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`UNITED STATES INTERNATIONAL TRADE COMMISSION
`Washington, D.C.
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`In the Matter of
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`CERTAIN HUMAN MILK
`OLIGOSACCHARIDES AND METHODS
`OF PRODUCING THE SAME
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`Inv. No. 337-TA-1120
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`COMMISSION ORDER
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`On May 19, 2020, the Commission issued a final determination finding a violation of
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`section 337 of the Tariff Act of 1930, as amended (19 U.S.C. § 1337) (“section 337”), based on
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`the importation into the United States, the sale for importation, and the sale within the United
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`States after importation of certain bacterial strains and 2’-fucosyllactose oligosaccharides
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`produced therefrom that infringe certain claims of U.S. Patent No. 9,970,018 (“the ’018 patent”).
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`See 85 Fed. Reg. 31549 (May 26, 2020); see also 83 Fed. Reg. 28865 (June 21, 2018) (defining
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`the scope of the investigation as “2’-fucosyllactose oligosaccharides”). The Commission also
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`adjudicated infringement with respect to a TTFL12 bacterial strain imported by the named
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`respondent and determined that it does not infringe the ’018 patent. See id. The Commission
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`issued a limited exclusion order (“LEO”) barring entry of 2’-fucosyllactose (“2’-FL”)
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`oligosaccharides that infringe the asserted patent claims but also including an explicit carve-out
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`for 2’-fucosyllactose oligosaccharides made with the non-infringing TTFL12 bacterial strain.
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`On June 2, 2020, complainant Glycosyn LLC (“Glycosyn”) filed a petition for
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`Commission reconsideration of part III(B) of the Commission Opinion (i.e., “Adjudication of
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`Infringement with Respect to the TTFL12 Strain”). Having considered Glycosyn’s petition, the
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`responses thereto, and the record in this investigation, the Commission has determined to deny
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`Glycosyn’s petition for reconsideration.
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`1
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`I.
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`BACKGROUND
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`A.
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`Procedural Background
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`The Commission instituted this investigation on June 21, 2018, based on a complaint, as
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`amended and supplemented, filed by Glycosyn of Waltham, Massachusetts. See 83 Fed. Reg.
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`28865 (June 21, 2018). The complaint alleged violations of section 337 based upon the
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`importation into the United States, the sale for importation, and the sale within the United States
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`after importation of certain human milk oligosaccharides, by reason of infringement of certain
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`claims of U.S. Patent No. 9,453,230 (“the ’230 patent”) and the ’018 patent. See id. The notice
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`of investigation named Jennewein of Rheinbreitbach, Germany as respondent in this
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`investigation. See id. The Office of Unfair Import Investigations was also a party to this
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`investigation. See id.
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`The Commission partially terminated the investigation as to certain claims of the ’018
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`patent and all asserted claims of the ’230 patent based on the withdrawal of the allegations
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`pertaining to those patent claims. See Order No. 5 (Aug. 9, 2018), unreviewed, Comm’n Notice
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`(Aug. 29, 2018); Order No. 15 (Oct. 30, 2018), unreviewed, Comm’n Notice (Nov. 29, 2018);
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`Order No. 17 (Nov. 19, 2018), unreviewed, Comm’n Notice (Dec. 12, 2018); Order No. 25 (Feb.
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`8, 2019), unreviewed, Comm’n Notice (Feb. 28, 2019). Claims 1-3, 5, 8, 10, 12, 18, and 23-28
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`of the ’018 patent remained pending in this investigation.
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`On September 9, 2019, the administrative law judge (“ALJ”) issued a final initial
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`determination (“FID”) finding a violation of section 337 based on the infringement of claims 1-3,
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`5, 8, 10, 12, 18, and 24-28, but not claim 23 of the ’018 patent based on non-infringement of that
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`claim. See FID at 35. On May 19, 2020, the Commission affirmed the FID’s finding of
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`infringement and issued a final determination finding a violation by certain bacterial strains.
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`2
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`See 85 Fed. Reg. 31549 (May 26, 2020). In particular, the Commission reversed the FID’s
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`decision not to adjudicate the TTFL12 bacterial strain and determined that it does not infringe
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`any of the asserted claims. See id. The Commission issued an LEO barring entry of 2’-FL
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`oligosaccharides that infringe the Asserted Claims but also including an explicit carve-out for 2’-
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`FL oligosaccharides made with the non-infringing TTFL12 bacterial strain.1 The Commission
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`also set a bond in the amount of five (5) percent of the entered value of Jennewein’s 2’-FL
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`product during the period of Presidential review.
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`On June 2, 2020, pursuant to Commission Rule 210.47 (19 C.F.R. § 210.47), Glycosyn
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`petitioned for reconsideration of part III(B) of the Commission Opinion (i.e., “Adjudication of
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`Infringement with Respect to the TTFL12 Strain”).2 On June 8 and 9, 2020, respectively,
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`Jennewein and the Commission’s Investigative Attorney opposed Glycosyn’s petition.3
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`II.
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`STANDARD FOR RECONSIDERATION
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`Commission Rule 210.47 governs petitions for reconsideration and provides that:
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`Within 14 days after service of a Commission determination, any
`party may file with the Commission a petition for reconsideration of
`such determination or any action ordered to be taken thereunder,
`setting forth the relief desired and the grounds in support thereof.
`Any petition filed under this section must be confined to new
`questions raised by the determination or action ordered to be taken
`thereunder and upon which the petitioner had no opportunity to
`submit arguments. . . .
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`See 19 C.F.R. § 210.47.
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`1 Complainant did not request, and the Commission did not issue, a cease and desist order.
`2 See Complainant Glycosyn LLC’s Petition for Reconsideration of Part III(B) of the
`Commission Opinion (June 2, 2020).
`3 See Respondent Jennewein Biotechnologie GmbH’s Opposition to Complainant Glycosyn
`LLC’s Petition for Reconsideration of Part III(B) of the Commission Opinion (June 8, 2020);
`Response of the Office of Unfair Import Investigations to Complainant’s Petition for
`Reconsideration of Part III(B) of the Commission Opinion (June 9, 2020).
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`3
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`III. DISCUSSION
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`Glycosyn’s petition for reconsideration does not identify new questions raised by the ALJ’s FID
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`or the Commission’s final determination or present arguments that Glycosyn did not have the
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`opportunity to address in previous filings before either the ALJ or the Commission. As such,
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`the Commission has determined that Glycosyn’s petition for reconsideration does not satisfy the
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`requirements of Commission Rule 210.47.4
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`IV. CONCLUSION
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`Accordingly, upon consideration of the record and the submissions in this matter, the
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`Commission hereby ORDERS that:
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`1.
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`2.
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`Glycosyn’s petition for reconsideration is DENIED.
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`The Secretary will serve this Order on all parties to the investigation.
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`By order of the Commission.
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`Issued: October 1, 2020
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`Lisa R. Barton
`Secretary to the Commission
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`4 Commissioner Schmidtlein respectfully dissents. In light of the particular facts (including the
`new evidence cited by Glycosyn in its petition for reconsideration) and the procedural history of
`this investigation, and given the rationale provided in her dissent, in her view, Glycosyn’s
`petition should be granted and Part III(B) of the majority’s opinion should be reconsidered.
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`4
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`CERTAIN HUMAN MILK OLIGOSACCHARIDES AND
`METHODS OF PRODUCING THE SAME
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`Inv. No. 337-TA-1120
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`PUBLIC CERTIFICATE OF SERVICE
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`I, Lisa R. Barton, hereby certify that the attached COMMISSION ORDER has
`been served via EDIS upon the Commission Investigative Attorney, Lisa Murray, Esq., and
`the following parties as indicated, on October 1, 2020
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`Lisa R. Barton, Secretary
`U.S. International Trade Commission
`500 E Street, SW, Room 112
`Washington, DC 20436
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`On Behalf of Complainant Glycosyn LLC:
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`Michael C. Newman, Esq.
`MINTZ LEVIN COHN FERRIS GLOVSKY AND POPEO, PC
`1 Financial Center
`Boston, MA 02111
`Email: MCNewman@mintz.com
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`☐ Via Hand Delivery
`☐ Via Express Delivery
`☐ Via First Class Mail
`☒ Other: Email Notification
`of Availability to Download
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`On Behalf of Respondent Jennewein Biotechnologie GmbH:
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`Gary M. Hnath
`MAYER BROWN LLP
`1999 K Street, NW
`Washington, DC 20006
`Email: ghnath@mayerbrown.com
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`☐ Via Hand Delivery
`☐ Via Express Delivery
`☐ Via First Class Mail
`☒ Other: Email Notification
`of Availability to Download
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