Case 1:17-cv-00379-LPS Document 36 Filed 09/11/17 Page 1 of 46 PageID #: 819
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`BRISTOL~MYERSSQUIBB COMPANY and
`PFIZER INC.,
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`Plaintiffs,
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`v.
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`MYLAN PHARMACEUTICALS INC.,
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`Defendant.
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`C.A. No. 17-379-LPS
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`Joseph J. Farnan, Jr., Brian E. Farnan, and Michael J. Farnan, FARNAN LLP, Wilmington, DE
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`Amy K. Wigmore, Gregory H. Lantier, Tracey C. Allen, Heather M. Petruzzi, and Jeffrey T.
`Hanston, WILMER CUTLER PICKERING HALE AND DORR LLP, Washington, DC
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`Andrew J. Danford, Timothy A. Cook, and Kevin M. Yurkerwich, WILMER CUTLER
`PICKERING HALE AND DORR LLP, Boston, MA
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`Attorneys for Plaintiffs.
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`Stamatios Stamoulis and Richard C. Weinblatt, STAMOULIS &·WEINBLATT LLC,
`Wilmington, DE
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`Robert L. Florence, Micheal L. Binns, Karen L. Carroll, and Sharad K. Bijanki, PARKER POE
`ADAMS & BERNSTEIN LLP, Atlanta, GA
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`Melanie Black Dubis, Christopher M. Thomas, anq Catherine R. L. Lawson, PARKER POE
`ADAMS & BERNSTEIN LLP, Raleigh, NC
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`I
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`Katherine H. Graham, PARKER POE ADAMS & BERNSTEIN LLP, Charlotte, NC
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`. Brandon M. White, PERKINS COIE LLP, Washington DC
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`Attorneys for Defendant.
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`OPINION
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`September 11, 2017
`Wilmington, Delaware
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`

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`Case 1:17-cv-00379-LPS Document 36 Filed 09/11/17 Page 2 of 46 PageID #: 820
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`Presently before the Court is Mylan Pharmaceuticals Inc.' s ("MPI" or "Defendant")
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`motion to dismiss for improper venue in light of the Supreme Court's recent decision in TC
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`Heartland LLC v. Kraft Food Group Brands LLC, 137 S. Ct. 1514 (2017). (D.I. 14)
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`l
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`.
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`It is undisputed that after TC Heaj,land, which hdd that a corporate defendant "resides"
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`only in its state of incorporation for purpJses of determining where venue is proper in a patent
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`.
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`case, see 28 U.S.C. § 1400(b), MPI, a W~st Virginia corporation, can no longer be said to
`"reside" in Delaware. TC Heartland did ~ot, however, address the second prong of§ 1400(b ),
`which makes venue proper in a district "~here the defendant has committed acts of infringeinent
`I i:
`and has a regular and established place of; business."
`MPI, which has submitted an Abb~eviated New Drug Application ("ANDA") to the
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`.
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`I
`I
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`i
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`I
`I
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`!
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`United States Food and Drug Administratn ("FDA") for permission to market and sell a
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`generic Version of one of Plaintiffs' patent-protected drug products, bears the burden to show that
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`.
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`I
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`it does not satisfy the requirements of the :second prong of§ l 400(b ). Given the language of the
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`I
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`I
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`statute giving rise. to Plaintiffs' cause of +tion, 3 5 U.S. C. § 271 ( e )(2), as well as the unique
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`realties of ANDA-related patent litigation'., MPI has failed to meet its burden to show that it has
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`I
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`t
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`not committed acts of infringement in DeJaware. However, the record is less clear with respect
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`to whether MPI has a "regular and establi~hed place of business" here. Accordingly, the Court
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`I
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`I
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`will permit expedited venue-related disco:Very so that it may thereafter determine if venue is
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`.
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`i
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`I
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`proper here. In the meantime, this case -lwhich is related to two dozen other cases relating to the
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`same branded pharmaceutical, Eliquis® i will proceed on the merits.
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`I
`I
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`I
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`Therefore, for the reasons set forth below, the Court will deny MPI' s motion to dismiss
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`I
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`1
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`Case 1:17-cv-00379-LPS Document 36 Filed 09/11/17 Page 3 of 46 PageID #: 821
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`for improper venue, without prejudice to MPI having an opportunity to renew its motion should
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`I
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`I
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`it believe, after expedited venue-related discovery is complete, it can meet its burden to show that
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`I
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`it does not have a "regular andestablisheq place of business" in Delaware.
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`I
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`I.
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`BACKGROUND
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`This is a patent infringement actioh brought by Bristol-Myers Squibb Co. and Pfizer Co.
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`(collectively, "BMS" or "Plaintiffs") unddr the 'Drug Price Competition and Patent Term
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`.
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`I
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`Restoration Act of 1984, commonly refeld to as the "Hatch-Waxman Act." 21 U .S .C. § 3 5 SG).
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`I
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`Defendant MPI submitted an ANDA to mlarket a generic version of BMS' Eliquis®, 2.5 mg and
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`5 mg strength apixaban tablets ("ANDA product"). (D.I. 1 at if 2) BMS asserts Orange Book-
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`-
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`-
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`I
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`-
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`listed1 U.S. Patent Nos. 6,967,208 and 9,126,945, which generally describe and claim chemical
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`compounds, including apixaban, and apixaban formulations.
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`.
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`MPI is a corporation organized un1~er the laws of West Virginia, having its principal place
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`of business in Morgantown, West Virginik. (D.I. 16 at if 3) MPI "is in the business of making
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`and selling generic pharmaceutical produ¢ts, which it distributes in the State of Delaware and
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`I
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`throughout the United States." (D.I. 1 at if 10) MPI is registered with the Delaware Board of
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`I
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`.
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`I
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`Pharmacy as a licensed "Pharmacy- Whjlesale" and "Distributor/Manufacturer CSR." (Jd. at
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`I
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`.
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`if 9) However, MPI does not have any mkufacturing plants, corporate offices, facilities, other
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`real property, telephone listings, mailing ~ddi-esses, or employees in Delaware. (See D.I. 16 at
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`1The FDA's Approved Drug Products with Therapeutic EquivalenceEvaluations -
`commonly called the "Orange Book" - includes a listing of approved drug products and, among
`other things, information about the patents that cover each drug product. See Intendis GMBH v.
`Glenmark Pharm. Inc., USA, 822 F.3d 1355, 1359 (Fed. Cir. 2016); see also 21 U.S.C.
`§ 355(b)(l); 21 C.F.R. §§ 314.3, 314.53.
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`2
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`

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`Case 1:17-cv-00379-LPS Document 36 Filed 09/11/17 Page 4 of 46 PageID #: 822
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`On March 2, 2017, MPI notified BMS that it had submitted its ANDA to the FDA
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`pursuant to§ 505(j) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 3550). (D.I. 1 at
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`if 20) The notice letter stated that MP~ seeks approval from.the FDA to engage in the commercial
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`manufacture, use, and sale of the MPI ANDA product before the expiration of the patents-in-suit.
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`(Id. at if 21)
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`On April 5, 2017, BMS initiated the present action by filing the complaint here in the
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`District of Delaware. BMS' complaint alleges that MPI's submission of the ANDA "to obtain
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`approval to engage in the commercial manufacture, use, offer to sell, or sale of the [MPI] ANDA
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`product prior to the expiration" of BMS' patents constituted a technical act of infringement under
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`35 U.S.C. § 271(e)(2)(A). (Id. at if~ 28, 34) The complaint further alleges that, upon FDA
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`approval ofMPI's ANDA, MPI will infringe, either literally or under the doctrine of equivalents,
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`BMS' patents "by making, using, offering to sell, and selling the [MPI] ANDA product in the
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`United States and/or importing said product into the United States, .or by actively inducing and
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`contributing to infringement ... by others, under 3 5 U.S. C. § 271 (a)-( c ), unless enjoined by the
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`Court." (Id. at ifif 31, 36)
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`Also in the complaint, BMS alleges that "[v]enue is proper in this Court under 28 U.S.C.
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`§ § 13 91 and/ or 1400(b ), including because, inter alia, [MPI] is subject to personal jurisdiction in
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`this district, as set forth above, has committed an act of infringement and will commit further acts
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`2The Court views the statements in this paragraph as being essentially uncontested facts.
`However, if venue-related discovery should reveal a dispute as to any factual statement that is
`contained in any portion of this Opinion about any Mylan entity, the parties may bring that to the
`Court's attention at a later point in this case.
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`3
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`

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`Case 1:17-cv-00379-LPS Document 36 Filed 09/11/17 Page 5 of 46 PageID #: 823
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`of infringement in this judicial district ... [and] has a regular and established place of business in
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`this judicial district." (Id. at ~ 15) BMS further alleges that MPI "has committed an act of patent
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`infringement under 35 U.S.C. § 271(e)(2) and intends a future course ofconduct that includes
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`acts of patent infringement in Delaware," elaborating that MPI "will make, use, import, sell,
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`and/or offer for sale the [MPI] ANDA product in the United States, including in Delaware, prior
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`to the expiration of the patents-in-suit." (Id. at if 12)
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`On May 10, 2017, MPI answered the complaint and, among other thi:p.gs, asserted
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`improper venue as an affirmative defense. (See D.I. 10 at 12)
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`I
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`On May 22, 2017, the Supreme Court issued its decision in TC Heartland, "hold[ing] that
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`_ a domestic corporation 'resides' only in its State of incorporation for purposes of the patent
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`venue statute," adding that "amendments to§ 1391 did not modify the meaning of§ 1400(b)."
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`137 S. Ct. at 1517. The Supreme Court did not construe the second prong of§ 1400(b), which
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`makes venue in a patent case proper where a defendant "has committed acts of infringement.and
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`has a regular and established place of business."
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`On July 25, 2017, MPI moved to dismiss for improper venue under Federal Rule of Civil
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`Procedure 12(b)(3), contending that venue is not proper under either the residency or place of
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`business prongs of§ 1400(b). (D.I. 14) Plaintiffs do not contend that MPI's motion is untimely.
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`Briefing on the motion was completed on August 18, 2017. (See D.I. 15, 21, 25) The
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`Court heard oral argument on August 24, 2017. (See D.I. 35 ("Tr."))3
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`3 At the motions hearing, both Chief Judge Stark and Magistrate Judge Burke presided.
`The hearing concerned not just the motion pending in the instant case, but also similar post-TC
`Heartland venue motions pending in other cases. (See D.I. 20) Judge Stark has been
`tremendously assisted in considering the pending motion by the efforts of Judge Burke.
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`4
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`

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`Case 1:17-cv-00379-LPS Document 36 Filed 09/11/17 Page 6 of 46 PageID #: 824
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`II.
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`LEGALSTANDARDS
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`Generally, "venue provisions are designed, not to keep suits out of the federal courts, but
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`merely to allocate suits to the most appropriate or convenient federal forum." Brunette Mach.
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`Works, Ltd. v. Kockum Indus., Inc., 406 U.S. 706, 710 (1972). Rule 12(b)(3) authorizes a party
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`to move to dismiss a lawsuit for improper venue. When such a motion is filed, the Court must
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`determine whether venue is proper in accordance with the applicable statutes. See Albright v.
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`WL. Gore & Assocs., Inc., 2002 WL 1765340, at *3 (D. Del. July 31, 2002). Venue in a patent
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`infringement action is governed solely and exclusively by the patent venue statute, 28 U.S.C.
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`§ 1400(b). See TC Heartland, 137 S. Ct. at 1516. The general venue statute, 28 U.S.C.
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`§ 1391(c), does not have any application in a patent case. See id. at 1521.
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`If the Court grants a Rule 12(b)(3) motion based on improper venue, the Court "shall
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`dismiss, or if it be in the interest of justice, transfer such case to any district or division in which
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`it could have been brought." 28 U.S.C. § 1406(a).4
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`Generally, "it is not necessary for the plaintiff to include allegations in his complaint
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`showing that venue is proper." Great W Mining & Mineral Co. v. ADR Options, Inc., 434 F.
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`App'x 83, 86-87 (3d Cir. 2011). Hence, when confronted with a motion to dismiss for improper
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`venue, the Court may consider both the complaint and evidence outside the complaint. See 14D
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`Wright & Miller, Federal Practice & Procedure§ 3826 (4th ed. 2017). The Court will accept any
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`venue-related allegations in the complaint as true, unless those allegations are contradicted by the
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`defendant's affidavits. See Bockman v. First Am. Mktg. Corp., 459 F. App'x 157, 158 n.l (3d
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`4While § 1406(a) authorizes the Court to either dismiss or transfer a suit brought in an
`improper venue, for simplicity this Opinion will refer to the improper venue motion as a "motion
`to dismiss."
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`5
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`Case 1:17-cv-00379-LPS Document 36 Filed 09/11/17 Page 7 of 46 PageID #: 825
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`Cir. 2012); In re First Solar, Inc. Derivative Litig., 2013 WL 817132, at *2 (D. Del. Mar. 4, ·
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`2013). In addition, the Court may consider affidavits submitted by the plaintiff. See Boclanan, ·
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`459 F. App'x at 161 (affirming District Court's dismissal of complaint "because Defendants
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`satisfied their burden of showing improper venue by offering evidence that the wrongful acts
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`alleged in the Complaint did not occur in Pennsylvania, and Plaintiffs failed to rebut that
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`evidence").
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`Courts are not uniform in their views as to which party bears the burden of proof with
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`respect to venue. Some hold that a plaintiff must prove that venue is proper in its chosen district,
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`while others hold instead that a defendant must prove that such district is an improper venue. See
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`14D Wright & Miller, Federal Practice & Procedure§ 3826 (4th ed. 2017) ("There are many
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`cases -predominantly, but not exclusively, from the Third and Fifth Circuits-:-- holding that the
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`burden is on the objecting defendant to establish that venue is improper, because venue rules are
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`for the convenience and benefit of the defendant."). At present, it appears the majority view is
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`that "when the defendant has made a proper objection, the burden is on the plaintiff to establish
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`that the chosen district is a proper venue." Id. Notably, however, the Court of Appeals for the
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`Third Circuit - the Circuit in which this District is located - has expressly held that the moving
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`party has the burden of proving that venue is improper. See Myers v. Am. Dental Ass 'n, 695 F .2d
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`716, 724 (3d Cir. 1982) ("[O]n a motion for dismissal for improper venue under Rule 12 the
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`movant has the burden of proving the affirmative defense asserted by it."); see also Great W.
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`Mining, 434 F. App'x at 87 ("Because improper venue is an affirmative defense, the burden of
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`proving lack of proper venue remains - at all times -with the defendant.").
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`While the parties here are in agreement as to what the Third Circuit has held with respect
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`6
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`Case 1:17-cv-00379-LPS Document 36 Filed 09/11/17 Page 8 of 46 PageID #: 826
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`to the burden on venue motions, they disagree as to whether Third Circuit law governs the
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`pending motion. BMS contends that Third Circuit law applies, while MPI insists that, rather, the
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`Court must apply the law of the Court of Appeals for the Federal Circuit. Notably, however,
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`MPI concedes that there is no Federal Circuit precedent' as to either (i) whether Federal Circuit
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`law controls a motion to dismiss for improper venue, or (ii) which party bears the burden of
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`proof on such a motion.
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`MPI does cite to Hoover Group, Inc. v. Custom Meta/craft, Inc., 84 F.3d 1408 (Fed. Cir.
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`1996), which observed that "[v]enue is based on the facts alleged in the well-pleaded complaint,"
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`id. at 1410 (citing Dody v. Brown, 659 F. Supp. 541, 544 n.2 (W.D. Mo. 1987); McGhan v. F.C.
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`Hayer Co., 84 F. Supp. 540, 541 (D. Minn. 1949)). But Hoover does not purport to answer the
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`questions this Court faces now. In Hoover, the Federal Circuit did not make clear whether it was
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`applying Federal Circuit law or regional-circuit law.5 Nor did Hoover make any statement as to
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`which party bears the burden of proof on venue issues. Thus, there appears to be no binding
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`Federal Circuit decision on these points.
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`The Federal Circuit, when reviewing a district court's decision, applies the law of the
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`regional circuit where that district court sits for non-patent issues but applies its own law for
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`issues of substantive patent law. See In re Queen's Univ. at Kingston, 820 F.3d 1287, 1290 (Fed.
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`Cir. 2016). Thus, to determine whether Federal Circuit law controls which party has the burden
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`here, the Court must examine whether the issue is one that is unique to patent law.
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`Procedural matters generally are not considered to be unique to patent law. See Versata
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`5 Hoover's citations to non-patent, district court opinions in the Eighth Circuit suggests
`that the Federal Circuit was applying regional-circuit law. See 84 F.3d at 1409-10 (noting appeal
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`was from decisions of United States District Court for District ofNebraska).
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`7
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`Case 1:17-cv-00379-LPS Document 36 Filed 09/11/17 Page 9 of 46 PageID #: 827
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`Software, Inc. v. Callidus Software, Inc., 780 F.3d 1134, 1136 (Fed. Cir. 2015); Bd. ofTrs. of
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`Leland Stanford Junior Univ. v. Roche Molecular Sys., Inc., 583 F.3d 832, 840 (Fed. Cir. 2009).
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`Still, "a procedural issue that is not itself a substantive patent law issue is nonetheless governed
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`by Federal Circuit law if the issue pertains to patent law, if it bears an essential relationship to
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`matters committed to [the Federal Circuit's] exclusive control by statute, or if it clearly
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`implicates the jurisprudential responsibilities of [the Federal Circuit] in a field within its
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`exclusive jurisdiction." .Midwest Indus., Inc. v. Karavan Trailers, Inc., 175 F.3d 1356, 1359
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`(Fed. Cir. 1999) (internal citations, alterations, and quotation marks'omitted).
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`In the Court's view, the issue of which party bears the burden of proof on a venue
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`challenge is a procedural, non-patent issue controlled by the law of the regional circuit. Such a
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`challenge must comply with, and is brought pursuant to, the Federal Rules of Civil Procedure.
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`By operation of the Federal Rules of Civil Procedure, the venue challenge must be brought ina
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`responsive pleading or as a separate motion under Rule 12(b)(3)- and the burden-of-proof
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`allocation is properly viewed as simply another procedural aspect of a venue dispute. A motion
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`for improper venue under Rule 12(b )(3) is akin to other motions authorized by the Federal Rules
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`of Civil Procedure, such as Rule 12(b )( 6) motions to dismiss for failure to state a claim and
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`motions for judgment as a matter of law. The procedural aspects of these types of motions are
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`controlled by regional-circuit law. See K-Tech Telecomms., Inc. v. Time Warner Cable, Inc., 714
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`F.3d 1277, 1282 (Fed. Cir. 2013) ("Because it raises a purely procedural issue, an appeal from an
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`order granting a motion to dismiss for failure to state a claim upon which relief can be granted is
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`reviewed under the applicable law of the regional circuit."); Finjan, Inc. v. Secure Computing
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`Corp., 626 F.3d 1197, 1202 (Fed. Cir. 2010) (reviewing "denial of post-trial motions for JMOL
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`8
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`Case 1:17-cv-00379-LPS Document 36 Filed 09/11/17 Page 10 of 46 PageID #: 828
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`and new trial under regional circuit law").
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`That venue motions are procedural - and therefore governed by the law of the regional
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`circuit - is true even though the substantive questions at issue may be controlled exclusively by
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`Federal Circuit law. See, e.g., In re TL! Commc 'ns LLC Patent Litig., 823 F.3d 607, 610 (Fed.
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`Cir. 2016) (applying "regional circuit law to the review of motions to dismiss for failure to state a
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`claim under Rule 12(b )( 6)" on issue of whether Rule 12' s plausibility standard had been met,
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`even where motion to dismiss was based on purported failure of patentee to claim patent-eligible
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`subject matter under 35 U.S.C. § 101). Hence, while the substance of a venue challenge in a
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`patent case will tum on§ 1400(b), subject matter that is controlled by Federal Circuit law, the
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`Federal Rules:___ as opposed to a patent-unique statute - provide the procedural vehicle for such a
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`challenge. 6 Cf Atlas IP, LLC v. Medtronic, Inc., 809 F.3d 599, 604-05 (Fed. Cii. 2015)
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`(applying Federal Circuit law to issues of finality because applicable statute, 28 U.S.C.
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`§ 1295(a)(l), is unique to patent law).
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`Accordingly, the Court will apply Third Circuit law to the procedural aspects of
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`Defendant's improper venue motion, which places the burden on Defendant to prove improper
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`venue. See, e.g., Koninklijke Philips N. V. v. ASUSTeK Comput. Inc., 2017 WL 30.55517, at *2
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`6This is not inconsistent with the Federal Circuit's application of its own law to issues of
`personal jurisdiction. See Acorda Therapeutics Inc. v. Mylan Pharm. Inc., 817 F.3d 755, 759
`(Fed. Cir. 2016), cert. denied, 137 S. Ct. 625 (2017). The Federal Circuit has long considered
`personal jurisdiction to be an issue "intimately related to substantive patent law" because it "is a
`critical determinant of whether and in what forum a patentee can seek redress for infringement of
`its rights." Beverly Hills Fan Co. v. Royal Sovereign Corp., 21F.3d1558, 1564 (Fed. Cir. 1994)
`(emphasis added). Venue, however, is not about "whether" a patentee can seek redress, only
`about "where." More importantly, Acorda and Beverly Hills Fan are considering whether
`Federal Circuit law controls the substance of a personal jurisdiction challenge, not the procedural
`vehicle (i.e., a motion under Rule 12(b)(2)) used to bring such a challenge.
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`9
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`Case 1:17-cv-00379-LPS Document 36 Filed 09/11/17 Page 11 of 46 PageID #: 829
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`(D. Del. July 19, 2017); Graphics Props. Holdings Inc. v. Asus Comput. Int'!, Inc., 964 F. Supp.
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`2d 320, 324 (D. Del. 2013). However, all issues of interpretation of§ 1400(b), a patent-specific
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`statute, are controlled by Federal Circuit law. See Midwest Indus., 175 F.3d at 1359; see also
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`D.I. 25 at 9-10 (Defendant agreeing on this point); Tr. at 49-50 (Plaintiffs agreeing on this
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`point).7 Therefore, the Court will look to Federal Circuit precedent to understand and apply the
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`provisions of§ 1400(b). See In re Cordis Corp., 769 F.2d 733, 737 (Fed. Cir. 1985).
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`III. DISCUSSION
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`The patent venue statute, 28 U.S.C. § 1400(b), provides:
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`Any civil action for patent infringement may be brought in ·
`the judicial district [1] where the defendant resides, or [2] [(a)]
`where the defendant has committed acts of infringement and [ (b)]
`has a regular and established place of business.
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`It is undisputed that under the Supreme Court's recent decision in TC Heartland, venue in this
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`case is not proper in Delaware under the "resides" portion of the statute, as MPI is incorporated
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`in West Virginia. (See D.I. 21 at 3, 8 n.7) MPI, therefore, "resides" in West Virginia, not
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`Delaware.
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`The parties' dispute, then, is whether venue is proper in Delaware in accordance with the
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`second prong of§ 1400(b). Venue in Delaware is proper under this portion of the statute unless
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`MPI can show either that (a) MPI has not committed acts of infringement in Delaware, or
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`(b) MPI does not have a regular and established place of business in Delaware. The Court will
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`7Because the motions hearing was consolidated with numerous other cases, the Court's
`citation to the transcript of the hearing should not be taken to mean that counsel for the particular
`Plaintiff or Defendant in the captioned case here expressly made this statement. Where the Court
`has cited to "Plaintiff' or "D.efendant" having said something at the hearing, it is with respect to
`a point on which the particular party in the captioned case here has advocated the sam~ position
`or has otherwise endorsed the position being noted.
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`10
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`Case 1:17-cv-00379-LPS Document 36 Filed 09/11/17 Page 12 of 46 PageID #: 830
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`address each of these requirements in tum.
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`A.
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`Acts of Infringement
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`1.
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`Analysis
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`The first requirement of the second prong of § 1400(b) is. that "the defendant has
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`committed acts of infringement" in this District. The parties do not point to any cases applying
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`this statutory language to a patent infringement case brought under the Hatch-Waxman Act. Nor
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`is the Court aware of any case on point. The issue appears to be one of first impression.
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`The Court begins with the language of the statute, which is written in the present perfect
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`tense: "where the defendant has committed acts of infringement." § 1400(b) (emphasis added).
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`The Supreme Court has emphasized the importance of analyzing "Congress' choice of verb tense
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`to ascertain a statute's temporal reach." Carr v. United States, 560 U.S. 438, 448-49 (2010); see
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`also Cullen v. Pinholster, 563 U.S. 170, 182 (2011) ("This backward-looking language requires
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`an examination of the state-court decision at the time it was made."); United States v. Wilson,
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`503 U.S. 329, 333 (1992) ("Congress' use of a verb tense is significant in construing statutes. By
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`using these verbs in the past and present perfect tenses, Congress has indicated that computation
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`of the credit must occur after the defendant begins his sentence.") (internal citations omitted).
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`But Congress' choice of verb tense in the patent venue statute creates an almost
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`impenetrable problem in the particular context of Hatch-Waxman patent litigation. This is
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`because the temporal focus of the Hatch-Waxman infringement analysis is the future, not - as is
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`true in essentially all other patent infringement suits - the past, or even the present. In a Hatch(cid:173)
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`W axman suit, the subject of the dispute is the generic drug product that the defendant will
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`manufacture and sell and offer for sale in the future (after obtaining FDA approval); a Hatch-
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`11
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`Case 1:17-cv-00379-LPS Document 36 Filed 09/11/17 Page 13 of 46 PageID #: 831
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`Waxman suit is not about a generic product the defendant has sold or is selling. See Acorda
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`Therapeutics Inc. v. Mylan Pharm. Inc., 817 F.3d 755, 760 (Fed. Cir. 2016). Thus, on the
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`surface there appears to be a complete mismatch between the backward-looking nature of the
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`patent venue statute and the forward-looking nature of Hatch-Waxman litigation.8
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`One aspect of the temporal mismatch between§ 1400(b) and the Hatch-Waxman Act
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`bears particular emphasis: much of the backward-looking, historical conduct that constitutes
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`patent infringement in a typical patent lawsuit is expressly and statutorily deemed non-infringing
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`in the context of Hatch-Waxman litigation. This is due to the "safe harbor" provision of Hatch-
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`Waxman, 35 U.S.C. § 271(e)(l), which provides:
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`It shall not be an act of infringement to make, use, offer to sell, or
`sell within the United States or import into the United States a
`patented invention ... solely for uses reasonably related to the
`development and submission of information under a Federal law
`which regulates the manufacture, use, or sale of drugs or veterinary
`biological products.
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`(Emphasis added) Thus, a generic drug company that "has committed" the otherwise infringing
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`acts of making, using, offering to sell, selling, or importing infringing drug products is deemed
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`by statute not to have committed an act of infringement so long as these actions are reasonably
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`related to the anticipated or actual submission of an ANDA. See Merck KGaA v. Integra
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`8In some ways, the forward-looking nature of an infringement case under the Hatch(cid:173)
`Waxman Act is similar to an action for a declaratory judgment of non-infringement or invalidity
`of a patent. "Venue in a declaratory judgment action for patent noninfringement and invalidity is
`governed by the general venue statute, 28 U.S.C. § 1391(b) and (c), and not the special patent
`infringement venue statute, 28 U.S.C. § 1400(b)." U.S. Aluminum Corp. v. Kawneer Co., 694
`F.2d 193, 195 (9th Cir. 1982); Horne v. Adolph Coors Co., 684 F.2d 255, 260 (3d Cir. 1982);
`Emerson Elec. Co. v. Black & Decker Mfg. Co., 606 F.2d 234, 238 (8th Cir. 1979); Gen. Tire &
`Rubber Co. v. Watkins, 326 F.2d 926, 929 (4th Cir. 1964); Barber-Greene Co. v. Blaw-Knox Co.,
`239 F.2d 774, 776 (6th Cir. 1957). Hence, the Court has not found much help in declaratory
`judgment cases in answering the questions presented here.
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`Case 1:17-cv-00379-LPS Document 36 Filed 09/11/17 Page 14 of 46 PageID #: 832
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`Lifesciences L Ltd., 545 U.S. 193, 202 (2005) ("[W]e think it apparent from the statutory text
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`that§ 271(e)(l)'s exemption from infringement extends to all uses of patented inventions that are
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`reasonably related to the development and submission of any information under the [Federal
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`Food, Drug, and Cosmetic Act].").
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`~at, then, does Hatch-Waxman define as an act of infringement? The submission of an
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`ANDA to the FDA, ifthe ANDA seeks approval before the expiration of a patent covering the
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`branded drug to which the generic product is bioequivalent. Thus,§ 271(e)(2) provides:
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`It shall be 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 [from
`the FDA] 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.
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`This "highly artificial-act of infringement" precipitates litigation between the branded drug
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`company and the generic drug company for the express purpose of resolving patent disputes
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`before a generic drug product is launched. Eli Lilly & Co. v. Medtronic, Inc., 496 U.S. 661, 678
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`(1990).9
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`Hence, with the Hatch-Waxman Act, and specifically§ 27l(e), Congress determined that
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`in the context of generic drug development, the submission of the ANDA by the applicant- but
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`not the acts that lead to the submission, which would otherwise be prototypical "acts of
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`9The ANDA applicant is required by statute to provide notice to the owner of the New
`Drug Application ("NDA") relating to the branded drug to which the generic product is
`bioequivalent. See 21 U.S.C. § 355(j)(2)(B). If the owner of the NDA files a patent infringement
`suit within 45 days after receiving such notice, the FDA' s authority to give final approval to the
`ANDA is automatically stayed for 30 months. See id. § 355(j)(5)(B)(iii). These specific,
`expedited, statutory deadlines are aimed at maximizing the opportunities for resolving the drug
`companies' patent disputes before the generic drug product can be marketed. See Apotex, Inc. v.
`Thompson, 347 F.3d 1335, 1338-39 (Fed. Cir. 2003).
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`Case 1:17-cv-00379-LPS Document 36 Filed 09/11/17 Page 15 of 46 PageID #: 833
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`. infringement" - is an act of infringement. Congress created this particularized framework in
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`order to trigger expedited patent litigation between branded and generic drug manufacturers
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`before the generic drug is launched into the market to compete with the branded drug.
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`Despite the "artificial" starting poirit for a Hatch-Waxman lawsuit, the litigation that
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`results from an ANDA submission is not about whether the documents submitted to the FDA are
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`somehow'unlawful. Rather, the ANDA-related litigation.is all about whether a valid patent
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`"[will or] will not be infringed by the manufacture, use, or sale of the new drug for which the
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`application is submitted," which is effectively the same type of analysis involved in a typical
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`patent infringement inquiry. 21 U.S.C. § 355G)(2)(A)(vii)(IV) (emphasis added). Crucially, in a
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`Hatch-Waxman lawsuit, the patent infringement inquiry is necessarily based on future events that
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`will occur following FDA approval, events that have not yet actually occurred. Therefore, as the
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`Federal Circuit "has long recognized," "the infringement inquiry called for by§ 271(e)(2) is
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`'whether, if a particular drug were put on the market, it would infringe the relevant patent' in the
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`usual, non-artificial sense." Acorda, 817 F.3d at 760 (quoting Bristol-Myers Squibb Co. v. Royce
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`Labs., Inc., 69 F.3d 1130, 1135 (Fed. Cir. 1995)); see also Ferring B. V. v. Watson Labs.,
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`Inc.-Florida, 764 F.3d 1401, 1408 (Fed. Cir. 2014) ("The ultimate infringement inquiry
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`provoked by such filing is focused on a comparison of the asserted patent claims against the
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`product that is likely to be sold following ANDA approval and determined by traditional patent
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`law principles.").
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`From all of this, the Court concludes that in the context of Hatch-Waxman litigation, the
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`"acts of infringement" an ANDA filer "has committed" includes all of the acts that would
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`constitute ordinary patent infringement if, upon FDA approval, the generic drug product is
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`Case 1:17-cv-00379-LPS Document 36 Filed 09/11/17 Page 16 of 46 PageID #: 834
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`launched into the market. The submission of an ANDA is a stand-in that serves to move forward
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`in time the infringement and invalidity challenges that otherwise would come later in time, such
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`as after approval or marketing of the ANDA drug. See Glaxo, Inc. v. Novopharm, Ltd., 110 F.3d
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`1562, 1569 (Fed. Cir. 1997) ("The only difference in actions brought under§ 271(e)(2) is that the
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`allegedly infringing drug has not yet been marketed and therefore the question of infringement
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`must focus on what the ANDA applicant will likely market if its application is approved, an act
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`that has not yet occurred."). Despite the fact that allegedly-infringing products have yet to be
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`approved and marketed, the patent infringement inquiry concerns the real-world impact and
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`consequences that would flow from the approval of an ANDA, the submission of whi