1151–52, 1260–61, 1684,
1897–98, 2102–09. Here, however, Ferring did not con-
duct any such testing and thus provided no basis from
which to draw any reliable inferences regarding whether
any of the inactive ingredients in Watson’s ANDA product
would modify the release of the tranexamic acid, regard-
less of the amount present.
Moreover, although it is not readily discernable from
the record that the district court applied its stated con-
struction in its infringement analysis, the only way for
the court to have found that Watson’s finished, coated
commercial tablets infringed the asserted claims would
have been for the court to have determined, as it suggest-
ed during trial, that a modified release material was any
18 FERRING B.V. v. WATSON LABORATORIES, INC. – FLORIDA

material that causes tranexamic acid to behave different-
ly in some way than in water alone. J.A. 1771–73, 1885–
87. That alone would constitute reversible error as it
would not follow its own claim construction.
We have considered Ferring’s remaining arguments
regarding infringement and find them unpersuasive.
Because we hold that the asserted independent claims of
Ferring’s patents are not infringed, the asserted depend-
ent claims are likewise not infringed. Becton Dickinson &
Co. v. C.R. Bard, Inc., 922 F.2d 792, 798 (Fed. Cir. 1990);
Wahpeton Canvas Co. v. Frontier, Inc., 870 F.2d 1546,
1552 n.9 (Fed. Cir. 1989) (“One who does not infringe an
independent claim cannot infringe a claim dependent (and
thus containing all the limitations of) that claim.”). We
thus conclude that the district court erred in finding that
Ferring proved by a preponderance of the evidence that
Watson’s finished, coated commercial tranexamic acid
ANDA product infringed the asserted claims. Therefore,
there is no basis for the district court’s order resetting the
FDA approval date of Watson’s ANDA or the court’s grant
of a permanent injunction against the manufacture, use,
sale, or offer for sale of Watson’s generic tranexamic acid
product, and we accordingly vacate both.
CONCLUSION
For the foregoing reasons, we conclude that the dis-
trict court did not err in holding that Watson failed to
prove by clear and convincing evidence that the asserted
claims of Ferring’s ’739, ’106, and ’795 patents are invalid
as obvious under 35 U.S.C. § 103 and we therefore affirm
that judgment. We also conclude that the district court’s
finding that Watson’s generic tranexamic acid product
infringes Ferring’s asserted claims was not in accordance
with law and therefore reverse that judgment. According-
ly, we vacate the district court’s order resetting the FDA
approval date of Watson’s ANDA 20-2093 and vacate the
district court’s permanent injunction of the manufacture,
FERRING B.V. v. WATSON LABORATORIES, INC. – FLORIDA 19

use, sale, or offer for sale of Watson’s generic tranexamic
acid product.
AFFIRMED IN PART, REVERSED IN PART, and
VACATED IN PART
COSTS
Costs to Watson.