81 FR 68454 - Certain Recombinant Factor VIII Products; Notice of Commission Determination To Grant a Joint Motion To Terminate the Investigation on the Basis of a Settlement Agreement; Termination of the Investigation

INTERNATIONAL TRADE COMMISSION

Federal Register Volume 81, Issue 192 (October 4, 2016)

Page Range		68454-68454
FR Document		2016-23864

Notice is hereby given that the U.S. International Trade Commission has determined to grant a joint motion to terminate the above-captioned investigation based on a settlement agreement.

Federal Register, Volume 81 Issue 192 (Tuesday, October 4, 2016)

[Federal Register Volume 81, Number 192 (Tuesday, October 4, 2016)]
[Notices]
[Page 68454]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-23864]


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INTERNATIONAL TRADE COMMISSION

[Investigation No. 337-TA-956]


Certain Recombinant Factor VIII Products; Notice of Commission 
Determination To Grant a Joint Motion To Terminate the Investigation on 
the Basis of a Settlement Agreement; Termination of the Investigation

AGENCY: U.S. International Trade Commission.

ACTION: Notice.

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SUMMARY: Notice is hereby given that the U.S. International Trade 
Commission has determined to grant a joint motion to terminate the 
above-captioned investigation based on a settlement agreement.

FOR FURTHER INFORMATION CONTACT: Ron Traud, Office of the General 
Counsel, U.S. International Trade Commission, 500 E Street SW., 
Washington, DC 20436, (202) 205-3427. 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, DC 20436, (202) 205-2000. 
General information concerning the Commission may also be obtained at 
https://www.usitc.gov. The public record for this investigation may be 
viewed on the Commission's electronic docketing system (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 at (202) 205-1810.

SUPPLEMENTARY INFORMATION: On May 22, 2015, the Commission instituted 
this investigation pursuant to Section 337 of the Tariff Act of 1930, 
as amended, based on a complaint filed by Baxter Healthcare Corporation 
and Baxter Healthcare SA, both of Deerfield, Illinois. 80 FR 29745 (May 
22, 2015). Baxalta Inc., Baxalta US Inc., and Baxalta GmbH were added 
as complainants after the filing of the complaint. 80 FR 62569 (Oct. 
16, 2015). (The complainants are collectively referred to as 
``Baxter.'') The Commission sought to determine whether there is a 
violation of Section 337(a)(1)(B) in the importation into the United 
States, the sale for importation into the United States, or the sale 
within the United States after importation of certain recombinant 
factor VIII products by reason of infringement of any of claims 19-21, 
36, 37, and 39 of U.S. Patent No. 6,100,061 (``the '061 patent''); 
claims 20 and 21 of U.S. Patent No. 6,936,441 (``the '441 patent''); 
and claims 1, 5, 8, 10, 14, and 18 of U.S. Patent No. 8,084,252 (``the 
'252 patent''). 80 FR at 29746. The Commission directed the ALJ to make 
findings of fact and provide a recommended determination with respect 
to the statutory public interest factors set forth in 19 U.S.C. 
1337(d)(1), (f)(1), and (g)(1). Id. The notice of investigation named 
as respondents Novo Nordisk A/S of Bagsvaerd, Denmark and Novo Nordisk 
Inc., of Plainsboro, NJ (collectively, ``Novo Nordisk''). Id. The 
Office of Unfair Import Investigations (``OUII'') is also a party to 
this investigation. Id.
    On December 8, 2015, Baxter moved for partial termination of this 
investigation based on the withdrawal of claims 21, 36, 37, and 39 of 
the '061 patent; claims 1 and 10 of the '252 patent; and claims 20 and 
21 of the '441 patent. That motion was granted, leaving only claims 19 
and 20 of the '061 and claims 5, 8, 14, and 18 of the '252 patent at 
issue. Order No. 23 (Dec. 10, 2016), unreviewed, Notice of Commission 
Determination Not to Review an Initial Determination Granting a Motion 
for Partial Termination of the Investigation with Respect to Certain 
Claims (Jan. 5, 2016).
    On February 26, 2016, the ALJ issued an initial determination 
(``the Summary ID'') (Order No. 30), which concluded that Novo Nordisk 
infringed the `061 patent. Novo Nordisk filed a petition requesting 
that the Commission review the Summary ID and related claim 
construction orders. The Commission determined to defer its decision on 
whether to review those orders until the date on which the Commission 
determines whether to review the ALJ's final ID (``the Final ID''). 
Notice of Comm'n Determination to Extend the Date for Determining 
Whether to Review a Non-Final Initial Determination Granting 
Complainants' Motion for Summary Determination that the Accused 
Products Infringe U.S. Patent No. 6,100,061 (Mar. 29, 2016).
    On May 27, 2016, the ALJ issued the Final ID, which found no 
violation of Section 337 as to either remaining asserted patent. On 
June 3, 2016, the ALJ issued the Recommended Determination on Remedy, 
Bonding, and the Public Interest, which contingently recommends both a 
limited exclusion order and a cease and desist order. The parties each 
petitioned for review of the Final ID. The Commission determined to 
review (1) the Summary ID's conclusion that the `061 patent is 
infringed (and the underlying claim constructions); (2) the Final ID's 
conclusion that the asserted claims of the `061 patent are anticipated 
and obvious; and (3) the Final ID's conclusion that the economic prong 
of the domestic industry is not met as to both remaining patents. 81 FR 
51463, 51464 (Aug. 4, 2016). The Commission requested briefing on one 
issue under review and on remedy, the public interest, and bonding. Id. 
at 51464-65.
    On September 12, 2016, the private parties filed a Joint Motion to 
Terminate the Investigation Based on a Settlement Agreement (``the 
Motion'') and a confidential and a public version of the settlement 
agreement. On September 14, 2016, OUII filed a response supporting the 
Motion.
    The Commission has determined that the Motion complies with the 
requirements of section 210.21(b)(1) of the Commission's Rules of 
Practice and Procedure (19 CFR 210.21(b)(1)), and that there are no 
extraordinary circumstances that would prevent the requested 
termination. The Commission also finds that granting the Motion would 
not be contrary to the public interest pursuant to section 210.50(b)(2) 
of the Commission's Rules of Practice and Procedure (19 CFR 
210.50(b)(2)). Accordingly, the Commission hereby grants the Motion. 
This investigation is terminated.
    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: September 28, 2016.
Katherine M. Hiner,
Acting Supervisory Attorney.
[FR Doc. 2016-23864 Filed 10-3-16; 8:45 am]
 BILLING CODE 7020-02-P

68454 Federal Register / Vol. 81, No. 192 / Tuesday, October 4, 2016 / Notices

meals are the responsibility of the whether there is a violation of Section contingently recommends both a limited
participating public. 337(a)(1)(B) in the importation into the exclusion order and a cease and desist
United States, the sale for importation order. The parties each petitioned for
Jenna Whitlock,
into the United States, or the sale within review of the Final ID. The Commission
Acting State Director. the United States after importation of determined to review (1) the Summary
[FR Doc. 2016–23937 Filed 10–3–16; 8:45 am] certain recombinant factor VIII products ID’s conclusion that the ‘061 patent is
BILLING CODE 4310–DQ–P by reason of infringement of any of infringed (and the underlying claim
claims 19–21, 36, 37, and 39 of U.S. constructions); (2) the Final ID’s
Patent No. 6,100,061 (‘‘the ’061 patent’’); conclusion that the asserted claims of
INTERNATIONAL TRADE claims 20 and 21 of U.S. Patent No.
the ‘061 patent are anticipated and
COMMISSION 6,936,441 (‘‘the ’441 patent’’); and
obvious; and (3) the Final ID’s
claims 1, 5, 8, 10, 14, and 18 of U.S.
[Investigation No. 337–TA–956]
Patent No. 8,084,252 (‘‘the ’252 patent’’). conclusion that the economic prong of
80 FR at 29746. The Commission the domestic industry is not met as to
Certain Recombinant Factor VIII both remaining patents. 81 FR 51463,
Products; Notice of Commission directed the ALJ to make findings of fact
and provide a recommended 51464 (Aug. 4, 2016). The Commission
Determination To Grant a Joint Motion requested briefing on one issue under
To Terminate the Investigation on the determination with respect to the
statutory public interest factors set forth review and on remedy, the public
Basis of a Settlement Agreement; interest, and bonding. Id. at 51464–65.
in 19 U.S.C. 1337(d)(1), (f)(1), and (g)(1).
Termination of the Investigation
Id. The notice of investigation named as On September 12, 2016, the private
AGENCY: U.S. International Trade respondents Novo Nordisk A/S of parties filed a Joint Motion to Terminate
Commission. Bagsvaerd, Denmark and Novo Nordisk the Investigation Based on a Settlement
ACTION: Notice. Inc., of Plainsboro, NJ (collectively, Agreement (‘‘the Motion’’) and a
‘‘Novo Nordisk’’). Id. The Office of confidential and a public version of the
SUMMARY: Notice is hereby given that Unfair Import Investigations (‘‘OUII’’) is settlement agreement. On September 14,
the U.S. International Trade also a party to this investigation. Id.
On December 8, 2015, Baxter moved 2016, OUII filed a response supporting
Commission has determined to grant a
for partial termination of this the Motion.
joint motion to terminate the above-
captioned investigation based on a investigation based on the withdrawal The Commission has determined that
settlement agreement. of claims 21, 36, 37, and 39 of the ’061 the Motion complies with the
FOR FURTHER INFORMATION CONTACT: Ron patent; claims 1 and 10 of the ’252 requirements of section 210.21(b)(1) of
Traud, Office of the General Counsel, patent; and claims 20 and 21 of the ’441 the Commission’s Rules of Practice and
U.S. International Trade Commission, patent. That motion was granted, Procedure (19 CFR 210.21(b)(1)), and
500 E Street SW., Washington, DC leaving only claims 19 and 20 of the that there are no extraordinary
20436, (202) 205–3427. Copies of non- ’061 and claims 5, 8, 14, and 18 of the circumstances that would prevent the
confidential documents filed in ’252 patent at issue. Order No. 23 (Dec. requested termination. The Commission
connection with this investigation are or 10, 2016), unreviewed, Notice of also finds that granting the Motion
will be available for inspection during Commission Determination Not to would not be contrary to the public
Review an Initial Determination
official business hours (8:45 a.m. to 5:15 interest pursuant to section 210.50(b)(2)
Granting a Motion for Partial
p.m.) in the Office of the Secretary, U.S. of the Commission’s Rules of Practice
Termination of the Investigation with
International Trade Commission, 500 E and Procedure (19 CFR 210.50(b)(2)).
Respect to Certain Claims (Jan. 5, 2016).
Street SW., Washington, DC 20436, On February 26, 2016, the ALJ issued Accordingly, the Commission hereby
(202) 205–2000. General information an initial determination (‘‘the Summary grants the Motion. This investigation is
concerning the Commission may also be ID’’) (Order No. 30), which concluded terminated.
obtained at https://www.usitc.gov. The that Novo Nordisk infringed the ‘061 The authority for the Commission’s
public record for this investigation may patent. Novo Nordisk filed a petition
be viewed on the Commission’s determination is contained in Section
requesting that the Commission review 337 of the Tariff Act of 1930, as
electronic docketing system (EDIS) at the Summary ID and related claim
https://edis.usitc.gov. Hearing-impaired amended (19 U.S.C. 1337), and in Part
construction orders. The Commission 210 of the Commission’s Rules of
persons are advised that information on determined to defer its decision on
this matter can be obtained by Practice and Procedure (19 CFR part
whether to review those orders until the 210).
contacting the Commission’s TDD date on which the Commission
terminal at (202) 205–1810. determines whether to review the ALJ’s By order of the Commission.
SUPPLEMENTARY INFORMATION: On May final ID (‘‘the Final ID’’). Notice of Issued: September 28, 2016.
22, 2015, the Commission instituted this Comm’n Determination to Extend the Katherine M. Hiner,
investigation pursuant to Section 337 of Date for Determining Whether to Review Acting Supervisory Attorney.
the Tariff Act of 1930, as amended, a Non-Final Initial Determination
[FR Doc. 2016–23864 Filed 10–3–16; 8:45 am]
based on a complaint filed by Baxter Granting Complainants’ Motion for
Healthcare Corporation and Baxter Summary Determination that the BILLING CODE 7020–02–P

Healthcare SA, both of Deerfield, Accused Products Infringe U.S. Patent
Illinois. 80 FR 29745 (May 22, 2015). No. 6,100,061 (Mar. 29, 2016).
mstockstill on DSK3G9T082PROD with NOTICES

Baxalta Inc., Baxalta US Inc., and On May 27, 2016, the ALJ issued the
Baxalta GmbH were added as Final ID, which found no violation of
complainants after the filing of the Section 337 as to either remaining
complaint. 80 FR 62569 (Oct. 16, 2015). asserted patent. On June 3, 2016, the
(The complainants are collectively ALJ issued the Recommended
referred to as ‘‘Baxter.’’) The Determination on Remedy, Bonding,
Commission sought to determine and the Public Interest, which

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Document Created: 2016-10-04 03:04:19
Document Modified: 2016-10-04 03:04:19

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Contact		Ron Traud, Office of the General Counsel, U.S. International Trade Commission, 500 E Street SW., Washington, DC 20436, (202) 205-3427. 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, DC 20436, (202) 205-2000. General information concerning the Commission may also be obtained at https://www.usitc.gov. The public record for this investigation may be viewed on the Commission's electronic docketing system (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 at (202) 205-1810.
FR Citation		81 FR 68454