Valeant Pharmaceuticals v. Mylan Pharmaceuticals ( 2020 )

Case: 19-2402 Document: 72 Page: 1 Filed: 11/05/2020
United States Court of Appeals
for the Federal Circuit
______________________
VALEANT PHARMACEUTICALS NORTH AMERICA
LLC, VALEANT PHARMACEUTICALS IRELAND
LTD., DOW PHARMACEUTICAL SCIENCES, INC.,
KAKEN PHARMACEUTICAL CO., LTD.,
Plaintiffs-Appellants
v.
MYLAN PHARMACEUTICALS INC., MYLAN
LABORATORIES LTD., MYLAN INC.,
Defendants-Appellees
______________________
2019-2402
______________________
Appeal from the United States District Court for the
District of New Jersey in No. 3:18-cv-14305-PGS-LHG,
Senior Judge Peter G. Sheridan.
______________________
Decided: November 5, 2020
______________________
THOMAS P. STEINDLER, McDermott, Will & Emery LLP,
Washington, DC, argued for all plaintiffs-appellants.
Plaintiffs-appellants Valeant Pharmaceuticals North
America LLC, Valeant Pharmaceuticals Ireland Ltd., Dow
Pharmaceutical Sciences, Inc. also represented by IAN
BARNETT BROOKS, CHRISTOPHER MICHAEL BRUNO, PAUL
MICHAEL SCHOENHARD; CHARLES H. CHEVALIER, Gibbons
P.C., Newark, NJ.
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2 VALEANT PHARMACEUTICALS v. MYLAN PHARMACEUTICALS
JOHN D. LIVINGSTONE, Finnegan, Henderson, Farabow,
Garrett & Dunner, LLP, Atlanta, GA, for plaintiff-appel-
lant Kaken Pharmaceutical Co., Ltd. Also represented by
CORA RENAE HOLT, Washington, DC; CHARLES H.
CHEVALIER, Gibbons P.C., Newark, NJ.
STEFFEN NATHANAEL JOHNSON, Wilson Sonsini
Goodrich & Rosati, Washington, DC, argued for defend-
ants-appellees. Also represented by ADAM WILLIAM
BURROWBRIDGE; WENDY L. DEVINE, KRISTINA M. HANSON,
TUNG ON KONG, San Francisco, CA.
______________________
Before NEWMAN, O’MALLEY, and TARANTO, Circuit Judges.
O’MALLEY, Circuit Judge.
In 2017, the Supreme Court dramatically changed the
venue landscape in patent cases. See TC Heartland LLC v.
Kraft Foods Grp. Brands LLC, 137 S. Ct. 1514 (2017). It
held that the general venue provision in 28 U.S.C. § 1391—
which provides that a corporation is deemed to “reside” in
any judicial district in which it is subject to personal juris-
diction—does not modify the term “resides” in 28 U.S.C.
§ 1400, the more specific venue statute applicable to patent
cases. Specifically, it held that “resides” in § 1400(b) refers
only to a corporation’s state of incorporation. That means
that a corporation may be sued for patent infringement in
only two categories of judicial districts: those in the state
in which it is incorporated and those in which it has a reg-
ular and established place of business and an act of in-
fringement has occurred. TC Heartland raised more
questions than it answered; we and district courts around
the country have been working through those questions
since 2017. Today we tackle one more.
Today we answer the question of where “acts of in-
fringement” under § 1400(b) occur with respect to
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VALEANT PHARMACEUTICALS v. MYLAN PHARMACEUTICALS 3
infringement claims brought pursuant to the Hatch-Wax-
man Act. 1 We conclude that, in cases brought under 35
U.S.C. § 271(e)(2)(A), infringement occurs for venue pur-
poses only in districts where actions related to the submis-
sion of an Abbreviated New Drug Application (“ANDA”)
occur, not in all locations where future distribution of the
generic products specified in the ANDA is contemplated.
Given this conclusion, we affirm the district court’s or-
der dismissing the claims against the two U.S.-based de-
fendants pursuant to Rule 12(b)(3) of the Federal Rules of
Civil Procedure for improper venue. See Valeant Pharms.
N. Am. LLC v. Zydus Pharms. (USA) Inc., No. 18-cv-13635-
PGS-LHG, 2019 WL 4179832 (D.N.J. Aug. 14, 2019). For
the reasons explained below, however, we vacate and re-
mand the portion of the court’s order dismissing the action
against the foreign defendant—as to which venue was un-
questionably proper—pursuant to Rule 12(b)(6), because
the court failed to address the substance of that motion.
I. BACKGROUND
Because this appeal is primarily a venue dispute, the
locations of the parties’ places of incorporation are im-
portant. Less significantly, Valeant Pharmaceuticals
North America LLC, Valeant Pharmaceuticals Ireland
Ltd., Dow Pharmaceutical Sciences, Inc. (“Dow”), and Ka-
ken Pharmaceuticals Co., Ltd. (collectively “Valeant” or
“plaintiffs”) reside in a range of locations, including Japan,
Ireland, and Delaware. On the defendants’ side, Mylan
Pharmaceuticals Inc. (“MPI”) is a West Virginia corpora-
tion with a principal place of business in Morgantown,
West Virginia; Mylan Inc. is a Pennsylvania corporation
with a principal place of business in Canonsburg,
1 The Hatch-Waxman Act is the common name for
the Drug Price Competition and Patent Term Restoration
Act of 1984, Pub. L. No. 98–417, 98 Stat. 1585.
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4 VALEANT PHARMACEUTICALS v. MYLAN PHARMACEUTICALS
Pennsylvania; and Mylan Laboratories Ltd. (“MLL”) is an
Indian corporation with a principal place of business in Hy-
derabad, India.
The parties are all players in the pharmaceutical in-
dustry. Dow holds New Drug Application No. 203567 for
the brand name drug Jublia®, approved by the United
States Food and Drug Administration (“FDA”) on June 6,
2014. Jublia® is a medication used to treat fungal infec-
tions (onychomycosis) of toenails. The active ingredient in
Jublia® is efinaconazole. There are nine patents listed in
the Orange Book for Jublia®.
In June 2018, MPI, a generic drug company, executed
an ANDA seeking approval to market a generic version of
Jublia®. MPI sent the ANDA from its West Virginia cor-
porate office to the FDA, located in White Oak, Maryland.
The ANDA included a Paragraph IV certification that the
Orange-Book-listed patents for Jublia® are invalid, unen-
forceable, or would not be infringed by the ANDA product.
MPI notified Valeant of the ANDA submission in August
2018.
On September 26, 2018, Valeant filed suit against
Mylan 2 in the District of New Jersey, alleging infringement
of Dow’s Orange Book patents pursuant to the Hatch-Wax-
man Act and requesting declaratory judgment of validity of
the Orange Book patents. 3 The complaint contained sev-
eral allegations about Mylan’s connection to New Jersey:
• Each Mylan defendant “directly, or indirectly, devel-
ops, manufactures, markets, and sells generic drug
products throughout the United States and in this
2 We refer to appellees collectively as “Mylan.”
3 Valeant also filed complaints in the District of New
Jersey against eighteen other ANDA filers. None of those
filers challenged venue and the cases have been consoli-
dated with trial scheduled for June 2, 2021.
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VALEANT PHARMACEUTICALS v. MYLAN PHARMACEUTICALS 5
judicial district, and this judicial district is a likely
destination for Mylan’s generic efinaconazole topical
solution.” J.A. 147, ¶ 10 (MPI), 148, ¶ 12 (MLL),
149, ¶ 13 (Mylan Inc.).
• Each Mylan defendant does business in New Jersey
and is registered to do so. J.A. 147, ¶ 10 (MPI), 148
¶ 12 (MLL), 149, ¶ 13 (Mylan Inc.).
• Each defendant has previously submitted to the ju-
risdiction of the court and has a place of business in
New Jersey. J.A. 147–48, ¶ 10 (MPI), 148–49 ¶ 12
(MLL), 149, ¶ 13 (Mylan Inc.).
• MPI applied for FDA approval of its generic drug,
which will be “purposefully directed at, upon infor-
mation and belief, New Jersey and elsewhere.
[MPI’s] ANDA filings constitute formal acts that re-
liably indicate plans to engage in marketing of the
proposed generic drugs.” And MPI plans to market
and sell its generic drug into New Jersey upon FDA
approval. J.A. 148 ¶ 11.
The next day, Valeant filed an essentially identical pro-
tective suit against Mylan in the Northern District of West
Virginia. See Complaint, Valeant Pharms. N. Am. LLC v.
Mylan Pharms. Inc., No. 18-cv-00184-IMK, D.I. 1 (N.D. W.
Va. Sept. 27, 2018). That suit is ongoing.
In January 2019, Mylan moved to dismiss Valeant’s
New Jersey District Court complaint against MPI and
Mylan Inc. for improper venue pursuant to Federal Rule of
Civil Procedure 12(b)(3). Mylan further moved to dismiss
MLL and Mylan Inc. for failure to state a claim pursuant
to Rule 12(b)(6). As to venue, Mylan did not deny the ma-
jority of the venue allegations in Valeant’s complaint. In-
stead, it argued that venue was improper under § 1400(b)
because no Mylan defendant resides in New Jersey, the
only alleged act of infringement—submission of the
ANDA—did not occur in New Jersey, and the Mylan
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6 VALEANT PHARMACEUTICALS v. MYLAN PHARMACEUTICALS
defendants do not have regular and established places of
business in New Jersey.
In response, Valeant argued that it is unduly narrow
to limit “an act of infringement” under § 1400(b) to the act
of submitting the ANDA. Valeant contended that “the
Court must consider Mylan’s planned, future acts.” J.A.
760. It maintained that, in the Hatch-Waxman context,
the language of § 1400(b) must be deemed to contemplate
such planned future conduct. In making this argument,
Mylan relied heavily on Bristol-Myers Squibb Co. v. Mylan
Pharmaceuticals Inc., No. 17-cv-379-LPS, 2017 WL
3980155 (D. Del. Sept. 11, 2017) (holding that venue was
appropriate in ANDA cases, even after TC Heartland,
wherever planned future acts likely would occur).
As to the Rule 12(b)(6) motion, Mylan argued that the
complaint alleged that MPI alone submitted the ANDA and
MPI was thus the only entity against which a case could be
brought under the Hatch-Waxman Act. Valeant answered
that liability for submitting an ANDA is not limited to the
entity that sends the final ANDA to the FDA. J.A. 404 (cit-
ing In re Rosuvastatin Calcium Patent Litig., 703 F.3d 511,
527–28 (Fed. Cir. 2012) (holding that a “submitter” can in-
clude those who participate in the preparation of the ANDA
and intend to directly benefit from marketing of the prod-
uct identified in it)).
In August 2019, the district court granted Mylan’s mo-
tion to dismiss the complaint against all defendants based
on improper venue. The court found that the ANDA was
submitted from West Virginia, rendering venue proper
there. The court then discussed the parties’ arguments
about the relevance of planned future acts to the venue
analysis under § 1400(b). Citing In re Cray Inc., 871 F.3d
1355, 1361 (Fed. Cir. 2017), and In re ZTE (USA) Inc., 890
F.3d 1008, 1014 (Fed. Cir. 2018), for the proposition that
the requirements of the venue statute are specific, unam-
biguous, and not amenable to liberal construction based on
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VALEANT PHARMACEUTICALS v. MYLAN PHARMACEUTICALS 7
policy concerns, the court concluded that the discussion of
venue in Bristol-Myers Squibb “does not follow from a plain
reading of the statute, which is clear: only where a defend-
ant has committed an act of infringement may a party
bring a patent suit.” Valeant Pharms., 2019 WL 4179832,
at *3. Accordingly, the court concluded that the two places
where an act of infringement might have occurred before
the filing of the action were West Virginia and Maryland,
not New Jersey. The court therefore dismissed the in-
fringement claims.
The district court did not separately address Mylan’s
Rule 12(b)(6) motion to dismiss as to MLL and Mylan Inc.
or explain its rationale for dismissing MLL. It did, how-
ever, insert a footnote acknowledging the argument that
MLL, a foreign entity, was properly subject to venue in
every judicial district. The court stated it would not con-
sider MLL in the venue analysis, but noted that venue
would be proper for MLL in West Virginia. Id. at *3 n.2. 4
Valeant timely filed a notice of appeal on September
10, 2019. We have jurisdiction to review the final decision
of the district court pursuant to 28 U.S.C. § 1295(a)(1).
II. ANALYSIS
This appeal presents two issues. First, as noted, we
have been asked to answer a question of first impression
relating to proper venue in Hatch-Waxman cases after TC
Heartland. Second, we apply well-established law to the
question of proper venue for patent cases brought against
foreign entities. We affirm the district court’s determina-
tion that venue was not proper in New Jersey as to the
4 The court also dismissed Valeant’s declaratory
judgment actions. Valeant Pharms., 2019 WL 4179832,
at *4. That decision is not contested on appeal.
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8 VALEANT PHARMACEUTICALS v. MYLAN PHARMACEUTICALS
domestic defendants. We reverse and remand, however, as
to foreign defendant MLL.
A. Venue in Hatch-Waxman Cases
For purposes of determining whether venue is proper
in a district other than one in a state in which a defendant
is incorporated, a court must determine, among other
things, “where the defendant has committed acts of in-
fringement.” 28 U.S.C. § 1400(b). 5 Under the Hatch-Wax-
man Act, it is “an act of infringement to submit [an ANDA]
for a drug claimed in a patent or the use of which is claimed
in a patent . . . if the purpose of such submission is to ob-
tain approval . . . to engage in the commercial manufac-
ture, use, or sale of a drug . . . claimed in 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). Once the act of in-
fringement occurs, the patent holder may then commence
an action under 35 U.S.C. § 271 for infringement. 6 The lit-
igation then proceeds to address the question of whether
any future distribution of the identified generic would in-
fringe a valid patent claim. If so, the court shall enter an
order barring the FDA from approving that distribution
5 To find that venue is proper, a court must also de-
termine that a defendant “has a regular and established
place of business” in the district. 28 U.S.C. § 1400(b). The
district court did not reach the question of whether Mylan
has a regular and established place of business in New Jer-
sey. As such, we do not address that issue on appeal.
6 If the patent holder files its action within forty-five
days of the ANDA submission the FDA’s authority to ap-
prove manufacture and distribution of the generic identi-
fied in the ANDA is stayed for thirty months so that the
litigation may proceed before such activities occur.
21 U.S.C. § 355(j)(5)(B)(iii).
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VALEANT PHARMACEUTICALS v. MYLAN PHARMACEUTICALS 9
prior to expiration of the infringed patent. 35 U.S.C.
§ 271(e)(4)(A).
The question we must answer in this appeal, therefore,
is whether the act of infringement identified in § 1400(b)
occurs only when and where an ANDA-filer submits its
ANDA to the FDA or occurs wherever future distribution
of the generic is contemplated. We address this question
in two parts. We first recount some of our pre-TC Heart-
land case law discussing infringement actions under the
Hatch-Waxman Act. We then address the specific argu-
ments made by Valeant and Mylan as to the propriety of
venue in New Jersey for this case, and how those argu-
ments fare in light of the two statutory schemes at issue.
1. Statutory and Legal Backdrop
Prior to 2017, defendants hoping to transfer Hatch-
Waxman cases to a different district generally objected to
a plaintiff’s chosen venue on personal jurisdiction grounds.
We definitively resolved those arguments in Acorda Ther-
apeutics Inc. v. Mylan Pharmaceuticals Inc., 817 F.3d 755(Fed. Cir. 2016), where we held that planned future acts
were sufficient to justify the exercise of specific personal
jurisdiction over a defendant in ANDA cases. In Acorda,
we held that planned future interactions with the state in
the form of marketing activities met the constitutional
minimum requirements for personal jurisdiction. Id. at
760. While we did not address any statutory venue ques-
tions and specifically disclaimed having done so, this hold-
ing was important to the then-extant venue analysis
because, at that point in time, our case law effectively had
equated personal jurisdiction with venue by incorporating
the definition of “reside” in the general venue statute,
28 U.S.C. § 1391(c)(2), into § 1400(b). See VE Holding
Corp. v. Johnson Gas Appliance Co., 917 F.2d 1574, 1584
(Fed. Cir. 1990) (holding that changes to the general venue
statute meant that, in patent cases, corporations reside in
every venue where personal jurisdiction is proper). Thus,
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10 VALEANT PHARMACEUTICALS v. MYLAN PHARMACEUTICALS
if personal jurisdiction over an ANDA filer could be ob-
tained in any district where that filer intended to market
the generic product described in the ANDA, then venue un-
der § 1400(b) would be proper in the same district because
the ANDA filer would be deemed to “reside” there for venue
purposes as well.
The practical significance of Acorda was markedly con-
tracted when the Supreme Court changed the venue land-
scape for patent cases in TC Heartland. That decision not
only overturned VE Holding and its progeny, it reopened
the effectively resolved question of where Hatch-Waxman
cases could be venued.
When faced with other questions growing out of TC
Heartland, we have narrowly construed the requirements
of venue in patent cases. In Cray, for example, we narrowly
construed § 1400(b)’s requirement of a “regular and estab-
lished place of business.” 871 F.3d at 1361 (“[T]he require-
ment of venue is specific and unambiguous; it is not one of
those vague principles which, in the interests of some over-
riding policy, is to be given a liberal construction.” (quoting
Schnell v. Peter Eckrich & Sons, Inc., 365 U.S. 260, 264
(1961))). We held that (1) there must be “a physical, geo-
graphical location in the district from which the business
of the defendant is carried out”; (2) the defendant’s pres-
ence “must for a meaningful time period be stable, estab-
lished”; and (3) “it must be a place of the defendant.” Id. at
1362–63 (emphasis in original). In In re Google LLC, we
further reinforced the narrowness of the venue inquiry by
clarifying that the venue statute excludes “agents’ activi-
ties, such as maintenance, that are merely connected to,
but do not themselves constitute, the defendant’s conduct
of business . . . .” 949 F.3d 1338, 1347 (Fed. Cir. 2020); see
also id. at 1346 (“[T]he Supreme Court has cautioned
against a broad reading of the venue statute.”). Consist-
ently, we have warned that “[c]ourts should be mindful of
[the specific and unambiguous nature of venue] in applying
the statute and be careful not to conflate showings that
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VALEANT PHARMACEUTICALS v. MYLAN PHARMACEUTICALS 11
may be sufficient for other purposes, e.g., personal jurisdic-
tion or the general venue statute, with the necessary show-
ing to establish proper venue in patent cases.” Cray, 871
F.3d at 1361.
We have had no chance since TC Heartland to address
the question of where infringement occurs in an ANDA
case, however. 7 District courts have struggled with the
question and two competing views have emerged. The first
significant case to address the question was Bristol-Myers
Squibb, 2017 WL 3980155. There, the district court iden-
tified what it called “an almost impenetrable problem” of
reconciling the venue statute’s use of the present perfect
tense (“where the defendant has committed acts of
7 The question of where infringement occurs in the
Hatch-Waxman context is unique in its lack of pre-TC
Heartland guidance. We answered the “where” question
with respect to traditional acts of infringement years ago
in extraterritorial infringement cases. See, e.g., Trans-
ocean Offshore Deepwater Drilling, Inc. v. Maersk Contrac-
tors USA, Inc., 617 F.3d 1296, 1309 (Fed. Cir. 2010)
(stating that the analysis for determining the location of an
offer for sale should focus on “the location of the future sale
that would occur pursuant to the offer”); Litecubes, LLC v.
N. Light Prods., Inc., 523 F.3d 1353, 1369–70 (Fed. Cir.
2008) (holding that an infringing sale may occur in more
than one location as a sale has both a physical and a con-
ceptual dimension to it); NTP, Inc. v. Research in Motion,
Ltd., 418 F.3d 1282, 1317 (Fed. Cir. 2005) (“The use of a
claimed system under section 271(a) is the place at which
the system as a whole is put into service, i.e., the place
where control of the system is exercised and beneficial use
of the system obtained.”); id. at 1318 (“[A] process cannot
be used ‘within’ the United States as required by section
271(a) unless each of the steps is performed within this
country.”).
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12 VALEANT PHARMACEUTICALS v. MYLAN PHARMACEUTICALS
infringement” (emphasis added)) with the Hatch-Waxman
scheme, which focuses on potential future acts. Id. at *6–
7. Ultimately, the court reasoned that, because the actual
substance of ANDA litigation is not about the documents
filed with the FDA but about whether potential future con-
duct would infringe a valid patent, it must be those future
acts that are relevant to the venue analysis. Id. at *8. The
court concluded that “[t]he submission of an ANDA is a
stand-in that serves to move forward in time the infringe-
ment and invalidity challenges that otherwise would come
later in time, such as after approval or marketing of the
ANDA drug.” Id. And, though acknowledging that it was
not controlling of the issue presented, the court noted that
our Acorda decision supported the result reached. Id. at
*8–10.
When faced with the same question a few months later,
one district court in the District of New Jersey adopted the
reasoning in Bristol-Myers Squibb. See Celgene Corp. v.
Hetero Labs Ltd., No. 17-cv-3387-ES-MAH, 2018 WL
1135334, at *3 (D.N.J. Mar. 2, 2018). On that basis, it de-
nied a motion to dismiss for improper venue filed by some
of the generic defendants in that case.
A district court in the Northern District of Texas re-
spectfully disagreed with the Delaware court’s reasoning.
Galderma Labs., L.P. v. Teva Pharms. USA, Inc., 290 F.
Supp. 3d 599, 606–09 (N.D. Tex. 2017). The court con-
cluded both that § 1400(b) requires a past infringement
and that the plain language of the Hatch-Waxman Act does
not identify any act of infringement other than the ANDA
submission. Id. at 607–08. The court reasoned that, be-
cause the potential future acts that the Hatch-Waxman act
anticipates are speculative—many actions never happen
precisely because of the litigation—they cannot control the
venue of the action. Id. at 608. Noting that Cray warned
away from conflating the personal jurisdiction and venue
analyses, the court held that only the locations where the
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VALEANT PHARMACEUTICALS v. MYLAN PHARMACEUTICALS 13
ANDA materials were prepared and from which it was sub-
mitted are relevant to the venue analysis. Id. at 608–09.
The district court’s opinion in this case took a position
akin to that taken by the district court in the Northern Dis-
trict of Texas. We agree with the district court that venue
is improper in New Jersey as to MPI and Mylan Inc. For
the reasons discussed below, we hold that venue in Hatch-
Waxman cases must be predicated on past acts of infringe-
ment—i.e., acts that occurred before the action alleging in-
fringement was filed. And we hold those acts occur only in
districts where actions related to the ANDA submission oc-
cur.
2. Venue Was Not Available in New Jersey for MPI and
Mylan Inc.
We review whether venue is proper under § 1400(b) de
novo. Westech Aerosol Corp. v. 3M Co., 927 F.3d 1378, 1381
(Fed. Cir. 2019). This is an issue unique to patent law and
is therefore governed by Federal Circuit precedent. ZTE,
890 F.3d at 1012.
We begin our analysis with the plain language of the
statutes. At least by the time briefing was complete in this
appeal, both parties agreed that § 1400(b) requires a past
act of infringement. See Appellees’ Br. 14–21; Appellants’
Reply Br. 5. Specifically, “has committed acts of infringe-
ment,” a present perfect phrase, counsels that the acts ac-
cused of infringement must have already occurred. This
understanding is supported by Congress’s choice of words
for the rest of the provision. Congress included two phrases
that are plainly in the present tense (“where the defendant
resides” and “where the defendant . . . has a regular and
established place of business”), indicating that its choice to
place the infringement in the past was intentional. The
heart of the dispute, therefore, is the nature and scope of
the act of infringement defined by 35 U.S.C. § 271(e)(2).
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14 VALEANT PHARMACEUTICALS v. MYLAN PHARMACEUTICALS
As noted, the Hatch-Waxman Act makes it “an act of
infringement to submit [an ANDA] for a drug claimed in a
patent or the use of which is claimed in a patent . . . if the
purpose of such submission is to obtain approval under
such Act to engage in the commercial manufacture, use, or
sale of a drug . . . claimed in 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). A plain language reading of this pro-
vision directs us to the conclusion that it is the submission
of the ANDA, and only the submission, that constitutes an
act of infringement in this context. Valeant makes several
arguments as to why we should understand § 271(e)(2) as
encompassing more. None persuade us to reach a different
conclusion.
Valeant first argues that the Hatch-Waxman act of in-
fringement is “artificial” and, therefore, requires us to look
to planned future conduct to define what is really infring-
ing. Appellants’ Br. 21–25. The Supreme Court, our court,
and district courts have referred to the ANDA submission
as an “artificial act of infringement.” See, e.g., Eli Lilly &
Co. v. Medtronic, Inc., 496 U.S. 661, 678 (1990); Acorda,
817 F.3d at 760; Belcher Pharms., LLC v. Int’l Medication
Sys., Ltd., 379 F. Supp. 3d 326, 330 (D. Del. 2019). The
Hatch-Waxman Act itself never says the act that consti-
tutes infringement is artificial, however. It speaks in real
terms—submission of the ANDA is the infringing act. It
does so, moreover, after declaring other acts, which other-
wise may have been infringing, to be non-infringing when
undertaken solely for purposes of requesting regulatory ap-
proval to market a drug—i.e., solely for purposes of submit-
ting the ANDA. 35 U.S.C. § 271(e)(1). Thus, the statute
“artificially” declares certain very real acts of infringement
to be non-infringing acts and other acts that would not oth-
erwise constitute infringement to be acts of infringement.
But, in both instances the result is real; the statute deline-
ates which acts may or may not give rise to a cause of action
under the Hatch-Waxman Act. The language used by
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VALEANT PHARMACEUTICALS v. MYLAN PHARMACEUTICALS 15
courts to characterize Hatch-Waxman cases does not
change that an ANDA submission is a real, albeit statuto-
rily created, act of infringement. See Eli Lilly, 496 U.S. at
678 (The Hatch-Waxman Act creates “a highly artificial act
of infringement that consists of submitting an ANDA.” (em-
phasis added)).
Valeant next focuses on the nature and substance of
Hatch-Waxman litigation and argues that the act of in-
fringement must encompass more than just submission of
the ANDA. Appellants’ Br. 24–25. As noted, it is true that
the judicial inquiry on the merits once an action has been
commenced considers the ANDA defendant’s potential fu-
ture conduct—i.e., whether the conduct in which that de-
fendant would like to engage would infringe a valid patent.
The content of the litigation does not, however, turn poten-
tial future acts into past infringement. Under the plain
language of the statute, the only past infringing act is the
ANDA submission, which creates the right to bring suit in
the first instance. The result of virtually all Hatch-Wax-
man litigation is, moreover, that no post-submission in-
fringement happens. Sales and offers for sale of the ANDA
product are either non-infringing as determined through
the litigation, or such acts typically never occur. In that
ordinary circumstance (where there is no at-risk market
entry of the generic), the only concrete locations that will
ever be touched by a non-hypothetical past act of infringe-
ment are those connected to the submission of the ANDA
itself.
Valeant also argues that congressional intent supports
its interpretation. Appellants’ Br. 34–39. Valeant argues
that Congress must have meant to allow venue in all the
places that might have been available had a generic en-
tered the market at-risk. The statute does not say that,
however. Importantly, the Supreme Court told us several
things in TC Heartland. First, that its own decision in
Fourco Glass Co. v. Transmirra Products Corp., 353 U.S.
222 (1957), made clear that Congress enacted § 1400(b) in
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16 VALEANT PHARMACEUTICALS v. MYLAN PHARMACEUTICALS
1948 to be a standalone venue statute for patent cases. TC
Heartland, 137 S. Ct. at 1519. Second, that the term “re-
sides” in the first clause of § 1400(b) was meant to have the
same meaning in 1948 as the term “inhabits” had in the
earlier version of that statute—i.e., that corporations were
only subject to suit in patent cases under the first clause of
§ 1400(b) in their state of incorporation. Id. Third, that
Congress expressed no intention to alter either clause of
§ 1400 in 1988 when it enacted amendments to the general
venue statute and made that intention even clearer when
it enacted the current version of the general venue statute
in 2011. Id. at 1521. Given this guidance, we similarly
must assume that, when Congress enacted the Hatch-Wax-
man Act in 1984, it did so with a clear understanding of
where § 1400(b) allowed patent actions to be commenced at
that time. And, we must assume that, when it excepted
Hatch-Waxman cases from the new joinder provisions for
patent cases enacted in 2011, Congress understood that it
was not sub silentio also excepting Hatch-Waxman cases
from 1400(b). As the Court noted in TC Heartland, when
Congress intends to effect a change as sweeping as a revi-
sion to § 1400(b), “it ordinarily provides a relatively clear
indication of its intent in the text” of the statute. Id. at
1520 (citing United States v. Madigan, 300 U.S. 500, 506
(1937)). We can glean no such clear guidance from the text
of the Hatch-Waxman Act.
Valeant further contends that the second clause of the
patent venue statute, allowing venue where an act of in-
fringement occurs if the accused infringer has a regular
and established place of business, is rendered superfluous
by a plain-language reading of the statute. Appellants’ Br.
25–26. Surely, a statute should be interpreted to give all
of its provisions meaning. Corley v. United States, 556 U.S.
303, 314 (2009). But Valeant’s argument fails to recognize
that the second clause retains meaning in every other type
of patent infringement case and will be operative in every
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VALEANT PHARMACEUTICALS v. MYLAN PHARMACEUTICALS 17
Hatch-Waxman case where the ANDA is submitted from a
venue different than the submitter’s place of incorporation.
Next, Valeant argues that we should hold that an
ANDA submission is a nationwide act of infringement
based on a “conceptual” aspect beyond the literal act de-
fined in the statute. Appellants’ Br. 28; Appellants’ Reply
Br. 16–21. It cites Transocean Offshore Deepwater Drill-
ing, Inc. v. Maersk Contractors USA, Inc., 617 F.3d 1296,
1309–11 (Fed. Cir. 2010), where we considered which loca-
tions can logically be said to be the locations of sales and
offers for sale in patent cases. We held that those acts can
occur in more than one location. The analysis looks to both
the location of the parties at the time of contracting and to
the location of anticipated performance. Valeant argues for
a similar, but markedly more expansive, analysis in this
case. Valeant would have us hold that the literal act of in-
fringement—submission of the ANDA—encompasses a
vast “conceptual” element of nationwide infringement in
every judicial district. While we have held that sales and
offers for sale have both physical and conceptual elements,
see Litecubes, LLC v. N. Light Prods., Inc., 523 F.3d 1353,
1369–70 (Fed. Cir. 2008), the conceptual elements in those
cases were connected to common law understandings of
“sales” and “offers for sale.” There is no analogous common
law here that would compel a conclusion that submitting
an ANDA has a purely conceptual effect of causing in-
fringement everywhere in the United States. To reach such
a broad interpretation of the infringing act, without any
textual hook in the statute, would be a bridge too far.
Valeant does have strong policy reasons for adopting
its reading of the statutes. For example, a generic company
may “game” the system to avoid venue in certain jurisdic-
tions. Appellants’ Reply Br. 20. And brand name drug
companies may “be required to file and maintain largely
identical suits in multiple districts” causing an increase in
time and expense to resolve the cases and “result[ing] in
inconsistent judgments.” Bristol-Myers Squibb, 2017 WL
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18 VALEANT PHARMACEUTICALS v. MYLAN PHARMACEUTICALS
3980155, at *12 n.17. While intuitively persuasive, these
policy arguments cannot trump the plain language of
§ 271(e)(2) and the requirements of § 1400(b). We are, as
we must be, guided in our analysis by controlling precedent
stating that venue is not amenable to such policy concerns.
See Cray, 871 F.3d at 1361 (quoting Schnell, 365 U.S. at
264). Congress can revise the two statutes to the extent it
finds these, or other, policy concerns compelling; all we can
do is give the statutes their current plain meaning.
Finally, Valeant looks to Acorda. Appellants’ Br. 29–
33. Acorda did not, however, address proper venue—a
question of statutory interpretation. It was focused on the
narrow constitutional question of whether minimum con-
tacts were present for purposes of personal jurisdiction
based on the ANDA submission. We held that submission
with an intent to distribute the generic product in a given
state was sufficient for personal jurisdiction purposes.
Acorda, 817 F.3d at 762. Acorda said nothing about
whether an act of infringement had already occurred in any
such state or venue. While our then-current venue law
meant Acorda had a big impact on the venue analysis in
Hatch-Waxman cases, we did not address venue in the
case. And, though our venue law has changed, we cannot
stretch Acorda to reach that issue now. As we indicated
then, we would be remiss to treat venue and personal ju-
risdiction as the same inquiry. See id. at 763.
Accordingly, we hold that, in Hatch-Waxman cases,
venue is not proper in all judicial districts where a generic
product specified in an ANDA is likely to be distributed. It
is proper only in those districts that are sufficiently related
to the ANDA submission—in those districts where acts oc-
curred that would suffice to categorize those taking them
as a “submitter” under § 271(e). We find ourselves bound
by the plain language of the statutes and a directive from
the Supreme Court that venue “is not one of those vague
principles which, in the interest of some overriding policy,
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VALEANT PHARMACEUTICALS v. MYLAN PHARMACEUTICALS 19
is to be given a liberal construction.” Schnell, 365 U.S. at
264 (internal quotation marks omitted).
The district court found that no act involved in the sub-
mitting of the ANDA occurred in New Jersey. Valeant does
not challenge that finding on appeal. We therefore affirm
the district court’s dismissal of MPI and Mylan Inc. for im-
proper venue. 8
B. Venue Is Proper for MLL in New Jersey
The district court decision clearly articulates, and it is
undisputed, that MLL is properly subject to venue in any
judicial district, including the District of New Jersey. See
Valeant Pharms., 2019 WL 4179832, at *3 n.2; see also In
re HTC Corp., 889 F.3d 1349, 1358 (Fed. Cir. 2018). The
court’s conclusion dismissing the complaint as to all de-
fendants after only evaluating Mylan’s venue argument is,
therefore, incongruous. Mylan invites us to affirm on an
alternative basis by holding, in the first instance, that Va-
leant failed to state a claim against MLL and that the dis-
trict court likely understood that fact. Appellees’ Br. 44–
46. Whether MLL can be held answerable to claims of
8 The district court’s suggestion that an act of in-
fringement for purposes of this case may have occurred in
the District of Maryland where the FDA received the
ANDA is not challenged in this appeal. While it may well
be that the District of Maryland satisfies the test for venue
that we have laid out here, we do not resolve that question.
We also do not define what all relevant acts involved in the
preparation and submission of an ANDA might be, leaving
those questions for other cases where the precise contours
are presented and briefed. We do agree with the Delaware
district court, however, that acts protected by the safe har-
bor provisions in § 271(e) are non-infringing for all pur-
poses, including venue. See Bristol-Myers Squibb, 2017
WL 3980155, at *7, 11.
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20 VALEANT PHARMACEUTICALS v. MYLAN PHARMACEUTICALS
infringement in this case turns on whether MLL’s involve-
ment in the submission of the ANDA is sufficient for it to
be considered a “submitter,” and thus, amenable to suit.
See Rosuvastatin, 703 F.3d at 527–29. For purposes of a
Rule 12(b)(6) motion, the court must decide whether Vale-
ant plausibly alleged sufficient involvement on the part of
MLL. See, e.g., Galderma, 290 F. Supp. 3d at 615–18;
Cephalon, Inc. v. Watson Pharms., Inc., 629 F. Supp. 2d
338, 349 (D. Del. 2009). Mylan points to paragraph 29 of
the complaint and says Valeant unambiguously asserted
that only MPI was involved in submitting the ANDA. Ap-
pellees’ Br. 44 (citing J.A. 153, ¶ 29). But, as Valeant notes,
there are eight other paragraphs in the complaint assert-
ing that “Mylan”—defined to encompass all three enti-
ties—“submitted” the ANDA and materials related to it.
J.A. 154–64, ¶¶ 35, 46, 57, 68, 79, 90, 101, 112. The district
court may well find that these paragraphs are sufficient to
state a claim against MLL, despite the phrasing in para-
graph 29, or that leave to amend to clarify any apparent
confusion would be appropriate. We thus reverse the dis-
trict court’s venue-based dismissal of MLL and remand for
further consideration. 9
III. CONCLUSION
While, as noted, we are sympathetic to the policy con-
cerns associated with limited venue for Hatch-Waxman
cases, especially those relating to lost judicial efficiencies
in the handling of these mostly multi-defendant cases, we
are compelled to our conclusion by the plain language of
9 The district court also did not answer whether a
claim under § 271(e) has been stated against Mylan Inc.
Because we affirm the dismissal of Mylan Inc. under Rule
12(b)(3), we do not address the district court’s failure to
consider the motion as to that entity under Rule 12(b)(6).
Case: 19-2402 Document: 72 Page: 21 Filed: 11/05/2020
VALEANT PHARMACEUTICALS v. MYLAN PHARMACEUTICALS 21
the two statutes at issue. 10 We therefore affirm the district
court’s dismissal of Valeant’s complaint as to MPI and
Mylan Inc. for improper venue. As to MLL, because venue
is proper in New Jersey for any foreign defendant, we re-
verse the district court’s dismissal and remand.
AFFIRMED-IN-PART, REVERSED-IN-PART, AND
REMANDED
COSTS
No costs.
10 While cumbersome for these types of cases, 28
U.S.C. § 1407 is at least a viable path for consolidation of
these cases for pretrial purposes.