In the Matter of
`
`CERTAIN HUMAN MILK
`OLIGOSACCHARIDES AND METHODS OF
`PRODUCING THE SAME
`
`337-TA-1120
`
`Publication 5254
`February 2022
`U.S. International Trade Commission
`
`Washington, DC 20436
`
`

`

`U.S. International Trade Commission
`
`COMMISSIONERS
`
`David S. Johanson, Chairman
`Rhonda K. Schmidtlein, Commissioner
`Jason E. Kearns, Commissioner
`Randolph J. Stayin, Commissioner
`Amy A. Karpel, Commissioner
`
`Address all communications to
`Secretary to the Commission
`United States International Trade Commission
`Washington, DC 20436
`
`

`

`U.S. International Trade Commission
`
`Washington, DC 20436
`www.usitc.gov
`
`In the Matter of
`
`CERTAIN HUMAN MILK
`OLIGOSACCHARIDES AND METHODS OF
`PRODUCING THE SAME
`
`337-TA-1120
`
`Publication 5254
`
`February 2022
`
`

`

`
`
`
`
`
`
`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
`
`COMMISSION ORDER
`
`On May 19, 2020, the Commission issued a final determination finding a violation of
`
`section 337 of the Tariff Act of 1930, as amended (19 U.S.C. § 1337) (“section 337”), based on
`
`the importation into the United States, the sale for importation, and the sale within the United
`
`States after importation of certain bacterial strains and 2’-fucosyllactose oligosaccharides
`
`produced therefrom that infringe certain claims of U.S. Patent No. 9,970,018 (“the ’018 patent”).
`
`See 85 Fed. Reg. 31549 (May 26, 2020); see also 83 Fed. Reg. 28865 (June 21, 2018) (defining
`
`the scope of the investigation as “2’-fucosyllactose oligosaccharides”). The Commission also
`
`adjudicated infringement with respect to a TTFL12 bacterial strain imported by the named
`
`respondent and determined that it does not infringe the ’018 patent. See id. The Commission
`
`issued a limited exclusion order (“LEO”) barring entry of 2’-fucosyllactose (“2’-FL”)
`
`oligosaccharides that infringe the asserted patent claims but also including an explicit carve-out
`
`for 2’-fucosyllactose oligosaccharides made with the non-infringing TTFL12 bacterial strain.
`
`On June 2, 2020, complainant Glycosyn LLC (“Glycosyn”) filed a petition for
`
`Commission reconsideration of part III(B) of the Commission Opinion (i.e., “Adjudication of
`
`Infringement with Respect to the TTFL12 Strain”). Having considered Glycosyn’s petition, the
`
`responses thereto, and the record in this investigation, the Commission has determined to deny
`
`Glycosyn’s petition for reconsideration.
`
`1
`
`

`

`
`
`I.
`
`BACKGROUND
`
`A.
`
`Procedural Background
`
`The Commission instituted this investigation on June 21, 2018, based on a complaint, as
`
`amended and supplemented, filed by Glycosyn of Waltham, Massachusetts. See 83 Fed. Reg.
`
`28865 (June 21, 2018). The complaint alleged violations of section 337 based upon the
`
`importation into the United States, the sale for importation, and the sale within the United States
`
`after importation of certain human milk oligosaccharides, by reason of infringement of certain
`
`claims of U.S. Patent No. 9,453,230 (“the ’230 patent”) and the ’018 patent. See id. The notice
`
`of investigation named Jennewein of Rheinbreitbach, Germany as respondent in this
`
`investigation. See id. The Office of Unfair Import Investigations was also a party to this
`
`investigation. See id.
`
`The Commission partially terminated the investigation as to certain claims of the ’018
`
`patent and all asserted claims of the ’230 patent based on the withdrawal of the allegations
`
`pertaining to those patent claims. See Order No. 5 (Aug. 9, 2018), unreviewed, Comm’n Notice
`
`(Aug. 29, 2018); Order No. 15 (Oct. 30, 2018), unreviewed, Comm’n Notice (Nov. 29, 2018);
`
`Order No. 17 (Nov. 19, 2018), unreviewed, Comm’n Notice (Dec. 12, 2018); Order No. 25 (Feb.
`
`8, 2019), unreviewed, Comm’n Notice (Feb. 28, 2019). Claims 1-3, 5, 8, 10, 12, 18, and 23-28
`
`of the ’018 patent remained pending in this investigation.
`
`On September 9, 2019, the administrative law judge (“ALJ”) issued a final initial
`
`determination (“FID”) finding a violation of section 337 based on the infringement of claims 1-3,
`
`5, 8, 10, 12, 18, and 24-28, but not claim 23 of the ’018 patent based on non-infringement of that
`
`claim. See FID at 35. On May 19, 2020, the Commission affirmed the FID’s finding of
`
`infringement and issued a final determination finding a violation by certain bacterial strains.
`
`2
`
`

`

`
`
`See 85 Fed. Reg. 31549 (May 26, 2020). In particular, the Commission reversed the FID’s
`
`decision not to adjudicate the TTFL12 bacterial strain and determined that it does not infringe
`
`any of the asserted claims. See id. The Commission issued an LEO barring entry of 2’-FL
`
`oligosaccharides that infringe the Asserted Claims but also including an explicit carve-out for 2’-
`
`FL oligosaccharides made with the non-infringing TTFL12 bacterial strain.1 The Commission
`
`also set a bond in the amount of five (5) percent of the entered value of Jennewein’s 2’-FL
`
`product during the period of Presidential review.
`
`On June 2, 2020, pursuant to Commission Rule 210.47 (19 C.F.R. § 210.47), Glycosyn
`
`petitioned for reconsideration of part III(B) of the Commission Opinion (i.e., “Adjudication of
`
`Infringement with Respect to the TTFL12 Strain”).2 On June 8 and 9, 2020, respectively,
`
`Jennewein and the Commission’s Investigative Attorney opposed Glycosyn’s petition.3
`
`II.
`
`STANDARD FOR RECONSIDERATION
`
`Commission Rule 210.47 governs petitions for reconsideration and provides that:
`
`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. . . .
`
`See 19 C.F.R. § 210.47.
`
`
`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).
`
`3
`
`

`

`
`
`III. DISCUSSION
`
`Glycosyn’s petition for reconsideration does not identify new questions raised by the ALJ’s FID
`
`or the Commission’s final determination or present arguments that Glycosyn did not have the
`
`opportunity to address in previous filings before either the ALJ or the Commission. As such,
`
`the Commission has determined that Glycosyn’s petition for reconsideration does not satisfy the
`
`requirements of Commission Rule 210.47.4
`
`IV. CONCLUSION
`
`Accordingly, upon consideration of the record and the submissions in this matter, the
`
`Commission hereby ORDERS that:
`
`1.
`
`2.
`
`Glycosyn’s petition for reconsideration is DENIED.
`
`The Secretary will serve this Order on all parties to the investigation.
`
`By order of the Commission.
`
`
`
`
`
`
`Issued: October 1, 2020
`
`
`
`
`Lisa R. Barton
`Secretary to the Commission
`
`
`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.
`
`4
`
`

`

`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 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
`
`Lisa R. Barton, Secretary
`U.S. International Trade Commission
`500 E Street, SW, Room 112
`Washington, DC 20436
`
`On Behalf of Complainant Glycosyn LLC:
`
`Michael C. Newman, Esq.
`MINTZ LEVIN COHN FERRIS GLOVSKY AND POPEO, PC
`1 Financial Center
`Boston, MA 02111
`Email: MCNewman@mintz.com
`
`☐ Via Hand Delivery
`☐ Via Express Delivery
`☐ Via First Class Mail
`☒ Other: Email Notification
`of Availability to Download
`
`On Behalf of Respondent Jennewein Biotechnologie GmbH:
`
`Gary M. Hnath
`MAYER BROWN LLP
`1999 K Street, NW
`Washington, DC 20006
`Email: ghnath@mayerbrown.com
`
`☐ Via Hand Delivery
`☐ Via Express Delivery
`☐ Via First Class Mail
`☒ Other: Email Notification
`of Availability to Download
`
`

`

`UNITED STATES INTERNATIONAL TRADE COMMISSION
`
`Washington, D.C.
`
`In the Matter of
`
`
`
`
`
`CERTAIN HUMAN MILK
`OLIGOSACCHARIDES AND
`METHODS OF PRODUCING
`THE SAME
`
`
`Investigation No. 337-TA-1120
`
`
`
`
`
`
`
`
`NOTICE OF COMMISSION FINAL DETERMINATION FINDING
`A VIOLATION OF SECTION 337; ISSUANCE OF A LIMITED EXCLUSION
`ORDER; TERMINATION OF THE INVESTIGATION
`
` U.S. International Trade Commission.
`
`Notice.
`
`
`AGENCY:
`
`ACTION:
`
`SUMMARY: Notice is hereby given that the U.S. International Trade Commission has found a
`violation of section 337 of the Tariff Act of 1930 (“section 337”), as amended, in this
`investigation. The Commission has issued a limited exclusion order (“LEO”) prohibiting the
`importation by respondent Jennewein Biotechnologie GmbH (“Jennewein”) of Rheinbreitbach,
`Germany of certain human milk oligosaccharides that infringe complainant’s asserted claims.
`The investigation is terminated.
`
`FOR FURTHER INFORMATION CONTACT: Houda Morad, Office of the General
`Counsel, U.S. International Trade Commission, 500 E Street SW., Washington, DC 20436,
`telephone (202) 708-4716. Copies of non-confidential documents filed in connection with this
`investigation are or will be available for inspection during official business hours (8:45 a.m. to
`5:15 p.m.) in the Office of the Secretary, U.S. International Trade Commission, 500 E Street
`SW., Washington, D.C. 20436, telephone (202) 205-2000. General information concerning the
`Commission may also be obtained by accessing its Internet server at https://www.usitc.gov. The
`public record for this investigation may be viewed on the Commission’s electronic docket
`(EDIS) at https://edis.usitc.gov. Hearing-impaired persons are advised that information on this
`matter can be obtained by contacting the Commission’s TDD terminal on (202) 205-1810.
`
`SUPPLEMENTARY INFORMATION: The Commission instituted this investigation on June
`21, 2018, based on a complaint, as amended and supplemented, filed on behalf of Glycosyn LLC
`of Waltham, Massachusetts (“Glycosyn”). See 83 Fed. Reg. 28865 (June 21, 2018). The
`complaint, as amended and supplemented, alleges violations of section 337 of the Tariff Act of
`1930, as amended, 19 U.S.C. 1337 (“section 337”), based upon the importation into the United
`States, the sale for importation, and the sale within the United States after importation of certain
`human milk oligosaccharides by reason of infringement of claims 1-40 of U.S. Patent No.
`9,453,230 (“the ’230 patent”) and claims 1-28 of U.S. Patent No. 9,970,018 (“the ’018 patent”).
`
`1
`
`

`

`See id. The notice of investigation named Jennewein as a respondent in this investigation. See
`id. The Office of Unfair Import Investigations (“OUII”) is also named as a party to the
`investigation. See id.
`
`
`The ALJ conducted an evidentiary hearing on May 14-17, 2019, and on September 9,
`2019, issued the FID finding a violation of section 337 based on the infringement of claims 1-3,
`5, 8, 10, 12, 18, and 24-28 of the ’018 patent (hereinafter, the “Asserted Claims”). In addition,
`the FID finds that the Asserted Claims are neither invalid under 35 U.S.C. §§ 103 and 112, nor
`unenforceable for inequitable conduct. Furthermore, the FID finds that the domestic industry
`requirement is satisfied. All asserted claims in the ’230 patent were withdrawn during the
`investigation. The FID also contains a recommended determination (“RD”) recommending that
`the Commission issue an LEO barring entry of articles that infringe the ’018 patent. The RD
`also recommends that the Commission impose a 5 percent bond during the period of Presidential
`review. Furthermore, as directed by the Commission, the RD provides findings with respect to
`the public interest and recommends that the Commission determine that the public interest
`factors do not preclude entry of the proposed LEO. Glycosyn does not seek and the RD does not
`recommend issuance of a cease and desist order.
`
`On October 9 and 10, 2019, respectively, Glycosyn and Jennewein filed statements on the
`public interest pursuant to Commission Rule 210.50. On October 23, 2019, non-party DuPont
`Nutrition & Health filed a public interest submission pursuant to the Commission’s notice
`requesting public interest comments. See 84 Fed. Reg. 49335 (Sept. 19, 2019).
`
`On January 30, 2020, the Commission issued a notice determining to review the FID in
`part. See 85 Fed. Reg. 6573 (Feb. 5, 2020). The Commission’s notice requested written
`submissions in response to certain questions relating to issues under review and on issues of
`remedy, the public interest, and bonding. On February 18, 2020, the parties, including OUII,
`filed written submissions in response to the notice, and on February 25, 2020, the parties filed
`responses to each other’s submissions. On February 18, 2020, non-party Abbott Laboratories
`filed a written submission concerning the public interest.
`
`Having examined the record of this investigation, including the FID, the RD, and the
`parties’ and non-parties’ submissions, the Commission has determined to affirm with
`modification the FID’s determination of a violation of section 337 with respect to claims 1-3, 5,
`8, 10, 12, 18, and 24-28 of the ’018 patent. Specifically, as explained in the Commission
`Opinion filed concurrently herewith, the Commission has determined to affirm with modification
`the FID’s findings with respect to infringement by the accused Jennewein bacterial strains and to
`reverse the FID’s decision not to adjudicate infringement with respect to Jennewein’s TTFL12
`bacterial strain. As to the TTFL12 strain, the Commission has determined that it does not
`infringe the Asserted Claims. All findings in the FID that are not inconsistent with the
`Commission’s determination are affirmed.
`
`The Commission has determined that the appropriate remedy is an LEO against
`Jennewein’s infringing products. The Commission has also determined that the public interest
`factors enumerated in subsection 337(d)(1) (19 U.S.C. 1337(d)(1)) do not preclude the issuance
`of the LEO. The Commission has further determined to set a bond during the period of
`
`2
`
`

`

`Presidential review at five (5) percent of the entered value of Jennewein’s infringing products
`(19 U.S.C. 1337(j)).
`
`The Commission’s order and opinion were delivered to the President and to the United
`States Trade Representative on the day of their issuance.
`
`The Commission’s vote for these determinations took place on May 19, 2020.
`
`The authority for the Commission’s determination is contained in section 337 of the
`Tariff Act of 1930, as amended (19 U.S.C. 1337), and in part 210 of the Commission’s Rules of
`Practice and Procedure (19 CFR part 210).
`
`
`By order of the Commission.
`
`Issued: May 19, 2020
`
`
`Lisa R. Barton
`Secretary to the Commission
`
`
`
`3
`
`

`

`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 NOTICE has been served via EDIS
`upon the Commission Investigative Attorney, Lisa Murray, Esq., and the following parties
`as indicated, on May 19, 2020.
`
`Lisa R. Barton, Secretary
`U.S. International Trade Commission
`500 E Street, SW, Room 112
`Washington, DC 20436
`
`On Behalf of Complainant Glycosyn LLC:
`
`Michael C. Newman, Esq.
`MINTZ LEVIN COHN FERRIS GLOVSKY AND POPEO, PC
`1 Financial Center
`Boston, MA 02111
`Email: MCNewman@mintz.com
`
`☐ Via Hand Delivery
`☐ Via Express Delivery
`☐ Via First Class Mail
`☒ Other: Email Notification
`of Availability to Download
`
`On Behalf of Respondent Jennewein Biotechnologie GmbH:
`
`Gary M. Hnath
`MAYER BROWN LLP
`1999 K Street, NW
`Washington, DC 20006
`Email: ghnath@mayerbrown.com
`
`☐ Via Hand Delivery
`☐ Via Express Delivery
`☐ Via First Class Mail
`☒ Other: Email Notification
`of Availability to Download
`
`

`

`UNITED STATES INTERNATIONAL TRADE COMMISSION
`Washington, D.C.
`
`In the Matter of
`
`CERTAIN HUMAN MILK
`OLIGOSACCHARIDES AND METHODS
`OF PRODUCING THE SAME
`
`Investigation No. 337-TA-1120
`
`LIMITED EXCLUSION ORDER
`
`The United States International Trade Commission (“Commission”) has determined that
`
`there is a violation of Section 337 of the Tariff Act of 1930, as amended (19 U.S.C. § 1337), in
`
`the unlawful importation, sale for importation, or sale within the United States after importation
`
`by Jennewein Biotechnologie GmbH (“Jennewein” or “Respondent”) of certain 2’-fucosyllactose
`
`oligosaccharides that infringe one or more of claims 1-3, 5, 8, 10, 12, 18, and 24-28 (“the
`
`Asserted Claims”) of U.S. Patent No. 9,970,018 (“the ’018 patent”).
`
`Having reviewed the record of this investigation, including the written submissions of the
`
`parties, the Commission has made its determination on the issues of remedy, public interest, and
`
`bonding. The Commission has determined that the appropriate form of relief includes a limited
`
`exclusion order prohibiting the unlicensed entry into the United States of 2’-fucosyllactose
`
`oligosaccharides manufactured abroad by or on behalf of, or imported by or on behalf of, Respondent
`
`or any of its affiliated companies, parents, subsidiaries, or other related business entities, or its
`
`successors or assigns. The exclusion order does not apply to Respondent’s TTFL12 bacterial
`
`strain and 2’-fucosyllactose oligosaccharides produced by that strain, which, as the Commission
`
`determined, do not infringe the Asserted Claims.
`
`The Commission has also determined that the public interest factors enumerated in 19
`
`U.S.C. § 1337(d) do not preclude the issuance of the limited exclusion order, and that the bond
`
`1
`
`

`

`during the period of Presidential review shall be in the amount of five (5) percent of the entered
`
`value of the covered articles.
`
`Accordingly, the Commission hereby ORDERS that:
`
`1.
`
`2’-fucosyllactose oligosaccharides that infringe one or more of the Asserted
`
`Claims that are manufactured abroad by or on behalf of, or imported by or on behalf of,
`
`Respondent, or its affiliated companies, parents, subsidiaries, or other related business entities, or
`
`its successors or assigns (“covered articles”), are excluded from entry for consumption into the
`
`United States, entry for consumption from a foreign-trade zone, or withdrawal from a warehouse
`
`for consumption, for the remaining term of the ’018 patent, except under license of the patent
`
`owner or as provided by law.
`
`2.
`
`This Order does not apply to Respondent’s TTFL12 bacterial strain and
`
`2’-fucosyllactose oligosaccharides produced by that strain, which, as the Commission
`
`determined, do not infringe the Asserted Claims.
`
`3.
`
`Notwithstanding paragraph 1 of this Order, covered articles are entitled to entry
`
`into the United States for consumption, entry for consumption from a foreign trade zone, or
`
`withdrawal from a warehouse for consumption, under bond in the amount of five (5) percent of
`
`the entered value of the infringing products pursuant to subsection (j) of section 337 of the Tariff
`
`Act of 1930, as amended (19 U.S.C. § 1337(j)), and the Presidential Memorandum for the United
`
`States Trade Representative of July 21, 2005, (70 FR 43251), from the day after this Order is
`
`received by the United States Trade Representative, and until such time as the United States
`
`Trade representative notifies the Commission that this Order is approved or disapproved but, in
`
`any event, not later than sixty (60) days after the date of receipt of this Order. All entries of
`
`2
`
`

`

`covered articles made pursuant to this paragraph are to be reported to U.S. Customs and Border
`
`Protection (“CBP”), in advance of the date of the entry, pursuant to procedures CBP establishes.
`
`4.
`
`At the discretion of CBP and pursuant to the procedures it establishes, persons
`
`seeking to import 2’-fucosyllactose oligosaccharides, that are potentially subject to this Order may
`
`be required to certify that they are familiar with the terms of this Order, that they have made
`
`appropriate inquiry, and thereupon state that, to the best of their knowledge and belief, the
`
`products being imported are not excluded from entry under paragraph 1 of this Order. At its
`
`discretion, CBP may require persons who have provided the certification described in this
`
`paragraph to furnish such records or analyses as are necessary to substantiate this certification.
`
`5.
`
`In accordance with 19 U.S.C. § 1337(l), the provisions of this Order shall not
`
`apply to 2’-fucosyllactose oligosaccharides that are imported by or for the use of the United
`
`States, or imported for and to be used for, the United States with the authorization or consent of
`
`the Government.
`
`6.
`
`The Commission may modify this Order in accordance with the procedures
`
`described in Rule 210.76 of the Commission’s Rules of Practice and Procedure (19 C.F.R.
`
`§ 210.76).
`
`7.
`
`The Secretary shall serve copies of this Order upon each party of record in this
`
`Investigation and upon CBP.
`
`8.
`
`Notice of this Order shall be published in the Federal Register.
`
`
`
`
`
`
`
`
`3
`
`

`

`By order of the Commission.
`
`
`
`
`
`
`
`
`Issued: May 19, 2020
`
`
`
`Lisa R. Barton
`Secretary to the Commission
`
`4
`
`

`

`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, COMMISION has been
`served via EDIS upon the Commission Investigative Attorney, Lisa Murray, Esq., and the
`following parties as indicated, on May 19, 2020.
`
`Lisa R. Barton, Secretary
`U.S. International Trade Commission
`500 E Street, SW, Room 112
`Washington, DC 20436
`
`On Behalf of Complainant Glycosyn LLC:
`
`Michael C. Newman, Esq.
`MINTZ LEVIN COHN FERRIS GLOVSKY AND POPEO, PC
`1 Financial Center
`Boston, MA 02111
`Email: MCNewman@mintz.com
`
`☐ Via Hand Delivery
`☐ Via Express Delivery
`☐ Via First Class Mail
`☒ Other: Email Notification
`of Availability to Download
`
`On Behalf of Respondent Jennewein Biotechnologie GmbH:
`
`Gary M. Hnath
`MAYER BROWN LLP
`1999 K Street, NW
`Washington, DC 20006
`Email: ghnath@mayerbrown.com
`
`☐ Via Hand Delivery
`☐ Via Express Delivery
`☐ Via First Class Mail
`☒ Other: Email Notification
`of Availability to Download
`
`

`

`
`
`
`
`
`
`
`
`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
`
`COMMISSION OPINION
`
`The Commission has determined that there has been a violation of section 337 of the
`
`Tariff Act of 1930, as amended, 19 U.S.C. § 1337 (“section 337”), on review of the final initial
`
`determination (“FID”) of the presiding administrative law judge (“ALJ”), based on the
`
`infringement of U.S. Patent No. 9,970,018 by respondent’s accused bacterial strains. The
`
`Commission has also determined to reverse the FID’s decision declining to adjudicate
`
`respondent’s alternative TTFL12 strain and finds no infringement as to that strain. This opinion
`
`sets forth the Commission’s reasoning in support of that determination. In addition, the
`
`Commission adopts the findings in the FID that are not inconsistent with this opinion.
`
`I.
`
`BACKGROUND
`
`A.
`
`Procedural Background
`
`The Commission instituted this investigation on June 21, 2018, based on a complaint, as
`
`amended and supplemented, filed by Glycosyn LLC (“Glycosyn”) of Waltham, Massachusetts.
`
`See 83 Fed. Reg. 28865-66 (June 21, 2018). The complaint alleged violations of section 337
`
`based upon the importation into the United States, the sale for importation, and the sale within
`
`the United States after importation of certain human milk oligosaccharides, by reason of
`
`infringement of certain claims of U.S. Patent Nos. 9,453,230 (“the ’230 patent”) and 9,970,018
`
`(“the ’018 patent”). See id. The complaint also alleges the existence of a domestic industry.
`
`1
`
`

`

`
`The notice of investigation named Jennewein Biotechnologie GmbH of Rheinbreitbach,
`
`PUBLIC VERSION
`
`Germany (“Jennewein”) as respondent in this investigation. See id. The Office of Unfair
`
`Import Investigations (“OUII”) is also a party to this investigation. See id.
`
`The Commission later terminated the investigation as to all asserted claims of the ’230
`
`patent and certain asserted claims of the ’018 patent based on the withdrawal of the allegations
`
`pertaining to those claims. See Order No. 5 (Aug. 9, 2018), unreviewed, Comm’n Notice (Aug.
`
`29, 2018); Order No. 15 (Oct. 30, 2018), unreviewed, Comm’n Notice (Nov. 29, 2018); Order
`
`No. 17 (Nov. 19, 2018), unreviewed, Comm’n Notice (Dec. 12, 2018); Order No. 25 (Feb. 8,
`
`2019), unreviewed, Comm’n Notice (Feb. 28, 2019). Claims 1-3, 5, 8, 10, 12, 18, and 23-28 of
`
`the ’018 patent remain pending in this investigation.
`
`The ALJ conducted an evidentiary hearing on May 14-17, 2019. On September 9, 2019,
`
`the ALJ issued the FID finding a violation of section 337 based on the infringement of claims 1-
`
`3, 5, 8, 10, 12, 18, and 24-28 (hereinafter, “the Asserted Claims”) but not claim 23 of the ’018
`
`patent, based on non-infringement of that claim.1 See FID at 35. Furthermore, the FID finds
`
`that the domestic industry requirement is satisfied.
`
`The FID also contains a Recommended Determination (“RD”) recommending, should a
`
`violation of section 337 be found, that the Commission issue a limited exclusion order (“LEO”)
`
`barring entry of articles that infringe the Asserted Claims.2 The RD also recommends that the
`
`Commission impose a bond in the amount of five (5) percent of the entered value of the
`
`infringing articles during the period of Presidential review. Furthermore, as directed by the
`
`
`1 Glycosyn did not petition for review of the FID’s finding that Jennewein does not infringe
`claim 23.
`2 Glycosyn did not request, and the RD does not recommend, a cease and desist order against
`Jennewein.
`
`2
`
`

`

`
`Commission (see 83 Fed. Reg. at 28865), the RD provides findings with respect to the public
`
`PUBLIC VERSION
`
`interest and recommends that the Commission determine that the public interest factors do not
`
`preclude entry of the proposed LEO.
`
`On September 23, 2019, Jennewein and the Commission’s Investigative Attorney (“IA”)
`
`filed petitions for review of the FID.3 Jennewein petitioned for review of the FID’s findings
`
`with respect to claim construction and infringement, and both Jennewein and the IA petitioned
`
`for review of the FID’s decision not to adjudicate infringement with respect to Jennewein’s
`
`TTFL12 bacterial strain, which Glycosyn did not accuse in its complaint. On October 1, 2019,
`
`Glycosyn and the IA filed responses to the various petitions.4
`
`On October 9 and 10, 2019, respectively, Glycosyn and Jennewein filed statements on the
`
`public interest pursuant to Commission Rule 210.50(a)(4), 19 C.F.R. 210.50(a)(4).5 On October
`
`23, 2019, non-party DuPont Nutrition & Health (“DuPont”) filed a public interest submission
`
`pursuant to the Commission’s notice requesting public interest comments, see 84 Fed. Reg.
`
`49335 (Sept. 19, 2019), supporting the ALJ’s recommended LEO and asserting that it has the
`
`capacity to replace the excluded products in a commercially reasonable time.6
`
`
`3 See Respondent Jennewein Biotechnologie GmbH’s Petition for Commission Review (Sep. 23,
`2019) (hereinafter, “Jennewein’s Pet.”); OUII Petition for Review (Sep. 23, 2019) (hereinafter,
`“IA’s Pet.”).
`4 See Complainant Glycosyn LLC’s Consolidated Response to Respondent Jennewein
`Biotechnologie GmbH’s and Office of Unfair Import Investigations’ Petitions for Commission
`Review (Oct. 1, 2019) (hereinafter, “Glycosyn’s Pet. Resp.”); Office of Unfair Import
`Investigations’ Response to Respondent’s Petition for Review (Oct. 1, 2019) (hereinafter, “IA’s
`Pet. Resp.”).
`5 See Complainant Glycosyn LLC’s Statement of Information Relating to the Public Interest
`(Oct. 9, 2019) (hereinafter, “Glycosyn’s PI Br.”); Public Interest Statement of Respondent
`Jennewein Biotechnologie GmbH (Oct. 10, 2019) (hereinafter, “Jennewein’s PI Br.”).
`6 See Public Interest Submission of DuPont Nutrition & Health (hereinafter, “DuPont PI Br.”).
`
`3
`
`

`

`
`
`PUBLIC VERSION
`
`On January 30, 2020, the Commission issued a notice determining to review the FID in
`
`part. See 85 Fed. Reg. 6573-75 (Feb. 5, 2020) (“the WTR/Remedy Notice”). Specifically, the
`
`Commission determined to review: (1) the FID’s infringement findings with respect to
`
`Jennewein’s bacterial strains adjudicated in this investigation; and (2) the FID’s decision not to
`
`adjudicate infringement as to Jennewein’s alternative bacterial strain, i.e., the TTFL12 strain.
`
`See id. The Commission determined not to review the remainder of the FID. See id. The
`
`notice invited written submissions from the parties on issues under review, and from the parties,
`
`interested government agencies, and any other interested parties on issues of remedy, the public
`
`interest, and bonding. See id.
`
`On February 18, 2020, the parties, including OUII, filed written submissions in response
`
`to the WTR/Remedy Notice,7 and on February 25, 2020, the parties filed responses to each
`
`other’s submissions.8 Also on February 18, 2020, non-party Abbott Laboratories (“Abbott”)
`
`filed a written submission concerning the public interest in response to the WTR/Remedy Notice,
`
`
`7 See Complainant Glycosyn LLC’s Response to Questions in the Commission’s Notice of
`Commission Decision to Review in Part a Final Initial Determination Finding a Violation of
`Section 337 (Feb. 18, 2020) (hereinafter, “Glycosyn’s Resp.”); Complainant Glycosyn LLC’s
`Initial Submission on the Form of Remedy, the Public Interest, and Bonding Pursuant to the
`Commission’s Notice of Commission Decision to Review in Part a Final Initial Determination
`Finding a Violation of Section 337 (Feb. 18, 2020) (hereinafter, “Glycosyn’s Remedy Br.”);
`Respondent Jennewein Biotechnologie GmbH’s Responses to Questions Raised by the
`Commission (Feb. 18, 2020) (hereinafter, “Jennewein’s Resp.”); Brief of the Office of Unfair
`Import Investigations on Issues under Review and on Remedy, the Public Interest, and Bonding
`(Feb. 18, 2020) (hereinafter, “IA’s Resp.”).
`8 See Complainant Glycosyn LLC’s Reply to Respondent’s and OUII’s Responses to the
`Commission’s Questions regarding Final Initial Determination Finding a Violation of Section
`337 (Feb. 25, 2020) (hereinafter, “Glycosyn’s Reply”); Respondent Jennewein Biotechnologie
`GmbH’s Reply to Responses by Glycosyn LLC and the Office of Unfair Import Investigations to
`Questions Raised by the Commission and Responses to Glycosyn’s and OUII’s Submissions on
`Remedy, the Public Interest, and Bonding (Feb. 25, 2020) (hereinafter, “Respondents’ Reply”);
`Reply Brief of the Office of Unfair Import Investigations on Issues under Review and on
`Remedy, the Public Interest, and Bonding (Feb. 25, 2020) (hereinafter, “IA’s Reply”).
`
`4
`
`

`

`
`and alleged that “Jennewein is the only supplier whose product has been fully qualified through
`
`PUBLIC VERSION
`
`Abbott’s quality and regulatory processes, raising public interest concerns from remedial
`
`relief.”9
`
`B.
`
`The Asserted Patent
`
`The ’018 patent issued on May 15, 2018. See JX-3, ’018 Patent. The ’018 patent, titled
`
`“Biosynthesis of Human Milk Oligosaccharides in Engineered Bacteria,” relates to
`
`“compositions and methods for producing fucosylated oligosaccharides” which are “typically
`
`found in human milk” and which “serve critical roles in the establishment of a hea