throbber
Case 1:22-cv-11090-NMG Document 144 Filed 02/15/24 Page 1 of 22
`
`United States District Court
`District of Massachusetts
`
`
`
`Chr. Hansen HMO GmbH,
`
` Plaintiff and Counterclaim-Defendant,
`
` v.
`
`Glycosyn LLC,
`
` Defendant and Counterclaim-Plaintiff,
`
` v.
`
`Abbott Laboratories,
`
` Third-Party Defendant.
`
`
`)
`)
`)
`)
`)
`) Civil Action No.
`) 22-11090-NMG
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`
`
`
`GORTON, J.
`
`MEMORANDUM & ORDER
`
`This case arises out of patent infringement claims brought
`
`by Glycosyn LLC (“Glycosyn”) against Chr. Hansen HMO GmbH (“Chr.
`
`Hansen”) relating to Chr. Hansen’s method of manufacturing a
`
`human milk sugar known as 2’-fucosyllactose (“2’-FL”), which was
`
`an ingredient in certain infant formulas sold by Abbott
`
`Laboratories (“Abbott”).1 Chr. Hansen seeks a declaratory
`
`judgment that its manufacturing method does not infringe the
`
`
`1 The original manufacturer, Jennewein Biotechnologie GmbH, was acquired by
`Chr. Hansen HMO GmbH in 2021, and is therefore included in all further
`references to “Chr. Hansen”.
`
`
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`Case 1:22-cv-11090-NMG Document 144 Filed 02/15/24 Page 2 of 22
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`claims in Glycosyn’s U.S. Patent No. 9,970,018 (“the ’018
`
`patent”) and that furthermore those claims are invalid.
`
`This memorandum and order addresses only issues of claim
`
`construction and follows submission by the parties of claim
`
`construction briefs, responsive pleadings and the Markman
`
`hearing held on January 10, 2024. The parties dispute two terms
`
`in the ’018 patent.
`
`I.
`
`Background
`
`A. History of the Parties
`
`Glycosyn and Chr. Hansen have been embroiled in litigation
`
`for nearly six years. In March, 2018, Glycosyn filed suit
`
`against Chr. Hansen in the District of Massachusetts for patent
`
`infringement but that suit was stayed pending resolution of a
`
`parallel action brought by Glycosyn one month later at the
`
`International Trade Commission (“ITC”). Glycosyn LLC v.
`
`Jennewein Biotechnologie GmbH, No. 18-cv-10423-PBS, Docket No.
`
`1, 13 (D. Mass. Mar. 5, 2018).
`
`In December, 2018, an administrative law judge (“ALJ”)
`
`issued a claim construction order in the ITC action. In the
`
`Matter of Certain Hum. Milk Oligosaccharides & Methods of
`
`Producing the Same, 2018 WL 6837945, at *22-23 (U.S.I.T.C. Dec.
`
`18, 2018) (hereinafter “ITC Construction Order”). The ALJ
`
`construed “functional β-galactosidase gene” to mean “a
`
`functional sequence of DNA that encodes β-galactosidase,” id. at
`
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`Case 1:22-cv-11090-NMG Document 144 Filed 02/15/24 Page 3 of 22
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`*22–23, and “β-galactosidase activity comprises between 0.05 and
`
`[200 units / 5 units / 4 units / 3 units / 2 units]” as “β-
`
`galactosidase activity is measurable at between exactly 0.05 and
`
`exactly [200/5/4/3/2) Miller Units, as defined in Miller, J.H.,
`
`Experiments in Molecular Genetics (Cold Spring Harbor Lab. 1912)
`
`at 352-355,” id. at *18. A different ALJ of the ITC applied
`
`that construction order and determined that Chr. Hansen
`
`infringed certain claims of the Glycosyn patent under the
`
`doctrine of equivalents. 2019 WL 5677974 (U.S.I.T.C. Sept. 9,
`
`2019) (hereinafter “ITC Initial Determination”).
`
`In May, 2020, the ITC issued a Limited Exclusion Order
`
`against Chr. Hansen after reviewing the ALJ’s decision. The
`
`Federal Circuit Court of Appeals affirmed that decision in
`
`September, 2021 after finding the ITC “did not err in its claim
`
`construction or in its finding of infringement.” Jennewein
`
`Biotechnologie GmbH v. Int’l Trade Comm’n, 2021 WL 4250784, at
`
`*1 (Fed. Cir. Sept. 17, 2021).
`
`In June, 2022, Glycosyn voluntarily dismissed the 2018
`
`District of Massachusetts suit and filed suit against Abbott in
`
`the United States District Court for the Western District of
`
`Texas for infringement of the ’018 patent. Glycosyn LLC, No. 18-
`
`cv-10423-PBS, Docket No. 19; Glycosyn LLC v. Abbott
`
`Laboratories, No. 22-cv-00619-ADA, Docket No. 1 (W.D. Tex. June
`
`14, 2022).
`
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`Case 1:22-cv-11090-NMG Document 144 Filed 02/15/24 Page 4 of 22
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`Chr. Hansen filed the pending declaratory judgment action
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`in this Court against Glycosyn in July, 2022, seeking
`
`declaratory judgment of non-infringement and invalidity of the
`
`’018 patent. One month later, Glycosyn dismissed the Western
`
`District of Texas suit against Abbott and filed an answer and
`
`counterclaim against Chr. Hansen and a cross-claim against
`
`Abbott in the Massachusetts action. See Glycosyn LLC, No. 22-cv-
`
`00619-ADA, Docket No. 4.
`
`In response, Abbott moved to sever and stay the claim
`
`against it pending resolution of the cross claims between
`
`Glycosyn and the manufacturer, Chr. Hansen. In March, 2023,
`
`this Court denied Abbott’s motion to sever and stay after
`
`finding the customer suit exception and traditional stay factors
`
`inapplicable. Docket No. 47.
`
`B. The ’018 Patent
`
`This matter revolves around the ’018 Patent, which bears
`
`the name “Biosynthesis of Human Milk Oligosaccharides in
`
`Engineered Bacteria.” That patent was filed on September 21,
`
`2017 and issued on May 15, 2018. According to the patent, human
`
`milk contains a diverse set of human milk oligosaccharides
`
`(“HMOs”) that support the establishment of healthy gut
`
`microbiome in infants. Scientists have historically been unable
`
`to develop HMOs inexpensively at scale.
`
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`Case 1:22-cv-11090-NMG Document 144 Filed 02/15/24 Page 5 of 22
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`The ’018 Patent purports to help solve that problem by
`
`engineering E. coli bacterial strains to produce fucosylated
`
`oligosaccharides (such as 2’-fucosyllactose, or “2’-FL”) which
`
`can be used in products, such as infant formula or dietary
`
`supplements. According to Glycosyn’s claim construction brief,
`
`bacteria are genetically modified
`
`(1) [to] increase the intracellular guanosine
`diphosphate (GDP)-fucose pool; (2) [to] increase the
`intracellular lactose pool; and (3) [to] add a
`fucosyltransferase that will bind a fucose to the
`lactose and thus form a fucosylated oligosaccharide
`such as 2ʹ-FL.
`
`β-galactosidase is one enzyme that can break a molecule
`
`into two parts. For example, β-galactosidase can break down
`
`lactose into galactose and glucose. β-galactosidase, which
`
`breaks down a lactose, and fucosyltransferase, which uses
`
`lactose to create fucosylated oligosaccharides, can conflict
`
`with one another.
`
`To ensure the availability of lactose for the
`
`fucosyltransferase reaction, which can result in the creation of
`
`needed fucosylated oligosaccharides, the intracellular lactose
`
`pool must be increased. To do that, the engineered bacterium is
`
`modified to delete or functionally inactivate the β-
`
`galactosidase gene (referred to as “lacZ”) in such a way that
`
`the downstream lactose permease (“lacY”) gene is left intact.
`
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`Case 1:22-cv-11090-NMG Document 144 Filed 02/15/24 Page 6 of 22
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`While some elimination of β-galactosidase is helpful when
`
`producing fucosylated oligosaccharides, complete elimination can
`
`result in purification issues later in the manufacturing
`
`process. Accordingly, the engineered bacterium includes an
`
`exogenous functional β-galactosidase gene “to direct the
`
`expression of a low, but detectable level of β-galactosidase
`
`activity.”
`
`According to the patent, this results in low levels of β-
`
`galactosidase activity between 0.05 and 200 Miller units. At
`
`that level, the β-galactosidase activity is not too low to
`
`create purification issues nor too high to diminish the
`
`intracellular lactose pool needed to produce fucosylated
`
`oligosaccharides. In essence, the process produces a
`
`“Goldilocks” outcome.
`
`Claim 1 of the ’018 patent describes Glycosyn’s method for
`
`producing a fucosylated oligosaccharide in an engineered E. coli
`
`bacterium. The key disputed terms are written below in bold:
`
`
`1. A method for producing a fucosylated
`oligosaccharide in a bacterium, comprising providing
`an isolated E. coli bacterium comprising,
`(i) a deletion or functional inactivation of an
`endogenous β-galactosidase gene;
`(ii) an exogenous functional β-galactosidase gene
`comprising a detectable level of β-galactosidase
`activity that is reduced compared to that of a
`wildtype E. coli bacterium, wherein the level of β-
`galactosidase activity comprises between 0.05 and 200
`units;
`
`
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`Case 1:22-cv-11090-NMG Document 144 Filed 02/15/24 Page 7 of 22
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`(iii) an inactivating mutation in a colanic acid
`synthesis gene; and
`(iv) an exogenous lactose-accepting fucosyltransferase
`gene; culturing said bacterium in the presence of
`lactose; and retrieving a fucosylated oligosaccharide
`from said bacterium or from a culture supernatant of
`said bacterium.
`
`
`(Emphasis added.)
`
`II.
`
`
`Terms
`
`A. Overview of Claim Construction
`
`In analyzing a patent infringement action, a Court must 1)
`
`determine the meaning and scope of the patent claims asserted to
`
`be infringed and 2) compare the properly construed claims to the
`
`infringing device. Markman v. Westview Instruments, Inc., 52
`
`F.3d 967, 976 (Fed. Cir. 1995) (en banc), aff’d, 517 U.S. 370
`
`(1996). The first step, known as claim construction, is an
`
`issue of law for the court to decide. Id. at 979. The second
`
`step is determined by the finder of fact. Id.
`
`The Court’s responsibility in construing claims is to
`
`determine the meaning of claim terms as they would be understood
`
`by persons of ordinary skill in the relevant art. Bell Atl.
`
`Network Servs., Inc. v. Covad Commc’ns Grp., Inc., 262 F.3d
`
`1258, 1267 (Fed. Cir. 2001). The meaning of the terms is
`
`initially discerned from three sources of intrinsic evidence: 1)
`
`the claims themselves, 2) the specification and 3) the
`
`prosecution history of the patent. See Vitronics Corp. v.
`
`Conceptronic, Inc., 90 F.3d 1576, 1582–83 (Fed. Cir. 1996).
`
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`Case 1:22-cv-11090-NMG Document 144 Filed 02/15/24 Page 8 of 22
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`The claims themselves define the scope of the patented
`
`invention. See Philips v. AWH Corp., 415 F.3d 1303, 1312 (Fed
`
`Cir. 2005). Claim terms are generally given their “ordinary and
`
`customary meaning”, which is the meaning that a person skilled
`
`in the art would attribute to the claim term. See id. at 1312-
`
`13. Even if a particular term has an ordinary and customary
`
`meaning, however, a court may need to examine the patent as a
`
`whole to determine if that meaning controls. Id. at 1313 (“[A]
`
`person of ordinary skill in the art is deemed to read the claim
`
`term ... in the context of the entire patent....”); see also
`
`Medrad, Inc. v. MRI Devices Corp., 401 F.3d 1313, 1319 (Fed.
`
`Cir. 2005) (noting that a court cannot construe the ordinary
`
`meaning of a term “in a vacuum”). Ultimately, the correct
`
`construction will be one that “stays true to the claim language
`
`and most naturally aligns with the patent's description of the
`
`invention....” Id. at 1316 (citation omitted).
`
`The patent specification is
`
`the single best guide to the meaning of a disputed
`term [and may reveal] a special definition given to a
`claim term that differs from the meaning it would
`otherwise possess [or contain] an intentional
`disclaimer, or disavowal, of claim scope by the
`inventor.
`
`Phillips v. AWH Corp., 415 F.3d 1303, 1313-16 (Fed. Cir. 2005)
`
`(en banc) (cleaned up). The Court should also consult the
`
`prosecution history to see how the inventor and PTO understood
`
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`Case 1:22-cv-11090-NMG Document 144 Filed 02/15/24 Page 9 of 22
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`the patent and to ensure the patentee does not argue in favor of
`
`an interpretation it has disclaimed. Id. at 1317.
`
`In the rare event that analysis of the intrinsic evidence
`
`does not resolve an ambiguity in a disputed claim term, the
`
`Court may consider extrinsic evidence, such as inventor and
`
`expert testimony, treatises and technical writings. Id. at 1314;
`
`Markman, 52 F.3d at 980 (“The court may, in its discretion,
`
`receive extrinsic evidence in order to aid the court in coming
`
`to a correct conclusion as to the true meaning of the language
`
`employed in the patent.” (internal quotation marks and citation
`
`omitted)). Although extrinsic evidence may be helpful in
`
`construing claims, the intrinsic evidence is afforded the
`
`greatest weight in determining what a person of ordinary skill
`
`in the art would have understood a claim to mean. Phillips, 415
`
`F.3d at 1324.
`
`B. Level of the Person of Ordinary Skill in the Art
`
`
`
`The parties provide the same definition for the person of
`
`ordinary skill in the art (“POSITA”) for the purposes the ’018
`
`patent. It is:
`
`a person having a Ph.D. in molecular biology,
`biochemistry, biological or chemical engineering, or
`an equivalent field, and 1-2 years of experience
`working with E. coli bacteria or related systems.
`Alternatively, a person of ordinary skill could have a
`lower level degree (e.g., a M.A.) in a similar field
`to those listed above, but a greater amount of
`relevant working experience (e.g., 5-6 years of
`
`
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`Case 1:22-cv-11090-NMG Document 144 Filed 02/15/24 Page 10 of 22
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`experience working with E. coli bacteria or related
`systems).
`
`C. Undisputed Terms
`
`
`
`The parties agree on the construction of the following
`
`terms of the ’018 patent:
`
`
`Term
`
`“wild-type”
`
`Asserted Claims of
`the ’018 Patent
`Claims 1, 24
`
`“colanic acid
`synthesis gene”
`
`Claims 1-3
`
`“E. coli lacZ gene” Claim 8
`
`Proposed
`Construction
`Plain and ordinary
`meaning, i.e. “the
`type most commonly
`found in nature”
`“a gene involved in
`a sequence of
`reactions, usually
`controlled and
`catalyzed by enzymes
`that result in the
`synthesis of colanic
`acid”
`Plain and ordinary
`meaning, i.e. “a
`structural gene that
`encodes the β-
`galactosidase
`protein and is part
`of the lac operon in
`the DNA of E. coli”
`
`
`
`
`
`
`D. Disputed Terms
`
`There are two disputed terms at issue, which are
`
`hereinafter dealt with sequentially.
`
`Disputed Term #1
`
`Glycosyn’s
`Construction
`
`“[an] exogenous
`functional β-
`galactosidase gene”
`
`
`Plain and ordinary
`meaning, i.e.,
`“contiguous or non-
`contiguous DNA,
`
`
`
`- 10 -
`
`Chr. Hansen &
`Abbott’s
`Construction
`“a single functional
`sequence of DNA,
`originating outside
`the E.coli
`
`

`

`Case 1:22-cv-11090-NMG Document 144 Filed 02/15/24 Page 11 of 22
`
`(‘018 patent claims
`1, 8, 23, 24)
`
`originating outside
`the E. coli
`bacterium, that
`encodes for a
`working β-
`galactosidase
`enzyme”
`
`bacterium, that
`encodes a working β-
`galactosidase
`enzyme”
`
`
`
`
`The parties agree that “exogenous” means “originating
`
`outside the organism” and that a “functional β-galactosidase
`
`gene” must encode a working β-galactosidase gene. The parties
`
`disagree about what a “gene” is for the purposes of the ‘018
`
`patent.
`
`
`
`1.
`
`Glycosyn
`
`Glycosyn urges the Court to adopt the plain and ordinary
`
`meaning of “gene,” a term it contends can refer to contiguous or
`
`non-contiguous DNA. Glycosyn acknowledges that the ITC
`
`construed the term “functional β-galactosidase gene” to mean “a
`
`functional sequence of DNA that encodes β-galactosidase,” ITC
`
`Construction Order, 2018 WL 6837945, at *22-23, but notes that
`
`neither party included the word “sequence” in their own
`
`preceding proposed claim construction.
`
`
`
`Glycosyn contends that the ITC’s use of “sequence” is
`
`contrary to the basis of the field art because a gene is merely
`
`a “basic unit of inheritance.” The patent is designed to cover
`
`a variety of β-galactosidase genes from “any number” of
`
`organisms. The patentee did not circumscribe the meaning of
`
`
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`Case 1:22-cv-11090-NMG Document 144 Filed 02/15/24 Page 12 of 22
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`gene by including limiting qualifiers such as “contiguous” or
`
`“sequence.”
`
`
`
`Glycosyn highlights extrinsic evidence that it contends
`
`bolsters its construction. Specifically, it identifies two
`
`examples of non-contiguous DNA: “introns” and the LacZ gene.
`
`Introns are internal sequences in protein-producing genes that
`
`do not encode for the resulting functional protein. The LacZ
`
`gene can be separated into two sequences of DNA: LacZα and
`
`LacZΩ. According to Glycosyn, LacZα and LacZΩ comprise an
`
`entire sequence of DNA that can still produce a working β-
`
`galactosidase enzyme despite being non-contiguous DNA. The
`
`LacZα and LacZΩ genes encode for different β-galactosidase
`
`peptides. When both peptides are present, they spontaneously
`
`assemble into a working β-galactosidase enzyme. This is known
`
`as “α-complementation.”
`
`
`
`Glycosyn finally contends that because Chr. Hansen and
`
`Abbott do not offer the plain and ordinary meaning of the term
`
`when read in the context of the intrinsic record, they must
`
`satisfy one of two exceptions: lexicography and disavowal. See
`
`Thorner v. Sony Comput. Ent. Am. LLC, 669 F.3d 1362, 1365 (Fed.
`
`Cir. 2012). Chr. Hansen and Abbott respond that those
`
`exceptions are inapplicable because they seek to offer the plain
`
`and ordinary meaning of the term.
`
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`Case 1:22-cv-11090-NMG Document 144 Filed 02/15/24 Page 13 of 22
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`
`
`At the Markman hearing, Glycosyn’s counsel allowed that the
`
`ITC construction would be acceptable but that inclusion of the
`
`term “contiguous” or “single” would impose unwarranted limiting
`
`qualifiers.
`
`2.
`
`Chr. Hansen and Abbott
`
`
`
`
`Chr. Hansen and Abbott propose that the construction should
`
`be “a single functional sequence of DNA” because that comports
`
`with the ITC’s construction. They cite authority that explains
`
`that “[w]hile not binding, the previous claim construction of
`
`the [] patent should be consulted.” See Trustees of Bos. Univ.
`
`v. Everlight Elecs. Co., 23 F. Supp. 3d 50, 62 (D. Mass. 2014).
`
`They also cite dictionary definitions that define a gene as “a
`
`distinct sequence”, “a sequence of DNA” and “the sequence of
`
`nucleotides of DNA.” See Phillips, 415 F.3d at 1318 (“Within the
`
`class of extrinsic evidence, . . . dictionaries and treatises
`
`can be useful in claim construction.”).
`
`
`
`Chr. Hansen and Abbott reject the notion that a POSITA
`
`would understand “gene” to imply a non-contiguous sequence of
`
`DNA. They note that the ITC previously considered such an
`
`argument and determined that “a plain and ordinary meaning of
`
`sequence does imply contiguity.” ITC Initial Determination, 2019
`
`WL 5677974, at *28 (cleaned up). They contend that Glycosyn’s
`
`proffered construction serves as an end-around of the ITC’s
`
`determination and that Glycosyn’s own expert, Dr. Kristala L.
`
`
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`Case 1:22-cv-11090-NMG Document 144 Filed 02/15/24 Page 14 of 22
`
`Jones Prather, repeatedly described a gene as “a sequence of
`
`DNA” in declarations and witness statements both during the ITC
`
`proceeding and before this Court.
`
`Finally, Chr. Hansen and Abbott reject Glycosyn’s reliance
`
`on introns and LacZ as examples of genes that are made up of
`
`non-contiguous DNA. They cite dictionary definitions that
`
`suggest that an intron is merely a component of a gene rather
`
`than a gene itself and assert that Glycosyn brings up LacZα and
`
`LacZΩ now only because the accused strain of Chr. Hansen used to
`
`produce 2’-FL relies on α-complementation to produce β-
`
`galactosidase enzyme. Essentially, they accuse Glycosyn of
`
`arguing an infringement issue at claim construction, which is
`
`improper. See SRI Int'l v. Matsushita Elec. Corp. of Am., 775
`
`F.2d 1107, 1118 (Fed. Cir. 1985).
`
`Analysis
`
`3.
`
`The Court begins with careful consideration of the
`
`construction adopted by the ITC and left untouched by the albeit
`
`unreported Federal Circuit opinion. While all parties agree
`
`that this Court is not bound by the ITC construction, it may
`
`afford it whatever persuasive value and deference it deems
`
`appropriate. See Texas Instruments, Inc. v. Cypress
`
`Semiconductor Corp., 90 F.3d 1558, 1569 (Fed. Cir. 1996).
`
`As noted supra, the ALJ in the ITC proceeding construed
`
`“functional . . . β-galactosidase gene” as “a functional
`
`
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`Case 1:22-cv-11090-NMG Document 144 Filed 02/15/24 Page 15 of 22
`
`sequence of DNA that encodes β-galactosidase.” ITC Construction
`
`Order, 2018 WL 6837945, at *22-23.
`
`At the Markman hearing before this Court, Glycosyn
`
`initially quibbled with the ITC’s inclusion of the word
`
`“sequence” but ultimately accepted the ITC construction which
`
`aligns with that of Chr. Hansen and Abbott. They construe the
`
`term to mean a “singular functional sequence of DNA,” but
`
`conceded at the Markman hearing that the word “singular” is
`
`redundant because “sequence” is a singular noun. Glycosyn, for
`
`its part, emphasizes that none of the dictionary definitions
`
`cited by Abbott and Chr. Hansen includes the word “single”.
`
`Thus neither party provides a compelling reason to depart from
`
`the ITC construction.
`
`In light of the ITC construction and perhaps reluctant
`
`concessions of the parties at the Markman hearing, resolution of
`
`the first disputed term is simplified. The Court will construe
`
`“functional . . . β-galactosidase gene” as “a functional
`
`sequence of DNA, originating outside the E. coli bacterium, that
`
`encodes a working β-galactosidase enzyme.” The first clause
`
`follows the ITC construction, while the second and third adopt
`
`the constructions proffered by the parties.
`
`
`
`
`
`
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`

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`Case 1:22-cv-11090-NMG Document 144 Filed 02/15/24 Page 16 of 22
`
`Disputed Term #2
`
`Glycosyn’s
`Construction
`
`“the level of β-
`galactosidase
`activity comprises
`between 0.05 and
`[200 units / 5 units
`/ 4 units / 3 units
`/ 2 units]”
`(’018 patent claims
`1, 18, 25-28)
`
`Not indefinite;
`
`“when a culture of
`the E. Coli bacteria
`comprising the
`exogenous functional
`β-galactosidase gene
`is assayed using the
`Miller protocol, β-
`galactosidase
`activity is
`measurable at
`between exactly 0.05
`and exactly
`[200/5/4/3/2] Miller
`Units, as defined in
`Miller, J.H.,
`Experiments in
`Molecular Genetics.
`Cold Spring Harbor
`Laboratory (Cold
`Spring Harbor, N.Y.;
`1972) at 352-355”
`
`Chr. Hansen &
`Abbott’s
`Construction
`Indefinite;
`
`“β-galactosidase
`activity is
`measurable at
`between exactly 0.05
`and exactly
`[200/5/4/3/2] Miller
`Units, as defined in
`Miller, J.H.,
`Experiments in
`Molecular Genetics
`(Cold Spring Harbor
`Lab. 1972) at 352-
`355, where the β-
`galactosidase
`activity is the β-
`galactosidase
`activity
`attributable to the
`expression of the
`exogenous functional
`β-galactosidase gene
`only”
`
`
`
`With respect to the second disputed term, both parties
`
`recognize that this Court will address indefiniteness at the
`
`summary judgment stage. Docket No. 81-1. Accordingly, the
`
`parties did not brief that issue.
`
`They agree that “units” means “Miller Units, as set forth
`
`in Miller, J.H., Experiments in Molecular Genetics (Cold Spring
`
`Harbor Lab. 1972) at 352-355.” That term is defined in the
`
`patent specifications and the ITC and Federal Circuit both
`
`adopted that construction during the earlier proceeding.
`
`
`
`- 16 -
`
`

`

`Case 1:22-cv-11090-NMG Document 144 Filed 02/15/24 Page 17 of 22
`
`1.
`
`Glycosyn
`
`
`
`Glycosyn contends that its construction aligns with the
`
`plain and ordinary meaning of the claim term and emphasizes that
`
`if a company puts an exogenous functional β-
`galactosidase gene into a bacterial strain, and then
`performs the Miller protocol on the strain and gets
`results in the claimed range, the company practices
`this claim element.
`
`Glycosyn suggests that even if it is not obvious on the
`
`face of the proffered constructions, the real dispute here is
`
`whether one may modify the Miller protocol when determining the
`
`claimed “units”. It maintains that the ITC and Federal Circuit
`
`have already held that such modification is not permitted.
`
`Glycosyn further argues that nothing in the patent permits any
`
`changes to the Miller protocol, a proposition that Chr. Hansen
`
`purportedly agreed with during the Markman proceeding before the
`
`ITC.
`
`Glycosyn accuses Chr. Hansen and Abbott of engaging in
`
`mischief by purposefully modifying the Miller protocol to avoid
`
`infringement. Specifically, it claims Chr. Hansen had a third
`
`party subtract negative control strains which is not permitted
`
`under the Miller Test protocol.
`
`Glycosyn avers that the construction proffered by Chr.
`
`Hansen and Abbott will permit them to tinker with the Miller
`
`protocol under the pretense of discerning “activity attributable
`
`to the expression of the exogenous functional β-galactosidase
`
`
`
`- 17 -
`
`

`

`Case 1:22-cv-11090-NMG Document 144 Filed 02/15/24 Page 18 of 22
`
`gene only.” Glycosyn asserts that such construction will
`
`confuse the jury and insert unnecessary and uncontemplated
`
`verbiage into the ’018 patent.
`
`In its reply brief, Glycosyn emphasizes that the term
`
`“comprise”, which appears in the claim at issue, is a term of
`
`art designed to broaden a claim. It argues that Abbott and Chr.
`
`Hansen “turn the law on its head” by suggesting that comprising
`
`restricts the patent to only β-galactosidase attributable to the
`
`inserted β-galactosidase gene. The patent is designed to claim
`
`that the
`
`inserted β-galactosidase gene, paired with anything
`else, could produce the claimed β-galactosidase
`activity so long as the β-galactosidase gene is
`present.
`
`(Emphasis added.)
`
`
`2.
`
`Chr. Hansen and Abbott
`
`
`
`Chr. Hansen and Abbott contend that their proposed
`
`construction is supported by the patent, its specification and
`
`its file history.
`
`First, the patent claims
`
`
`
`(1) a method for producing a fucosylated
`oligosaccharide in a bacterium, comprising . . . (ii)
`an exogenous functional β-galactosidase gene
`comprising a detectable level of β-galactosidase
`activity . . . .
`
`That language purportedly demonstrates that only the
`
`“exogenous functional β-galactosidase gene,” and nothing else,
`
`
`
`- 18 -
`
`

`

`Case 1:22-cv-11090-NMG Document 144 Filed 02/15/24 Page 19 of 22
`
`is the source of the level of β-galactosidase activity. Chr.
`
`Hansen and Abbott suggest such terminology should end the
`
`inquiry because the plain text of the claim controls. See
`
`Renishaw PLC v. Marposs Societa’ per Azioni, 158 F.3d 1243, 1248
`
`(Fed. Cir. 1998).
`
`Chr. Hansen and Abbott argue that the patent specification
`
`also supports their construction because it explains that the
`
`objective of the patent is
`
`achieved by utilizing a functional β-galactosidase
`(e.g., lacZ) gene insert carefully engineered to
`direct the expression of a low, but detectable level
`of β-galactosidase activity in an otherwise β-
`galactosidase negative host cell.
`
`They question what is meant by Glycosyn’s inclusion of the
`
`phrase “a culture of the E. Coli bacteria comprising the
`
`exogenous functional β-galactosidase gene”. They suggest that
`
`1) Glycosyn’s construction is redundant because the parties have
`
`already agreed on the construction of “units”, 2) the reference
`
`to “assay[ing] using the Miller protocol” could confuse the jury
`
`and 3) a second reference to the Miller protocol “would
`
`contribute nothing but meaningless verbiage.” Harris Corp. v.
`
`IXYS Corp., 114 F.3d 1149, 1152 (Fed. Cir. 1997).
`
`
`
`Chr. Hansen and Abbott reject Glycosyn’s contention that
`
`the “real dispute” is whether it is appropriate to modify the
`
`Miller protocol. While Glycosyn seeks recognition by the Court
`
`that nothing in the patent permits changes to the Miller
`
`
`
`- 19 -
`
`

`

`Case 1:22-cv-11090-NMG Document 144 Filed 02/15/24 Page 20 of 22
`
`protocol, Chr. Hansen and Abbott insist that the Court cannot
`
`decide at the claim construction stage what hypothetical changes
`
`to the Miller test are proper because that question relates to
`
`infringement.
`
`3.
`
`Analysis
`
`
`
`In their supporting memoranda, the parties resemble ships
`
`passing in the night. Chr. Hansen and Abbott focus on whether
`
`the measured β-galactosidase activity is attributable to the
`
`expression of the exogenous functional β-galactosidase gene only
`
`and suggest that Glycosyn doesn’t really disagree with their
`
`proposed construction. Glycosyn, meanwhile, offers an entirely
`
`different understanding of the claim and focuses on whether it
`
`is appropriate to modify the Miller protocol.
`
`The Court agrees with Glycosyn that Chr. Hansen and
`
`Abbott’s use of “attributable to . . . only” would narrow the
`
`scope of the patent claim, a limitation that appears to be
`
`improper given the use of the term “comprising”. See Invitrogen
`
`Corp. v. Biocrest Mfg., L.P., 327 F.3d 1364, 1368 (Fed. Cir.
`
`2003) (explaining that comprising “indicates that the claim is
`
`open-ended”). As counsel for Glycosyn noted at the Markman
`
`hearing, even if Chr. Hansen and Abbott are correct that the
`
`claimed β-galactosidase activity is the β-galactosidase activity
`
`attributable to the expression of the exogenous functional β-
`
`
`
`- 20 -
`
`

`

`Case 1:22-cv-11090-NMG Document 144 Filed 02/15/24 Page 21 of 22
`
`galactosidase gene only, performing the Miller test as written
`
`should accomplish that. Additional verbiage would be redundant.
`
`The Court also finds, however, that Glycosyn’s inclusion of
`
`“assayed using the Miller protocol” is redundant given that the
`
`parties already have agreed on wording with respect to the
`
`Miller protocol.
`
`The Court acknowledges the Federal Circuit’s warning that
`
`“courts should not resolve questions that do not go to claim
`
`scope, but instead go to infringement,” Eon Corp. IP Holdings v.
`
`Silver Spring Networks, Inc., 815 F.3d 1314, 1319 (Fed. Cir.
`
`2016), and agrees with Chr. Hansen and Abbott that it would be
`
`improper to opine on whether the Miller protocol may be modified
`
`at this stage. As Glycosyn concedes, that issue is not
`
`addressed directly in the construction proffered by either
`
`party.
`
`The Court returns again to the construction adopted by the
`
`ITC, which both parties implicitly acknowledge as being correct.
`
`No additional interpretation is necessary: the plain meaning of
`
`the ITC construction will do. Both parties seek to add
`
`additional verbiage to strengthen their infringement arguments
`
`rather than clarify the terms at issue. The Court declines to
`
`accept their invitation.
`
`Accordingly, the term “the level of β-galactosidase
`
`activity comprises between 0.05 and [200 units / 5 units / 4
`
`
`
`- 21 -
`
`

`

`Case 1:22-cv-11090-NMG Document 144 Filed 02/15/24 Page 22 of 22
`
`units / 3 units / 2 units]” will be construed as “β-
`
`galactosidase activity is measurable at between exactly 0.05 and
`
`exactly [200/5/4/3/2] Miller Units, as defined in Miller, J.H.,
`
`Experiments in Molecular Genetics (Cold Spring Harbor Lab. 1972)
`
`at 352-355”.
`
`ORDER
`
`In accordance with the foregoing,
`
`1) the term “functional . . . β-galactosidase gene” means
`
`“a functional sequence of DNA, originating outside the E. coli
`
`bacterium, that encodes a working β-galactosidase enzyme”.
`
`2) the term “the level of β-galactosidase activity
`
`comprises between 0.05 and [200 units / 5 units / 4 units / 3
`
`units / 2 units]” means “β-galactosidase activity is measurable
`
`at between exactly 0.05 and exactly [200/5/4/3/2] Miller Units,
`
`as defined in Miller, J.H., Experiments in Molecular Genetics
`
`(Cold Spring Harbor Lab. 1972) at 352-355”.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`So ordered.
`
`
`
`
`
`
`Dated February 15, 2024
`
`
` /s/ Nathaniel M. Gorton
` Nathaniel M. Gorton
` United States District Judge
`
`
`
`
`
`
`
`
`
`- 22 -
`
`

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