Case 1:20-cv-00755-RGA-JLH Document 92 Filed 05/14/21 Page 1 of 34 PageID #: 6673
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`UNITED THERAPEUTICS
`CORPORATION,
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`LIQUIDIA TECHNOLOGIES, INC.,
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`Plaintiff,
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`Defendant.
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`v.
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`C.A. No. 20-755 (RGA)
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`) REDACTED -
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`PLAINTIFF’S MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT OF
`THEIR MOTION FOR ISSUANCE OF A REQUEST FOR JUDICIAL ASSISTANCE
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`Plaintiff United Therapeutics Corporation (“United Therapeutics”) respectfully submits
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`this Memorandum of Law in support of its Motion for the Issuance of a Hague Convention Letter
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`of Request to take the depositions of fact witnesses located in South Korea, pursuant to 28 U.S.C.
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`§ 1781(b), Fed. R. Civ. P. 28(b) and the Convention of 18 March 1970 on the Taking of Evidence
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`Abroad in Civil or Commercial Matters (the “Hague Convention”). Specifically, United
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`Therapeutics seeks the production of the requested documents and property of Yonsung relating
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`to the alleged infringing manufacturing process and the resulting active pharmaceutical ingredient
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`(“API”) product used in Defendant Liquidia Technologies Inc.’s proposed generic copy of UTC’s
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`Tyvaso® (treprostinil) Inhalation Solution, 0.6 mg/ml (“Proposed Generic Product”). It is also
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`requested that testimony be obtained from three employees of Yonsung – Chang Young Oh, Yong
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`Hyun Kim, and Eunhee Ban – regarding the manufacturing process and the resulting API product
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`used in Defendant Liquidia Technologies Inc.’s Proposed Generic Product, and that the answers
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`to those questions be recorded verbatim by a court reporter, at the expense of Plaintiff. United
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`1
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`Original Filing Date: April 30, 2021
`Redacted Filing Date: May 14, 2021
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`PUBLIC VERSION
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`IPR2021-00406
`United Therapeutics EX2027
`Page 1 of 34
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`Case 1:20-cv-00755-RGA-JLH Document 92 Filed 05/14/21 Page 2 of 34 PageID #: 6674
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`Therapeutics’ proposed Letter of Request was submitted to the Court for review and consideration
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`as Exhibit “A” to this Motion.
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`I. THE DISTRICT COURT HAS THE AUTHORITY TO ISSUE LETTERS OF
`REQUEST UNDER THE HAGUE CONVENTION
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`The Hague Convention provides that “[i]n civil or commercial matters a judicial authority
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`of a Contracting State may, in accordance with the provision of the law of that State, request the
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`competent authority of another Contracting State, by means of a Letter of Request, to obtain
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`evidence, or to perform some other judicial act.” Hague Convention, Art. 1. Both the United
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`States and the Republic of Korea are parties to the Hague Convention. The Republic of Korea
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`ratified the Hague Convention on August 20, 1997. See Hague Conf. on Private Int’l Law, Status
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`Table, Member: Republic of Korea, http://www.hcch.net/index_en.php?act=states.details&sid=48
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`(last visited April 22, 2021).
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`The Hague Convention authorizes the District Court for the District of Delaware to issue
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`the Letter of Request. See Societe Nationale Industrielle Aerospatiale v. U.S. Dist. Court for S.
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`Dist. of Iowa, 482 U.S. 522, 535 (1987) (stating that “a judicial authority in one contracting state
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`‘may’ forward a letter of request to the competent authority in another contracting state for the
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`purpose of obtaining evidence”); see, e.g., 28 U.S.C. § 1781(b)(2) (permitting “the transmittal of
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`a letter rogatory or request directly from a tribunal in the United States to the foreign or
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`international tribunal, officer, or agency to whom it is addressed and its return in the same manner”
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`and reproducing the Hague Convention). The purpose of the Hague Convention is to establish a
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`system, based on international comity, that enables a requesting state to obtain evidence abroad in
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`a manner “tolerable” to the state executing the request. See Societe Nationale, 482 U.S. at 530.
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`Accordingly, United Therapeutics requests that the Court issue the attached Letter of
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`Request to the Korean Judicial Authorities on behalf of United Therapeutics. See Ingenico Inc. v.
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`2
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`IPR2021-00406
`United Therapeutics EX2027
`Page 2 of 34
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`Case 1:20-cv-00755-RGA-JLH Document 92 Filed 05/14/21 Page 3 of 34 PageID #: 6675
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`
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`IOENGINE, LLC, C.A. No. 18-826-WCB (D. Del. Mar. 17, 2021) (granting motion to issue Letters
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`of Request to Israel under Hague Convention); Helios Streaming, LLC v. Vudu, LLC, C.A. Nos.
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`19-1792-CFC-SRF, -1978-CFC-SRF (D. Del. Mar. 12, 2021) (granting motion to issue Letters of
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`Request to Korea and to Japan to compel testimony under Hague Convention); Pfizer Inc. v.
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`Apotex, Inc., C.A. No. 18-795-RGA (D. Del. May 21, 2019) (granting motion to issue Letter of
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`Request to China under Hague Convention); 3G Licensing, S.A. v. HTC Corp., C.A. No. 1-17-cv-
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`00083-LPS (D. Del. Apr. 6, 2020) (granting motion to issue Letter of Request to the Netherlands
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`under Hague Convention); Mallinckrodt IP Unlimited Co. v. B Braun Medical Inc., C.A. Nos. 1-
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`17-cv-00365-LPS, -00660-LPS (D. Del. Apr. 24, 2018) (granting motion to issue Letter of Request
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`under Hague Convention); Plastic Ominum Advanced Innovation and Research v. Donghee
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`America, Inc., C.A. No. 16-187-LPS-CJB (D. Del. May 11, 2017) (granting motion to issue Letter
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`of Request to Korea under Hague Convention); Pronova BioPharma Norge AS v. Teva Pharm.
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`USA, Inc., 708 F. Supp. 2d 450, 456 (D. Del. 2010) (granting motion to issue Letters of Request
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`to Sweden under Hague Convention); AstraZeneca v. Ranbaxy Pharm. Inc., 2008 WL 314627 at
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`*6 (D. N.J. Jan. 29, 2008) (granting motion to issue Letter of Request for oral deposition testimony
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`and to obtain related documents in Sweden under Hague Convention); cf. Miller v. Holzmann, No.
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`95-1231, 2006 WL 3093122 (D.D.C. Oct. 31, 2006) (granting motion to issue Letters of Request
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`to Germany under Hague Convention).
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`II. BACKGROUND
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`Plaintiff United Therapeutics Corporation (“UTC”) holds New Drug Application No.
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`022387, which has been approved for Tyvaso® (treprostinil) Inhalation Solution, 0.6 mg/ml,
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`indicated for the treatment of pulmonary arterial hypertension, which UTC markets and sells under
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`the registered trademark Tyvaso®. UTC owns three U.S. patents covering Tyvaso® and its United
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`3
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`IPR2021-00406
`United Therapeutics EX2027
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`Case 1:20-cv-00755-RGA-JLH Document 92 Filed 05/14/21 Page 4 of 34 PageID #: 6676
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`States Food and Drug Administration’s (“FDA”) approved manufacture and uses, which have been
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`listed in connection with Tyvaso® in the FDA’s Approved Drug Products with Therapeutic
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`Equivalents publication (also known as the “Orange Book”): United States Patent Nos. 9,593,066
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`(“the ’066 patent”), 9,604,901 (“the ’901 patent”), and 10,716,793 (“the ’793 patent”)
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`(collectively, “the asserted patents”).
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`Defendant Liquidia Technologies Inc. (“Liquidia”) submitted New Drug Application No.
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`213005 under § 505(b)(2) of the Federal Food, Drug and Cosmetic Act (“Liquidia’s 505(b)(2)
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`Application”) to the FDA seeking approval, prior to the expiration of the ’066 patent, the ’901
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`patent, and the ’793 patent, to manufacture, market, and sell a generic copy of UTC’s Tyvaso®
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`(treprostinil) Inhalation Solution, 0.6 mg/ml (“Liquidia’s Proposed Generic Product”).
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`In June 2020, UTC filed the present lawsuit. UTC claims that Liquidia’s Proposed Generic
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`Product infringes the asserted patents. Liquidia denied these claims, even though (1) Liquidia’s
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`Proposed Generic Product contains the same active compound, treprostinil, as UTC’s approved
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`Tyvaso® product; (2) Liquidia’s 505(b)(2) Application seeks approval from the FDA to market
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`Liquidia’s Proposed Generic Product for the same indication as UTC’s approved Tyvaso® product;
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`and (3) Liquidia’s 505(b)(2) Application refers to and relies upon UTC’s NDA No. 022387 for
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`Tyvaso® (treprostinil) Inhalation Solution, 0.6 mg/ml. In this case, UTC must show that the
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`process by which Liquidia prepares its Proposed Generic Product (and Liquidia’s Proposed
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`Generic Product itself) is the same as the process and product covered by the claims of the asserted
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`patents.
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`Accordingly, Yonsung Fine Chemicals Co., Ltd. (“Yonsung”) is a critical third party to
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`this case. It manufactures the active pharmaceutical ingredient (“API”) in Liquidia’s Proposed
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`Generic Product. Documents produced by Liquidia include Supply and Quality agreements with
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`4
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`IPR2021-00406
`United Therapeutics EX2027
`Page 4 of 34
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`Case 1:20-cv-00755-RGA-JLH Document 92 Filed 05/14/21 Page 5 of 34 PageID #: 6677
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`Yonsung, referencing for example, that the API will be manufactured for Liquidia by Yonsung
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`pursuant to a Drug Master File (DMF) prepared by Yonsung, testing, manufacturing, quality
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`checks, processing, reporting, auditing, and other interactions; portions of the DMF submitted on
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`behalf of Yonsung; and correspondence with Yonsung employees, regarding, for example,
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`materials, synthesized materials, processes, and FDA submissions relating to Yonsung’s
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`manufacturing process and the resulting API product. However, the partial correspondence,
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`agreements, and partial documents (e.g., portions of a single DMF version confirming the
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`existence of other sections and versions) produced by Liquidia to-date are incomplete and do not
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`fully explain the interactions or information relevant to the infringement inquiry. Therefore, it is
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`critical that Yonsung produce the requested documents and property of Yonsung relating to the
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`alleged infringing manufacturing process and the resulting API product, and that at least certain
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`Yonsung employees testify about their knowledge of Yonsung’s alleged infringing manufacturing
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`process and resulting API product. The requested documents, property and testimony, are
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`necessary, in the interests of justice, for UTC to support its infringement case at trial.
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`III. ARGUMENT
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`The issuance of the Letter of Request is warranted for several reasons. First, documents
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`produced by Liquidia including Supply and Quality agreements with Yonsung, referencing for
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`example, that
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` portions of a 2020 version of the DMF submitted on behalf of Yonsung as a
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`manufacturer; and correspondence with Yonsung employees, regarding, for example, materials,
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`synthesized materials, processes, and FDA submissions relating to Yonsung’s manufacturing
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`5
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`IPR2021-00406
`United Therapeutics EX2027
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`process and the resulting API product confirm that Yonsung manufactures the API in Liquidia’s
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`Proposed Generic Product, pursuant to Yonsung’s DMF. Therefore, Yonsung is a critical third
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`party to the case, and only Yonsung can provide samples from the steps of the synthesis process
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`discussed above. The correspondence between Liquidia and Yonsung does not fully explain the
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`interactions or information relevant to the infringement inquiry, and so it is critical that Yonsung
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`produce these samples. These samples will assist UTC in showing that Liquidia’s process for
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`preparing its Proposed Generic Product, as well as the product itself, is a process and product
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`covered by the claims of the asserted patents. Production of the samples is thus in the interest of
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`justice. These materials should be produced pursuant to Articles 364 and 366 of the Korean Civil
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`Procedure Act.
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`Second, concerning document production, Yonsung is the holder of documents which UTC
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`requires in order to establish that the Treprostinil Sodium manufactured by Yonsung and used by
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`Liquidia infringes UTC’s patents relating to the manufacture of Treprostinil Sodium. For example,
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`Liquidia’s recent responses to UTC’s Requests for Production of “documents and things
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`concerning testing . . . created by or in the process described in Yonsung’s DMF” repeatedly
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`“object[ed] to this request to the extent it seeks documents in possession of third parties, e.g.,
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`Yonsung, and thus not within the possession, custody, or control of Liquidia.” Liquidia’s recently
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`amended Paragraph 3 ESI Disclosures confirm that “Liquidia has not, to date, engaged in third-
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`party discovery under Fed. R. Civ. P. 45. Liquidia has, as communicated to UTC, contacted
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`Yonsung to request documents in Yonsung’s possession, custody, or control, as described in
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`Section 2.4 of the LIQ861 Supply agreement between LGM Pharma LLC, Yonsung Fine
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`Chemicals Co., Ltd., and Liquidia Technologies, Inc. dated as of January 10, 2020.” Section 2.4,
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`among others in the Supply and Quality agreements between Liquidia and Yonsung, confirms that
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`However, Liquidia has not been able to confirm, or provide any certainty to UTC, including
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`in correspondence or conference between counsel for the parties on April 29, 2021, that
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`Liquidia/counsel will be able to obtain copies of the requested DMF, testing or other information
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`requested by UTC and relevant to this case, whether by the substantial completion of discovery
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`date, or otherwise. These documents should be produced pursuant to Article 344(2) of the Korean
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`Civil Procedure Act.
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`Third, the deposition testimony requested in the Letter of Request is highly relevant to
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`United Therapeutics’ allegations of infringement. United Therapeutics’ complaint alleges that
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`Liquidia’s ANDA product infringes the asserted patents which cover the manufacturing process
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`and the API in Tyvaso®. Accordingly, United Therapeutics seeks deposition testimony tailored to
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`determine Yonsung’s manufacturing process and form of API produced therefrom that is then
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`supplied to Liquidia for use in Liquidia’s allegedly infringing ANDA product. United
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`Therapeutics anticipates that the requested testimony will be highly material to the issue of
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`infringement in this lawsuit. United Therapeutics does not seek information the disclosure of
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`which would compromise the security of the Republic of Korea.
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`United Therapeutics recognizes that in accordance with Article 23 of the Hague
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`Convention, the Republic of Korea will not execute Letters of Request issued for the purpose of
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`obtaining pre-trial discovery of documents where the Letter of Request requires a person “to state
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`what documents relevant to the proceedings to which the Letter of Request relates are, or have
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`been, in his or her possession, custody or power,” or “to produce any documents other than
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`particular documents specified in the Letter of Request, which are likely to be, in his or her
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`7
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`IPR2021-00406
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`possession, custody or power.” See Republic of Korea, Declaration 2 to Hague Convention,
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`http://www.hcch.net/index_en.php?act=status.comment&csid=1057&disp=resdn
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`(last visited
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`April 22, 2021). Consistent with this reservation, the attached Letter of Request seeks only the
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`oral testimony of three knowledgeable Yonsung witnesses regarding the manufacturing process
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`and resulting API used in Liquidia’s ANDA Product. The Letter of Request does not request that
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`the witnesses, Yonsung, or any other Korean entity, state which documents are relevant to the
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`proceedings. Moreover, United Therapeutics will comply with any procedures required under
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`Korean law for the taking of depositions.
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`United Therapeutics is unable to obtain the testimony of the witnesses by any other means,
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`inasmuch as the relevant witness are in the Republic of Korea and, upon information and belief,
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`are not domiciled in the United States, and thus are beyond the reach of the Court’s regular
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`subpoena power. Without the requested Yonsung witnesses, United Therapeutics’ ability to prove
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`infringement in this action will be prejudiced.
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`United Therapeutics is fully prepared to meet the procedural requirements for obtaining
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`evidence through a Letter of Request. The steps in the process of obtaining judicial assistance are:
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` United Therapeutics must obtain a Letter of Request with a District Court judge’s signature
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`and the District Court’s seal.
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` The Letter of Request must include the identities of the parties, the nature of the
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`proceedings, the discovery sought, special procedures, the identity of the party that will
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`bear any costs, and other information as recommended by the Hague Convention. See
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`Hague Convention, Model for Letters of Request recommended for use in applying the
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`Hague Convention of 18 March 1970 on the Taking of Evidence Abroad in Civil or
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`8
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`IPR2021-00406
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`Case 1:20-cv-00755-RGA-JLH Document 92 Filed 05/14/21 Page 9 of 34 PageID #: 6681
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`
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`Commercial Matters, http://www.hcch.net/upload/actform20e.pdf (last visited April 22,
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`2021).
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` United Therapeutics must transmit the letter to the Central Authority for the Republic of
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`Korea for enforcement in a Korean court. The Korean court will serve the requests on
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`Yonsung.
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`In view of the Republic of Korea’s ratification, reservations, and declarations to the Hague
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`Convention, United Therapeutics respectfully requests that the Court issue the attached Letter of
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`Request directed to the Central Authority for the Republic of Korea (Exhibit A).
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`The United States District Court for the District of Delaware (“the District Court”) presents
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`its compliments to the Director of International Affairs, and has the honor of requesting
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`international judicial assistance in obtaining evidence to be used in civil proceedings before this
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`MORRIS, NICHOLS, ARSHT & TUNNELL LLP
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`/s/ Michael J. Flynn
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`
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`Jack B. Blumenfeld (#1014)
`Michael J. Flynn (#5333)
`1201 North Market Street
`P.O. Box 1347
`Wilmington, DE 19899
`(302) 658-9200
`jblumenfeld@morrisnichols.com
`mflynn@morrisnichols.com
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`Attorneys for Plaintiff United Therapeutics
`Corporation
`
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`Court in the above-captioned matter.
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`
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`OF COUNSEL:
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`William C. Jackson
`BOIES SCHILLER FLEXNER LLP
`1401 New York Avenue NW
`Washington, DC 20005
`(202) 237-2727
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`Bill Ward
`BOIES SCHILLER FLEXNER LLP
`725 S Figueroa Street, 31st Floor
`Los Angeles, CA 90017
`(213) 995-5745
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`Douglas Carsten
`MCDERMOTT WILL & EMERY LLP
`18565 Jamboree Road, Suite 250
`Irvine, CA 92615
`(949) 851-0633
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` April 30, 2021
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`9
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`Page 9 of 34
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`Case 1:20-cv-00755-RGA-JLH Document 92 Filed 05/14/21 Page 10 of 34 PageID #: 6682
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`EXHIBIT A
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`IPR2021-00406
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`Page 10 of 34
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`Case 1:20-cv-00755-RGA-JLH Document 92 Filed 05/14/21 Page 11 of 34 PageID #: 6683
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`
`)
`)
`)
`)
`)
`)
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`)
`)
`)
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`Plaintiff,
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`Defendant.
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`C.A. No. 20-755 (RGA)
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`FILED UNDER SEAL
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`UNITED THERAPEUTICS
`CORPORATION,
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`LIQUIDIA TECHNOLOGIES, INC.,
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`v.
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`REQUEST FOR INTERNATIONAL JUDICIAL ASSISTANCE PURSUANT TO THE
`CONVENTION OF 18 MARCH 1970 ON THE TAKING OF EVIDENCE ABROAD IN
`CIVIL OR COMMERCIAL MATTERS (THE HAGUE CONVENTION)
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`To the extent that this request may be handled in an expedited manner, the Requesting Authority
`respectfully requests that it be so handled.
`
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`The United States District Court for the District of Delaware (“the District Court”) presents
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`its compliments to the Director of International Affairs, and has the honor of requesting
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`international judicial assistance in obtaining evidence to be used in civil proceedings before this
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`Court in the above-captioned matter.
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`The District Court requests that the Director of International Affairs appoint an Executing
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`Court for the purpose of ordering a hearing to obtain documents and testimony for trial from a non-
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`party witness, Yonsung Fine Chemicals Co., LTD (“Yonsung”).
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`This request is made pursuant to, and in conformity with, Chapter I of the Convention of
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`18 March 1970 on the Taking of Evidence Abroad in Civil or Commercial Matters (“the Hague
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`Convention”), to which both the United States and the Republic of Korea are a party, and Rules
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`28 and 30 of the United States Federal Rules of Civil Procedure.
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`Plaintiff in this matter represents that the documents sought are directly relevant to the
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`1
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`issues in dispute, are necessary for purposes of trial, and are not discovery within the meaning of
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`Article 23 of the Hague Convention. Plaintiff further represents that this Request complies with
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`reservations made by the Republic of Korea under the Hague Convention.
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`The particulars of this Hague Evidence Request are as follows:
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`1.
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`Sender:
`
`The Honorable Judge Richard G. Andrews
`United States District Judge
`United States District Court for the District of Delaware
`J. Caleb Boggs Federal Building
`844 North King Street
`Wilmington, Delaware 19801
`United States of America
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`Central Authority of the Requested State:
`
`National Court Administration
`Attn: Director of International Affairs
`Seocho-daero 219
`Seocho-gu
`Seoul 137-750
`Republic of Korea
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`Person to whom the executed request is to be returned:
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`Plaintiff United Therapeutic Corporation’s attorneys/representatives:
`
`
`Douglas Carsten
`MCDERMOTT WILL & EMERY LLP
`18565 Jamboree Road, Suite 250
`Irvine, CA 92612-2565
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`Specification of the date by which the requesting authority requires receipt of the
`response to the Letter of Request:
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`Date: June 18, 2021
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`Reason for urgency: The Scheduling Order of the U.S. District Court of Delaware in this
`litigation provides that document production shall be substantially complete by June 18,
`2021 and that all fact discovery (including fact depositions) shall be completed on or before
`September 17, 2021. Accordingly, United Therapeutics Corporation needs to obtain the
`requested documents and property from Yonsung Fine Chemicals Co., Ltd. and take
`depositions of the three Yonsung employees by June 18, 2021 in order to have adequate
`time to prepare for fact depositions that are required to be completed on or before
`September 17, 2021.
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`2
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`2.
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`3.
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`4.
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`Case 1:20-cv-00755-RGA-JLH Document 92 Filed 05/14/21 Page 13 of 34 PageID #: 6685
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`5.
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`In conformity with Article 3 of the Convention, the undersigned applicant has the
`honor to submit the following request:
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`a.
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`Requesting judicial authority:
`
`The Honorable Judge Richard G. Andrews
`United States District Judge
`United States District Court for the District of Delaware
`844 North King Street
`Room 4124, Unit 4124
`Wilmington, Delaware, 19801 U.S.A.
`Phone: (302) 573-6155
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`b.
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`c.
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`To the competent authority of
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`Republic of Korea
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`Names of the case and any identifying number:
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`United Therapeutics Corporation v. Liquidia Technologies, Inc., Civil Action No.
`1:20-cv-00755-RGA (D. Del.)
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`6.
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`Names and addresses of the parties and their representatives:
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`PLAINTIFF:
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`United Therapeutics Corporation
`1040 Spring Street
`Silver Spring, Maryland 20910 U.S.A
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`PLAINTIFF’S REPRESENTATIVES:
`
`Douglas Carsten
`MCDERMOTT WILL & EMERY LLP
`18565 Jamboree Road, Suite 250
`Irvine, CA 92612-2565
`
`William C. Jackson
`BOIES, SCHILLER & FLEXNER LLP
`5301 Wisconsin Avenue, NW
`Washington, DC 20015
`
`Bill Ward
`BOIES, SCHILLER & FLEXNER LLP
`725 S Figueroa Street, 31st Floor
`Los Angeles, CA 90017
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`
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`3
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`IPR2021-00406
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`Case 1:20-cv-00755-RGA-JLH Document 92 Filed 05/14/21 Page 14 of 34 PageID #: 6686
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`DEFENDANT:
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`Liquidia Technologies, Inc.
`419 Davis Drive, Suite 100,
`Morrisville, North Carolina 27560 U.S.A
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`DEFENDANT’S REPRESENTATIVES:
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`Karen E. Keller
`Jeff Castellano
`David M. Fry
`Nathan R. Hoeschen
`SHAW KELLER LLP
`I.M. Pei Building
`1105 North Market Street, 12th Floor
`Wilmington, DE 19801
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`Sanya Sukduang
`Jonathan Davies
`COOLEY LLP
`1299 Pennsylvania Avenue, NW, Suite 700
`Washington, DC 20004-2400
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`Erik Milch
`COOLEY LLP
`11951 Freedom Drive, 14th Floor
`Reston, VA 20190-5640
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`Ivor Elrifi
`COOLEY LLP
`55 Hudson Yards
`New York, NY 10001-2157
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`Lauren Krickl
`Deepa Kannappan
`COOLEY LLP
`3175 Hanover Street
`Palo Alto, CA 94304-1130
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`7.
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`Nature and purpose of the proceedings and summary of the facts:
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`Plaintiff United Therapeutics Corporation (“UTC”) holds New Drug Application No.
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`022387, which has been approved for Tyvaso® (treprostinil) Inhalation Solution, 0.6 mg/ml,
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`indicated for the treatment of pulmonary arterial hypertension, which UTC markets and sells
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`under the registered trademark Tyvaso®. UTC owns three U.S. patents covering Tyvaso® and its
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`4
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`IPR2021-00406
`United Therapeutics EX2027
`Page 14 of 34
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`Case 1:20-cv-00755-RGA-JLH Document 92 Filed 05/14/21 Page 15 of 34 PageID #: 6687
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`United States Food and Drug Administration’s (“FDA”) approved manufacture and uses, which
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`have been listed in connection with Tyvaso® in the FDA’s Approved Drug Products with
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`Therapeutic Equivalents publication (also known as the “Orange Book”): United States Patent
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`Nos. 9,593,066 (“the ’066 patent”), 9,604,901 (“the ’901 patent”), and 10,716,793 (“the ’793
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`patent”) (collectively, “the asserted patents”).
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`Defendant Liquidia Technologies Inc. (“Liquidia”) submitted New Drug Application No.
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`213005 under § 505(b)(2) of the Federal Food, Drug and Cosmetic Act (“Liquidia’s 505(b)(2)
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`Application”) to the FDA seeking approval, prior to the expiration of the ’066 patent, the ’901
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`patent, and the ’793 patent, to manufacture, market, and sell a generic copy of UTC’s Tyvaso®
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`(treprostinil) Inhalation Solution, 0.6 mg/ml (“Liquidia’s Proposed Generic Product”).
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`In June 2020, UTC filed the present lawsuit. UTC claims that Liquidia’s Proposed
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`Generic Product infringes the asserted patents. Liquidia denied these claims, even though
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`Liquidia’s Proposed Generic Product contains the same active compound, treprostinil, as UTC’s
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`approved Tyvaso® product; Liquidia’s 505(b)(2) Application seeks approval from the FDA to
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`market Liquidia’s Proposed Generic Product for the same indication as UTC’s approved Tyvaso®
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`product; and Liquidia’s 505(b)(2) Application refers to and relies upon UTC’s NDA No. 022387
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`for Tyvaso® (treprostinil) Inhalation Solution, 0.6 mg/ml. Accordingly, UTC must show that the
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`process by which Liquidia prepares its Proposed Generic Product (and Liquidia’s Proposed
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`Generic Product itself) is the same as the process and product covered by the claims of the
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`asserted patents.
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`Yonsung Fine Chemicals Co., Ltd. (“Yonsung”) is a critical third party to the case. It
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`manufactures the active pharmaceutical ingredient (“API”) in Liquidia’s Proposed Generic
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`Product. Documents produced by Liquidia include Supply and Quality agreements with
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`Yonsung, referencing for example, that
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`IPR2021-00406
`United Therapeutics EX2027
`Page 15 of 34
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`Case 1:20-cv-00755-RGA-JLH Document 92 Filed 05/14/21 Page 16 of 34 PageID #: 6688
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`; portions of a 2020 version of a
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`DMF submitted on behalf of Yonsung as a manufacturer; and correspondence with Yonsung
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`employees, regarding, for example, materials, synthesized materials, processes, and FDA
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`submissions relating to Yonsung’s manufacturing process and the resulting API product.
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`However, the partial correspondence, agreements, and partial documents (e.g., portions of a
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`single DMF version confirming the existence of other sections and versions) produced by
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`Liquidia to-date are incomplete and do not fully explain the interactions or information relevant
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`to the infringement inquiry. Liquidia has represented that it has requested documents of
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`Yonsung, but not initiated third party discovery formally. Therefore, it is critical that Yonsung
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`produce the requested documents and property of Yonsung relating to the alleged infringing
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`manufacturing process and the resulting API product, and that at least certain Yonsung employees
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`testify about their knowledge of Yonsung’s alleged infringing manufacturing process and
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`resulting API product. The requested documents, property and testimony, are necessary, in the
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`interests of justice, for UTC to support its infringement case at trial.
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`8.
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`a.
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`Evidence to be obtained or other judicial act to be performed:
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`It is requested that Yonsung Fine Chemicals Co., LTD (“Yonsung”) produce the
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`requested documents and property of Yonsung relating to the alleged infringing manufacturing
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`process and the resulting API product used in Defendant Liquidia Technologies Inc.’s Proposed
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`Generic Product. It is also requested that testimony be obtained from three employees of
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`Yonsung – Chang Young Oh, Yong Hyun Kim, and Eunhee Ban – regarding the manufacturing
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`process and the resulting API product used in Defendant Liquidia Technologies Inc.’s Proposed
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`6
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`IPR2021-00406
`United Therapeutics EX2027
`Page 16 of 34
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`Case 1:20-cv-00755-RGA-JLH Document 92 Filed 05/14/21 Page 17 of 34 PageID #: 6689
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`Generic Product, and that the answers to those questions be recorded verbatim by a court reporter,
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`at the expense of Plaintiff. If any portion of this request is deemed to be improper under the laws
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`of the Republic of Korea, please disregard that portion and continue to comply with as much of
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`the Request as legally permissible.
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`b.
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`Purpose of the evidence or judicial act sought:
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`The evidence is to be used at the trial of this matter pursuant to Federal law, Delaware
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`law, the Federal Rules of Civil Procedure, and the Federal Rules of Evidence. The requested
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`documents and testimony are relevant to numerous aspects of this case. The testimony provided
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`will be subject to the protective order issued by the Requesting Court that prohibits the use of the
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`documents and testimony for any purpose other than the two instant litigations. A copy of the
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`protective order is attached as Exhibit 3.
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`Identity and address of any person to be examined:
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`Chang Young Oh
`207, Sujeong-ro, Jangan-myeon, Hwaseong-si, Gyeonggi-do,
`18581, Republic of Korea
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`Yong Hyun Kim
`207, Sujeong-ro, Jangan-myeon, Hwaseong-si, Gyeonggi-do,
`18581, Republic of Korea
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`Eunhee Ban
`R&D Center, 6th Floor, 2-Dong Innoplex,
`306, Sinwon-ro, Yeongtong-gu, Suwon-si, Gyeonggi-do,
`16675, Republic of Korea
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`9.
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`10. Questions to be put to the person to be examined or statement of the subject matter
`about which he is to be examined:
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`Generally, Plaintiff United Therapeutics Corporation is seeking the testimony of certain
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`employees of Yonsung Fine Chemicals Co., LTD relating to the alleged infringing manufacturing
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`process and the resulting API product used in Defendant Liquidia Technologies Inc.’s Proposed
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`7
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`IPR2021-00406
`United Therapeutics EX2027
`Page 17 of 34
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`Case 1:20-cv-00755-RGA-JLH Document 92 Filed 05/14/21 Page 18 of 34 PageID #: 6690
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`Generic Product. For the specific questions to be put to the persons to be examined, see the
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`Schedule attached hereto as Exhibit 1.
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`11.
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`Documents or other property to be inspected:
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` Generally, Plaintiff United Therapeutics Corporation is seeking the requested documents
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`and property of Yonsung Fine Chemicals Co., LTD relating to the alleged infringing
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`manufacturing process and the resulting API product used in Defendant Liquidia Technologies
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`Inc.’s Proposed Generic Product. For the specific document and property requests, see the
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`Schedule attached hereto as Exhibit 2.
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`12.
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`Any requirement that the evidence to be given on oath or affirmation and any
`specific form to be used:
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`The witnesses, Chang Young Oh, Yong Hyun Kim, and Eunhee Ban shall testify under
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`oath pursuant to Korean law.
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`13.
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`Special methods or procedure to be followed:
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`This Court respectfully requests the Competent Authority of the Republic of Korea that:
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`(a)
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`(b)
`(c)
`(d)
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`witness testimony be audio-recorded and that the audio-recorded media be sent (in
`mp3 or another suitable format) to the requesting judicial authority;
`the witness testimony be transcribed verbatim in Korean;
`the presence of the parties and their United States counsel be all