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
`
`NOTICE OF INSTITUTION OF INVESTIGATION
`
`Institution of Investigation Pursuant to 19 U.S.C.1337
`
`AGENCY: U.S. International Trade Commission
`
`ACTION: Notice
`
`SUMMARY: Notice is hereby given that a complaint was filed with the U.S. International
`Trade Commission on April 2, 2018, under section 337 of the Tariff Act of 1930, as amended, on
`behalf of Glycosyn LLC. An amended complaint was filed on May 16, 2018. An additional
`supplement to the complaint was also filed on May 25, 2018. The complaint, as amended and
`supplemented, alleges 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 U.S. Patent No. 9,453,230 ("the '230
`patent") and U.S. Patent No. 9,970,018 ("the '018 patent"). The complaint further alleges that an
`industry in the United States exists as required by the applicable Federal Statute.
`
`The complainant requests that the Commission institute an investigation and, after the
`investigation, issue a limited exclusion order and cease and desist order.
`
`ADDRESSES: The complaint, except for any confidential information contained therein, is
`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, S.W., Room 112, Washington,
`D.C. 20436, telephone (202) 205-2000. Hearing impaired individuals are advised that
`information on this matter can be obtained by contacting the Commission's TDD terminal on
`(202) 205-1810. Persons with mobility impairments who will need special assistance in gaining
`access to the Commission should contact the Office of the Secretary at (202) 205-2000. General
`information concerning the Commission may also be obtained by accessing its intemet 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.usite.gov.
`
`

`

`FOR FURTHER INFORMATION CONTACT: Pathenia Proctor, The Office of Unfair
`Import Investigations, U.S. International Trade Commission, telephone (202) 205-2560.
`
`SUPPLEMENTARY INFORMATION:
`
`AUTHORITY: The authority for institution of this investigation is contained in section 337 of
`the Tariff Act of 1930, as amended, 19 U.S.C. 1337 and in section 210.10 of the Commission's
`Rules of Practice and Procedure, 19 C.F.R. 210.10 (2018).
`
`SCOPE OF INVESTIGATION: Having considered the complaint, the U.S. International
`Trade Commission, on June 14, 2018, ORDERED THAT —
`
`(1) Pursuant to subsection (b) of section 337 of the Tariff Act of 1930, as amended, an
`investigation be instituted to determine whether there is a violation of subsection (a)(1)(B) of
`section 337 in the importation into the United States, the sale for importation, or the sale within
`the United States after importation of products identified in paragraph (2) by reason of
`infringement of one or more of claims 1-40 of the '230 patent; and claims 1-28 of the '018
`patent; and whether an industry in the United States exists as required by subsection (a)(2) of
`section 337;
`
`(2) Pursuant to section 210.10(b)(1) of the Commission's Rules of Practice and
`Procedure, 19 C.F.R. 210.10(b)(1), the plain language description of the accused products or
`category of accused products, which defines the scope of the investigation, is "2'-fucosyllactose
`oligosaccharides";
`
`(3) Pursuant to Commission Rule 210.50(b)(1), 19 C.F.R. 210.50(b)(1), the presiding
`administrative law judge shall take evidence or other information and hear arguments from the
`parties and other interested persons with respect to the public interest in this investigation, as
`appropriate, and provide the Commission with findings of fact and a recommended
`determination on this issue, which shall be limited to the statutory public interest factors set forth
`in 19 U.S.C. 1337(d)(1), (f)(1), (g)(1);
`
`(4) For the purpose of the investigation so instituted, the following are hereby named as
`parties upon which this notice of investigation shall be served:
`
`(a) The complainant is:
`
`Glycosyn LLC
`890 Winter Street, Suite 208
`Waltham, MA 95131
`
`(b) The respondent is the following entities alleged to be in violation of section
`337, and is the party upon which the complaint is to be served:
`
`

`

`Jennewein Biotechnologie GmbH
`Maarweg 32
`D-53619 Rheinbreitbach
`Germany
`
`(c) The Office of Unfair Import Investigations, U.S. International Trade
`Commission, 500 E Street SW, Suite 401, Washington, DC 20436; and
`
`(5) For the investigation so instituted, the Chief Administrative Law Judge, U.S.
`International Trade Commission, shall designate the presiding Administrative Law Judge.
`
`Responses to the complaint and the notice of investigation must be submitted by the
`named respondents in accordance with section 210.13 of the Commission's Rules of Practice and
`Procedure, 19 C.F.R. 210.13. Pursuant to 19 C.F.R. 201.16(e) and 210.13(a), such responses
`will be considered by the Commission if received not later than 20 days after the date of service
`by the Commission of the complaint and the notice of investigation. Extensions of time for
`submitting responses to the complaint and the notice of investigation will not be granted unless
`good cause therefor is shown.
`
`Failure of a respondent to file a timely response to each allegation in the complaint and in
`this notice may be deemed to constitute a waiver of the right to appear and contest the allegations
`of the complaint and this notice, and to authorize the administrative law judge and the
`Commission, without further notice to the respondent, to find the facts to be as alleged in the
`complaint and this notice and to enter an initial determination and a final determination
`containing such findings, and may result in the issuance of an exclusion order or a cease and
`desist order or both directed against the respondent.
`
`By order of the Commission.
`
`Issued: June 15, 2018
`
`Lisa R. Barton
`Secretary to the Commission
`
`

`

`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
`
`DESIGNATION OF OUII ATTORNEY
`FOR SERVICE OF PROCESS
`
`The Office of Unfair Import Investigations (OUII) hereby designates Lisa Murray, Esq.
`
`(202) 205-2734, lisa.murray@usitc.gov as OUII's lead attorney for service of process.
`
`Therefore, it is requested that all documents served by the Commission or filed by the parties in
`
`the above-referenced investigation be served upon this investigative attorney.
`
`Respectfully submitted,
`
`Margaret Macdonald, Director
`
`OFFICE OF UNFAIR IMPORT INVESTIGATIONS
`U.S. International Trade Commission
`500 E Street, S.W., Suite 401
`Washington, D.C. 20436
`(202) 205-2560
`(202) 205-2158 (facsimile)
`
`June 15, 2018
`
`

`

`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 OF INSTITUTION OF
`IVNESTIGATION has been served by hand upon the Commission Investigative Attorney, Lisa
`Murray, Esq., and the following parties as indicated, on 6/15/2018
`
`Lisa R. Barton, Secretary
`U.S. International Trade Commission
`500 E Street, SW, Room 112
`Washington, DC 20436
`
`O Via Hand Delivery
`O Via Express Delivery
`O Via First Class Mail
`10 Other:
`
`Complainants:
`
`Glycosyn LLC
`890 Winter Street, Suite 208
`Waltham, MA 02451-1470
`
`On Behalf of Complainants:
`
`Michael C. Newman, Esq.
`MINTZ LEVIN COHN FERRIS GLOVSKY AND POPEO, PC
`1 Financial Center
`Boston, MA 02111
`
`0 Via Hand Delivery
`Z Via Express Delivery
`O Via First Class Mail
`O Other:
`
`Respondents:
`
`Jennewein Biotechnologie GmbH
`Maarweg 32
`D-53619 Rheinbreitbach
`Germany
`
`Embassy:
`
`Embassy of Germany
`4645 Reservoir Road
`NW Washington, DC 20007
`
`0 Via Hand Delivery
`O Via Express Delivery
`O Via First Class Mail
`CI Other:
`
`El Via Hand Delivery
`El Via Express Delivery
`E Via First Class Mail
`O Other:
`
`

`

`CERTAIN HUMAN MILK OLIGOSACCHARIDES AND
`METHODS OF PRODUCING THE SAME
`
`Inv. No. 337-TA-1120
`
`Certificate of Service — Page 2
`
`Government Agencies:
`
`Edward T. Hand, Chief
`Foreign Commerce Section
`Antitrust Division
`U.S. Department of Justice
`450 5th Street NW, Room 11000
`Washington, DC 20530
`
`U.S. Bureau of Customs and Border Protection
`Intellectual Property Rights Branch
`Mint Annex Building
`799 9th Street, NW, 7th floor
`Washington, DC 20229-1177
`
`Elizabeth Kraus, Deputy Director
`International Antitrust, Office of
`International Affairs
`Federal Trade Commission
`600 Pennsylvania Avenue, Room 498
`Washington, DC 20580
`
`Dale D. Berkley, Ph.D., J.D.
`Office of the General Counsel, PHD, NIH Branch
`National Institutes of Health
`31 Center Drive
`Bldg. 31, Rm. 47
`Bethesda, MD 20892
`
`0 Via Hand Delivery
`El Via Express Delivery
`0 Via First Class Mail
`0 Other:
`
`0 Via Hand Delivery
`El Via Express Delivery
`El Via First Class Mail
`CI Other:
`
`El Via Hand Delivery
`Li Via Express Delivery
`0 Via First Class Mail
`El Other:
`
`0 Via Hand Delivery
`CI Via Express Delivery
`El Via First Class Mail
`El Other:
`
`

`

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`UNITED STATES
`COMMISSION
`
`INTERNATIONAL TRADE
`
`WASHINGTON, DC 20436
`
`June 15, 2018
`
`Glycosyn LLC
`890 Winter Street, Suite 208
`Waltham, MA 2451
`
`Re: Certain Human Milk Oligosaccharides and Methods of Producing the Same
`Inv. No. 337-TA-1120
`
`Dear Sir/Madam:
`
`This letter is to advise you that the U.S. International Trade Commission has instituted an
`investigation pursuant to section 337 of the Tariff Act of 1930 (19 U.S.C. 1337). A copy
`of the Commission's notice of investigation is enclosed. Also enclosed is the Section
`337 Mediation Program brochure. After reviewing the brochure, please sign and return
`the enclosed certification of receipt.
`
`Sincerely,
`
`Lisa R. Barton
`Secretary
`
`Enclosures:
`1. Notice of Investigation
`2. Publication Regarding the Section 337 Mediation Program
`3. Certification of Receipt of Mediation Materials
`
`

`

`UNITED STATES
`COMMISSION
`
`INTERNATIONAL TRADE
`
`WASHINGTON, DC 20436
`
`June 15, 2018
`
`Michael C. Newman
`Mintz Levin Cohn Ferris Glovsky and Popeo PC
`1 Financial Center
`Boston, MA 2111
`
`Re: Certain Human Milk Oligosaccharides and Methods of Producing the Same
`Inv. No. Inv. 337-TA-1120
`
`Dear Michael C. Newman:
`
`This letter is to advise you that the U.S. International Trade Commission has instituted an
`investigation pursuant to section 337 of the Tariff Act of 1930 (19 U.S.C. 1337). A copy
`of the Commission's notice of investigation is enclosed. Also enclosed is the Section
`337 Mediation Program brochure. After reviewing the brochure, please sign and return
`the enclosed certification of receipt.
`
`Sincerely,
`
`Lisa R. Barton
`Secretary
`
`Enclosures:
`1. Notice of Investigation
`2. Publication Regarding the Section 337 Mediation Program
`3. Certification of Receipt of Mediation Materials
`
`

`

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`UNITED STATES INTERNATIONAL TRADE COMMISSION
`
`WASHINGTON, DC 20436
`June 15, 2018
`
`Jennewein Biotechnologie GmbH
`Maarweg 32
`D-53619 Rheinbreitbach
`Germany
`
`Re: Certain Human Milk Oligosaccharides and Methods of Producing the Same
`Inv. No. 337-TA-1120
`
`Dear Sir/Madam:
`This letter is to advise you that the United States International Trade Commission has instituted
`an investigation pursuant to Section 337 of the Tariff Act of 1930 (19 U.S.C. 1337). 2BULBS
`Technology Co. Ltd. is a named respondent in this investigation.
`We are hereby serving you with a copy of the Complaint and the Notice of Investigation issued
`in this matter. Enclosed is a copy of the Code of Federal Regulations. Also enclosed is a the
`Section 337 Mediation Program brochure. After reviewing this brochure, please sign and return
`the enclosed certification of receipt.
`Please note that the Notice requires a response to the allegations in the Complaint and the
`response must be received not later than twenty (20) days after the date of service of the
`Complaint. Failure to file a response may result in inferences being drawn against your interests.
`Sincerely,
`
`Lisa R. Barton
`Secretary
`
`Enclosures:
`1. Complaint
`2. Notice of Investigation
`3. Code of Federal Regulation
`4. Publication Regarding the Section 337 Mediation Program
`5. Certification of Receipt of Mediation Materials
`
`

`

`UNITED STATES
`
`INTERNATIONAL TRADE
`
`COMMISSION
`
`WASHINGTON, DC 20436
`
`June 15, 2018
`
`Embassy of the Federal Republic of Germany
`4645 Reservoir Road, NW
`Washington, DC 20007
`
`Re: Certain Human Milk Oligosaccharides and Methods of Producing the Same
`Inv. No. 337-TA-1120
`
`Dear Sir/Madam:
`
`This letter is to advise you that the United States International Trade Commission has
`instituted an investigation pursuant to Section 337 of the Tariff Act of 1930 (19 U.S.C.
`1337). One or more of the parties named in the investigation is located in Germany.
`
`Pursuant to Commission Rule 210.11(a) (3), we are hereby serving you with a copy of
`the Complaint filed in this investigation together with a copy of the Commission's Notice
`of Investigation.
`
`Sincerely,
`
`Lisa R. Barton
`Secretary
`
`Enclosures:
`1. Complaint
`2. Notice of Investigation
`
`

`

`UNITED STATES INTERNATIONAL TRADE COMMISSION
`
`WASHINGTON, DC 20436
`
`June 15, 2018
`
`Edward T. Hand, Chief
`Foreign Commerce Section
`Antitrust Division
`U.S. Dept of Justice
`450 5th Street NW, Room 11000
`Washington, DC 20530
`
`Re: Certain Human Milk Oligosaccharides and Methods of Producing the Same
`Inv. No. 337-TA-1120
`
`Dear Mr. Hand:
`
`This letter is to advise you that the United States International Trade Commission has
`instituted an investigation pursuant to Section 337 of the Tariff Act of 1930 (19 U.S.C.
`1337). A copy of the Notice of Investigation is enclosed. Non-confidential copies of the
`Complaint and any supplements filed in the investigation will be provided upon request.
`Requests should be directed to Docket Services at (202) 205-1802.
`
`If you have any questions concerning this investigation, please contact the Commission
`Investigative Attorney whose name and telephone number appear in the enclosed Notice.
`
`Sincerely,
`
`Lisa R. Barton
`Secretary
`
`Enclosure:
`1. Notice of Investigation
`
`

`

`UNITED STATES INTERNATIONAL TRADE COMMISSION
`
`WASHINGTON, DC 20436
`
`June 15, 2018
`
`Intellectual Property Rights Branch
`Regulations and Rulings
`Office of International Trade
`U.S. Customs and Border Protection
`90 K Street, NE, 10th floor
`Washington, DC 20229-1177
`
`Re: Certain Human Milk Oligosaccharides and Methods of Producing the Same
`Inv. No. 337-TA-1120
`
`Dear Sir/Madam:
`
`This letter is to advise you that the United States International Trade Commission has
`instituted an investigation pursuant to Section 337 of the Tariff Act of 1930 (19 U.S.C.
`1337). A copy of the Notice of Investigation is enclosed. Non-confidential copies of the
`Complaint and any supplements filed in the investigation will be provided upon request.
`Requests should be directed to Docket Services at (202) 205-1802.
`
`If you have any questions concerning this investigation, please contact the Commission
`Investigative Attorney whose name and telephone number appear in the enclosed Notice.
`
`Sincerely,
`
`Lisa R. Barton
`Secretary
`
`Enclosure:
`1. Notice of Investigation
`
`

`

`UNITED STATES INTERNATIONAL TRADE COMMISSION
`
`WASHINGTON, DC 20436
`
`June 15, 2018
`
`Elizabeth Kraus, Deputy Director
`International Antitrust, Office of
`International Affairs
`Federal Trade Commission
`600 Pennsylvania Avenue, Room 498
`Washington, DC .20580
`
`Re: Certain Human Milk Oligosaccharides and Methods of Producing the Same
`Inv. No. 337-TA-1120
`
`Dear Ms. Kraus:
`
`This letter is to advise you that the United States International Trade Commission has
`instituted an investigation pursuant to Section 337 of the Tariff Act of 1930 (19 U.S.C.
`1337). A copy of the Notice of Investigation is enclosed. Non-confidential copies of the
`Complaint and any supplements filed in the investigation will be provided upon request.
`Requests should be directed to Docket Services at (202) 205-1802.
`
`If you have any questions concerning this investigation, please contact the Commission
`Investigative Attorney whose name and telephone number appear in the enclosed Notice.
`
`Sincerely,
`
`Lisa R. Barton
`Secretary
`
`Enclosure:
`1. Notice of Investigation
`
`

`

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`UNITED STATES INTERNATIONAL TRADE COMMISSION
`
`WASHINGTON, DC 20436
`
`June 15, 2018
`
`Dale D. Berkley, Ph.D., J.D.
`Office of the General Counsel, PHD, NIH Branch
`National Institutes of Health
`31 Center Drive
`Bldg. 31, Rm. 47
`Bethesda, MD 20892
`
`Re: Certain Human Milk Oligosaccharides and Methods of Producing the Same
`Inv. No. 337-TA-1120
`
`Dear Mr. Berkley:
`
`This letter is to advise you that the United States International Trade Commission has
`instituted an investigation pursuant to Section 337 of the Tariff Act of 1930 (19 U.S.C.
`1337). A copy of the Notice of Investigation is enclosed. Non-confidential copies of the
`Complaint and any supplements filed in the investigation will be provided upon request.
`Requests should be directed to Docket Services at (202) 205-1802.
`
`If you have any questions concerning this investigation, please contact the Commission
`Investigative Attorney whose name and telephone number appear in the enclosed Notice.
`
`Sincerely,
`
`Lisa R. Barton
`Secretary
`
`Enclosure:
`1. Notice of Investigation
`
`