Chr. Hansen HMO GMBH v. Glycosyn LLC

Filing 186

Magistrate Judge Donald L. Cabell: ORDER entered. MEMORANDUM AND ORDER ON GLOCOSYN LLC'S MOTION TO COMPEL granting in part and denying in part 134 Motion to Compel. (Russo, Noreen)

UNITED STATES DISTRICT COURT
DISTRICT OF MASSACHUSETTS
CHR. HANSEN HMO GMBH,
Plaintiff and
Counterclaim Defendant,
v.
GLYCOSYN LLC,

No.

22-cv-11090-NMG

Defendant and
Counterclaim Plaintiff,
v.
ABBOTT LABORATORIES,
Counterclaim Defendant.

MEMORANDUM AND ORDER ON GLOCOSYN LLC’S MOTION TO COMPEL
CABELL, U.S.M.J.
I.

Introduction
In this complex action, counterclaim plaintiff Glycosyn LLC

(“Glycosyn”) accuses counterclaim defendants Chr. Hansen HMO GMBH
(“Chr. Hansen”) and Abbott Laboratories (“Abbott”) of infringing
its patents, which cover a process for manufacturing certain
complex sugars.

Through this motion, (D. 134), Glycosyn seeks an

order compelling Chr. Hansen to produce several categories of
documents relating to three different bacteria strains Chr. Hansen
uses or has used to produce these complex sugars.

1

Chr. Hansen

opposes the motion. 1

(D. 140).

For the following reasons, the

motion to compel is granted in part and denied in part.
II.

Relevant Background
Glycosyn holds two patents that cover methods of producing

complex sugars known as human milk oligosaccharides, so called
because they occur naturally in human milk. These oligosaccharides
promote immune health in infants.

The patents, U.S. Patent Nos.

9,453,230 (“the ‘230 Patent”) and 9,970,018 (“the ‘018 Patent”),
are

specifically

directed

toward

production

of

fucosylated

oligosaccharides, which are oligosaccharides comprised of simple
sugars glucose, galactose, and fucose.

Two types of fucosylated

oligosaccharides are relevant here: 2’-FL and 3-FL. 2
Historically,

artificial

production

of

fucosylated

oligosaccharides has proved to be difficult and costly.

However,

Glycosyn engineered a process to genetically modify strains of E.
coli bacteria such that they would produce either 2’-FL or 3-FL in
commercially viable quantities, depending on the specific genetic

1 Abbott also filed an opposition to the motion to compel while expressing
uncertainty as to whether the motion was directed to Abbott in the first place.
(D. 138). As discussed below, to the extent that Glycosyn also seeks to compel
Abbott to produce the documents at issue, the motion is denied.

Fucosylated oligosaccharides are categorized based on (1) whether the fucose
molecule is bonded with the galactose molecule or the glucose molecule and (2)
where the bond occurs.
For example, 2’-FL is so named because the fucose
molecule bonds with the second carbon atom of the galactose molecule. Compare
that to 3-FL, where the fucose molecule bonds with the third carbon atom of the
glucose molecule.

2

2

modification.

That process is the subject of the ‘018 Patent and

the ‘230 Patent. 3
Glycosyn

and

Chr.

Hansen

both

produce

oligosaccharides on a commercial scale.
fucosylated oligosaccharides to Abbott.

fucosylated

Chr. Hansen supplies
Abbott, in turn, uses

these oligosaccharides in some of its baby formula products.
In 2018, Glycosyn filed a complaint with the International
Trade Commission (“ITC”) against Jennewein Biotechnologie GMBH
(“Jennewein”), Chr. Hansen’s predecessor in interest.

Certain

Human Milk Oligosaccharides and Methods of Producing the Same,
Inv. No. 337-TA-1120, 2020 WL 3073788, at *1 (USITC June 8, 2020),
aff’d sub nom. Jennewein Biotechnologie GmbH v. Int’l Trade Comm’n,
No.

2020-2220,

2021

WL

4250784

(Fed.

Cir.

Sept.

17,

2021).

Initially, the complaint asserted that Jennewein infringed both
the ‘230 Patent and the ‘018 Patent, but Glycosyn later withdrew
the allegations related to the ‘230 Patent.

Id.

Ultimately, the

ITC considered whether three different strains of E. coli bacteria
developed by Jennewein -- #1540, #2410, and TTFL12 -- infringed
the ‘018 Patent.

Jennewein Biotechnologie, 2021 WL 4250784, at *2

The idea of using E. coli to produce 2’-FL is not original to Glycosyn.
Glycosyn’s innovation, as captured in the patents, consists of a sequence of
two gene edits that result in a lower level of an enzyme called β-galactosidase.
β-galactosidase cleaves lactose into separate glucose and galactose molecules,
which leaves less lactose available to bond with fucose to make 2’-FL and 3FL. At the same time, having some β-galactosidase activity is helpful to break
down excess lactose before harvesting the 2’-FL or 3-FL. Glycosyn’s process is
intended to reach a happy medium.
3

3

(summarizing ITC proceedings).

The ITC determined that #1540 and

#2410 infringed the ‘018 Patent but TTFL12 did not.

Id.

In the wake of the ITC’s decision (and the Federal Circuit’s
affirmance), Jennewein, and later Chr. Hansen, purportedly stopped
using the #1540 strain to produce 2’-FL for sale in American
markets. 4

Instead, Chr. Hansen switched to a strain known as

#1242, which was not considered in the ITC action.

Chr. Hansen

contends that it continues to use #1242 to produce 2’-FL for
products
formulas.

sold

in

the

United

States,

including

Abbott’s

baby

Similarly, Chr. Hansen uses a strain known as JBT-3FL

to produce 3-FL for use in products sold in the United States.
Chr. Hansen filed the current action against Glycosyn seeking
a declaratory judgment of invalidity and non-infringement of the
‘018 Patent.

(D. 1).

Glycosyn filed a counterclaim against Chr.

Hansen and a third-party complaint against Abbott, accusing both
of infringing the ‘018 Patent.

(D. 15).

The court recently

granted Glycosyn leave to file an amended counterclaim to add
allegations that Chr. Hansen and Abbott infringed the ‘230 Patent.
(D. 185).

Chr. Hansen has filed a motion to strike portions of

Glycosyn’s infringement contentions as to any strains other than
the #1540 strain.

(D. 119).

Glycosyn has filed a motion for leave

It is not clear from the record whether Jennewein or Chr. Hansen ever used
the #2410 strain to produce fucosylated oligosaccharides destined for the United
States or elsewhere.

4

4

to

serve

Patent.

amended

infringement

(D. 177).

contentions

regarding

the

‘230

Those motions are currently pending.

III. Legal Standard
A party moving to compel discovery bears the initial burden
of showing the relevance of the information sought.

DMO Norwood

LLC v. Kia Am., Inc., --- F. Supp. 3d ---, 2023 WL 5353744, at *2
(D. Mass. 2023).

Once the movant makes this showing, the burden

shifts to the nonmoving party to show that the requested discovery
is nonetheless improper.

Id.

For requested materials to be discoverable, they must be both
“relevant to any party’s claim or defense and proportional to the
needs of the case.”

Fed. R. Civ. P. 26(b)(1).

The proportionality

analysis considers “the importance of the issues at stake in the
action, the amount in controversy, the parties' relative access to
relevant information, the parties' resources, the importance of
the discovery in resolving the issues, and whether the burden or
expense of the proposed discovery outweighs its likely benefit.”
Id.

While the information sought must be relevant to a party’s

claim or defense, it need not be narrowly tailored to prove a claim
or defense, as materials may be discoverable even if they are not
admissible

in

evidence.

Id.;

see

Oppenheimer

Fund,

Inc.

v.

Sanders, 437 U.S. 340, 351 (1978) (“[D]iscovery is not limited to
issues raised by the pleadings, for discovery itself is designed
to help define and clarify the issues.”).
5

Because this action centers on “the infringement, validity,
or enforceability of a United States Patent,” it is also governed
by Local Rule 16.6.

L.R. 16.6(a).

Local Rule 16.6(d) sets out

each party’s obligation to make certain automatic disclosures in
addition to those required by Federal Rule of Civil Procedure
26(a)(1).

For the patentee, these automatic disclosures include,

inter alia, infringement claim charts that identify “each accused
product

and/or

method”

and

provide

“an

element-by-element

description of where and how each element of each asserted claim
is found in each accused product or method.”
An

accused

infringer

must

including

technical

information,
source

code

(where

disclose

applicable),

L.R. 16.6(d)(1)(A).

several

documents,

categories

product

noninfringement

of

samples,

claim

charts,

invalidity claim charts, other grounds for invalidity, supporting
evidence for any asserted invalidity defense, and the identity of
all real parties in interest.

L.R. 16.6(d)(4).

The rule further

provides that “[t]he parties’ failure to agree on the sufficiency
of the patentee’s disclosures . . . shall not entitle the accused
infringer

to

avoid

subsection (d)(4).”
IV.

or

delay

its

disclosure

obligations

in

L.R. 16.6(d)(3).

Discussion
Glycosyn

Hansen:
records,

batch
and

seeks

five

records,

categories

production

laboratory

information

protocols,

notebooks.
6

of

gene

Glycosyn

from

Chr.

maps,

test

seeks

this

information as to #1242, #1540, TTFL12, and JBT-3FL, although it
indicated at the hearing on this motion that it would accept a
more limited production as to #1242 and TTFL12.

Chr. Hansen

asserts (and Glycosyn does not dispute) that it already produced
these materials to Glycosyn as to the #1540 strain in the previous
ITC action. 5

Chr. Hansen further argues that it has provided

sufficient materials to Glycosyn as to the other strains and that
the further discovery Glycosyn seeks is not proportional to the
needs of the case.
A.

The court largely agrees with Chr. Hansen.

#1242 and TTFL12

Glycosyn does not contend that the #1242 or TTFL12 strains
infringe the ‘018 Patent or the ‘230 Patent.

(D. 120-18, email

from Glycosyn’s counsel to Chr. Hansen’s counsel).

Glycosyn’s

concern is that Chr. Hansen has covertly continued to use the #1540
strain

to

produce

2’-FL

for

American

markets

representing that it was using the #1242 strain.

while

falsely

Glycosyn bases

its suspicions in part on the fact that Chr. Hansen (or Jennewein)
apparently developed the #1242 strain before the #1540 strain 6 and
in part on Chr. Hansen’s reluctance to provide full strain and
batch records, which Glycosyn interprets as concealment.
The parties have agreed that discovery from the ITC action may be used in this
case.
5

The implication here is that the #1242 strain must be inferior to the #1540
strain. Otherwise, the argument goes, Jennewein would not have used the #1540
strain to produce 2’-FL prior to the ITC action if it already had the #1242
strain.

6

7

Chr. Hansen argues that Glycosyn’s suspicions are unfounded.
In support of that argument, Chr. Hansen points to the Customs and
Border Patrol (“CBP”) certifications dating back to June 2020 that
it has produced in this action.

In those certifications, Chr.

Hansen affirmed, under penalty of perjury, that each batch of 2’FL it imported into the United States was made using the #1242
strand.

Glycosyn, for its part, does not contest that Chr. Hansen

has produced those certifications.

Instead, Glycosyn argues that

it needs Chr. Hansen’s batch records to test the certifications’
veracity, especially since CBP does not independently verify the
information Chr. Hansen provides. 7
Glycosyn’s

concerns

about

whether

and

when

Chr.

Hansen

imported allegedly infringing strains into the United States makes
the batch records relevant to the subject matter of this case.
While the veracity of Chr. Hansen’s certifications to CBP is
somewhat tangential to Glycosyn’s core infringement claims, that
does not make the issue totally irrelevant.

See Oppenheimer Fund,

437 U.S. at 351 (“discovery is not limited to issues raised by the
pleadings”); see also Hudson-RPM Distribs., LLC v. Bowditch &
Dewey, LLP, Civil Action No. 19-cv-40095-TSH, 2021 WL 9649662, at

Glycosyn also argues that the requested discovery is relevant to damages.
Specifically, Glycosyn needs to know when Chr. Hansen and Abbott were using
infringing strains and noninfringing strains to calculate its damages. This
is, in essence, a repackaged version of Glycosyn’s argument that the CBP
certifications are insufficient to show when and whether Chr. Hansen used the
#1242 strain instead of the #1540 strain.
7

8

*3 (D. Mass. Feb. 12, 2021) (“the standard for relevance in
discovery is low”).
Of

course,

discoverable.

relevance

alone

does

not

render

materials

Chr. Hansen argues that the discovery requests at

issue are unduly burdensome and thus not “proportional to the needs
of the case.”

Fed. R. Civ. P. 26(b)(1).

Chr. Hansen asserts,

with some support, that producing records for every batch of 2’FL it has produced would require hundreds of hours of manual
document collection.
re

Betapharm

421996,

at

This would be a substantial burden.

Arzneimittel

*4-*5

(D.

GmbH,

Mass.

No.

Feb.

5,

23-mc-91600-IT,
2024)

See In
2024

(finding

WL

request

burdensome where it “would take hundreds of hours of effort to
categorize, redact, and prepare for use” requested records); see
also Fine v. Sovereign Bank, Civil Action No. 06-cv-11450-NG, 2008
WL 11388664, at *4 (D. Mass. July 2, 2008) (affirming magistrate
judge’s

determination

that

discovery

requiring

“hundreds

of

employee hours” of review and substantial expense was unduly
burdensome).
Glycosyn argues that Chr. Hansen could easily produce the
requested batch records, notwithstanding its present objections,
based

on

Jennewein’s

previous

representation

that

it

could

“identify the strain used to produce each lot number of 2’-FL
within

four

hours

of

a

request.”

Certain

Human

Milk

Oligosaccharides and Methods of Producing the Same, Inv. No. 3379

TA-1120, 2019 WL 5677974, at *24 (USITC Sept. 9, 2019), aff’d in
part and rev’d in part, 2020 WL 3073788.

This argument is facially

attractive, but it elides two potentially important points. First,
there is likely a meaningful difference between simply identifying
the

strain

used

to

produce

a

particular

batch

collecting a full set of records for that batch.

of

2’-FL

and

Second, even if

Chr. Hansen could pull together all the relevant documents for one
batch within four hours, that is entirely consistent with the idea
that it would require hundreds of hours to collect documents for
the scores of batches Chr. Hansen has produced.

As such, Chr.

Hansen’s ability to identify one batch’s strain within four hours
does not necessarily mean that producing all batch records would
not be significantly burdensome.
Again, it bears restating that Glycosyn does not allege that
the #1242 or TTFL12 strains infringe its patents, which makes the
relevance

of

records

about

those

strains

unclear

at

best.

Nonetheless, Glycosyn argues that it needs batch records to test
Chr. Hansen’s sworn certifications to CBP that it uses the #1242
strain, and not the #1540 strain, to make the 2’-FL it imports
into the United States.

In this context, the batch records are

relevant to this action, but only tangentially so, especially since
there is no basis on the record to suspect that Chr. Hansen has
routinely committed perjury by deceiving CBP.

Weighed against

this marginal relevance is the significant burden collecting and
10

producing the batch records would impose on Chr. Hansen. Balancing
these considerations, the court finds that Glycosyn’s discovery
requests are not proportional to the needs of the case.

See Doe

v. Sanderson, Civil Action No. 16-cv-12068-IT, 2021 WL 828379, at
*2 (D. Mass. Mar. 4, 2021) (finding burden or expense of proposed
discovery outweighed likely benefit based on “marginal relevance”
of discovery sought).

Accordingly, the motion to compel is denied

as to the #1242 and TTFL12 strains.
B.

JBT-3FL

Unlike the two strains discussed above, Glycosyn alleges that
the JBT-3FL strain infringes the ‘018 Patent. The parties’ dispute
about Glycosyn’s requests related to this strain turn in part on
their arguments about the adequacy of Glycosyn’s infringement
contentions.

Chr. Hansen asserts that “Glycosyn has failed to

provide an element-by-element description of where and how each
element of each asserted claim is found in each accused product or
method for JBT-3FL, as required by the Local Rules.”
17).

(D. 140, p.

Chr. Hansen asks this court to reserve its ruling on the

motion to compel until its motion to strike Glycosyn’s infringement
contentions (D. 119) is decided.
As mentioned above, Local Rule 16.6(d)(4) requires an accused
infringer to produce certain documents automatically.

Local Rule

16.6(d)(3) directs that the accused infringer must make this
production notwithstanding the parties’ disagreement about the
11

sufficiency of the patentee’s disclosures.

The text of the rule

reveals no exception for cases where the patentee’s disclosures
(allegedly) fall well short of the requirements imposed by Local
Rule 16.6(d)(1), nor is the court aware of any cases interpreting
the rule this way.
range

of

Therefore, Chr. Hansen must provide the full

discovery

notwithstanding

its

contemplated
arguments

by

about

Local
the

Rule

16.6(d)(4)

insufficiency

of

Glycosyn’s infringement contentions. 8
To the extent that the discovery Glycosyn seeks goes beyond
the requirements of Local Rule 16.6(d)(4), the court agrees with
Chr. Hansen that it makes the most sense to defer ruling on those
requests until Chr. Hansen’s motion to strike is resolved.

As

such, the court will deny the motion to compel without prejudice
as to discovery regarding JBT-3FL other than what is covered by
Local Rule 16.6(d)(4).

Glycosyn may renew its motion following a

ruling on Chr. Hansen’s motion to strike to the extent that the
motion remains viable based on that ruling.
C.

Discovery From Abbott

At the hearing on this motion, Glycosyn clarified that the
motion is directed to Abbott as well as Chr. Hansen because Abbott
has a contractual right to obtain some or all of the requested
documents from Chr. Hansen.

“[T]he court must limit the frequency

Chr. Hansen asserts that it has already produced discovery sufficient to meet
its obligations under Local Rule 16.6(d)(4). The court makes no finding as to
whether Chr. Hansen has already complied with the rule.
8

12

or extent of discovery otherwise allowed by these rules or by local
rule if it determines that[] the discovery sought . . . can be
obtained from some other source that is more convenient, less
burdensome, or less expensive.”

Fed. R. Civ. P. 26(b)(2)(C).

Here, Chr. Hansen is clearly a more convenient source than Abbott
given that Chr. Hansen, and not Abbott, actually possesses the
requested records.

Therefore, the court denies the motion to

compel as to Abbott.
V.

Conclusion
For the reasons discussed above, Glycosyn’s motion to compel

(D. 134) is GRANTED IN PART and DENIED IN PART.

The motion is

granted in that Chr. Hansen must make the disclosures required by
Local Rule 16.6(d)(4) as to JBT-2FL.

The motion is denied without

prejudice to the extent it seeks other discovery from Chr. Hansen
regarding JBT-3FL.

The motion is otherwise denied.

So ordered.

DATED:

/s/ Donald L. Cabell
DONALD L. CABELL, U.S.M.J.

May 10, 2024

13