ACUITAS THERAPEUTICS INC. v. GENEVANT SCIENCES GMBH

CourtDistrict Court, D. New Jersey
DecidedMay 20, 2024
Docket3:23-cv-04200
StatusUnknown

This text of ACUITAS THERAPEUTICS INC. v. GENEVANT SCIENCES GMBH (ACUITAS THERAPEUTICS INC. v. GENEVANT SCIENCES GMBH) is published on Counsel Stack Legal Research, covering District Court, D. New Jersey primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
ACUITAS THERAPEUTICS INC. v. GENEVANT SCIENCES GMBH, (D.N.J. 2024).

Opinion

NOT FOR PUBLICATION

UNITED STATES DISTRICT COURT DISTRICT OF NEW JERSEY

ACUITAS THERAPEUTICS INC., Plaintiit, Civil Action No, 23-4200 (ZNQ) (TIB) OPINION GENEVANT SCIENCES GMBH, ef al, Defendants.

QURAISHL, District Judge THIS MATTER comes before the Court upon a Motion to Dismiss filed by Defendants Genevant Sciences GmbH and Arbutus Biopharma Corp. (“Defendants”) (ECF No. 13.) Defendants filed a Brief in Support of the Motion. (“Moving Br.”, ECF No. 13-1.) Plaintiff Acuitas Therapeutics Inc, (“Plaintiff”) filed a Memorandum in Opposition (“Opp.”, ECF No. 20) and Defendants filed a Reply Brief (ECF No. 27). The Court has carefully considered the parties’ submissions and decides the Motion without oral argument pursuant to Federal Rule of Civil Procedure 78 and Local Civil Rule 78.1. For the reasons set forth below, the Court will GRANT the Motion to Dismiss and DISMISS the Complaint WITHOUT PREJUDICE, 1. BACKGROUND AND PROCEDURAL HISTORY Plaintiff develops lipid nanoparticle (““LNP”) formulations for delivering mRNA therapeutics. (See Compl. 6.) It supplies and licenses its LNPs to non-parties Pfizer and BioNTech for use in COMIRNATY®, a COVID-19 vaccine marketed by Pfizer and BioNTech.

(Compl. §] 3, 44.) Plaintiff seeks a declaratory judgment that the Comirnaty vaccine does not infringe Arbutus’s patents. Ud. J§] 3, 32.) The parties’ dispute began in November 2020 when Defendants sent Pfizer and BioNTech a first letter notifying them that the Comirnaty vaccine might infringe eight of Defendants’ patents. (See id. 435.) Defendants sent two more notice letters in October 2021 and June 2022 that identified additional patents. (dd. 36-37.) In March of 2022, after the second letter, Plaintiff filed suit against Defendants in New York seeking a declaration of noninfringement and invalidity of the patents identified in the letters (the “New York DJA Suit”). Ud. 938.) In April 2023, Defendants began their own suit against Pfizer and BioNTech in this court alleging infringement of five of their patents. (/d. ]40.) That matter is before the undersigned as Arbutus Biopharma Corp., et al. v. Pfizer Inc., et al., 23-cv-1876 (the “New Jersey Infringement Suit”), In response, Plaintiff withdrew the New York DJA Suit in August 2023 and filed the present suit. (id. | 40— 41.) In this suit, Plaintiff again seeks a declaratory judgment that ten of Defendants’ patents are invalid and not infringed. (/d. J 42.) H, JURISDICTION Based on the claims alleged by the Complaint, the Court has subject matter jurisdiction pursuant to 28 ULS.C. §§ 1331, 1338(a), and 2201, LEGAL STANDARD A. MOTION TO DISMISS FOR LACK OF SUBJECT MATTER JURISDICTION Federal Rule of Civil Procedure 12(b)(1) allows a court to dismiss a complaint for lack of subject matter jurisdiction because a party lacks standing. Ballentine v. United States, 486 F.3d

?

806, 810 (3d Cir. 2007).! Two types of challenges can be made under Rule 12(b)(1): a facial attack or a factual attack. In re Horizon Healthcare Servs. Inc. Data Breach Litig., 846 F.3d 625, 632 (3d Cir, 2017). A facial attack “challenges subject matter jurisdiction without disputing the facts alleged in the complaint, and it requires the court to consider the allegations of the complaint as true.” Davis vy. Wells Fargo, 824 F.3d 333, 346 (3d Cir. 2016) (internal quotation marks and citations omitted). A factual challenge “attacks the factual allegations underlying the complaint's assertion of jurisdiction, either through the filing of an answer or ‘otherwise presenting] competing facts.’ ” Jd. (quoting Const. Party of Penn. vy. Aichele, 757 F.3d 347, 358 (3d Cir. 2014)). “Tn reviewing facial challenges to standing, [courts] apply the same standard as on review of a motion to dismiss under Rule 12(b)(6).” Jn re Horizon, 846 F.3d at 633. Courts “only consider the allegations of the complaint and documents referenced therein and attached thereto, in the light most favorable to the plaintiff” Const. Party of Penn., 757 F.3d at 358 (citations omitted). When considering a factual challenge, by contrast, “a court may weigh and consider evidence outside the pleadings.” /d. (quotation marks and citations omitted). B. ARTICLE HI STANDING The Declaratory Judgment Act (“DJA”) provides that, in the case of actual controversy within its jurisdiction... any court of the United States, upon the filing of an appropriate pleading, may declare the rights and other legal relations of any interested party seeking such declaration, whether or not further relief is or could be sought.

Here, the Court applies Third Circuit law to those aspects of a standing analysis that do not implicate patent law. See Salix Pharm, Ltd. v, Norwich Pharm. Ine., 98 F Ath 1056, 1069 (Fed, Cir, 2024); Jn re Lipitor Antitrust Litig., 855 F.3d 126, 148 (3d Cir, 2017).

28 ULS.C. § 2201 (a). The Supreme Court has explained that the “actual controversy” requirement of the Act refers to the types of “cases” and “controversies” justiciable under Article II. See Medimmune, Inc. v. Genentech, Inc., 549 U.S. 118 (2007) (citation omitted). In the patent context, the Court of Appeals for the Federal Circuit has articulated the considerations for assessing whether a plaintiff seeking a declaratory judgment has met the case- or-controversy requirement of Article III.? See Mitek Sys., Inc, v. United Servs, Auto. Ass'n, 34 F. 4th 1334 (Fed. Cir, 2022). Under Mitek, to determine whether a plaintiff might reasonably be liable for infringement, a district court should look to the elements of the potential cause of action, then consider both the patent claims at issue and the alleged facts concerning the plaintiff in light of those elements. □□□ at 1343. Although the plaintiff is not obligated to prove, for jurisdictional purposes, that it infringes the patents-in-suit (which is what it ultimately seeks to disprove in its case), “there must be allegations by the patentee or other record evidence that establish at least a reasonable potential that infringement claims against him could be brought.” Jd. (quoting Microsoft, 755 F.3d at 905). “This requires separate consideration of the separate types of infringement (notably, direct infringement, inducement of infringement, and contributory infringement) of the claims of the patents-in-suit, and of the bearing on any infringement of such claims of the fact stressed by the district court... .” Jd, Cc, A DISTRICT COURT'S DISCRETION TO DECLINE TO HEAR A DECLARATORY JUDGMENT ACTION Importantly, the DJA provides that courts “say declare the rights and other legal relation of any interested party seeking such declaration.” 28 U.S.C. § 2201 (emphasis added). Based on

? The Court applies the law of the Court of Appeals for the Federal Circuit to this issue because an assessment of liability for patent infringement implicates substantive patent law. See In re Spalding Sports Worldwide, Inc., 203 F.3d 800, 803 (Fed. Cir. 2000).

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ACUITAS THERAPEUTICS INC. v. GENEVANT SCIENCES GMBH, Counsel Stack Legal Research, https://law.counselstack.com/opinion/acuitas-therapeutics-inc-v-genevant-sciences-gmbh-njd-2024.