Ferring B v. v. Watson Laboratories, Inc. , 764 F.3d 1382 ( 2014 )

United States Court of Appeals
for the Federal Circuit
______________________
FERRING B.V.,
Plaintiff-Appellant,
v.
WATSON LABORATORIES, INC. - FLORIDA,
Defendant,
AND
APOTEX, INC., AND APOTEX CORP.,
Defendants-Appellees.
______________________
2014-1377
______________________
Appeal from the United States District Court for the
District of Nevada in Nos. 3:11-cv-0481-RCJ-VPC, 3:11-
cv-0485-RCJ-VPC, 3:11-cv-00854-RCJ-VPC and 2:12-cv-
01941-RCJ-VPC, Judge Robert Clive Jones.
______________________
Decided: August 22, 2014
______________________
JAMES B. MONROE, Finnegan, Henderson, Farabow,
Garrett & Dunner, LLP, of Washington, DC, argued for
plaintiff-appellant. With him on the brief were PAUL W.
BROWNING, JUSTIN J. HASFORD and MARY E. CHLEBOWSKI.
2 FERRING B.V. v. APOTEX INC.
DONALD R. MCPHAIL, Cozen O’Connor, of Washington,
DC, argued for defendants-appellees. With him on the
brief were BARRY P. GOLOB, KERRY B. MCTIGUE, W. BLAKE
COBLENTZ, and AARON S. LUKAS.
______________________
Before LOURIE, DYK, and REYNA, Circuit Judges.
DYK, Circuit Judge.
Ferring Corporation (“Ferring”), the owner of U.S. Pa-
tent Nos. 7,947,739 (“the ’739 patent”), 8,022,106 (“the
’106 patent”), and 8,273,795 (“the ’795 patent”) (collective-
ly, the “patents-in-suit”), alleges that Apotex Corporation
(“Apotex”) infringed each and every claim of the patents-
in-suit by filing an Abbreviated New Drug Application
(“ANDA”). The United States District Court for the
District of Nevada dismissed Ferring’s claims as moot in
light of Apotex’s amendment to its ANDA which rendered
the ANDA non-infringing. We affirm.
BACKGROUND
Tranexamic acid, the active ingredient in Ferring’s
patented product, is used to treat heavy menstrual bleed-
ing, or menorrhagia, in women. Tranexamic acid has
been widely used in an immediate release formulation for
more than three decades to treat menorrhagia in other
countries. The inventors of the patents-in-suit sought to
develop a tranexamic acid formulation with fewer gastro-
intestinal side effects than the immediate release version
used abroad, but with the same benefits. They attempted
to do so by creating a formulation with a tranexamic acid
release rate that matched the rate of absorption in the
gastrointestinal tract. Ultimately, the inventors designed
a modified-release formulation that would provide the
same overall dosage of tranexamic acid, but reduce irrita-
tion of the gastrointestinal system with lower dosages
released at a time.
FERRING B.V. v. APOTEX, INC. 3
Ferring’s commercial product embodying the patented
invention is known as Lysteda. In 2004, the Food and
Drug Administration (“FDA”) approved a fast-track
designation for approval of Lysteda, and the Lysteda New
Drug Application (“NDA”) was approved in 2009. Lysteda
is the first tranexamic acid drug approved by the FDA for
treating menorrhagia in the United States.
Ferring 1 filed the applications that gave rise to the
’795, ’106, and ’739 patents in 2008, 2009, and 2010,
respectively. The ’739 and ’106 patents issued in 2011,
and the ’795 patent issued in 2012. Representative claim
1 of the ’106 patent recites:
1. A tranexamic acid oral dosage form comprising:
tranexamic acid or a pharmaceutically acceptable
salt thereof; and
a modified release material . . . ;
wherein the modified release material is present
in the formulation in an amount from about
10% to about 35% by weight [i.e., “wt%”] of the
formulation;
wherein said dosage form provides an in-vitro dis-
solution release rate of the tranexamic acid or
pharmaceutically acceptable salt thereof,
when measured by a USP 27 Apparatus Type
II Paddle Method @ 50 RPM in 900 ml water
at 37±0.5°C., of less than about 40% tranex-
amic acid or pharmaceutically acceptable salt
thereof released at about 15 minutes, less
than about 70% by weight tranexamic acid or
1 The original patent applications were filed by Xa-
nodyne Pharmaceuticals, Inc. Ferring purchased Lysteda
and the rights to the patents-in-suit in 2010. We refer to
Ferring and its predecessor as Ferring.
4 FERRING B.V. v. APOTEX INC.
pharmaceutically acceptable salt thereof re-
leased at about 45 minutes and not less than
about 50% by weight of said tranexamic ac-
id or pharmaceutically acceptable salt thereof
released by about 90 minutes; and
wherein each tranexamic acid oral dosage form
provides a dose of about 650 mg tranexamic
acid.
’106 Patent col. 68 l. 60 to col. 69 l. 21.
The issue of infringement here relates entirely to dis-
solution rates, i.e., the rate at which the salt dissolves into
water. The following chart shows the dissolution rates
specified in the asserted claims of the patents-in-suit:
Claimed Dissolution Rates of Patents-in-Suit
’739 patent, ’106 patent, ’795 patent,
claim 1 claim 1 claim 1
15 No limitation < 40 wt% < 40 wt%
minutes
45 < 70 wt% < 70 wt% < 70 wt%
minutes
90 No limitation ≥ 50 wt% ≥ 50 wt%
minutes
120 100 wt% No limitation No limitation
minutes
Apotex sought to market a generic version of Lysteda.
It attempted to design a generic product that would avoid
infringement of Ferring’s patent applications, but that
would be bioequivalent to Lysteda. Apotex submitted its
initial ANDA to the FDA on August 31, 2010 (“2010
FERRING B.V. v. APOTEX, INC. 5
ANDA”), seeking FDA approval for its generic version of
Lysteda. The 2010 ANDA only had one dissolution speci-
fication: that at least 80 percent by weight of the active
ingredient (tranexamic acid) would dissolve in 60
minutes.
After the ’739 patent issued, Apotex filed a paragraph
IV certification that the generic product specified in the
2010 ANDA did not infringe. Ferring then sued Apotex
for infringement of the ’739 patent. When the ’106 and
’795 patents issued, Apotex submitted paragraph IV
certifications for those patents as well, and Ferring filed
new complaints against Apotex asserting infringement of
the newly issued patents. The three cases were consoli-
dated with a suit that Ferring had filed against Watson
Laboratories, Inc – Florida (“Watson”) concerning the
same patents. 2
In 2012, the district court held a Markman hearing to
construe the disputed terms. Although a number of terms
were at issue, the only relevant construction for the
purposes of this appeal is of the term “about” to mean
“approximately.” “About” is used in the patents-in-suit
multiple times. However, only one use is relevant to this
appeal: where it is used to describe the amount of tranex-
amic acid released at specified times (e.g., “less than
about 70% by weight . . . at about 45 minutes,” ’739 patent
col. 69 ll. 61–63 (emphasis added)). Both parties suggest-
ed that “about” should be construed to demarcate particu-
lar numerical ranges, but disagreed as to what those
2 Watson also had filed an ANDA seeking to market
a generic version of Lysteda, and certified that the ANDA
was not infringing. Ferring then sued Watson. We today
decide Watson’s companion appeal, No. 14-1416, holding
that Watson’s product did not infringe Ferring’s patents,
which also were not shown to be invalid.
6 FERRING B.V. v. APOTEX INC.
numerical ranges should be. Ferring proposed that
“about 70% by weight” includes quantities within 10
percent of the 70 percent by weight specified value (e.g.,
from 63 to 77 percent by weight at 45 minutes), and
Apotex proposed that “about” means “plus or minus 5
percent by weight of the stated value” (e.g., from 66.5 to
73.5 percent by weight at 45 minutes). J.A. 2505. The
district court declined to adopt a numerical range and
ruled that “‘about’ means ‘approximately.’” J.A. 2506.
In January 2014, the district court held a trial on
infringement. At trial, Ferring conceded, and the district
court found, that Apotex’s actual product, based on its
dissolution sample data, did not infringe the patents-in-
suit under 35 U.S.C. § 271(a). However, the district court,
analyzing Apotex’s 2010 ANDA under Sunovion Pharma-
ceuticals, Inc. v. Teva Pharmaceuticals, Inc., 731 F.3d
1271 (Fed. Cir. 2013), concluded that because the 2010
ANDA was silent with respect to the weight percent of
tranexamic acid released at the times specified in the
patent-in-suit, the ANDA permitted Apotex to sell an
infringing product and “permitted [Apotex] to violate the
patent.” J.A. 8945. However, at trial, Apotex agreed to
amend its ANDA specification to include a restriction that
not less than 75 percent by weight of the tranexamic acid
was released at 45 minutes. The district court made a
finding at trial that a tablet with such a dissolution rate
by weight at 45 minutes would be outside the scope of the
patents-in-suit, and therefore, Apotex’s proposed amend-
ment would be outside the scope (because the amount was
in excess of “the about 70% by weight” permitted by the
patent claims), and would not be enjoined.
After trial, Apotex amended its ANDA on February
10, 2014 (the “February 2014 amendment”), to specify
that “not less than 75%” by weight tranexamic acid would
be dissolved at 45 minutes” (the “2014 ANDA”). J.A.
3634. The FDA approved the change on February 21,
FERRING B.V. v. APOTEX, INC. 7
2014. At a hearing on March 5, 2014, the district court
concluded that the 2014 ANDA did not infringe the pa-
tents-in-suit. At this hearing, Apotex also agreed to
stipulate and inform the FDA that both the district court
and Ferring would be notified if Apotex ever attempted to
change the dissolution specification in the future. Accord-
ingly, on March 18, 2014, Apotex sent an additional letter
to the FDA specifying that
[t]he Honorable Judge Jones [i.e., the district
court judge] has therefore instructed Apotex to in-
form the FDA that Apotex will stipulate that its
additional specification of [not less than] 75% in
45 minutes will not be removed from its ANDA
without first informing the Court, counsel for Fer-
ring and the FDA. Further, this stipulation will
be referenced in a court-enforceable judg[]ment
and order to be entered by the Court.
J.A. 5000 (emphasis added). The FDA acknowledged the
second letter on March 19, 2014.
On March 24, 2014, the district court dismissed the
case and “found that Apotex’s [2010] ANDA No. 202286
infringed [the patents-in-suit],” but concluded that “Apo-
tex having Stipulated to amend its ANDA No. 202286
[i.e., the 2014 ANDA] . . . moots Plaintiff’s Complaint with
regard to Apotex’s proposed ANDA amendment.” J.A. 18.
Ferring appealed. We have jurisdiction pursuant to
28 U.S.C. § 1295(a)(1). 3
3 Ferring argues that we cannot consider whether
the original 2010 ANDA is not infringing because Apotex
has not filed a cross-appeal. However, this is simply an
alternative ground for denial of relief to Ferring and
would not enlarge the district court’s judgment. There-
fore, no cross-appeal was required.
8 FERRING B.V. v. APOTEX INC.
DISCUSSION
We address whether either of Apotex’s filed ANDAs—
the original 2010 ANDA or the amended 2014 ANDA—
infringed the patents-in-suit.
I. 2010 ANDA Infringement
Apotex’s 2010 ANDA specified that “NLT [i.e., not less
than] 80% . . . of the labelled amount of tranexamic acid
dissolved in 60 minutes.” J.A. 5067. The district court
concluded that under Sunovion, Apotex was infringing
because Apotex could violate the patents-in-suit based on
the 2010 ANDA, and Ferring makes the same argument
on appeal. We disagree. Sunovion only applies when “an
ANDA specification defines a compound such that it
meets the limitations of an asserted claim.” 731 F.3d at
1280. In Sunovion, that was the case. The ANDA speci-
fied an infringing product. Id. The Sunovion court con-
cluded that a generic drug company could not then avoid
infringement by certifying that it would not infringe,
overriding the language of its own ANDA. Id. Here,
however, the ANDA does not “clearly describe[] a product
that meets the limitations of the asserted claims.” Id. at
1280. Rather, the 2010 ANDA is silent with respect to the
claim limitations of the patents-in-suit, which do not
specify dissolved dissolution rate at 60 minutes. 4
When an ANDA is silent with respect to infringement,
as is the 2010 ANDA, the correct analysis is under Glaxo,
Inc. v. Novopharm, Ltd., 110 F.3d 1562, 1570 (Fed. Cir.
1997), not Sunovion. See also Sunovion, 731 F.3d at
1279–80 (“In Glaxo, we likewise upheld a judgment of no
4 Ferring also contends that 80 percent by weight
dissolution at 60 minutes is contained within one of its
preferred embodiments. But claims are not measured by
the preferred embodiments, but by the claim language.
FERRING B.V. v. APOTEX, INC. 9
literal infringement because the ANDA application speci-
fied only that the generic product would have one crystal-
line form with certain purity, but did not reveal whether a
different crystalline form claimed by the asserted patents
would be present at all.” (citing Glaxo, 110 F.3d at 1569)).
In Glaxo, the patent-holder argued, as Ferring does here,
that “the alleged infringer must disprove infringement if
the ANDA permits sale of a composition that may include
an infringing product.” 110 F.3d at 1567. We disagreed
and concluded that “[t]he relevant inquiry is whether the
patentee has proven by a preponderance of the evidence
that the alleged infringer will likely market an infringing
product. What is likely to be sold, or, preferably, what
will be sold, will ultimately determine whether infringe-
ment exists.” Id. at 1570. For the patent-holder to prove
that a Glaxo-type ANDA is infringing, it must rely on
evidence that the ANDA applicant “would likely sell an
infringing composition pursuant to an approved ANDA.”
Id.Here, in accordance with Glaxo, Apotex has provided
bio-batch data that shows what Apotex is likely to sell.
Ferring’s expert testified that none of the tablets pro-
duced by Apotex in discovery was infringing. At trial,
Ferring conceded that “there’s [no] basis for [the district
court] to find Apotex has violated 271(a),” i.e., that the
product being sold by Apotex did not infringe the patents-
in-suit. J.A. 8875:9–10. Therefore, the evidence shows
that Apotex is not likely to sell an infringing product and
that the district court erred in finding that the 2010
ANDA was infringing.
II. 2014 ANDA Infringement
We must also determine whether the ANDA now in
effect infringes the patents-in-suit. Apotex amended that
ANDA in 2014 in an effort to preclude infringement.
Apotex’s 2014 ANDA—the 2010 ANDA with the February
10 FERRING B.V. v. APOTEX INC.
2014 amendment—specified that “each unit dissolved
NLT [i.e., not less than] 75% [by weight tranexamic acid]
in 45 minutes.” J.A. 3634. We first address whether the
2014 ANDA, stating that not less than 75 percent by
weight tranexamic acid would be dissolved at 45 minutes,
would likely infringe the patents-in-suit. The district
court concluded that the 2014 ANDA would not infringe
because the patents-in-suit required that less than about
70 percent by weight tranexamic acid be dissolved at 45
minutes, and therefore, the February 2014 amendment
mooted Ferring’s complaint. The district court construed
the term “about” as “approximately,” rejecting Ferring’s
proposed construction limiting the term to a particular
numerical range.
Ferring argues that the 2014 ANDA infringes because
Ferring’s proposed construction of “about” to mean ± 10
percent should have been adopted by the district court,
and, under that construction, the patented range of disso-
lution at 45 minutes would include from 63 to 77 percent
by weight dissolution. Under this construction, the 2014
ANDA would infringe because 75 percent by weight
dissolution would fall within the above patented range.
We disagree with Ferring’s proposed construction.
The reference in the specification that Ferring claims
creates a tolerance does no such thing. The basis for
Ferring’s proposed construction is the claims’ reference to
the United States Pharmacopeia (“USP”) 27 Type II
Paddle Method. Ferring argues that under this method,
test results may reflect plus or minus 10 percent of the
stated value, i.e., that “less than about 70% by weight”
would mean less than 63 to 77 percent by weight. That is
not what USP 27 states. USP 27 provides that
In stating the appropriate quantities to be taken
for assays and tests, the use of the word “about”
indicates a quantity within 10% of the specified
FERRING B.V. v. APOTEX, INC. 11
weight or volume. However, the weight or volume
taken is accurately determined and the calculated
result is based upon the exact amount taken. The
same tolerance applies to specified dimensions.
J.A. 3820.
The USP cited by Ferring does not create a tolerance
but, rather, provides that where a dissolution rate is
measured using 900 mL volume as the patents-in-suit
require, a chemist may use a volume of 810 mL or 990 mL
sample for the assay. However, the chemist must still
calculate the 70 percent by weight based on the exact
volume of the sample actually used. The dissolution rate
calculated based on that volume must be exact—“the
calculated result is based upon the exact amount taken.”
J.A. 3820. Therefore, the USP does not suggest that
“about 70% by weight” should be interpreted to include a
10 percent error tolerance.
“About” is not defined either explicitly or by implica-
tion by the specification. We think that the district court
did not err in giving the term “about” its ordinary mean-
ing and in refusing to give it a more specific construction.
See also Merck & Co., Inc. v. Teva Pharms. USA, Inc., 395
F.3d 1364, 1369–70 (Fed. Cir. 2005) (the term “about”
should be given its ordinary and accepted meaning of
“approximately” unless the patentee clearly redefines
“about” in the specification). We affirm the district court’s
construction of “about” to mean “approximately,” as well
as its refusal to construe “about” to represent a particular
numerical error rate. Under the circumstances it fell to
Ferring, the party with the burden of proof on infringe-
ment, to produce evidence that the 2014 ANDA infringed
by proposing a 75 percent by weight dissolution rate,
under the district court’s claim construction. Ferring
produced no such evidence and made no claim that the
12 FERRING B.V. v. APOTEX INC.
ANDA infringed under the district court’s claim construc-
tion. 5
We conclude that the 2014 ANDA specification speaks
directly to the question of infringement and would not
permit Apotex to market an infringing product.
Alternatively, Ferring objects to the district court’s
decision to consider the 2014 ANDA, stating that 35
U.S.C. § 271(e)(4)(A) requires that once a section 271(e)(2)
infringement is found based on the ANDA as first submit-
ted, the district court must order a change in the effective
date of the ANDA. Section 271(e)(2) provides that
[i]t shall be an act of infringement to submit—an
application under section 505(j) of the Federal
Food, Drug, and Cosmetic Act [i.e., 21 U.S.C.
§ 355(j)] . . . for a drug claimed in a patent or the
use of which is claimed in a patent . . . if the pur-
pose of such submission is to obtain approval un-
der such Act to engage in the commercial
manufacture, use, or sale of a drug . . . claimed in
5 While Ferring does not argue for infringement
under the district court’s construction of “about” to mean
“approximately,” it does argue that there is infringement
under Apotex’s proposed construction of “about” to mean
±5 percent. This involves a meaningless apples to oranges
comparison. Under the ±5 percent construction, the
“about 70% by weight” in the patent could mean as high
as 73.5 percent. Because the ANDA allows a 5 percent
variance in the weight of the tablet, comparing the total
weight at the higher end (682.5 mg) with the amount
dissolved using 75 percent by weight rate at 45 minutes
using the sample size required by the patent (650 mg)
yields a 71.4 percent dissolution rate, which is lower than
73.5 percent. There is no basis for making a calculation
that utilizes tablets of different sample weights.
FERRING B.V. v. APOTEX, INC. 13
a patent or the use of which is claimed in a patent
before the expiration of such patent.
35 U.S.C. § 271(e)(2). Section 271(e)(4)(A) specifies that
“[f]or an act of infringement described in [§ 271(e)(2)] the
court shall order the effective date of any approval of the
drug or veterinary biological product involved in the
infringement to be a date which is not earlier than the
date of the expiration of the patent which has been in-
fringed.” 35 U.S.C. § 271(e)(4)(A) (emphasis added). The
district court is not precluded from considering an
amended ANDA when deciding the issue of infringement.
Both section 355(j), referred to in section 271(e)(2),
and the FDA’s regulations contemplate that a pending
application may be amended for various reasons. 6 For the
purposes of section 271(e)(2), “an application” means the
ANDA as filed and all amendments to that application
that have been allowed by the FDA. There is no support
for the proposition that the question of infringement must
be addressed solely based on the initial ANDA filing,
given that the statute contemplates that the ANDA will
6 For example, an applicant may amend and re-
submit an application if the FDA refuses to file the initial
application for various reasons, including where the
reference drug is entitled to a 5-year exclusivity period.
21 C.F.R. § 314.101(a)(3); see also 21 U.S.C. § 355(j)(D)(ii)
(“nothing in this subsection prohibits an applicant from
amending or supplementing the application to seek ap-
proval of a different strength”); 21 C.F.R. § 314.102(b)
(permitting applicants to correct application deficiencies
by amendment during the review process); id. § 314.100
(different review timelines when applicant submits a
major amendment). Newly submitted data can also
provide the basis for approval of a previously refused,
suspended, or withdrawn drug application. Id. § 314.160.
14 FERRING B.V. v. APOTEX INC.
be amended as a matter of course. Nor does it appear
that Ferring contends otherwise.
Indeed, our own precedent conclusively establishes
that sections 271(e)(2) and (4) require consideration of the
amended ANDA. In Bayer AG v. Elan Pharmaceutical
Research Corp., 212 F.3d 1241 (Fed. Cir. 2000), the al-
leged infringer—a generic drug company—filed its ANDA
and paragraph IV certification in 1997, whereupon it was
sued for § 271(e)(2) infringement. Id. at 1246. In 1998,
the generic drug company amended its ANDA to avoid
infringement. Id. The district court in Bayer looked only
to the language of the 1998 ANDA and concluded that the
generic drug company did not infringe. Id. at 1246–47 We
affirmed. Id. at 1249–50. We concluded there that an
amended ANDA that addresses the issue of infringement
and precludes such infringement is generally dispositive.
Id. 7 Here, the conclusion is equally clear—the 2014
ANDA shows that Apotex is not permitted to sell an
infringing product.
However, Ferring contends that this case is different
from Bayer because the ANDA was amended after the
finding of infringement. But the statute does not refer to
the date of the infringement determination by the district
court. Instead, it refers to the date that the ANDA was
filed, and we have already determined that, in this re-
spect, the statute refers not to the initial filing but to the
filing as amended. A district court may reconsider its own
finding of infringement in light of an amended ANDA or
7 We note that in other cases the challenged origi-
nal ANDA was amended during the pendency of litiga-
tion. In those cases, this court and the district court
considered the amended ANDA in determining the issue
of infringement. See Sunovion, 731 F.3d at 1274–75,
1278.
FERRING B.V. v. APOTEX, INC. 15
other information. Only when the district court has
entered a judgment finding that the operative ANDA
infringes must it enter a § 271(e)(4) resetting order. We
do not suggest that a district court must always consider
any ANDA amendment. Allowing an amendment is
within the discretion of the district court, guided by
principles of fairness and prejudice to the patent-holder.
Here, the district court concluded at trial that the
2010 ANDA permitted Apotex to infringe, but agreed not
to enter an injunction or resetting order because Apotex
agreed to amend its ANDA. We conclude that the district
court did not abuse its discretion in reconsidering its
judgment of infringement in light of Apotex’s amendment.
Ferring also argues that its complaint was not mooted
by Apotex’s amendment. A case becomes moot when
interim relief or events have eradicated the effects of a
defendant’s act or omission, and there is no reasonable
expectation that the alleged violation will recur. County
of Los Angeles v. Davis, 440 U.S. 625, 631 (1979). In cases
where a defendant voluntarily ceases the challenged
practice, it is necessary for the court to determine wheth-
er “there is no reasonable expectation that the wrong will
be repeated.” United States v. W.T. Grant Co., 345 U.S.
629, 633 (1953). As a result, “‘a defendant claiming that
its voluntary compliance moots a case bears the formida-
ble burden of showing that it is absolutely clear the
allegedly wrongful behavior could not reasonably be
expected to recur.’” Already, LLC v. Nike, Inc., 133 S. Ct.
721, 727 (2013) (quoting Friends of the Earth, Inc. v.
Laidlaw Envtl. Servs. (TOC), Inc., 528 U.S. 167, 190
(2000)).
Ferring makes no argument that Apotex would file an
infringing ANDA in the future. Apotex’s 2014 amend-
ment meets the governing standard. Apotex cannot sell
an infringing product without modifying its ANDA. If
16 FERRING B.V. v. APOTEX INC.
Apotex introduced a drug into interstate commerce with-
out complying with the FDA approval process, it would be
subject to additional penalties, including criminal sanc-
tions or seizure of the unapproved drug. Bayer, 212 F.3d
at 1250 (citing 21 U.S.C. §§ 331(d), 332(a), 333(a),
334(a)(1), 335a). Here, as in Bayer, “if [the generic drug
company] attempts to change its ANDA specification, it
must pursue approval of the change(s) [with the FDA].
Thus, [the patent-holder] would be able to sue under 35
U.S.C. § 271(e)(2)(A) if any proposed change puts the
drug’s [specification] into an infringing range.” Id. Here
too, Apotex has agreed to notify Ferring and the district
court if an amendment to the ANDA is filed with the
FDA. Therefore, even if the 2010 ANDA were infringing,
the 2014 ANDA is properly considered for the purposes of
§ 271(e)(2) infringement, and any allegedly infringing
conduct is unlikely to recur, given the restrictions that
Apotex has placed on the amendment and the FDA’s own
governing statute.
Finally, Ferring argues that it was prejudiced by Apo-
tex’s late amendment of the ANDA, which precluded
Ferring from presenting evidence at trial on the issue of
infringement. But even at trial the district court made
clear that it was inclined to allow an amendment by
Apotex clarifying the dissolution rate of its product, and
the district court judge discussed the language of the
amendment on the record on January 30, 2014. Ferring
did not request to reopen the record to submit additional
evidence. 8 At the hearing on March 5, 2014, after Apo-
tex’s amendment had been approved, Ferring never
requested that the district court reopen the record to
8 Ferring also argues here that it needed additional
discovery to determine if Apotex’s 2014 amendment was
infringing, but Ferring never requested such discovery.
FERRING B.V. v. APOTEX, INC. 17
address infringement by the 2014 ANDA. In its appellate
brief, Ferring even stated that it had “presented undis-
puted evidence,” Appellant’s Br. 45, relevant to the ques-
tion of whether Apotex’s ANDA infringed and relied on
this evidence to argue that Apotex’s 2014 ANDA was
infringing. Ferring did not show what evidence it would
have proffered if the record were reopened. Therefore, we
conclude that Ferring has not shown that it was preju-
diced by the timing of Apotex’s amendment.
We affirm on the ground that Ferring has not estab-
lished that either Apotex’s 2010 or 2014 ANDA infringes
the patents-in-suit.
AFFIRMED
COSTS
Costs to Apotex.