PUBLIC VERSION
`
`UNITED STATES INTERNATIONAL TRADE COMMISSION
`
`Washington, D.C.
`
`In the Matter of
`
`CERTAIN HUMAN MILK
`OLIGOSACCHARIDES AND METHODS
`OF PRODUCING THE SAME
`
`Inv. No. 337-TA-1120
`
`ORDER NO. 38:
`
`GRANTING-IN-PART RESPONDENT JENNEWEIN
`BIOTECHNOLOGIE GmbH'S MOTION TO STRIKE UNTIMELY
`ARGUMENTS IN GLYCOSYN POST-HEARING BRIEF
`
`(June 14, 2019)
`
`On June 10, 2019, respondent Jennewein Biotechnologie GmbH ("Jennewein") filed a
`
`motion (1120-032) to strike untimely arguments in complainant Glycosyn, LLC's ("Glycosyn")
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`initial post-hearing brief under Ground Rule 9.2. The motion represents "[t]he Staff stated that it
`
`supports the motion in its entirety." (Mot. at 1.)
`
`Pursuant to Order No. 37, responses to the motion were due June 13, 2019. On June 13,
`
`2019, Glycosyn opposed the motion. No other responses were received.
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`Jennewein's motion to strike (1120-032) is hereby granted-in-part. Ground Rule 9.2
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`states, in relevant part:
`
`The pre-trial brief shall be prefaced with a table of contents and a table of
`authorities. The pre-trial brief shall set forth a party's contentions on each of the
`proposed issues, including citations to legal authorities in support thereof, and
`shall conform to the general outline set forth in Appendix B hereto. . . . Any
`contentions not set forth in detail as required herein shall be deemed abandoned or
`withdrawn, except for contentions of which a party is not aware and could not be
`aware in the exercise of reasonable diligence at the time of filing the pre-trial
`brief.
`
`(Order No. 24.) Jennewein identifies four sections of Glycosyn's initial post-hearing brief (EDIS
`
`Doc. No. 677661 (hereafter, "CIB")) that allegedly lack prior disclosure in Glycosyn's pre-
`
`
`
`UNITED STATES INTERNATIONAL TRADE COMMISSION
`
`Washington, D.C.
`
`In the Matter of
`
`CERTAIN HUMAN MILK
`OLIGOSACCHARIDES AND METHODS
`OF PRODUCING THE SAME
`
`Inv. No. 337-TA-1120
`
`ORDER NO. 38:
`
`GRANTING-IN-PART RESPONDENT JENNEWEIN
`BIOTECHNOLOGIE GmbH'S MOTION TO STRIKE UNTIMELY
`ARGUMENTS IN GLYCOSYN POST-HEARING BRIEF
`
`(June 14, 2019)
`
`On June 10, 2019, respondent Jennewein Biotechnologie GmbH ("Jennewein") filed a
`
`motion (1120-032) to strike untimely arguments in complainant Glycosyn, LLC's ("Glycosyn")
`
`initial post-hearing brief under Ground Rule 9.2. The motion represents "[t]he Staff stated that it
`
`supports the motion in its entirety." (Mot. at 1.)
`
`Pursuant to Order No. 37, responses to the motion were due June 13, 2019. On June 13,
`
`2019, Glycosyn opposed the motion. No other responses were received.
`
`Jennewein's motion to strike (1120-032) is hereby granted-in-part. Ground Rule 9.2
`
`states, in relevant part:
`
`The pre-trial brief shall be prefaced with a table of contents and a table of
`authorities. The pre-trial brief shall set forth a party's contentions on each of the
`proposed issues, including citations to legal authorities in support thereof, and
`shall conform to the general outline set forth in Appendix B hereto. . . . Any
`contentions not set forth in detail as required herein shall be deemed abandoned or
`withdrawn, except for contentions of which a party is not aware and could not be
`aware in the exercise of reasonable diligence at the time of filing the pre-trial
`brief.
`
`(Order No. 24.) Jennewein identifies four sections of Glycosyn's initial post-hearing brief (EDIS
`
`Doc. No. 677661 (hereafter, "CIB")) that allegedly lack prior disclosure in Glycosyn's pre-
`
`
`
`PUBLIC VERSION
`
`hearing brief (EDIS Doc. No. 672522 (hereafter, "CPB")); specifically: (1) Section IV.D.2
`
`regarding a presumption of infringement under 35 U.S.C. § 295, (2) Section IV.D.1.a regarding a
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`lack of sufficient discovery for Jennewein's TTFL12 process, (3) Section IV.D.1.b regarding the
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`status of the TTFL12 design, and (4) Section IV.D.1.d discussing whether TTFL12 "could"
`
`infringe. (See generally Mot. Mem. at 1, 3-10.)
`
`Having carefully reviewed the pleadings, I find inadequate support in Glycosyn's pre-
`
`hearing brief for Section IV.D.2 of its post-hearing brief. This section is dedicated to an
`
`argument that: (1) under the facts of this case, certain statutory factors under 35 U.S.C. § 295
`
`have been met, (2) which satisfaction creates a rebuttal presumption of infringement, and (3)
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`Jennewein has failed to rebut that presumption. (See CIB at 84-91.) This is a very particular
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`theory presented in support of Glycosyn's overall claim of "Jennewein has not met its burden to
`
`show that TTFL12 does not infringe." (See Opp. at 13.)
`
`Glycosyn acknowledges 35 U.S.C. § 295, the very basis for the theory, was not cited in
`
`its pre-hearing brief, but seems to argue that that citation to the statute and related cases is all that
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`is missing. (Id.) I disagree. Glycosyn's pre-hearing brief is devoid of any comparison between
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`evidence and the statutory factors in substance, if not by name, or even the concept that a
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`"presumption" has been created or that the statute's standard of "substantial likelihood" has been
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`met. The fact that some pre-hearing brief argument given in the context of other issues happens,
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`roughly, to correspond to the factors of 35 U.S.C. § 295 does not allow Glycosyn to introduce a
`
`35 U.S.C. § 295 theory in its post-hearing brief for the first time. (See Opp. at 15-16 (citing CPB
`
`at 104-105, 145-146); compare CPB at 104-105 (discussing invalidity), 145-146 (discussing
`
`whether TTFL12 is within the scope of investigation) with CIB at 84-91 (discussing presumption
`
`2-
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`
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`PUBLIC VERSION
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`of infringement).) The same is true for argument presented by Jennewein and the Staff. (See
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`Opp. at 16-17 (citing Staff-Pre-HB at 68); EDIS Doc. No. 673388 (Staff Pre-Hearing Brief) at 68
`
`(discussing whether TTFL12 is within the scope of investigation).) Thus, this portion of
`
`Jennewein's motion is granted. Section IV.D.2 is hereby struck.
`
`I find inadequate support for Section IV.D.1.a as well. The thrust of this section is that
`
`there has been insufficient discovery on the TTFL12 strain so as to meet the "extensive
`
`discovery" requirement for adjudication of redesigned products. (See CIB at 69-72 (citing
`
`Certain Two-Way Radio Equipment and Systems, Related Software, and Components Thereof;
`
`Inv. No. 337-TA-1053, Comm'n Op. at 27 (Dec. 18, 2018) ("Two-Way Radios")).) I find no
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`mention of "discovery" anywhere in Glycosyn's pre-hearing brief, however, and it is difficult to
`
`understand how the argument could be made without using that term. Moreover, Glycosyn's
`
`pre-hearing arguments, cited in its opposition for alleged support, that: (1) Jennewein "failed to
`
`produce sufficient evidence to demonstrate that TTFL12 []
`
`or that
`
`2'-FL produced by TTFL12 has been imported into the United States," and (2) "Jennewein relies
`
`upon 'only two documents' to support its position [of non-infringement]" (see Opp. at 8 (citing
`
`CPB at 145)) are distinct from the argument that an overall insufficient amount of discovery had
`
`taken place so as to deny adjudication on a redesigned product. This distinction is further shown
`
`by Glycosyn's dedication of discrete sections to each of these three arguments in its post-hearing
`
`brief. (Compare CIB at 69-72 (alleging insufficient discovery) with id at 75-82 (alleging no
`
`showing of importation) with id at 82-84 (alleging the evidence shows possible infringement))
`
`Glycosyn's other arguments—that its earlier filings in the investigation act to preserve the
`
`position (Opp. at 8-9) or that Staffs analysis of sufficient discovery in its own pre-hearing brief
`
`3
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`
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`PUBLIC VERSION
`
`must mean Glycosyn also disclosed it (id. at 9-10) are not persuasive. Thus, this portion of
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`Jennewein's motion is granted. Section IV.D.La is hereby struck.
`
`I find adequate support for Section IV.D.1.b, however. Here, Jennewein argues
`
`"Glycosyn has also abandoned the argument that the TTFL12 strain is not 'sufficiently fixed in
`
`design' . . . ." yet acknowledges that "Glycosyn previously argued that `Jennewein's own
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`evidence suggests that the TTFL12 strain needs significant retooling if it is ever going to be
`
`viable." (Mot. Mem. at 7 (citing CPB at 147).) I do not agree these are materially different
`
`positions—the commercial viability of product is a logical consideration (but by no means a
`
`dispositive one) as to whether that product is "fixed in design." I further find that Glycosyn's
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`pre-hearing brief explains this position with sufficient detail. (See CPB at 147.) Thus, this
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`portion of Jennewein's motion is denied.
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`Finally, I find adequate support for Section IV.D.1.d. Glycosyn's pre-hearing brief
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`alleges Jennewein will not be able to sufficiently show the TTFL12 strain does not infringe,
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`based on expert testimony regarding disclosures found in a Jennewein patent application ("host
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`cell . . . comprise[s] a deregulated beta-galactosidase encoding gene"). (CPB at 145 (citation
`
`omitted)) This theory is essentially repeated in the first paragraph of Section IV.D.1.d and will
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`not be struck. The remaining paragraphs of Section IV.D.1.d, however, constitute a different
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`theory albeit in support of the same claim. (See CIB at 83-84
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`) It does not appear that Glycosyn's pre-
`
`hearing brief contains this theory. Nevertheless, I agree the testimony Glycosyn cites in support
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`arose during the evidentiary hearing in such a way so as to justify the added theory. (See id.
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`(citing Hr'g Tr. at 528-529, 305); see also Opp. at 12
`
`4
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`
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`PUBLIC VERSION
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`and "[t]his testimony came in without objection by Staff or
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`Jennewein").) Thus, this portion of Jennewein's motion is denied.
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`Regarding Glycosyn's ancillary argument—that the proper course is to address
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`Jennewein's motion in the initial determination (Opp. at 19-20)-1 am not persuaded. There is
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`an obvious benefit to addressing Jennewein's motion now. It clarifies the issues Jennewein and
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`the Staff must address in their reply post-hearing briefs due Monday, June 17, 2019. Further,
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`Glycosyn is undercut by its own use of an order from a prior investigation to show what is
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`permitted in post-hearing briefing—an order that issued before that investigation's initial
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`determination. (See Opp. at 12 (citing Certain Automated Media Library Devices, Inv. No. 337-
`
`TA-746, Order No. 33 (Oct. 26, 2011)))
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`Accordingly, Jennewein's motion (1120-032) is hereby granted-in-part. Glycosyn shall
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`file a corrected version of its initial post-hearing brief with the above-identified redactions no
`
`later than Monday, June 17, 2019.
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`Within seven days of the date of this document, the parties shall submit to the Office of
`
`the Administrative Law Judges a joint statement as to whether or not they seek to have any
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`portion of this document deleted from the public version. If the parties do seek to have portions
`
`of this document deleted from the public version, they must submit to this office a copy of this
`
`document with red brackets indicating the portion or portions asserted to contain confidential
`
`5
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`
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`PUBLIC VERSION
`
`business information. The submission may be made by email and/or hard copy by the
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`aforementioned date and need not be filed with the Commission Secretary.
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`SO ORDERED.
`
`Cameron Elliot
`Administrative Law Judge
`
`6 -
`
`
`
`CERTAIN HUMAN MILK OLIGOSACCHARIDES AND
`METHODS OF PRODUCING THE SAME
`
`INV. NO. 337-TA-1120
`
`PUBLIC CERTIFICATE OF SERVICE
`
`I, Lisa R. Barton, hereby certify that the attached Order No. 38 has been served by hand upon
`the Commission Investigative Attorney, Lisa Murray, Esq. and the following parties as
`indicated, on JUN 2 6 20T9
`
`Lisa R. Barton, Secretary
`U.S. International Trade Commission
`500 E Street SW, Room 112A
`Washington, DC 20436
`
`FOR COMPLAINANT GLYCOSYN LLC
`
`Michael C. Newman, Esq.
`MINTZ LEVIN COHN FERRIS GLOVSKY
`AND POPEO PC
`One Financial Center
`Boston, MA 02111
`
`.
`
`( ) Via Hand Delivery
`( ),Express Delivery
`(,, 1 Via First Class Mail
`( ) Other:
`
`FOR RESPONDENT JENNEWEIN BIOTECHNOLOGIE GmbH
`
`Gary M. Hnath, Esq.
`MAYER BROWN, LLP
`1999 K Street, NW
`Washington, DC 20006
`
`( ) Via Hand Delivery
`( ) press Delivery
`( Via First Class Mail
`( ) Other:
`
`
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