お知らせ • Sep 12
Arbutus Pharma Corp. and Genevant Sciences GmbH Provides Lawsuit Update
On September 9, 2025, the U.S. District Court for the District of New Jersey issued a claim construction ruling in the lawsuit brought by Arbutus Biopharma Corporation and its licensee Genevant Sciences against Pfizer Inc. and BioNTech SE seeking damages for infringement of U.S. Patent Nos. 9,504,561, 8,492,359, 11,141,378, 11,298,320 and 11,318,098 in the manufacture and sale of Pfizer/BioNTech’s COVID-19 mRNA-based vaccines. In this Opinion, the Court construes claim terms from five patents directed to compositions and methods for preparing lipid nanoparticles containing therapeutic agents. The parties submitted the following briefs in support of their respective positions: Defendants’ Opening Brief (ECF No. 83); Plaintiffs’ Opening Brief (ECF No. 84); Defendants’ Response Brief (ECF No. 135); and Plaintiffs’ Response Brief (ECF No. 136). Plaintiffs Arbutus Pharma Corp. and Genevant Sciences GmbH brought this patent infringement suit against Defendants Pfizer Inc., and BioNTech SE. (collectively, “Defendants”) for infringement of United States Patent Nos. 9,504,651 (“the ‘651 Patent”), 8,492,359 (“the ‘359 Patent”), 11,141,378 (“the ‘378 Patent”), 11,298,320, and 11,318,098. By design, the inside of a human body is a hostile place. The bloodstreams contain a series of enzymes that digest various proteins and nucleic acids. This poses certain well-known challenges to medical science: therapeutics vulnerable to these enzymes survive only briefly in a patient’s blood stream after they are administered by injection. In succinct terms, the inventors of the patents in suit address this problem by tucking a vulnerable therapeutic inside nanoscopic particles of fat with a particular structure-referred to as “liposomes” or “lipid nanoparticles” or “lipid vesicles.” Inside these structures, the therapeutics are shielded from enzymatic digestion. Messenger ribonucleic acid (mRNA) is an example of a vulnerable therapeutic when it is administered to patients to treat a disease or disorder. It is well-known that mRNA figured prominently in the world’s response to COVID-19. Notably, it formed the basis of Defendants’ COMIRNATY® COVID-19 vaccine. The Complaint in this case accuses Defendants of infringing the patents in suit by using Plaintiffs’ liposome technology in Defendants’ vaccine without Plaintiffs’ permission. A patent infringement case typically involves two steps: construing the claims and determining whether the accused product infringes the claims. See Markman v. Westview Instruments Inc., 52 F.3d 967, 976 (Fed. Cir. 1995) (en banc), aff’d, 517 U.S. 370 (1996); Hormone Research Found. Inc. v. Genentech Inc., 904 F.2d 1558, 1562 (Fed. Cir. 1990), cert. dismissed, 499 U.S. 955 (1991). Claim construction is primarily a question of law. See Teva Pharm. U S.A. Inc. v. Sandoz Inc., 574 U.S. 318, 325-26 (2015). It begins with the claim language. Innova/Pure Water Inc. v. Safari Water Filtration Sys. Inc., 381 F.3d 1111, 1115 (Fed. Cir. 2004); Markman, 52 F.3d at 980. Claim language is generally “given [its] ordinary and customary meaning.” Vitronics Corp. v. Conceptronic Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996) (“[W]e look to the words of the claims themselves . . . to define the scope of the patented invention.”); see also Interactive Gift Express Inc. v. Compuserve Inc., 256 F.3d 1323, 1331 (Fed. Cir. 2001) (“In construing claims, the analytical focus must begin and remain centered on the language of the claims themselves, for it . is that language that the patentee chose to use to ‘particularly point [] out and distinctly claim[] the subject matter which the patentee regards as his invention.’”) (quoting 35 U.S.C. § 112). Ordinary meaning is determined by “a person of ordinary skill in the art in question at the time of the invention.”1 Phillips v. AHW Corp., 415 F.3d 1303, 1313 (Fed. Cir. 2005) (collecting cases); Brookhill-Wilk 1, LLC v. Intuitive Surgical Inc., 334 F.3d 1294, 1298 (Fed. Cir. 2003). However, if a patentee has used the claim language in some manner other than its ordinary meaning, as indicated by the balance of intrinsic evidence, such as the specification, then that meaning controls. See, e.g., Phillips, 415 F.3d at 1226; Ecolab Inc. v. Envirochem Inc., 264 F.3d 1358, 1366 (Fed. Cir. 2001); Allen Engineering Corp. v. Bartell Industries Inc., 299 F.3d 1336, 1344 (Fed. Cir. 2002) (“It is thus necessary to review [intrinsic evidence] to determine whether the patentee has assigned any special meaning to claim terms.”). Because “there is no magic formula or catechism” for determining ordinary meaning, nor a “rigid algorithm” or “specific sequence,” Phillips, 415 F.3d at 1324, a court must read claims in context. See Medrad Inc. v. MRI Devices Corp., 401 F.3d 1313, 1319 (Fed. Cir. 2005) (“We cannot look at the ordinary meaning of the term . in a vacuum.”); see also DeMarini Sports Inc. v. Worth, 239 F.3d 1314, 1324 (Fed. Cir. 2001). To this end, a court must consider “the written description and prosecution history,” Medrad, 401 F.3d at 1319, “the specification,” Phillips, 415 F.3d at 1313, which is “always highly relevant to the claim construction analysis,” Vitronics, 90 F.3d at 1582, because it “may reveal whether the patentee has used a term in a way different from its plain meaning,” Brookhill-Wilk, 334 F.3d at 1298, and “the surrounding words of the claim.” ACTV Inc. v. Walt Disney Co., 346 F.3d 1082, 1088 (Fed. Cir. 2003). In addition to “the words of the claims themselves, the remainder of the specification, [and] the prosecution history,” a court may also consider “extrinsic evidence concerning relevant scientific principles, the meaning of technical terms, and the state of the art.” Innova, 381 F.3d at 1116; see also Gemstar-TV Guide Int’! Inc. v. Int’! Trade Comm’n, 383 F.3d 1352, 1364 (Fed. Cir. 2004). Even “[o]ther claims of the patent in question, both asserted and unasserted, can be valuable sources of enlightenment as to the meaning of a claim term.” Vitronics, 90 F.3d at 1582. In short, the “entire patent” matters, Phillips, 415 F.3d at 1313; Multiform Desiccants Inc. v. Medzam, Ltd, 133 F.3d 1473, 1477 (Fed. Cir. 1998), and “[t]he construction that stays true to the claim language” while “most naturally align[ing] with the patent’s description of the invention will be, in the end, the correct construction.” Renishaw PLC v. Marposs Societa’ per Azioni, 158 F.3d 1243, 1250 (Fed. Cir. 1998).
