Case: 19-2402 Document: 72 Page: 1 Filed: 11/05/2020
`United States Court of Appeals
`for the Federal Circuit
`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
`P.C., Newark, NJ.


`Case: 19-2402 Document: 72 Page: 2 Filed: 11/05/2020
` JOHN D. LIVINGSTONE, Finnegan, Henderson, Farabow,
`Garrett & Dunner, LLP, Atlanta, GA, for plaintiff-appel-
`lant Kaken Pharmaceutical Co., Ltd. Also represented by
`CHEVALIER, Gibbons P.C., Newark, NJ.
`Goodrich & Rosati, Washington, DC, argued for defend-
`ants-appellees. Also represented by ADAM WILLIAM
`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


`Case: 19-2402 Document: 72 Page: 3 Filed: 11/05/2020
`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.
`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.


`Case: 19-2402 Document: 72 Page: 4 Filed: 11/05/2020
`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
`On September 26, 2018, Valeant filed suit against
`Mylan2 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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`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


`Case: 19-2402 Document: 72 Page: 6 Filed: 11/05/2020
`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


`Case: 19-2402 Document: 72 Page: 7 Filed: 11/05/2020
`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).
`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.


`Case: 19-2402 Document: 72 Page: 8 Filed: 11/05/2020
`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.
`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).


`Case: 19-2402 Document: 72 Page: 9 Filed: 11/05/2020
`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,


`Case: 19-2402 Document: 72 Page: 10 Filed: 11/05/2020
`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


`Case: 19-2402 Document: 72 Page: 11 Filed: 11/05/2020
`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


`Case: 19-2402 Document: 72 Page: 12 Filed: 11/05/2020
`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
`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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`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-
`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).


`Case: 19-2402 Document: 72 Page: 14 Filed: 11/05/2020
`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
`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


`Case: 19-2402 Document: 72 Page: 15 Filed: 11/05/2020
`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
`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


`Case: 19-2402 Document: 72 Page: 16 Filed: 11/05/2020
`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


`Case: 19-2402 Document: 72 Page: 17 Filed: 11/05/2020
`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

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