Case 1:22-cv-00252-MSG Document 266 Filed 04/03/24 Page 1 of 37 PageID #: 16329
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`ARBUTUS BIOPHARMA CORPORATION
`and GENEVANT SCIENCES GMBH,
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`Plaintiffs,
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`v.
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`MODERNA, INC. and MODERNATX, INC.,
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`:
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`:
`:
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`:
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`CIVIL ACTION
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`NO. 22-252
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`Goldberg, J.
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`April 3, 2024
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`MEMORANDUM OPINION1
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`During the COVID-19 pandemic, Defendants Moderna, Inc. and ModernaTX, Inc.
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`(collectively, “Moderna”) brought to market an mRNA-based vaccine. On February 28, 2022,
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`after many of the quarantine orders had been lifted in the United States, Plaintiffs Arbutus
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`Biopharma Corporation (“Arbutus”) and Genevant Sciences GmbH (“Genevant”) (collectively,
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`“Plaintiffs”) brought this infringement suit claiming that Defendant used—without payment or a
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`license—a revolutionary lipid nanoparticle (“LNP”) delivery platform, created and patented by
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`Plaintiffs. Plaintiffs now demand compensation for the use of the technology they claim to have
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`developed.
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`Presently, the parties seek construction of several terms of the patents-in-suit pursuant to
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`Markman v. Westview Instruments, Inc., 52 F.3d 967, 976 (Fed. Cir. 1995), aff’d, 517 U.S. 370
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`(1996). I have construed the disputed claims as set forth in this Opinion and accompanying Order.
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`The Chief of the United States Court of Appeals for the Third Circuit has designated me as a
`visiting judge for the District of Delaware, pursuant to 28 U.S.C. § 292(b), to handle this and other Delaware
`cases.
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`Case 1:22-cv-00252-MSG Document 266 Filed 04/03/24 Page 2 of 37 PageID #: 16330
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`I.
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`FACTUAL BACKGROUND
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`A. Background on mRNA Vaccines2
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`Viruses are typically small packets of DNA or RNA. If a viral DNA or RNA enters the
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`host cell, it hijacks the cell’s machinery and instructs the cell to make copies of the virus. These
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`copies, often numbering into the millions, leave the infected cell and hijack other cells where the
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`process repeats. Infected cells can become damaged or die while hosting the virus, and left
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`unchecked, the host organism can itself die.
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`Vaccines traditionally work by injecting a weakened or inactive form of the virus that is
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`unable to cause infection but nonetheless retains features of the virus, which can teach the body’s
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`immune system to recognize and attack the infectious virus if it invades in the future. Moderna’s
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`COVID-19 vaccine, however, belongs to a new class of medicines that deliver nucleic acids into
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`the cells of the body to treat diseases or trigger an immune response to protect a person from future
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`infection. Nucleic acids are molecules that encode the genetic information essential to sustain life.
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`One type of nucleic acid is DNA, which is found within our chromosomes and contains our genetic
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`information. In order to make the protein encoded by a particular gene, the cell first converts the
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`genetic code in the gene’s DNA into another type of nucleic acid known as messenger ribonucleic
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`acid, or “mRNA.” The mRNA then carries the code to the cell’s protein-making machinery, which
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`assembles the protein from the code stored in the mRNA.
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`RNA-based medicines have been difficult to develop because mRNA molecules are fragile
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`and, without adequate protection, are susceptible to degradation before entering the cell. For
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`decades, the need for an effective delivery technology had been a significant challenge in the
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`This background was taken from the parties’ technology tutorials.
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`development of RNA-based products. Without the means to protect the mRNA outside the cell,
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`mRNA-based vaccines have been ineffective.
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`B. The Lipid Nano-Particle Delivery Approach
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`One delivery approach found to be effective for mRNA vaccines is the use of a lipid nano-
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`particle (“LNP”) technology that relies on fat-like molecules, called lipids, to encapsulate and
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`protect nucleic acids like mRNA from degradation in the body. The LNP releases the nucleic acid
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`so that it can express the protein it encodes.
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`According to Plaintiffs, early lipoplex structures were unsuccessful in delivering nucleic
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`acids to cells in living systems because the nucleic acids were simply interspersed with the
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`liposomes, leaving them susceptible to degradation in the body. In the late 1990s to early 2000s,
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`ionizable cationic lipids were developed, and Plaintiffs’ scientists used them to create LNPs.
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`LNPs are comprised of several different types of lipids. Cationic lipids carry positive
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`charges which attract negatively charged nucleic acid. Conjugated lipids contain a lipid attached
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`to a compound to help prevent the LNP from sticking to other LNPs during manufacture and to
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`shield the LNP during delivery. Structural lipids, such as phospholipids and cholesterol, help keep
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`the structure of the particles. These various lipids exist in specified ratios, expressed in terms of
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`the “mol %” which refers to the percentage of each type of lipid molecule counted by number of
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`molecules.
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`C. The Patents-in-Suit
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`The parties agree that there are two categories of patents-in-suit. The first category is the
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`“Encapsulation Patent,” which includes only U.S. Patent No. 9,504,651, “Lipid Compositions for
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`Nucleic Acid Delivery,” issued on November 29, 2016. The ’651 patent claims a new method for
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`developing LNPs which involves continuously and rapidly mixing two solutions to form lipid
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`vesicles that can encapsulate nucleic acids.
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`The second category of patents-in-suit are the “Molar Ratio Patents, which include U.S.
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`Patent No. 8,058059 (the “’069 patent”) issued on November 15, 2011, U.S. Patent No. 8,492,359
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`(the “’359 patent”) issued on July 23, 2013, U.S. Patent No. 8,822,668 (the “’668 patent”) issued
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`on September 2, 2014, U.S. Patent No. 9,364,435 (the “’435 patent”) issued on June 14, 2016, and
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`U.S. Patent No. 11,141,378 (the “’378 patent”) issued on October 12, 2021. These patents claim
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`particles comprising a nucleic acid and specific molar ratio amounts of phospholipids, cationic
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`lipids, PEG lipids, and cholesterol.
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`II.
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`STANDARD OF REVIEW
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`The first step in a patent infringement analysis is to define the meaning and scope of the
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`claims of the patent. Markman, 52 F.3d at 976. Claim construction, which serves this purpose, is
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`a matter of law exclusively for the court. Id. at 979. “‘[T]here is no magic formula or catechism
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`for conducting claim construction.’ Instead, the court is free to attach the appropriate weight to
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`appropriate sources ‘in light of the statutes and policies that inform patent law.’” SoftView LLC
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`v. Apple Inc., No. 10-cv-389, 2013 WL 4758195, at *1 (D. Del. Sept. 4, 2013) (quoting Phillips
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`v. AWH Corp., 415 F.3d 1303, 1324 (Fed. Cir. 2005)).
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` “It is a bedrock principle of patent law that the claims of a patent define the invention to
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`which the patentee is entitled the right to exclude.” Phillips, 415 F.3d at 1312 (internal quotation
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`marks omitted). The focus of a court’s analysis must therefore begin and remain on the language
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`of the claims, “for it is that language that the patentee chose to use to ‘particularly point[ ] out and
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`distinctly claim[ ] the subject matter which the patentee regards as his invention.’” Interactive Gift
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`Express, Inc. v. Compuserve, Inc., 256 F.3d 1323, 1331 (Fed. Cir. 2001) (quoting 35 U.S.C. § 112,
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`¶ 2). The terms used in the claims bear a “heavy presumption” that they mean what they say and
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`have their ordinary and customary meaning. Texas Digital Sys., Inc. v. Telegenix, Inc., 308 F.3d
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`1193, 1202 (Fed. Cir. 2002). That ordinary meaning “is the meaning that the term would have to
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`a person of ordinary skill in the art in question at the time of the invention, i.e., as of the effective
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`filing date of the patent application.” Phillips, 415 F.3d at 1313.
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`
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`Generally, a person of ordinary skill in the art (“POSITA”) would not understand the
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`ordinary and customary meaning of a claim term in isolation. As such, the ordinary meaning may
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`be derived from a variety of sources including intrinsic evidence, such as the claim language, the
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`written description, drawings, and the prosecution history; as well as extrinsic evidence, such as
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`dictionaries, treatises, or expert testimony. Dow Chem. Co. v. Sumitomo Chem. Co., Ltd., 257
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`F.3d 1364, 1373 (Fed. Cir. 2001).
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`
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`The “most significant source” of authority is “the intrinsic evidence of record, i.e., the
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`patent itself, including the claims, the patent specification3 and, if in evidence, the prosecution
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`history.” Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996); see also
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`Phillips, 415 F.3d at 1313 (holding that a person of ordinary skill in the art is deemed to have read
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`the claim terms in the context of the entire patent, including the specification). The specification
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`“is the single best guide to the meaning of a disputed term” and is usually dispositive as to the
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`meaning of words. Vitronics, 90 F.3d at 1582. Although it is improper to import limitations from
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`the specification into the claims, “one may look to the written description to define a term already
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`in a claim limitation, for a claim must be read in view of the specification of which it is a part.”
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`The specification is “that part of a patent application which precedes the claim and in which the
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`inventor specifies, describes, and discloses the invention in detail.” McCarthy’s Desk Encyclopedia of
`Intellectual Property 408 (2d ed. 1995).
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`Renishaw PLC v. Marposs Societa’ per Azioni, 158 F.3d 1243, 1248 (Fed. Cir. 1998). On
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`occasion, “the specification may reveal a special definition given to a claim term . . . that differs
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`from the meaning it would otherwise possess. In such cases, the inventor’s lexicography governs.”
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`Phillips, 415 F.3d at 1316. The specification may also “reveal an intentional disclaimer, or
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`disavowal, of claim scope by the inventor . . . [, which] is regarded as dispositive.” Id. “The
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`construction that stays true to the claim language and most naturally aligns with the patent’s
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`description of the invention will be, in the end, the correct construction.” Renishaw, 158 F.3d at
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`1250.
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`The court “should also consider the patent’s prosecution history, if it is in evidence.”
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`Markman, 52 F.3d at 980. This consists of “the complete record of proceedings before the Patent
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`Office and includes the prior art cited during examination.” Phillips, 415 F.3d at 1317. “Like the
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`specification, the prosecution history provides evidence of how the [Patent and Trademark Office]
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`and the inventor understood the patent.” Id. at 1317. Nonetheless, it is the least probative form of
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`intrinsic evidence because it “represents an ongoing negotiation between the PTO and the
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`applicant, rather than the final product of that negotiation.” Id.
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`If ambiguity still exists after considering all the intrinsic evidence, the court may rely on
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`extrinsic evidence, which is “all evidence external to the patent and prosecution history, including
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`expert and inventor testimony, dictionaries, and learned treatises.” Markman, 52 F.3d at 980.
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`“[D]ictionaries, and especially technical dictionaries, . . . have been properly recognized as among
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`the many tools that can assist the court in determining the meaning of particular terminology.”
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`Phillips, 415 F.3d at 1318. Additionally, expert testimony can provide background on the
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`technology at issue, explain how it works, speak to what a person of ordinary skill in the art would
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`understand, and establish that a particular term has a particular meaning in the pertinent field. Id.
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`Extrinsic evidence, however, is “less significant than the intrinsic record in determining ‘the
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`legally operative meaning of claim language.’” C.R. Bard, Inc. v. U.S. Surgical Corp., 388 F.3d
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`858, 862 (Fed. Cir. 2004) (quoting Vanderlande Indus. Nederland BV v. Int’l Trade Comm’n, 366
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`F.3d 1311, 1318 (Fed. Cir. 2004)).
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`Ultimately, during claim construction, “[t]he sequence of steps used by the judge in
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`consulting various sources is not important; what matters is for the court to attach the appropriate
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`weight to be assigned to those sources in light of the statutes and policies that inform patent law.”
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`Phillips, 415 F.3d at 303.
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`III. DISCUSSION
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`In dispute are three claim terms from the patents-in-suit: (1) “___mol % of the total lipid
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`present in the particle” appearing in all of the molar ratio patents; (2) “a cationic lipid having a
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`protonatable tertiary amine” appearing in the ’378 patent; and (3) “wherein at least 70% /at least
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`80% /about 90% of the mRNA in the formulation is fully encapsulated in the lipid vesicles”/”fully
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`encapsulated” appearing the ’651 patent.
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`A. “Mol % of the total lipid present in the particle”
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`The first disputed claim term is the phrase “____ mol % of the total lipid present in the
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`particle” which appears in multiple claims within all the Molar Ratio Patents.4 For example,
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`claim 1 of the ’069 patent states:
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`What is claimed is:
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`(c)
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`1.
`(a)
`(b)
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`A nucleic acid-lipid particle comprising:
`a nucleic acid;
`a cationic lipid comprising from 50 mol % to 65 mol % of
`the total lipid present in the particle.
`a non-cationic lipid comprising a mixture of a phospholipid
`and cholesterol or a derivative thereof, wherein the
`phospholipid comprises from 4 mol % to 10 mol % of the
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`These include the ’069 patent, the ’359 patent, the ’668 patent, the ’435 patent, and the ’378 patent.
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`total lipid present in the particle and the cholesterol or
`derivative thereof comprises from 30 mol % to 40 mol %
`of the total lipid present in the particle; and
`a conjugated lipid that inhibits aggregation of particles
`comprising from 0.5 mol % to 2 mol % of the total lipid
`present in the particle.
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`(’069 patent, cl. 1 (emphasis added.)
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`(d)
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`
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`The parties dispute two aspects of this claim term. First, as to the phrase “particle,”
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`Plaintiffs seek to give the term its plain and ordinary meaning, while Moderna’s suggested
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`construction is a “finished lipid particle.” Second, as to the recited “mol %” ranges in the claim,
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`Plaintiffs contend that the scientific conventions concerning significant figures and rounding
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`apply, while Moderna contends that the recited ranges must be given absolute precision. I address
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`each dispute separately.
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`1. Whether the Particle Must Be “Finished”
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`Claim Term
`“___ mol % of the total lipid
`present in the particle”
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`Plaintiffs’ Proposal
`Plain and ordinary meaning
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`Moderna’s Proposal
`“___ mol % of the total lipid
`present in the finished lipid
`particle”
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`The party’s first disagreement is whether I should interpret the word “particle” in claim 1
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`to mean “finished particle.” Pointing to Plaintiffs’ prior statements, Moderna argues that “particle”
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`means only finished particles that are not subject to further processing. Plaintiffs respond that
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`adding the word “finished” is unnecessary as the claim covers all particles, regardless of whether
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`they are subject to further processing. Plaintiffs’ view is that its prior statements distinguish only
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`between formed particles and disordered starting ingredients.
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`As an initial point of reference, I turn to the claim language itself because “[t]he claim
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`construction inquiry . . . begins and ends in all cases with the actual words of the claim.” Homeland
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`Howewares, LLC v. Whirlpool Corp., 865 F.3d 1372, 1375 (Fed. Cir. 2017) (quoting Renishaw
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`PLC v. Marposs Societa’ per Azioni, 158 F.3d 1243, 1248 (Fed. Cir. 1998)). The Federal Circuit
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`has clarified that “[i]f we need not rely on a limitation to interpret what the patentee meant by a
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`particular term or phrase in a claim, that limitation is ‘extraneous’ and cannot constrain the claim.”
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`Renishaw, 158 F.3d at 1249. Thus, when a claim term is expressed in general descriptive words,
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`the court should not “add a narrowing modifier before an otherwise general term that stands
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`unmodified in a claim.” Id. at 1249.
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`Here, the claim language contains no limitation to “finished” particles and only uses the
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`generalized term “particle.” Thus, nothing in the claim language suggests that the particle
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`disclosed in the patent cannot be subject to any further processing.
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`Because the claim language does not fully resolve the dispute, I next turn to the
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`specification and any relevant definitions. “The specification is the single best guide to the
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`meaning of a disputed term.” Pressure Prods. Med. Supplies, Inc. v. Greatbatch Ltd., 599 F.3d
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`1308, 1314–15 (Fed. Cir. 2010) (quotations omitted). “When a patentee explicitly defines a claim
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`term in the patent specification, the patentee’s definition controls.” Martek Biosicences Corp. v.
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`Nutrinova, Inc., 579 F.3d 1364, 1380 (Fed. Cir. 2009).
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`The ’069 patent defines the term “lipid particle” to “refer to a lipid formulation that can be
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`used to deliver an active agent or therapeutic agent, such as a nucleic acid . . . to a target site of
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`interest. In the lipid particle of the invention, which is typically formed from a cationic lipid, a
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`non-cationic lipid, and a conjugated lipid that prevents aggregation of the particle, the active agent
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`or therapeutic agent may be encapsulated in the lipid, thereby protecting the agent from enzymatic
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`degradation.” (’069 patent 10:64–11:12.) The specification goes on to state that “[t]he lipid
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`particles of the present invention, e.g., SNALP,5 in which an active agent such as an interfering
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`5 “SNALP” refers to a stable nucleic acid-lipid particle.
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`RNA is encapsulated in a lipid bilayer and is protected from degradation, can be formed by any
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`method known in the art including, but not limited to, a continuous mixing method or direct
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`dilution process. (Id. at 57:50–55.) These portions of the specification support Plaintiffs’
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`construction. This is because the claim language’s reference to a “nucleic acid-lipid particle”
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`denotes a particle that has been formed by some process using the starting ingredients disclosed in
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`the patent, without restricting whether that formed particle can undergo further processing.
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`Moderna’s argument—that the “lipid particle” in the claim must be a “finished” particle
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`that cannot be subject to further processing—is undermined by additional portions of the
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`specification. Nothing in the specification suggests that the word “particle” requires a modifier.
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`To the contrary, the specification sets forth multiple embodiments where the claimed nucleic acid-
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`lipid particles can be further modified after formation:
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`•
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`•
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`In one embodiment of the ’378 patent, the methods will comprise “adding non-lipid
`polycations [such as salts of hexadimethrine] which are useful to effect the
`lipofection of cells using the present compositions . . . . Addition of these salts is
`preferably after the particles have been formed.” (’378 patent 61:37–47 (emphasis
`added).)
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`In another embodiment, the conjugated lipid may further include a CPL (a cationic-
`polymer-lipid conjugate). There are “[a] variety of general methods for making
`SNALP-CPLs (CPL-containing SNALP),” one of which is a “‘post-insertion’
`technique, that is, insertion of a CPL into, for example, a pre-formed SNALP,” and
`the other of which is including the CPL in the lipid mixture during the SNALP
`formation steps. (Id. at 62:8–15 (emphasis added).)
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`• Finally, the ’378 patent notes that, “[i]f needed, the lipid particles of the invention
`(e.g., SNALP) can be sized by any of the methods available for sizing liposomes.
`The sizing may be conducted in order to achieve a desired size range and relatively
`narrow distribution of particle sizes.” (Id. at 61:4–8.)
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`Thus, the specification contemplates that the lipid particle described in the claim may be
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`subject to further processing, negating any notion that the particle must be “finished,” as Moderna
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`suggests. See generally Exxon Chem. Patents, Inc. v. Lubrizol Corp., 64 F.3d 1553, 1558 (Fed.
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`Cir. 1995) (where the specification as a whole and the claims in particular contain no temporal
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`limitation to the term “composition,” the patentee “is entitled to a broader scope that is not time-
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`limited, one that reads on any product at any time that contains the claimed proportions of
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`ingredients” and not simply a finished product ready for consumer use).
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`Moderna attempts to support its proposed construction by focusing on the prosecution
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`history as developed during the inter partes review (“IPR”) proceedings. Specifically, Moderna
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`contends that, during the IPR proceedings for the ’435 patent, the patent examiner found
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`anticipation by (a) an L054 lipid mixture and (b) ranges of components of lipid particles. To
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`distinguish the claims from the prior art, Plaintiffs differentiated between “input formulation (i.e.,
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`lipid particle)” described in the prior art, and the claimed “output formulation (i.e., lipid particle)”
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`in the patented invention. Moderna contends that Plaintiffs repeatedly asserted that the invention
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`constituted a “finished particle” that had to be tested to determine its composition. According to
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`Moderna, the PTAB and the Federal Circuit relied on Plaintiffs’ repeated characterizations of the
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`“finished lipid particle” in assessing patentability. Thus, it asserts that Plaintiffs have made a clear
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`and unmistakable disavowal of the claim scope and should not now be permitted to reclaim that
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`scope.
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`The law is well established that “to invoke the doctrine of prosecution disclaimer, any such
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`statements must ‘be both clear and unmistakable.’” Aylus Networks, Inc. v. Apple Inc., 856 F.3d
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`1353, 1361 (Fed. Cir. 2017). While statements made by patent owners during an IPR can be
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`considered for prosecution disclaimer, id., statements that are too vague or ambiguous to qualify
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`as a disavowal of claim scope cannot function as a disclaimer. Omega Eng’g, Inc. v. Raytek Corp.,
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`334 F.3d 1314, 1325 (Fed. Cir. 2003). The alleged disavowing statements must be “both so clear
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`as to show reasonable clarity and deliberateness.” Id.
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`The statements relied upon by Modern and set forth below do not meet that standard.
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`During the initial IPR proceedings before the Patent Trial and Appeal Board (“PTAB”), Plaintiffs
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`made the following statements:
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`• “Claim 1 recites a nucleic acid-lipid particle with specific concentration ranges of a cationic
`lipid (50 mol % to 85 mol %), non-cationic lipid (13 mol % to 49.5 mol %), conjugated
`lipid (0.5 mol % to 2 mol %) in a nucleic acid-lipid particle. The L054 lipid mixture is not
`a particle and fails to meet these limitations.” (JA002521–002522 (emphasis in original).)
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`• “It was widely documented in the art that a finished lipid particle must be tested to
`determine its composition . . . . It was known that the method of lipid particle formation
`effects the incorporation of lipids and nucleic acids into finished particles.” (JA002522
`(emphasis added).)
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`• “The significance of the difference between the starting lipid ratio and that of the lipid
`particle is one of the reasons why FDA guidance specifies identifying the lipid ratio of the
`finished formulation.” (JA002523 (emphasis added).)
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`• “The ’554 publication is entirely silent as to the composition of the particle formed from
`the L054 mixture. The L054 lipid mixture cannot meet each and every limitation recited
`in independent claim 1.” (JA002523.)
`
`• “The claims are directed to nucleic acid-lipid particles. They’re not—they do not recite a
`starting mixture for making particles. So pointing to the starting mixture is not sufficient
`to establish anticipation with this aspect of the claim. And this all matters, of course,
`because as set forth in the briefing and established with evidence of record, one does not
`simply assume that the particles that result from a process have the exact same lipid
`composition as the starting material.” (JA 2577.)
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`Moderna also cites to the following representations made by Plaintiffs on appeal from the
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`’435 patent IPR to the Federal Circuit:
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`• “Independent claim 1 is drawn to a nucleic acid-lipid particle of specified lipid
`concentrations. It was undisputed before the Board that the relied upon L054 formulation
`is a list of starting ingredients used in making particles and not the lipid concentrations of
`the particles that ultimately result from the downstream fabrication process.” (JA 2876)
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`• “The claims of the ’435 patent are directed to ‘nucleic acid-lipid particles’ of defined
`composition.” (JA 2844.)
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`• “[T]he method used for formulating particles often affects the composition of finished
`product, and most certainly would have done so in the case of L054.” (JA 2847.)
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`• “That L054 is not a lipid particle is not disputed by the parties or the Board. It is also
`undisputed that the ’554 publication does not report lipid composition of finished particles,
`it is entirely silent on this aspect.” (JA 2848.)
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`• “The claims are directed to a ‘nucleic acid-lipid particle.’ The ’554 publication does not
`disclose lipid compositions of resulting particles, nor does it disclose sufficient detail to
`reasonably assume the resulting particles fall within the scope of claim 1.” (JA 3006.)
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`• “The ’435 patent discloses detailed descriptions of particle production methods and
`extensive characterization of finished particles.” (JA 3006.)
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`A close inspection of the context of these statements—both before the PTAB and the
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`Federal Circuit—reveals that Plaintiffs’ use of the word “finished” during IPR proceedings was
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`different than the meaning of the word “finished” that Moderna now seeks to import into the clam
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`language. The critical distinction Plaintiffs sought to make during the IPR proceedings was
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`between (a) the lipid composition of the starting ingredients for making lipid particles, as disclosed
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`by the L054 publication, and (b) the different lipid composition of a particle resulting from the
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`fabrication process, i.e., any resulting particle as opposed to one ready for inclusion in a
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`commercial product.
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`All the above passages from the IPR proceedings support this interpretation. In fact, on
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`appeal of the PTAB’s finding that certain claims were anticipated by the L054 publication,
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`Plaintiffs explicitly argued that “[n]either Moderna nor the Board ever resolved the critical
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`distinction between 1) starting ingredients for making lipid particles; and 2) the different lipid
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`composition of particles resulting from the fabrication process.” They further argued that “the
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`L054 formulation . . . is a lipid mixture for making particles—not itself a particle . . . [it] does not
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`disclose lipid compositions of resulting particles, nor does it disclose sufficient detail to reasonably
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`assume the resulting particles fall within the scope of claim 1.” (JA002844–45.) The Federal
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`Circuit thereafter recognized that the dispute at issue in the IPR proceedings was not—as Moderna
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`claims—between a formed particle subject to further processing and a finished particle that could
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`13
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`Case 1:22-cv-00252-MSG Document 266 Filed 04/03/24 Page 14 of 37 PageID #: 16342
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`be included in a pharmaceutical product. Rather, the Court noted that the issue involved “a critical
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`distinction between starting ingredients and a final product. [Plaintiffs] contend that the claims of
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`the ’435 patent are directed to completed lipid particles of defined composition. In contrast,
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`Plaintiffs argue that the L054 formulation disclosed in the ‘554 publication is a lipid mixture of
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`starting ingredients for making lipid particles, not a completed lipid particle itself.” (JA002941.)
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`Nothing in those proceedings suggested that the formed particle claimed in the ’435 patent could
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`not be subject to any further processing.
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`In light of the foregoing, I find that Moderna has not pointed to any clear and unmistakable
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`disavowal. Thus, I must return to the claim language and specification, neither of which requires
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`that the particle referenced as a “finished” particle be completely free from further processing.
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`Indeed, to construe it that way would mean that several of the embodiments disclosed in the
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`specification would be excluded. Accordingly, I disagree with Moderna’s proposed construction
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`and will give the term its plain and ordinary meaning. 6
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`2. Whether the Recited Mol % Ranges are Numerically Precise
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`Claim Term
`“___ mol % of the total lipid
`present in the particle”
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`Plaintiffs’ Proposal
`The recited “mol %” ranges
`are understood to encompass
`their standard variation based
`on the number of significant
`figures recited in the claim.
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`Moderna’s Proposal
`Where the asserted claims do
`not recite “about mol%,” the
`recited “mol %” ranges are
`understood as the exact ranges
`recited in the claim.
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`The second dispute regarding the recited claim term in the Molar Ratio Patents involves
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`the mol % ranges expressed therein. Moderna contends that, based on Plaintiffs’ explicit
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`prosecution history disclaimer of the word “about,” the ranges are numerically “exact,” meaning
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`that the patent allows for no deviation above the high end or below the low end of the range.
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`Having reached this conclusion based on the intrinsic evidence, I need not consider the parties’
`6
`citations to the Plaintiffs’ expert report, which is extrinsic evidence.
`14
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`Case 1:22-cv-00252-MSG Document 266 Filed 04/03/24 Page 15 of 37 PageID #: 16343
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`Plaintiffs, on the other hand, posit that the plain meaning of the numbers in its claims adheres to
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`the standard scientific conventions of significant figures and rounding.
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`The Federal Circuit has emphasized that endpoints of a claimed range should not be given
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`any more precision than the claim language warrants. United States Philips Corp. v. Iwasaki Elec.
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`Co. Ltd., 505 F.3d 1371, 1377 (Fed. Cir. 2007). “In some scientific contexts, ‘1’ represents a less
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`precise quantity than ‘1.0,’ and ‘1’ may encompass values such as 1.1 that ‘1.0’ may not.” Id.
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`Under this “standard scientific convention” of significant figures and rounding, a POSITA must
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`look to the last significant figure of a number and include values that round up and down to that
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`number. See AstraZeneca AB v. Mylan Pharms., Inc., 19 F.4th 1325, 1329–30 (Fed. Cir. 2021).
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`For example, the number “9.1” would encompass values between 9.05 and 9.14, while the number
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`9.10 would encompass more specific values between 9.095 and 9.104. Similarly, the number “9”
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`would encompass 8.5 through 9.4, while “9.0” would encompass 8.95 through 9.04.
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`At the time the parties submitted their claim construction briefing, controlling case law
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`reflected that the application of the rules of significant figures and rounding varied on a case-by-
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`case basis. See Par Pharm., Inc. v. Eagle Pharms., Inc., 44 F.4th 1379, 1382–83 (Fed. Cir. 2022)
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`(affirming construction where patent claiming a pH range of 3.7–3.9 was deemed to actually
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`encompass a range of 3.65–3.94); San Huan New Materials High Tech, Inc. v. Int’l Trade
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`Comm’n, 161 F.3d 1347, 1361 (Fed. Cir. 1998) (affirming judgment of infringement where the
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`asserted claim recited a range of 30% to 36% of chemical compound TRE, and the accused product
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`had up to 36.45% TRE, and concluding that it “was not shown to be err