Case 1:20-cv-00755-RGA-JLH Document 29 Filed 08/26/20 Page 1 of 21 PageID #: 288
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`UNITED THERAPEUTICS
`CORPORATION,
`
`Plaintiff,
`
`v.
`
`LIQUIDIA TECHNOLOGIES, INC.,
`
`Defendant.
`
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`
`C.A. No. 20-755 (RGA)
`
`PLAINTIFF’S OPENING BRIEF IN SUPPORT OF ITS
`MOTION TO DISMISS DEFENDANT’S COUNTERCLAIM
`
`MORRIS, NICHOLS, ARSHT & TUNNELL LLP
`Jack B. Blumenfeld (#1014)
`Michael J. Flynn (#5333)
`1201 North Market Street
`P.O. Box 1347
`Wilmington, DE 19899
`(302) 658-9200
`jblumenfeld@mnat.com
`mflynn@mnat.com
`
`Attorneys for Plaintiff United Therapeutics
`Corporation
`
`OF COUNSEL:
`
`Douglas H. Carsten
`Joshua Mack
`WILSON SONSINI GOODRICH & ROSATI
`12235 El Camino Real
`San Diego, CA 92130
`(858) 305-2300
`
`Adam W. Burrowbridge
`WILSON SONSINI GOODRICH & ROSATI
`1700 K Street NW, Fifth Floor
`Washington, DC 20006
`(202) 973-8800
`
`William C. Jackson
`BOIES SCHILLER FLEXNER LLP
`1401 New York Avenue NW
`Washington, DC 20005
`(202) 237-2727
`
`August 26, 2020
`
`IPR2021-00406
`United Therapeutics EX2015
`Page 1 of 21
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`Case 1:20-cv-00755-RGA-JLH Document 29 Filed 08/26/20 Page 2 of 21 PageID #: 289
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`
`
`I. 
`
`II. 
`
`III. 
`
`IV. 
`
`V. 
`
`
`
`
`TABLE OF CONTENTS
`
`Page
`
`
`NATURE AND STAGE OF PROCEEDINGS .................................................................. 1 
`
`SUMMARY OF THE ARGUMENT ................................................................................. 1 
`
`STATEMENT OF FACTS ................................................................................................. 2 
`
`ARGUMENT ...................................................................................................................... 6 
`
`A. 
`
`B. 
`
`C. 
`
`Legal Standards ....................................................................................................... 6 
`
`Liquidia’s Invalidity Counterclaim and Defense Should be Dismissed for
`Failure to State a Claim under Rule 12(b)(6) ........................................................ 10 
`
`Alternatively, Liquidia’s Invalidity Counterclaim Defense Should be
`Dismissed for Lack of Jurisdiction under Rule 12(b)(1) ...................................... 13 
`
`CONCLUSION ................................................................................................................. 14 
`
`
`
`-i-
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`Case 1:20-cv-00755-RGA-JLH Document 29 Filed 08/26/20 Page 3 of 21 PageID #: 290
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`
`
`TABLE OF AUTHORITIES
`
`CASES
`
`Page(s)
`
`BASF Corp. v. Aristo Inc.,
`872 F. Supp. 2d 758 (N.D. Ind. 2012) .................................................................................8
`
`Cedars-Sinai Med. Ctr. v. Watkins,
`11 F.3d 1573 (Fed. Cir. 1993)............................................................................................13
`
`Diamond Sci. Co. v. Ambico, Inc.,
`848 F.2d 1220 (Fed. Cir. 1988)....................................................................................1, 6, 7
`
`Hologic, Inc. v. Minerva Surgical, Inc.,
`957 F.3d 1256 (Fed. Cir. 2020)............................................................................................7
`
`HTC Corp. v. IPCom GmbH & Co.,
`671 F. Supp. 2d 146 (D.D.C. 2009) .....................................................................................8
`
`Hunter Douglas, Inc. v. Harmonic Design, Inc.,
`153 F.3d 1318 (Fed. Cir. 1998)......................................................................................9, 14
`
`In re NAHC, Inc. Sec. Litig.,
`
`306 F.3d 1314 (3d Cir. 2002)...............................................................................................9
`In re Wellbutrin SR/Zyban Antitrust Litig.,
`281 F. Supp. 2d 751 (E.D. Pa. 2003) ...................................................................................8
`
`Intel Corp. v. U.S. Int’l Trade Comm’n,
`946 F.2d 821 (Fed. Cir. 1991)....................................................................................7, 8, 13
`
`Juniper Networks, Inc. v. Palo Alto Networks, Inc.,
`15 F. Supp. 3d 499 (D. Del. 2014) .................................................................................7, 13
`
`Kos Pharm., Inc. v. Andrx Corp.,
`369 F.3d 700 (3d Cir. 2004).................................................................................................8
`
`Lamson v. U.S.,
`101 Fed. Cl. 280 (Fed. Cl. 2011) .............................................................................9, 13, 14
`
`Leading Tech. Composites v. MV2, LLC, No. CCB-19-1256,
`2020 WL 790601 (D. Md. Feb. 18, 2020) ...........................................................................8
`
`LifeScan Scotland, Ltd. v. Shasta Tech, LLC, No. 11-cv-04494 EJD,
`2012 WL 2979028 (N.D. Cal. July 19, 2012) ......................................................................9
`
`Mag Aerospace Indus., Inc. v. B/E Aerospace, Inc.,
`816 F.3d 1374 (Fed. Cir. 2016)................................................................................7, 11, 12
`
`Oneida Indian Nation of N.Y. v. Cnty. of Oneida,
`414 U.S. 661 (1974) .............................................................................................................9
`
`
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`
`
`Oran v. Stafford,
`226 F.3d 275 (3d Cir. 2000).................................................................................................9
`
`Port-A-Pour, Inc. v. Peak Innovations, Inc., No. 13-cv-01511-WYD-BNB,
`2015 WL 292913 (D. Colo. Jan. 20, 2015) ..........................................................................8
`
`Schmidt v. Skolas,
`770 F.3d 241 (3d Cir. 2014).................................................................................................9
`
`Shamrock Techs., Inc. v. Medical Sterilization, Inc.,
`903 F.2d 789 (Fed. Cir. 1990)........................................................................................7, 12
`
`Steel Co. v. Citizens for a Better Env’t,
`523 U.S. 83 (1998) .........................................................................................................9, 13
`
`Tellabs, Inc. v. Makor Issues & Rights, Ltd.,
`551 U.S. 308 (2007) .............................................................................................................8
`
`Wells v. Kessler Corp., No. 17-cv-02709-AGF,
`2018 WL 1251928 (E.D. Mo. Mar. 12, 2018) .....................................................................8
`
`XpertUniverse, Inc. v. Cisco Sys., Inc.,
`868 F. Supp. 2d 376 (D. Del. 2012) .....................................................................................6
`
`RULES
`17 C.F.R. § 240.3b-7 ......................................................................................................................10
`Fed. R. Civ. P. 12(b)(1)................................................................................................................1, 2
`Fed. R. Civ. P. 12(b)(6)............................................................................................................1, 2, 6
`
`
`
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`
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`Plaintiff United Therapeutics Corporation (“UT”) moves under Fed. R. Civ. P. 12(b)(6),
`
`or, alternatively, under Fed. R. Civ. P. 12(b)(1), to dismiss Defendant Liquidia Technologies,
`
`Inc.’s (“Liquidia”) counterclaim for a declaration of invalidity of U.S. Patent No. 10,716,793 (the
`
`“’793 patent”) and related defenses (see D.I. 23 at pp. 10-11, 16-18) under the doctrine of assignor
`
`estoppel.
`
`I.
`
`NATURE AND STAGE OF PROCEEDINGS
`
`On June 4, 2020, UT filed a complaint for patent infringement (“Complaint”) against
`
`Liquidia based on the notice of paragraph IV certification letter that UT received from Liquidia on
`
`or about April 27, 2020. D.I. 1 ¶¶ 18-19. UT amended its Complaint on July 22, 2020 to add
`
`infringement claims for the newly issued ’793 patent. D.I. 16. On August 5, 2020, Liquidia filed
`
`an Answer to the Amended Complaint and Counterclaims. D.I. 23.
`
`II.
`
`
`
`SUMMARY OF THE ARGUMENT
`
`Assignor estoppel bars Liquidia from asserting that the ’793 patent is invalid because Dr.
`
`Robert Roscigno, a named inventor on the ’793 patent who assigned his rights in the patent to UT,
`
`is in privity with Liquidia by virtue of his role as Liquidia’s Senior Vice President, Product
`
`Development and his substantial equity interest in Liquidia. Assignor estoppel is “an equitable
`
`doctrine that prevents one who has assigned the rights to a patent (or patent application) from later
`
`contending that what was assigned is a nullity … [and] operates to bar other parties in privity with
`
`the assignor….” Diamond Sci. Co. v. Ambico, Inc., 848 F.2d 1220, 1224 (Fed. Cir. 1988). This
`
`case presents the classic assignor estoppel scenario.
`
`The Court should dismiss Liquidia’s invalidity counterclaims and defenses directed to the
`
`’793 patent under Federal Rule of Civil Procedure 12(b)(6). In the alternative, if the Court chooses
`
`not to take judicial notice of the additional facts that demonstrate assignor estoppel for the motion
`
`
`
`-1-
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`
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`to dismiss under Rule 12(b)(6), UT requests the Court to dismiss the counterclaims directed to
`
`invalidity of the ’793 patent under Federal Rule of Civil Procedure 12(b)(1), which permits the
`
`Court to look outside the pleadings and dismiss a claim for lack of subject matter jurisdiction if
`
`the claim is insubstantial, implausible, or frivolous. Here, in light of the assignor estoppel doctrine,
`
`it is plain that Liquidia will never be able to prevail on its assertion that the ’793 patent is invalid,
`
`and its counterclaim and defense to that effect should be dismissed.
`
`III.
`
`STATEMENT OF FACTS
`
`On June 4, 2020, UT filed a complaint for patent infringement against Liquidia based on
`
`the notice of paragraph IV certification letter that UT received from Liquidia on or about April 27,
`
`2020. D.I. 1 ¶¶ 18-19. Liquidia seeks to obtain FDA approval and market its infringing product
`
`prior to patent expiration for UT’s product, Tyvaso® (treprostinil) Inhalation Solution. Id. ¶¶ 2, 18-
`
`20. Because UT filed the Complaint within 45 days after receipt of Liquidia’s notice letter, FDA
`
`will stay approval of Liquidia’s infringing product for 30 months until October 24, 2022. See id.
`
`¶ 21; D.I. 20, Ex. A at 2. Liquidia requested an extension to answer the Complaint and answered
`
`the Complaint and asserted counterclaims against UT on July 16, 2020. D.I. 11.
`
`On July 21, 2020, the United States Patent & Trademark Office (“USPTO”) issued the ’793
`
`patent to UT. D.I. 16-1, Ex. C. The ’793 patent lists seven inventors, including Dr. Robert
`
`Roscigno. Id. Dr. Roscigno, along with all the other co-inventors of the ’793 patent, assigned his
`
`interest in the ’793 patent to UT. Id.; see also RJN No. 1 at REEL: 021148 FRAME: 005.1
`
`Specifically, Dr. Roscigno assigned all his interest in the parent application of the ’793 patent,
`
`U.S. Patent Application No. 11/748,205, to UT on June 18, 2007. RJN No. 1 at REEL: 021148
`
`
`1 RJN Nos. 1-9 are documents included with UT’s Motion for Judicial Notice and the Declaration
`of Joshua Mack, filed concurrently with this Motion to Dismiss.
`
`-2-
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`
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`FRAME: 005. Accordingly, the ’793 patent is assigned to UT, as is shown on the face of the patent.
`
`D.I. 16-1, Ex. C.; see also D.I. 16 ¶ 18. The day after the ’793 patent issued, UT filed its First
`
`Amended Complaint, alleging that Liquidia’s product also infringes claims of that patent. See
`
`generally D.I. 16 ¶¶ 69-83.
`
`On August 5, 2020, Liquidia filed an Answer to the Amended Complaint and
`
`Counterclaims. D.I. 23. Included in the Answer and Counterclaims are allegations by Liquidia that
`
`the ’793 patent is invalid. Liquidia alleges that “[o]ne or more claims of the ’066, ’901, and ’793
`
`patents are invalid for failure to satisfy the conditions of patentability in 35 U.S.C. §§ 101 et seq.,
`
`including, but not limited to §§ 101, 102, 103, and/or 112.” Id. at p. 10. Liquidia specifically
`
`alleges:
`
`the claims of the ʼ793 patent are invalid under §§ 102 and/or 103 at least
`over Plaintiff’s prior art patents and publications, including U.S. Patent Nos.
`6,756,033 and 6,521,212, disclosing methods for treating pulmonary
`hypertension by administering a single event dose of a 15 to 90 microgram
`inhalation formulation of treprostinil, including liquid and powder
`formulations of treprostinil, in 1 to 3 breaths; (7) at least claims 1, 4, and
`6-8 of the ʼ793 patent are invalid under § 112 as indefinite and lacking
`written description and enablement support at least with respect to
`administration of a “powder”; and (8) the claims of the ʼ793 patent are
`invalid for obviousness-type double patenting over Plaintiff’s prior
`issued patents, including U.S. Patent Nos. 6,756,033 and 6,521,212,
`disclosing and claiming methods for treating pulmonary hypertension by
`administering a single event dose of a 15 to 90 microgram inhalation
`formulation of treprostinil, including liquid and powder formulations of
`treprostinil, in 1 to 3 breaths.
`
`Id. at pp. 10-11 (emphasis added). Liquidia’s Answer and Counterclaims to the Amended
`
`Complaint further requests a declaratory judgment that the ’793 patent is invalid. Id. at pp. 16-18,
`
`24.
`
`Dr. Robert Roscigno was once the President and Chief Operating Officer at Lung Rx., Inc.,
`
`a wholly owned subsidiary of Plaintiff United Therapeutics Corporation (“UT”) and instrumental
`
`in the development of a UT product, Tyvaso® (treprostinil) Inhalation Solution (“Tyvaso®”). In
`
`-3-
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`
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`connection with that work, Dr. Roscigno is a listed inventor on a number of patents related to
`
`Tyvaso®, including the ’793 patent. As an employee of Lung Rx, Dr. Roscigno assigned to UT his
`
`ownership in the ’793 patent. Dr. Roscigno switched teams and until quite recently was the Senior
`
`Vice President, Product Development for Liquidia with a significant equity interest in Liquidia.2
`
`E.g., RJN No. 3 at 6 (listing Dr. Roscigno as Liquidia’s Senior Vice President, Product
`
`Development). Liquidia charged Dr. Roscigno with developing the accused product in this case,
`
`a product intended to directly compete with Tyvaso® and piggyback on Tyvaso®’s FDA approval.
`
`In the public stock offering prospectus issued by Liquidia on March 20, 2019 (the “Prospectus”),
`
`Liquidia describes the role of Dr. Roscigno at Liquidia and also references his work at UT on
`
`Tyvaso®:
`
`Dr. Robert Roscigno[] previously served as the executive vice president of
`GeNO, LLC, where he led the clinical development team working on a
`novel nitric oxide delivery system, and before that he served as the
`president and chief operating officer of Lung Rx, Inc., where he was
`part of the team responsible for bringing Tyvaso through Phase 3
`development, and he previously served in multiple leadership positions at
`United Therapeutics and its subsidiaries, contributing to the successful
`development and worldwide commercialization of Remodulin™, which is
`treprostinil administered through subcutaneous or intravenous infusion, for
`the treatment of PAH.
`
`Id. (emphasis added). The Prospectus further describes the role of Dr. Roscigno at both UT and
`
`Liquidia:
`
`Dr. Robert Roscigno has been our Senior Vice President, Product
`Development since December 2017. He served as our Senior Vice
`President, Research and Development from March 2016 until
`
`2 Public sources indicate that Dr. Roscigno remains a Liquidia employee, but in preparing the letter
`filed with the Court on August 21, 2020 (D.I. 26), Liquidia stated that Dr. Roscigno is no longer
`employed at Liquidia. For this motion, this is irrelevant for two reasons. First, that purported fact
`is not part of the record. Second, even assuming that Dr. Roscigno has departed, assignor estoppel
`is an equitable doctrine, and Liquidia cannot escape the consequences of leveraging the benefits
`of Dr. Roscigno’s expertise to design and develop its product by terminating his employment on
`the eve of anticipated approval.
`
`-4-
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`
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`December 2017 and our Vice President, Research and Development
`from September 2015 until March 2016. From January 2009 to
`September 2015, Dr. Roscigno served as the executive vice president,
`global clinical affairs of GeNO, LLC, a pharmaceutical company in the field
`of inhaled nitric oxide drug products. From July 2007 to January 2009, Dr.
`Roscigno provided scientific consulting for various companies in the
`pharmaceutical industry and also worked as a subject matter expert in PAH.
`From March 2005 to July 2007, Dr. Roscigno was the president and
`chief operations officer of Lung Rx, Inc., a subsidiary of United
`Therapeutics Corporation. Prior to Lung Rx, Inc., Dr. Roscigno served
`in multiple leadership positions at United Therapeutics Corporation.
`Dr. Roscigno graduated from Trinity College with a Bachelor of Science in
`Biology. He also holds a Doctor of Philosophy in Cell and Molecular
`Biology from Duke University.
`
`Id. at 130 (emphasis added). In fact, despite only starting at Liquidia in September 2015, Liquidia
`
`filed a patent application on May 5, 2016, directed to the use of dry powder treprostinil to treat
`
`pulmonary hypertension that listed Dr. Roscigno as an inventor. See id.; RJN No. 9. By October
`
`2016, Dr. Roscigno and Liquidia had successfully conducted a toxicity study of the infringing
`
`product, LIQ861. RJN No. 8 at 99. And by March 2017, Dr. Roscigno and Liquidia had
`
`successfully completed a Phase 1 trial of the infringing product in 57 healthy volunteers. Id. at 88.
`
`The Prospectus also describes a substantial Liquidia stock grant to Dr. Roscigno:
`
`On March 7, 2018, we granted incentive stock options to purchase shares of
`our common stock under the 2016 Plan, with an exercise price equal to
`$9.31 per share, to each of the following officers . . . Dr. Robert Roscigno,
`our Senior Vice President, Product Development, for 35,656 shares . . . .
`
`RJN No. 3 at 145. Indeed, Liquidia’s S-1 Registration Statement, S-3 and S-4 Statements disclose
`
`the significant interest that Dr. Roscigno owns in Liquidia. RJN No. 2 (disclosing the award of
`
`33,333 stock options to Dr. Roscigno, and the award of 8,333 restricted stock units); RJN No. 5
`
`(disclosing the award of 36,000 stock options to Dr. Roscigno); RJN No. 7 (disclosing the award
`
`of 25,553 stock options to Dr. Roscigno on September 28, 2016, and the award of 35,656 stock
`
`options on March 7, 2019).
`
`
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`-5-
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`
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`In Liquidia’s 8-K, dated March 8, 2019, Liquidia included Phase 1 results for LIQ861,
`
`which were described as being presented as a poster at the PVRI Annual World Congress in
`
`January 2018 by Dr. Roscigno. RJN. No. 4 at 13.
`
`Liquidia’s 8-K, dated January 7, 2019, listed Dr. Roscigno as part of Liquidia’s “[s]easoned
`
`team with relevant commercial and disease area expertise.” RJN No. 6 at 8. That 8-K included an
`
`extended quote from Dr. Roscigno:
`
`“Patient demographics and baseline characteristics in the trial suggest that
`LIQ861 may be attractive across disease severity and may have utility as a
`first-line prostacyclin,” added Robert Roscigno, PhD, Liquidia’s Senior
`Vice President of Product Development and LIQ861 Program Lead.
`“Interestingly, enrollment of the safety portion of the trial was driven
`primarily by stronger than anticipated interest from New York Heart
`Association Functional Class II add-on patients, which may imply that dry-
`powder delivery could be an alternative to oral delivery in prostacyclin
`naïve patients. We are pleased with these findings and believe they support
`the therapeutic potential and versatility of LIQ861 among patients across
`different functional classes.”
`
`Id. at 35-36.
`
`IV. ARGUMENT
`
`A.
`
`Legal Standards
`
`Under Federal Rule of Civil Procedure 12(b)(6), a counterclaim can be dismissed if it fails
`
`“to state a claim upon which relief can be granted.” In determining whether to dismiss a
`
`counterclaim under Rule 12(b)(6), the Court accepts the non-movant’s factual statements in the
`
`counterclaim as true and determines whether the counterclaimant can make a “plausible claim for
`
`relief.” XpertUniverse, Inc. v. Cisco Sys., Inc., 868 F. Supp. 2d 376, 378-79 (D. Del. 2012) (citation
`
`omitted).
`
`Assignor estoppel is “an equitable doctrine that prevents one who has assigned the rights
`
`to a patent (or patent application) from later contending that what was assigned is a nullity . . .
`
`[and] operates to bar other parties in privity with the assignor, such as a corporation founded by
`
`-6-
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`Case 1:20-cv-00755-RGA-JLH Document 29 Filed 08/26/20 Page 11 of 21 PageID #: 298
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`
`
`the assignor.” Diamond Sci., 848 F.2d at 1224. The Federal Circuit explained that assignor estoppel
`
`prevents “an injustice against the assignee to allow the assignor to make that representation at the
`
`time of the assignment (to his advantage) and later to repudiate it (again to his advantage).”
`
`Hologic, Inc. v. Minerva Surgical, Inc., 957 F.3d 1256, 1265 (Fed. Cir. 2020) (quoting Diamond
`
`Sci., 848 F.2d at 1224) (internal quotations omitted).
`
`For assignor estoppel to apply, Dr. Roscigno—who assigned his interest in the ’793
`
`patent—needs to be in privity with Liquidia, the party challenging the patent. Id. The Federal
`
`Circuit identified factors to consider when determining whether privity exists for assignor estoppel
`
`in Shamrock Technologies, Inc. v. Medical Sterilization, Inc., 903 F.2d 789 (Fed. Cir. 1990):
`
`(1) the assignor’s leadership role at the new employer; (2) the assignor’s
`ownership stake in the defendant company; (3) whether the defendant
`company changed course from manufacturing non-infringing goods to
`infringing activity after the inventor was hired; (4) the assignor’s role in the
`infringing activities; (5) whether the inventor was hired to start the
`infringing operations; (6) whether the decision to manufacture the
`infringing product was made partly by the inventor; (7) whether the
`defendant company began manufacturing the accused product shortly after
`hiring the assignor; and (8) whether the inventor was in charge of the
`infringing operation.
`
`Mag Aerospace Indus., Inc. v. B/E Aerospace, Inc., 816 F.3d 1374, 1380 (Fed. Cir. 2016) (citing
`
`Shamrock); see also Shamrock Techs., 903 F.2d at 794 (finding privity between employer and
`
`inventor hired as Vice President with responsibilities for developing accused product); Juniper
`
`Networks, Inc. v. Palo Alto Networks, Inc., 15 F. Supp. 3d 499, 508 (D. Del. 2014) (finding privity
`
`between employer and employee granted title of “founder”).
`
`Further, privity exists between an assigning inventor and a party infringing a patent when
`
`“the ultimate infringer availed itself of the inventor’s ‘knowledge and assistance’ to conduct
`
`infringement.” Intel Corp. v. U.S. Int’l Trade Comm’n, 946 F.2d 821, 839 (Fed. Cir. 1991) (quoting
`
`Shamrock Techs., 903 F.2d at 794). Indeed, even consultants or contractors will be found to be in
`
`-7-
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`
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`privity with the infringer when that consultant or contractor plays a “significant role” in the
`
`infringing product. BASF Corp. v. Aristo Inc., 872 F. Supp. 2d 758, 776 (N.D. Ind. 2012); Leading
`
`Tech. Composites v. MV2, LLC, No. CCB-19-1256, 2020 WL 790601, at *4 (D. Md. Feb. 18,
`
`2020) (finding privity and, thus, assignor estoppel between accused infringer and its “contractor”
`
`where the accused infringer “availed itself of [the contractor’s] knowledge and assistance to
`
`conduct the allegedly infringing operations.”). The “critical time” to look at to determine privity
`
`is when the infringing product was developed. Intel, 946 F.2d at 839 (quoting determination of
`
`ALJ).
`
`The ’793 Patent is identified in and attached as an exhibit to the First Amended Complaint.
`
`D.I. 16; D.I. 16-1, Ex. C. As such, it is appropriate for the Court to rely on the patent when ruling
`
`on a motion to dismiss. E.g., Tellabs, Inc. v. Makor Issues & Rights, Ltd., 551 U.S. 308, 322 (2007).
`
`Courts can also take judicial notice of other documents that are matters of public record, like filings
`
`with the USPTO. See Kos Pharm., Inc. v. Andrx Corp., 369 F.3d 700, 705 n.5 (3d Cir. 2004)
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`(taking judicial notice of public records available on the USPTO and FDA websites); HTC Corp.
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`v. IPCom GmbH & Co., 671 F. Supp. 2d 146, 150 n.3 (D.D.C. 2009) (“The Court takes judicial
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`notice of the PTO pleadings. A court may take judicial notice of court documents and other public
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`records.”); see also In re Wellbutrin SR/Zyban Antitrust Litig., 281 F. Supp. 2d 751, 754 n.2 (E.D.
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`Pa. 2003) (taking judicial notice of information from FDA website). Accordingly, the Court can
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`take judicial notice of patent assignments. E.g., Port-A-Pour, Inc. v. Peak Innovations, Inc., No.
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`13-cv-01511-WYD-BNB, 2015 WL 292913, at *2 (D. Colo. Jan. 20, 2015); see also Wells v.
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`Kessler Corp., No. 17-cv-02709-AGF, 2018 WL 1251928, at *3 (E.D. Mo. Mar. 12, 2018) (taking
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`judicial notice of USPTO records).
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`-8-
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`United Therapeutics EX2015
`Page 12 of 21
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`Case 1:20-cv-00755-RGA-JLH Document 29 Filed 08/26/20 Page 13 of 21 PageID #: 300
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`Similarly, the Court can take judicial notice of a company’s filings with the SEC. Schmidt
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`v. Skolas, 770 F.3d 241, 249 (3d Cir. 2014); Oran v. Stafford, 226 F.3d 275, 289 (3d Cir. 2000)
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`(taking judicial notice of SEC filings); In re NAHC, Inc. Sec. Litig., 306 F.3d 1314, 1331 (3d Cir.
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`2002) (noting that the court may consider on a motion to dismiss documents filed with the SEC).
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`Indeed, when a litigant cannot reasonably dispute a fact, it is appropriate for the court to take
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`judicial notice of that fact. See, e.g., LifeScan Scotland, Ltd. v. Shasta Tech, LLC, No. 11-cv-04494
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`EJD, 2012 WL 2979028, at *6 n.1 (N.D. Cal. July 19, 2012) (“[I]n their objection to LifeScan’s
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`request for judicial notice, Instacare and Pharmatech object generally to its SEC filings, websites,
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`and press releases being used to prove the truth of the statements they contain as hearsay. . . . As
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`a party to this action, Instacare’s admissions are not hearsay.”).
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`Alternatively, “frivolous claims may also be dismissed under [Rule] 12(b)(1) on
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`jurisdictional grounds so long as jurisdictional dismissals for frivolousness are confined to cases
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`that are very plain.” Lamson v. U.S., 101 Fed. Cl. 280, 287 n.6 (Fed. Cl. 2011) (internal quotations
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`omitted, citations omitted). Indeed, the Supreme Court has held that dismissing a claim for lack of
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`subject matter jurisdiction is appropriate “when the claim is so insubstantial, implausible,
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`foreclosed by prior decisions of this Court, or otherwise completely devoid of merit as not to
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`involve a federal controversy.” Steel Co. v. Citizens for a Better Env’t, 523 U.S. 83, 89 (1998)
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`(quoting Oneida Indian Nation of N.Y. v. Cnty. of Oneida, 414 U.S. 661, 666 (1974) (internal
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`quotations omitted)). “‘[W]holly insubstantial and frivolous’ claims do not merit federal
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`jurisdiction. A ‘question may be plainly unsubstantial ... because it is obviously without merit.’”
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`Hunter Douglas, Inc. v. Harmonic Design, Inc., 153 F.3d 1318, 1328 (Fed. Cir. 1998) (citations
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`omitted).
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`Page 13 of 21
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`Case 1:20-cv-00755-RGA-JLH Document 29 Filed 08/26/20 Page 14 of 21 PageID #: 301
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`
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`B.
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`Liquidia’s Invalidity Counterclaim and Defense Should be Dismissed for
`Failure to State a Claim under Rule 12(b)(6)
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`It is beyond dispute that (a) Dr. Roscigno is one of the ’793 patent named inventors, and
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`(b) Dr. Roscigno assigned all his rights in the patent to UT. The only issue is whether Liquidia is
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`in privity with Dr. Roscigno such that assignor estoppel also bars Liquidia from challenging the
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`validity of the ’793 patent. Liquidia is, in fact, in privity with Dr. Roscigno given his pivotal role
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`in developing Liquidia’s product intended to compete with Tyvaso®, his executive-level position,
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`and his substantial equity stake in Liquidia.
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`As Liquidia’s securities filings state, Dr. Roscigno is Liquidia’s Senior Vice President,
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`Product Development, or at least was until days ago. RJN No. 3 at 6; see supra n.2. Liquidia’s
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`SEC filings tout Dr. Roscigno’s previous experience with treprostinil while at UT. Id. (stating that
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`Dr. Roscigno “served as the president and chief operating officer of Lung Rx, Inc., where he was
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`part of the team responsible for bringing Tyvaso® through Phase 3 development”). Indeed, by
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`publicly disclosing Dr. Roscigno as one of the company’s executive officers under federal
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`securities law, Liquidia represented that Dr. Roscigno was an “officer who performs a policy
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`making function or any other person who performs similar policy making functions for the
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`registrant.” 17 C.F.R. § 240.3b-7; see also RJN Nos. 2 & 5 (SEC Form 4 submissions identifying
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`Dr. Roscigno in Box 5 as a Liquidia “officer”); RJN No. 3 at 129-130 (listing Dr. Roscigno as one
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`of Liquidia’s six “executive officers.”).
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`Liquidia’s emphasis on Dr. Roscigno’s prior experience with Tyvaso® at UT is not
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`surprising because it dovetails with his vital role in developing a competing product for Liquidia.
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`Dr. Roscigno is described by Liquidia as the “LIQ861 Program Lead,” which is the infringing
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`product in this action. Liquidia filed a patent application, naming Dr. Roscigno as an inventor, that
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`is directed to dry powder treprostinil to treat pulmonary hypertension within eight months of Dr.
`
`-10-
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`Case 1:20-cv-00755-RGA-JLH Document 29 Filed 08/26/20 Page 15 of 21 PageID #: 302
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`
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`Roscigno’s start at Liquidia. RJN No. 9. Five months after filing this patent application, in October
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`2016, Dr. Roscigno and Liquidia successfully conducted a preclinical study of infringing product
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`LIQ861. RJN No. 8 at 99. And by March 2017, Dr. Roscigno and Liquidia had successfully
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`completed a Phase 1 trial of the infringing product in 57 healthy volunteers. Id. at 88. Indeed, Dr.
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`Roscigno presented the results of the Phase 1 trial of the infringing product at a scientific
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`conference. RJN No. 4 at 13; RJN No. 8 at 88. Thus, Liquidia made Dr. Roscigno a highly placed
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`executive officer, touted his experience developing Tyvaso®, and placed him in charge of
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`developing the infringing product at issue here. As such, Dr. Roscigno played a key role in the
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`development of the infringing product.
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`Dr. Roscigno also has a significant ownership interest in Liquidia, as stated in Liquidia’s
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`SEC filings. Liquidia is a publicly traded company, and Liquidia has granted Dr. Roscigno
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`significant equity. Liquidia has disclosed several grants of equity stakes in Liquidia to Dr.
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`Roscigno. RJN No. 2 (option to purchase 33,333 shares and award of 8,333 restricted shares); RJN
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`No. 5 (option to purchase 36,000 shares); RJN No. 7 (option to purchase 25,553 shares awarded
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`on September 28, 2016, option to purchase 35,656 shares awarded on March 7, 2019). Thus,
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`Liquidia enticed Dr. Roscigno with a significant ownership interest in Liquidia. This ownership
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`interest is entirely consistent with Dr. Roscigno’s role at Liquidia—an executive officer critical in
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`developing Liquidia’s infringing product.
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`Such an executive position in Liquidia, with responsibility for development of the
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`infringing product, and a significant ownership in Liquidia, is s