UNITED STATES INTERNATIONAL TRADE COMMISSION
`
`Washington, D.C.
`
`In the Matter of
`
`Inv. No. 337-TA-956
`
`’
`
`CERTAIN RECOMBINANT FACTOR
`
`VIII PRODUCTS
`
`NOTICE OF INSTITUTION OF INVESTIGATION
`
`— Institution of investigation pursuant to 19 U.S.C. §41337
`
`AGENCY: U.S. International Trade Commission
`1
`
`ACTION: Notice
`
`_
`SUMMARY: Notice is hereby given that a complaint was filed with the U.S. International
`Trade Commission on April 16, 2015, under section 337 of the Tariff Act of 1930, as amended,
`19 U.S.C. § 1337, on behalf of Baxter International Inc. of Deerfield, Illinois; Baxter Healthcare
`Corporation of Deerfield, Illinois; and Baxter Healthcare SA, of Switzerland. Letters
`supplementing the complaint were filed on April 21, 2015; May 1, 2015; and May 4, 2015. The
`complaint 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
`recombinant factor VIII products by reason of infringement of certain claims of U.S. Patent No.
`6,100,061 (“the ’061 patent”); U.S. Patent No. 6,936,441 (“the ’441 patent”); and U.S. Patent
`. No. 8,084,252 (“the ’252 patent”). The complaint further alleges that an industry in the United
`States exists as required by subsection (a)(2) of section 337.
`
`The complainants request that the Commission institute an investigation and, after the
`investigation, issue a limited exclusion order and cease and desist orders.-
`~
`'
`
`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 internet server at
`http://www.usitc.gov. The public record for this investigation may be viewed on the
`Commission's electronic docket (EDIS) at http://edis.usitc.gov.
`
`FOR FURTHER INFORMATION CONTACT: The Office of Unfair Import Investigations,
`U.S. International Trade Commission, telephone (202) 205-2560.
`
`

`
`AUTHORITY:V The authority for institution of this investigation is contained in ‘section 33.7 of
`the Tariff Act of 1930, as amended, and in section 210.10 of the Commission’s Rules of Practice
`and Procedure, 19 C.F.R. § 210.10 (2015).
`
`SCOPE OF INVESTIGATION: Having considered the complaint, the U.S. International
`Trade Commission, on May 15, 2015, 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 certain recombinant factor VIII products by reason of
`infringement of one or more of claims 19-21, 36, 37, and 39 of the ’061 patent; claims. 20 and 21 j
`of the ’441 patent; claims 1, 5, 8, 10, 14, and 18 of the ’252 patent, and whether an industry in
`the United States exists as required by subsection (a)(2) of section 337;
`
`(2) 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)
`
`(3) 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 complainants are:
`
`Baxter International Inc.
`
`One Baxter Parkway
`Deerfield, IL 60015-4625
`
`Baxter Healthcare Corporation
`One Baxter Parkway
`Deerfield, IL 60015-4625
`
`Baxter Healthcare SA
`
`Thursgauerstrasse 130
`Glattpark (Opfikon)
`Switzerland
`
`(b) The respondents are the following entities alleged to be in violation of section
`337, and are the parties upon which the complaint is to be served:
`
`

`
`Novo Nordisk A/S
`
`Novo Allé
`
`2880 Bagsvaerd
`Denmark
`
`Novo Nordisk Inc.
`800 Scudders Mill Road
`
`,
`
`Plainsboro, NJ 08536
`
`(c) The Office of Unfair Import Investigations, U.S. International Trade
`Commission, 500 E Street, S.W., Suite 401, Washington, D.C. 20436; and
`
`(4) 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. §§ 20l.l6(e) and 2l0.13(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.
`‘
`0
`
`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: May 18, 2015
`
`Lisa R. Barton
`
`Secretary to the Commission
`
`

`
`UNITED STATES INTERNATIONAL TRADE ‘COMMISSION
`'
`Washington, D.C.
`
`In the Matter of CERTAIN RECOMBINANT FACTOR VIII
`
`PRODUCTS
`
`1"“ N°‘ 337"TA'956
`
`DESIGNATION OF OUII ATTORNEY
`FOR SERVICE OF PROCESS
`
`The Office of Unfair Import Investigations (“OUII”) hereby designates Brian Koo, Esq.
`
`(202) 205-2580, Brian.Koo@usitc.gov, as OUII's lead attorney for service of process.
`
`It is
`
`requested that all documents served by the Commission or filed by the parties in the
`
`above-referenced investigation he served upon this attorney.
`
`Respectfully submitted,
`
`Ming:t Macdonalg, Director
`
`OFFICE OF UNFAIR IMPORT INVESTIGATIONS
`U.S. International Trade Commission
`
`500 E Street, S.W., Suite 401
`Washington, D.C. 20436
`(202) 205-2576
`(202) 205-2158 (facsimile)
`
`May 18, 2015
`
`

`
`CERTAIN RECOMBINANT FACTOR VIII PRODUCTS
`
`Inv. N0. 337-TA-956
`
`PUBLIC CERTIFICATE OF SERVICE
`
`I, Lisa R. Barton, hereby certify that the attached NOTICE OF INSTITUTION OF
`INVESTIGATION has been served by hand upon the Commission Investigative Attorney,
`Brian Koo, Esq., and the following parties as indicated, on May 18, 2015.
`
`
`
`Lisa R. Barton, Secretary
`U.S. International Trade Commission
`
`500 E Street, SW, Room 112
`Washington, DC 20436
`
`:1 Via Hand Delivery
`
`X] Via Express Delivery
`:| Via First Class Mail
`
`3 Other:
`
`3 Via Hand Delivery
`
`IX! Via Express Delivery
`3 Via First Class Mail
`
`:1 Other:
`
`:1 Via Hand Delivery
`
`XI Via Express Delivery
`:| Via First Class Mail
`
`3 Other:
`
`Complainants:
`
`Baxter International Inc. -
`
`One Baxter Parkway
`Deerfield, IL 60015-4625
`
`Baxter Healthcare Corporation
`One Baxter Parkway
`Deerfield, IL 60015-4625
`
`Baxter Healthcare SA
`
`Thursgauerstrasse 130
`Glattpark (Opfikon)
`Switzerland
`
`On Behalf of Complainants:
`
`Tom M. Schaumberg, Esq.
`ADDUCI, MASTRIANI & SCHAUMBERG LLP
`1133 Connecticut Avenue, NW, 12th Floor
`
`Washington, DC 20036
`
`[3 Via Hand Delivery
`
`El Via Express Delivery
`D Via First Class Mail
`
`Cl Other:
`
`Respondents:
`
`Novo Nordisk A/S
`Novo Alle
`
`2880 Bagsvaerd
`Denmark
`
`D Via Hand Delivery
`
`Via Express Delivery
`Cl Via First Class Mail
`
`I: Other:
`
`

`
`CERTAIN RECOMBINANT FACTOR VIII PRODUCTS
`
`Inv. No. 337-TA—956
`
`Certificate of Service — Page 2
`
`Novo Nordisk Inc.
`Road
`SCUCICICTS
`P1ainsb°r°= NJ 08356
`
`Embassy:
`
`Embassy of Denmark, USA
`WhItChaV€n
`Washington» DC 20003
`
`Government Agencies:
`
`'
`
`Edward T. Hand, Chief
`Foreign Commerce Section
`AI1UtruStD1V1S10n
`_
`U.S. Department of Justice
`450 5”‘ Street NW, Room 11000
`Washington, DC 20530
`
`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
`
`C! Via Hand Delivery
`Express Delivgry
`Cl Via First Class Mail
`
`Cl Other:
`
`\
`
`|:| Via Hand Delivery
`E
`Express Delivery
`[3 Via First Class Mail
`
`D Other:
`
`Cl Via Hand Delivery
`Q Via Express Delivery
`E Via First Class Mail
`D other
`
`V
`
`'
`
`Cl Via Hand Delivery
`Q Via Express Delivery
`E Via First Class Mail
`D Other:
`
`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 General Counsel, PHD, NIH Branch
`National Institutes of Health
`31 Center Drive
`Bldg. 31, Rm. 47
`Bethesda, MD 20892 I
`
`’
`
`-
`
`Cl Via Hand Delivery
`Q Via Express Delivery
`Via First Class Mail
`D other
`'
`
`El Via Hand Delivery
`Q Via Express Delivery
`Via First Class Mail
`
`Cl
`
`h :
`0‘ 6‘
`
`

`
`
`
`UNITED STATES INTERNATIONAL TRADE COMMISSION
`
`WASH1NGTON,_DC 20436
`
`May 18‘, 2015
`
`Baxter International Inc.
`
`One Baxter Parkway
`Deerfield, IL 60015-4625 ’
`
`Re:
`
`Certain Recombinant Factor VIII Products
`
`Inv. No. 337-TA-956
`
`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,
`
`fiiflfi
`
`Lisa R. Barton
`
`Secretary
`
`Enclosures:
`
`I
`1. Notice of Investigation
`2. Publication No. 4497 Regarding the Section 337 Mediation Program
`3. Certification of Receipt of Mediation Materials
`
`

`
`
`
`UNITED STATES INTERNATIONAL TRADE COMMISSION
`
`WASHINGTON, DC 20436
`
`May 18, 2015
`
`Baxter Healthcare Corporation
`' One Baxter Parkway
`Deerfield, IL 60015-4625
`
`Re:
`
`Certain Recombinant Factor VIII Products
`
`Inv. No. 337-TA-956
`
`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 No. 4497 Regarding the Section 337 Mediation Program
`3. Certification of Receipt of Mediation Materials
`
`

`
`
`
`UNITED STATES INTERNATIONAL TRADE COMMISSION
`
`WASHINGTON, DC 20436
`
`May 18, 2015
`
`Baxter Healthcare SA
`
`Thursgauerstrasse 130
`Glattpark (Opfrkon)
`Switzerland
`
`Re:
`
`Certain Recombinant Factor VIII Products
`
`Inv. No. 337-TA-956
`
`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,
`
`7%
`
`Lisa R. Barton
`
`Secretary
`
`Enclosures:
`
`1. Notice of Investigation
`2. Publication No. 4497 Regarding the Section 337 Mediation Program
`3. Certification of Receipt of Mediation Materials
`
`

`
`
`
`UNITED STATES INTERNATIONAL TRADE COMMISSION
`
`WASHINGTON, DC 20436
`
`May 18, 2015
`
`Tom M. Schaumberg, Esq.
`Adduci, Mastriani & Schaumberg LLP
`1133 Connecticut Avenue, NW, 12th Floor
`
`Washington, DC 20036
`
`’
`
`Re:
`
`Certain Recombinant Factor VIII Products
`Inv. No. 337-TA-956
`
`. Dear Mr. Schaumberg:
`
`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 No. 4497 Regarding the Section 337 Mediation Program
`3. Certification of Receipt of Mediation Materials
`
`

`
`
`
`UNITED STATES INTERNATIONAL TRADE COMMISSION
`
`WASHINGTON, DC 20436
`
`May 18, 2015
`
`Novo Nordisk A/S
`
`Novo Alle
`
`2880 Bagsvaerd
`Denmark
`
`Re:
`
`Certain Recombinant Factor VIII Products
`Inv. No. 337-TA-956
`
`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). Novo Nordisk A/S 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
`
`Enclosures:
`1. Complaint
`2. Notice of Investigation
`'
`3. Code of Federal Regulation
`4. Publication No. 4497 Regarding the Section 337 Mediation Program
`5. Certification of Receipt of Mediation Materials
`
`Secretary
`
`

`
`
`
`UNITED STATES INTERNATIONAL TRADE COMMISSION
`
`WASHINGTON, DC 20436
`
`May 18, 2015
`
`Novo Nordisk Inc.
`
`800 Scudders Mill Road
`
`Plainsboro, NJ 08356
`
`Re:
`
`Certain Recombinant Factor VIII Products
`Inv. No. 337-TA-956
`
`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). Novo Nordisk Inc. 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
`enclosedis 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 No. 4497 Regarding the Section 337 Mediation Program
`5. Certification of Receipt of Mediation Materials
`
`

`
`
`
`UNITED STATES INTERNATIONAL TRADE COMMISSION
`
`WASHINGTON, DC 20436
`
`May 18, 2015
`
`Embassy of Denmark, USA
`3200 Whitehaven St. NW
`
`Washington, DC 20008
`
`Re:
`
`Certain Recombinant Factor VIII Products
`Inv. No. 337-TA-956
`
`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 Denmark. ’
`
`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,
`
`
`
`Secretary
`
`Enclosures:
`
`1. Complaint
`2. Notice of Investigation
`
`

`
`
`
`UNITED STATES INTERNATIONAL TRADE COMMISSION
`
`' WASHINGTON, DC 20436
`
`May 18, 2015
`
`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 Recombinant Factor VIII Products
`Inv. No. 337-TA-956
`
`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 Caitlin Stephens, Case Manager to the Hon. Dee Lord at
`(202) 205-2076.
`A
`
`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,
`
`flag
`
`LisamR. Barton I
`
`Secretary
`
`Enclosure:
`
`1. Notice of Investigation
`
`

`
`
`
`UNITED STATES INTERNATIONAL TRADE COMMISSION
`
`WASHINGTON, DC 20436
`
`May 18, 2015
`
`Intellectual Property Rights Branch
`Regulations and Rulings
`Office of International Trade
`
`U.S. Customs and Border Protection
`90 K'Street, NE, 10”‘ Floor
`Washington, DC 20229-1 177
`
`Re:
`
`Certain Recombinant Factor VIII Products
`Inv. No. 337-TA-956
`
`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 bedirected to Caitlin Stephens, Case Manager to the Hon. Dee Lord at
`(202) 205-2076.
`-
`'
`-
`
`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,
`
`7%@
`
`Lisa
`
`Barton.
`
`Secretary
`
`Enclosure:
`
`1. Notice oflnvestigation
`
`

`
`
`
`UNITED STATES INTERN_ATIONAL TRADE COMMISSION
`
`WASHINGTON, DC 20436
`
`May 18, 2015
`
`Elizabeth Kraus, Deputy Director
`International Antitrust, Office of International Affairs
`Federal Trade Commission
`.
`
`600 Pennsylvania Avenue, Room 498
`Washington, DC 20580
`
`Re:
`
`Certain Recombinant Factor VIII Products
`
`Inv. No. 337-TA-956 _
`
`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 Caitlin Stephens, Case Manager to the Hon. Dee Lord at
`(202) 205-2076.
`
`If you have any questions concerning this investigation, please contact the Commission
`Investigative Attorney whose name and telephone number appearin the enclosed Notice.
`
`Sincerely,
`
`Lisa
`
`Barton
`
`Secretary
`
`Enclosure:
`
`1. Notice of Investigation
`
`

`
`UNITED STATES INTERNATIONAL TRADE COMMISSION
`
`WASHINGTON, DC 20436
`
`May 18, 2015
`
`Dale D. Berkley, Ph.D., J.D.
`Office of General Counsel, PHD, NIH Branch
`National Institutes of Health
`
`31 Center Drive
`
`Bldg. 31, Km. 47
`Bethesda, MD 20892
`
`Re:
`
`Certain Recombinant Factor VIII Products
`Inv. No. 337-TA-956
`
`Dear Dr. 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 Caitlin Stephens, Case Manager to the Hon. Dee Lord at
`(202) 205-2076.
`'
`
`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
`
`Barton
`
`Secretary
`
`Enclosure:
`
`1. ’ Notice of Investigation