Case 1:22-cv-02229-MKV Document 44 Filed 10/04/22 Page 1 of 30
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`UNITED STATES DISTRICT COURT
`SOUTHERN DISTRICT OF NEW YORK
`
`
`ACUITAS THERAPEUTICS INC.,
`
`Plaintiff,
`
`Case No. 1:22-cv-02229-MKV
`
`vs.
`
`GENEVANT SCIENCES GMBH, and
`ARBUTUS BIOPHARMA CORP.,
`
`Defendants.
`
`
`
`
`
`
`
`
`
`
`
`MEMORANDUM OF LAW IN SUPPORT OF DEFENDANTS’
`MOTION TO DISMISS THE FIRST AMENDED COMPLAINT
`
`
`
`Daralyn J. Durie (pro hac vice granted)
`Eric C. Wiener (pro hac vice granted)
`DURIE TANGRI LLP
`217 Leidesdorff Street
`San Francisco, CA 94111
`T: 415-362-6666
`
`Kira A. Davis
`DURIE TANGRI LLP
`953 E. 3rd Street
`Los Angeles, CA 90013
`T: 213-992-4499
`
`Raymond N. Nimrod
`Isaac Nesser
`Matthew D. Robson
`QUINN EMANUEL URQUHART &
`SULLIVAN, LLP
`51 Madison Avenue, 22nd Floor
`New York, NY 10010
`T: 212-849-7000
`
`Kevin P.B. Johnson
`QUINN, EMANUEL, URQUHART &
`SULLIVAN, LLP
`555 Twin Dolphin Drive, 5th Floor
`Redwood Shores, CA 94065
`T: 650-801-5000
`
`Sandra Haberny (pro hac vice granted)
`QUINN, EMANUEL, URQUHART &
`SULLIVAN, LLP
`865 S. Figueroa Street, 10th Floor
`Los Angeles, CA 90017
`T: 213-443-3000
`
`Attorneys for Defendant Genevant Sciences
`GmbH
`
`Attorneys for Defendant Arbutus Biopharma Corp.
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`
`
`
`
`

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`Case 1:22-cv-02229-MKV Document 44 Filed 10/04/22 Page 2 of 30
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`TABLE OF CONTENTS
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`Page
`
`I.
`
`II.
`
`III.
`
`IV.
`
`V.
`
`INTRODUCTION ...............................................................................................................1
`
`SUMMARY OF ARGUMENT ...........................................................................................1
`
`BACKGROUND .................................................................................................................5
`
`LEGAL STANDARDS .......................................................................................................7
`
`ARGUMENT .......................................................................................................................8
`
`A.
`
`2.
`
`The Court Should Dismiss The Amended Complaint For Lack Of Subject
`Matter Jurisdiction ...................................................................................................8
`1.
`The Amended Complaint Fails To Plead An Actual Controversy
`Between Acuitas And Defendants ...............................................................8
`a.
`Reason 1: Acuitas Has Not Pled Any Affirmative Act Of
`Patent Enforcement By Defendants Directed At Acuitas ................8
`Reason 2: Acuitas Has Not Pled Any Legally Cognizable
`Injury-In-Fact .................................................................................10
`Reason 3: Acuitas Has Not Shown That Acuitas And
`Defendants Have Adverse Legal Interests .....................................13
`Reason 4: Acuitas Has Not Shown That There Is A
`Substantial Controversy Of Sufficient Immediacy And
`Reality ............................................................................................14
`Acuitas’s Attempt To Rely On Its Alleged Supplier-Customer
`Relationship With Pfizer/BNT Fails To Establish Jurisdiction .................15
`a.
`Acuitas’s Indemnity Theory Fails To Establish Jurisdiction .........15
`b.
`Acuitas’s Indirect Infringement Theory Fails To Establish
`Jurisdiction .....................................................................................18
`Acuitas’s Supplier-Customer Argument Fails For The
`Separate Reason That There Is No Actual Controversy
`Between Defendants And Pfizer/BNT, So Acuitas Cannot
`Step Into Pfizer/BNT’s Shoes To Defend Them ...........................22
`
`b.
`
`c.
`
`d.
`
`c.
`
`B.
`
`The Court Should Exercise Its Discretion To Decline To Hear Acuitas’s
`Request For Declaratory Judgment ........................................................................24
`
`CONCLUSION ..................................................................................................................25
`
`i
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`VI.
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`

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`Case 1:22-cv-02229-MKV Document 44 Filed 10/04/22 Page 3 of 30
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`
`
`TABLE OF AUTHORITIES
`
`Cases
`
`Page
`
`Adenta GmbH v. OrthoArm, Inc.,
` 501 F.3d 1364 (Fed. Cir. 2007).................................................................................................. 8
`
`Adobe Sys. Inc. v. Kelora Sys. LLC,
` No. 11-3938, 2011 WL 6101545 (N.D. Cal. Dec. 7, 2011) ....................................................... 9
`
`Allied Mineral Products, Inc. v. Osmi, Inc.,
` 870 F.3d 1337 (Fed. Cir. 2017)...................................................................................... 9, 12, 22
`
`Alnylam Pharms., Inc. v. Pfizer, Inc.,
` No. 22-336 (D. Del. Mar. 17, 2022) ............................................................ 7, 11, 13, 14, 15, 22
`
`Arris Group v. British Telecom. PLC,
` 639 F.3d 1368 (Fed. Cir. 2011).................................................................................... 13, 15, 22
`
`Asia Vital Components Co. v. Asetek Danmark A/S,
` 837 F.3d 1249 (Fed. Cir. 2016)................................................................................................ 12
`
`Ass’n for Molecular Pathology v. U.S. Pat. & Trademark Off.,
` 653 F.3d 1329 (Fed. Cir. 2011)............................................................................................ 8, 13
`
`BroadSign Int’l, LLC v. T-Rex Prop. AB,
` No. 16-cv-04586, 2018 WL 357317 (S.D.N.Y. Jan. 10, 2018) ............................... 9, 10, 18, 20
`
`Commc’ns Test Design, Inc. v. Contec, LLC,
` 952 F.3d 1356 (Fed. Cir. 2020)................................................................................................ 24
`
`EMC Corp. v. Norand Corp.,
` 89 F.3d 807 (Fed. Cir. 1996).................................................................................................... 25
`
`Gordon v. Target Corp.,
` No. 20-CV-9589, 2022 WL 836773 (S.D.N.Y. Mar. 18, 2022) ................................................ 6
`
`Hesse v. Godiva Chocolatier, Inc.,
` 463 F. Supp. 3d 453 (S.D.N.Y. 2020)...................................................................................... 11
`
`Intel Corp. v. Future Link Sys., LLC,
` No. 14-377, 2015 WL 649294 (D. Del. Feb. 12, 2015) ............................................... 16, 17, 18
`
`LaserDynamics, Inc. v. Quanta Comp., Inc.,
` 694 F.3d 51 (Fed. Cir. 2012).................................................................................................... 14
`
`
`
`ii
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`

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`Case 1:22-cv-02229-MKV Document 44 Filed 10/04/22 Page 4 of 30
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`
`
`MedImmune, Inc. v. Genentech, Inc.,
` 549 U.S. 118 (2007) ............................................................................................................. 7, 13
`
`Microchip Tech., Inc. v. Chamberlain Group, Inc.,
` 441 F.3d 936 (Fed. Cir. 2006).................................................................................................. 13
`
`Microsoft Corp. v. DataTern,
` 755 F.3d 899 (Fed. Cir. 2014).................................................................... 16, 18, 19, 20, 21, 22
`
`Microsoft Corp. v. SynKloud Techs., LLC,
` 484 F. Supp. 3d 171 (D. Del. 2020) ............................................................................... 8, 16, 18
`
`ModernaTx, Inc. v. Arbutus Biopharma Corp.,
` 18 F.4th 1364 (Fed. Cir. 2021) ................................................................................................ 24
`
`Organic Seed Growers & Trade Ass’n v. Monsanto Co.,
` 851 F. Supp. 2d 544 (S.D.N.Y. 2012)...................................................................................... 10
`
`Prasco, LLC v. Medicis Pharm. Corp.,
` 537 F.3d 1329 (Fed. Cir. 2008).......................................................................................... 10, 11
`
`Proofpoint, Inc. v. InNova Pat. Licensing, LLC,
` No. 5:11-CV-02288, 2011 WL 4915847 (N.D. Cal. Oct. 17, 2011) ....................................... 18
`
`SanDisk Corp. v. STMicroelectronics, Inc.,
` 480 F.3d 1372 (Fed. Cir. 2007)................................................................................................ 23
`
`SRI Intern., Inc. v. Advanced Technology Laboratories, Inc.,
` 127 F.3d 1462 (Fed. Cir. 1997)................................................................................................ 23
`
`Statutory Authorities
`
`35 U.S.C. § 271(b) ........................................................................................................................ 19
`35 U.S.C. § 271(c) ......................................................................................................................... 19
`35 U.S.C. § 287(a) ..................................................................................................................... 6, 22
`
`Fed. R. Civ. P. 12(b)(1)................................................................................................................... 1
`
`Rules and Regulations
`
`
`
`iii
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`Case 1:22-cv-02229-MKV Document 44 Filed 10/04/22 Page 5 of 30
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`
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`I.
`
`INTRODUCTION
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`Acuitas Therapeutics Inc. (“Acuitas”) initiated this declaratory judgment action against
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`Genevant Sciences GmbH (“Genevant”) and Arbutus Biopharma Corp. (“Arbutus” and, together
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`with Genevant, “Defendants”) on March 18, 2022, and filed a First Amended Complaint
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`(“Amended Complaint”) on September 6, 2022. Acuitas seeks declarations that the manufacture,
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`use, offer to sell, and sale of the COVID-19 vaccine COMIRNATY® (“Comirnaty”) made and
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`sold by nonparties Pfizer Inc. (“Pfizer”) and BioNTech SE (“BNT”) does not infringe any claim
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`of nine patents owned by Arbutus and licensed to Genevant (“Defendants’ Patents”) and that
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`Defendants’ Patents are invalid. The Court should dismiss the Amended Complaint under Fed. R.
`
`Civ. P. 12(b)(1) because Acuitas has failed to meet its burden to show that there is an actual
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`controversy between Acuitas and Defendants. Even if Acuitas could somehow establish subject
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`matter jurisdiction, the Court should use its discretion to decline to hear Acuitas’s request for
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`declaratory judgment for at least two independent reasons. First, this suit runs the serious risk of
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`creating a multiplicity of actions regarding the same vaccine and the same patents, thereby serving
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`no useful purpose. Second, pending discussions between Genevant1 and Pfizer/BNT regarding a
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`potential license for Comirnaty could moot this suit at any time, resulting in the Court having
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`expended its time and resources unnecessarily.
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`II.
`
`SUMMARY OF ARGUMENT
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`Acuitas’s Amended Complaint is perhaps most notable for what it does not allege. It does
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`not allege that Defendants have ever sent Acuitas any communication regarding Comirnaty. It
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`does not allege that Defendants have ever accused Acuitas of infringing Defendants’ Patents,
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`whether directly or indirectly. It does not allege that Acuitas makes or sells Comirnaty. It does
`
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`1 Genevant has the authority by contract to license Defendants’ Patents in this situation.
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`

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`Case 1:22-cv-02229-MKV Document 44 Filed 10/04/22 Page 6 of 30
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`not allege that Defendants have ever tried to stop Acuitas from licensing or supplying any lipid or
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`lipid nanoparticle (“LNP”) technology to Pfizer/BNT for use in Comirnaty. And it does not allege
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`that Pfizer/BNT have stopped paying Acuitas royalties on Comirnaty, or that Acuitas has lost any
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`potential business deals. These failures lead to dismissal for four independent reasons.
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`First, under Federal Circuit law, declaratory judgment jurisdiction in a patent case is
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`available only where there have been affirmative acts by the patentee relating to patent
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`enforcement that were directed at the specific Plaintiff. Here, the Amended Complaint does not
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`allege that Defendants have taken any affirmative act whatsoever directed at the Plaintiff Acuitas
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`regarding potential infringement by Comirnaty. Rather, Acuitas relies exclusively on two letters
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`Defendants directed and sent to nonparties Pfizer/BNT offering to discuss a partnering
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`arrangement to help with the vaccine and a license to Defendants’ Patents. But those letters do
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`not even mention Acuitas, much less accuse it of infringing or threaten enforcement against
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`Acuitas.
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`Second, Acuitas has failed to allege any concrete injury-in-fact fairly traceable to
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`Defendants’ conduct, which is required to establish standing. Nowhere does the Amended
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`Complaint identify any specific lost licensing opportunity, lost business deal, lost royalty, lost
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`revenue, or any other form of concrete injury caused by Defendants’ letters to Pfizer/BNT. Acuitas
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`has been on notice for months of this deficiency, which Defendants noted in the parties’ joint letter
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`to the Court. Dkt. 36 at 4. Despite opting to amend the complaint, Acuitas still has not—
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`presumably because it cannot—identified any concrete injury caused by the letters sent to
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`Pfizer/BNT.
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`Instead, Acuitas relies on vague allegations of injury, including “concerns” raised by
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`unidentified potential future business partners, presumably (because it is not alleged) after learning
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`2
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`

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`Case 1:22-cv-02229-MKV Document 44 Filed 10/04/22 Page 7 of 30
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`
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`of Defendants’ letters to Pfizer/BNT. Dkt. 42, ¶ 54. But, even if such concerns could establish an
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`injury-in-fact (they do not), such injury is certainly not fairly traceable to Defendants’ conduct as
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`required for jurisdictional purposes. Defendants sent the letters privately to Pfizer/BNT. It was
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`Acuitas itself that exposed the letters to the public in its complaint. Simply put, if there is any
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`injury here relating to Acuitas’s potential future business partners, it is self-inflicted.
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`Third, Acuitas fails to meet its burden to show that it has legal interests adverse to
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`Defendants. Defendants have never demanded that Acuitas cease licensing or supplying any lipid
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`or LNP technology for Pfizer/BNT to use in the vaccine. Defendants’ statement to Pfizer/BNT
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`that they may require a license from Defendants does not create any adverse legal interests between
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`Defendants and Acuitas, nor does it suggest that Acuitas must cease licensing or supplying
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`Pfizer/BNT. Pfizer/BNT could take a license to Defendants’ Patents and also continue to license
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`Acuitas’s technology for Comirnaty. Multiple licenses are common and do not create actual
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`controversies between the various licensors—they can each obtain royalties as appropriate for the
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`use of their inventions.
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`Fourth, Acuitas has not met its burden to show there is a substantial controversy of
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`sufficient immediacy and reality to warrant a declaratory judgment. The letters to Pfizer/BNT that
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`Acuitas relies on were sent nearly two years ago and one year ago, respectively, and neither Pfizer
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`nor BNT (or either Defendant) has sought judicial intervention since then. Acuitas does not allege
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`that discussions regarding a potential license have been terminated, nor have they. Acuitas has not
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`pled anything about the state of the discussions, nor could Acuitas because it is not privy to them.
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`Attempting to manufacture a basis for subject matter jurisdiction despite these pleading
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`failures, Acuitas amended its complaint to allege two new theories based on supplier-customer
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`caselaw, namely indemnity and indirect infringement. Neither succeeds. As to indemnity, Federal
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`3
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`

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`Case 1:22-cv-02229-MKV Document 44 Filed 10/04/22 Page 8 of 30
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`Circuit law instructs that subject matter jurisdiction cannot be based merely on potential
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`indemnity—a plaintiff-supplier must allege that it is actually obligated to indemnify its customer.
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`Acuitas does not allege it actually has any such indemnity obligation to Pfizer/BNT—instead
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`Acuitas, if anything, appears to dispute that it has that obligation. Acuitas’s reliance on an indirect
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`infringement theory also fails because Defendants have never asserted that Acuitas has committed
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`an act that contributes to or induces infringement. Acuitas’s purported indirect infringement
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`concern is based entirely on the letters to Pfizer/BNT, but those letters do not even mention
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`Acuitas, let alone allege that Acuitas has committed any of the prerequisite acts to contribute to or
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`induce infringement.
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`Lastly, even if Acuitas could somehow demonstrate subject matter jurisdiction, the Court
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`should exercise its discretion to decline to hear this suit because it runs the serious risk of creating
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`a multiplicity of actions regarding the same vaccine and the same patents. For example, if the
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`Court were to determine in this action that Comirnaty infringes Defendants’ Patents or that they
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`are not invalid, Pfizer/BNT might very well on the next day file an independent action for
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`noninfringement and invalidity and attempt to argue that, as nonparties here, they are not bound
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`or estopped by this Court’s judgment. The Court ought not waste its resources deciding the
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`question of whether the vaccine infringes when the actual makers and sellers of the vaccine can
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`turn around and claim they are not bound by the Court’s judgment.
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`The Court should decline to hear this suit for the additional reason that it seeks to adjudicate
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`issues that may never require judicial resolution given the pending discussions between Genevant
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`and Pfizer/BNT regarding a potential license. There is no need to burden the Court with Acuitas’s
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`premature side-show action when the actual parties to the discussions have not sought judicial
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`intervention and a license could moot this case at any time.
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`4
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`

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`Case 1:22-cv-02229-MKV Document 44 Filed 10/04/22 Page 9 of 30
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`For these reasons, and as discussed in more detail below, this Court should dismiss the
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`Amended Complaint for lack of subject matter jurisdiction or in the alternative exercise its
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`discretion to decline to entertain Acuitas’s suit.
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`III. BACKGROUND
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`Genevant is a technology-focused nucleic acid delivery company and a world leader in the
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`LNP space, with the industry’s most robust and expansive LNP patent portfolio and decades of
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`expertise in nucleic acid drug delivery and development. Genevant has licensed LNP-related
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`patents from Arbutus, which is a clinical-stage biopharmaceutical company with deep virology
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`expertise and an unwavering focus on curing a variety of conditions. Defendants’ Patents cover
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`important aspects of LNP technology for delivering RNA to cells in the body for therapeutic effect
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`and are generally directed to nucleic acid-lipid particles comprising specific types of lipids,
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`sometimes in required ratios. See, e.g., Dkt. 1-1 (U.S. Patent No. 8,058,069, claim 1). All the
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`patents require both a nucleic acid (e.g., mRNA) and an LNP with specific lipid types.
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`Genevant and BNT have a long history of collaboration on LNP-related research and
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`development programs. In 2018, BNT licensed Defendants’ Patents from Genevant, among other
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`patents, in connection with BNT’s development of therapeutics in the oncology field. That BNT
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`agreement describes Genevant’s platform as “the best lipid nanoparticle technology,” confirming
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`BNT’s understanding of the value of Genevant’s LNP technology. Ex. A2 at 1.3 This 2018 license
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`was limited, however, to the development of certain cancer or rare disease treatments and did not
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`cover infectious diseases, such as COVID-19.
`
`
`2 All references to “Ex. __” in this brief are to the exhibits to the Declaration of Matthew D. Robson, submitted
`herewith.
`3 Available at www.sec.gov/Archives/edgar/data/1776985/000119312519241112/d635330dex1017.htm. On a
`Rule 12(b)(1) motion, “[c]ourts may take judicial notice of public documents or documents of public record ….”
`Gordon v. Target Corp., No. 20-CV-9589, 2022 WL 836773, at *2 (S.D.N.Y. Mar. 18, 2022).
`
`5
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`

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`Case 1:22-cv-02229-MKV Document 44 Filed 10/04/22 Page 10 of 30
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`Accordingly, on November 23, 2020, Defendants sent a letter to Pfizer/BNT asking for the
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`opportunity to discuss a partnering arrangement that would enable Pfizer/BNT to benefit from
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`Genevant scientists’ extensive expertise with the formulation and manufacture of LNP delivery
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`systems and welcoming discussions of licensing Defendants’ patents. On October 12, 2021,
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`Defendants sent a second letter identifying another Arbutus patent relevant to the proposed
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`discussion. These letters also noted, under 35 U.S.C. § 287(a), that the making, using, selling,
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`offering for sale, or importing into the United States of Comirnaty may infringe Defendants’
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`Patents. See Exs. B & C.4 The letters do not include an analysis of potential infringement (e.g.,
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`they did not attach claim charts). Importantly, Defendants never sent either letter to Acuitas, nor
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`made them public.
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`Following this correspondence, Genevant and BNT (acting also on behalf of Pfizer) entered
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`into discussions regarding a potential license to Defendants’ Patents for Comirnaty. These
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`discussions are referenced in Defendants’ October 2021 letter, and, in the months following that
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`letter, the parties to the discussions agreed to terms of confidentiality covering the discussions.
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`This agreement, made in January 2022, prohibits any entity other than Defendants and Pfizer/BNT
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`from being privy to the discussions. That is, far from standing in the shoes of Pfizer/BNT to
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`resolve any potential dispute with Defendants, Acuitas is prohibited from even being privy to their
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`discussions.
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`Acuitas does not manufacture or sell Comirnaty. Acuitas alleges that it licenses and
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`supplies lipids, including the ALC-315 cationic lipid, and LNPs to Pfizer/BNT. The Amended
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`Complaint does not allege that Acuitas’s license agreement with Pfizer/BNT precludes Pfizer/BNT
`
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`4 On a Rule 12(b)(1) motion, the Court may consider documents incorporated into the complaint where, as here
`with respect to the two letters to Pfizer/BNT, the plaintiff relies on the materials in framing the complaint, (2) the
`complaint clearly and substantially references the documents, and (3) the documents’ authenticity or accuracy is
`undisputed. Gordon, 2022 WL 836773, at *2.
`
`6
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`

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`Case 1:22-cv-02229-MKV Document 44 Filed 10/04/22 Page 11 of 30
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`
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`from licensing additional LNP-related technology from others, and indeed, in a suit actually
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`involving Pfizer, Pfizer itself has noted that BNT has licensed technology used in the vaccine from
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`“multiple partners,” of which Acuitas is only one. Alnylam Pharms., Inc. v. Pfizer, Inc., No. 22-
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`336 (D. Del. Mar. 17, 2022), Dkt. 13, ¶ 24. This is common. See, e.g., Taorui Guan, Evidence-
`
`Based Patent Damages, 28 J. INTELL. PROP. L. 1, 18 (2020) (“In some industries, such as …
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`biotechnology, one product can involve multiple patents. A product infringing the patentee’s
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`patent might therefore also apply the patents of third parties.”). In this way, Pfizer/BNT are not
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`required to license only Acuitas’s patents or only Defendants’ patents, but may require licenses
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`from both Acuitas and Defendants, and potentially additional parties too. There is no inherent
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`conflict between licensors of LNP technology. And Defendants have never asserted that Acuitas
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`must stop licensing or supplying any lipid or LNP technology to Pfizer/BNT for use in Comirnaty.
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`IV.
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`LEGAL STANDARDS
`
`To establish subject matter jurisdiction, it is Acuitas’s burden to establish that there is “a
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`case of actual controversy” between itself and Defendants. The Supreme Court has instructed that
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`“the question in each case is whether the facts alleged, under all the circumstances, show that there
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`is a substantial controversy, between parties having adverse legal interests, of sufficient immediacy
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`and reality to warrant the issuance of a declaratory judgment.” MedImmune, Inc. v. Genentech,
`
`Inc., 549 U.S. 118, 127 (2007). Where an action seeks a declaratory judgment regarding rights
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`arising under patent law, Federal Circuit law controls the subject matter jurisdiction inquiry.
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`Adenta GmbH v. OrthoArm, Inc., 501 F.3d 1364, 1368 (Fed. Cir. 2007).
`
`7
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`Case 1:22-cv-02229-MKV Document 44 Filed 10/04/22 Page 12 of 30
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`V.
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`ARGUMENT
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`A.
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`The Court Should Dismiss The Amended Complaint For Lack Of Subject
`Matter Jurisdiction
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`The Amended Complaint fails to plead an actual controversy between Acuitas and
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`Defendants. Moreover, Acuitas’s attempt to rely on its alleged supplier-customer relationship with
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`Pfizer/BNT to create an actual controversy also fails.
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`1.
`
`The Amended Complaint Fails To Plead An Actual Controversy
`Between Acuitas And Defendants
`
`The Amended Complaint fails to establish an actual controversy between Acuitas and
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`Defendants for four reasons, each of which is independently dispositive and compels dismissal.
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`First, Acuitas has not pled an affirmative act of patent enforcement by Defendants directed at
`
`Acuitas. Second, Acuitas has not pled any legally cognizable injury-in-fact. Third, Acuitas has
`
`not shown that Acuitas and Defendants have adverse legal interests. Fourth, Acuitas has not
`
`shown that there is a substantial controversy of sufficient immediacy and reality.
`
`a.
`
`Reason 1: Acuitas Has Not Pled Any Affirmative Act Of Patent
`Enforcement By Defendants Directed At Acuitas
`
`A declaratory judgment plaintiff must allege “an affirmative act by the patentee related to
`
`the enforcement of his patent rights” to establish an actual controversy. Ass’n for Molecular
`
`Pathology v. U.S. Pat. & Trademark Off., 653 F.3d 1329, 1348 (Fed. Cir. 2011) (overruled on
`
`other grounds). Moreover, the patentee’s affirmative acts of enforcement must be directed at the
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`“specific plaintiffs” seeking the declaratory judgment. Id. at 1348; see also Microsoft Corp. v.
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`SynKloud Techs., LLC, 484 F. Supp. 3d 171, 177 (D. Del. 2020) (“The patentee’s affirmative acts
`
`must be directed at the ‘specific plaintiffs’ seeking a declaratory judgment.” (citing Molecular
`
`Pathology)).5 Acuitas has not pled any affirmative act of patent enforcement of Defendants’
`
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`5 All emphases in this brief are supplied unless otherwise noted.
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`8
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`Case 1:22-cv-02229-MKV Document 44 Filed 10/04/22 Page 13 of 30
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`Patents by Defendants directed specifically at Acuitas, and thus it has failed to establish an actual
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`controversy.
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`Indeed, Acuitas does not even allege that the Defendants ever contacted or communicated
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`with it in any way regarding Comirnaty. Nor is there any allegation that Defendants have
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`threatened Acuitas with litigation, demanded a royalty from Acuitas, or demanded that Acuitas
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`stop licensing or supplying Pfizer/BNT with any lipids or LNP technology. The circumstances
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`here are similar to other cases where dismissal was appropriate because there was no
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`communication whatsoever between the patentee and plaintiff regarding patent infringement. For
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`example, in Allied Mineral Products, Inc. v. Osmi, Inc., the Federal Circuit affirmed dismissal of
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`a declaratory judgment action where, as here, there were “no veiled threats of litigation or even
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`any direct communication from [defendants] to [plaintiff].” 870 F.3d 1337, 1340 (Fed. Cir. 2017).
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`Other courts, considering the totality of the circumstances, have likewise dismissed declaratory
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`judgment actions where, as here, “[plaintiff] has not alleged that [defendant] has communicated
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`with [plaintiff] at all before [plaintiff] instituted this suit.” Adobe Sys. Inc. v. Kelora Sys. LLC,
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`No. 11-3938, 2011 WL 6101545, at *4 (N.D. Cal. Dec. 7, 2011); see also BroadSign Int’l, LLC v.
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`T-Rex Prop. AB, No. 16-cv-04586, 2018 WL 357317, at *4 (S.D.N.Y. Jan. 10, 2018) (dismissing
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`complaint where there was “no indication of any discussion or threat of litigation against
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`Plaintiff”).
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`Moreover, the Amended Complaint does not allege that Defendants have ever contended
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`or asserted that Acuitas infringes Defendants’ Patents in connection with Comirnaty. The
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`Amended Complaint is devoid of any allegation that Defendants have ever stated to Pfizer, BNT,
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`or anyone else that Acuitas infringes Defendants’ Patents. The Amended Complaint attempts to
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`rely on the two letters Defendants sent to nonparties Pfizer/BNT but these letters do not even
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`mention Acuitas, much less identify any act of Acuitas as infringing. Dismissal under Rule
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`12(b)(1) is proper where, as here, the patentee has never identified any of the plaintiff’s conduct
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`as infringing. See Organic Seed Growers & Trade Ass’n v. Monsanto Co., 851 F. Supp. 2d 544,
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`551 (S.D.N.Y. 2012) (dismissing declaratory judgment complaint lacking any “alleg[ation] that
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`defendants have ever demanded royalty payments from plaintiffs, identified any of plaintiffs’
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`conduct as potentially infringing, or even initiated any contact with plaintiffs whatsoever.”).
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`Acuitas’s failure to plead any affirmative act of patent enforcement against it requires
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`dismissal.
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`b.
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`Reason 2: Acuitas Has Not Pled Any Legally Cognizable Injury-
`In-Fact
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`The Amended Complaint is also subject to dismissal because Acuitas has not alleged any
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`legally cognizable injury-in-fact. As the Federal Circuit has instructed, to establish standing, a
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`plaintiff must (1) “allege [] an injury-in-fact, i.e., a harm that is ‘concrete’ and actual or
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`imminent, not ‘conjectural’ or ‘hypothetical;” and (2) the injury-in-fact must be “‘fairly
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`traceable’ to the defendant’s conduct,” among other things. Prasco, LLC v. Medicis Pharm. Corp.,
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`537 F.3d 1329, 1338 (Fed. Cir. 2008). Acuitas does not come close to meeting this burden.
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`Acuitas Impermissibly Attempts To Rely On Alleged Harms That Are Self-Inflicted,
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`Rather Than Being Traceable To Defendants’ Conduct—The majority of Acuitas’s allegations
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`attempting to show injury-in-fact are based on the purported impact that the letters to Pfizer/BNT
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`had or may have on potential customers in the market besides Pfizer/BNT. For example, Acuitas
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`alleged that “[p]otential licensing partners have raised concerns about Arbutus’s and Genevant’s
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`demands against Pfizer and BioNTech.” Dkt. 42, ¶ 54. But, even if Acuitas’s vague allegations
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`regarding “concerns” raised by potential licensing partners were sufficient to establish an injury-
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`in-fact (they are not), the injury would not be fairly traceable to Defendants’ conduct. Defendants
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`sent the letters privately to Pfizer and BNT—not to any other potential licensing partner of Acuitas
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`or to the public. It was Acuitas itself that made Defendants purported “demands” publicly
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`available in its complaint. Simply put, if there is any injury here, it is self-inflicted. That does not
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`suffice. See Prasco, 537 F.3d at 1338 (injury must be “‘fairly traceable’ to defendants’ conduct”).
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`Acuitas Has Not Pled A Concrete Injury—The Amended Complaint is devoid of a single
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`allegation of a concrete injury. It identifies no specific lost licensing opportunity, lost business
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`deal, lost royalty, lost revenue, or any other form of concrete injury. This failure is all the more
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`telling given that Defendants specifically highlighted the lack of an allegation of any specific lost
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`business deal or royalties in the parties’ joint letter to the Court. Dkt. 36 at 4 (“Acuitas has not
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`alleged injury-in-fact, such as the loss of specific business deals or royalties, resulting from the
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`letters Defendants sent to Pfizer and BioNTech.”). Yet, in its Amended Complaint, Acuitas still
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`has not—presumably because it cannot—identified any specific lost business deals, royalties, or
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`revenues.
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`The most Acuitas has been able to say about any effect Defendants’ letters have had on its
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`current relationship with Pfizer/BNT is they have “impact[ed] the relationship,” without alleging
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`how. Dkt. 42, ¶ 54. This tepid allegation of an “impact” falls well short of a concrete harm. To
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`the contrary, Acuitas announced a new licensing deal with Pfizer in January 2022,6 indicating that
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`its business relationship with Pfizer is in fact thriving. And Acuitas’s May 2022 deal with another
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`6 See Ex. D (https://acuitastx.com/wp-content/uploads/2022/01/Acuitas-Pfizer-Agreement-Release.pdf). On a
`Rule 12 motion, “a court may take judicial notice of information publicly announced on a party’s website, as long as
`the website’s authenticity is not in dispute and ‘it is capable of accurate and ready determination.’” Hesse v. Godiva
`Chocolatier, Inc., 463 F. Supp. 3d 453, 463 (S.D.N.Y. 2020).
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