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, 68454 [2016-23864]

Agencies

• INTERNATIONAL TRADE COMMISSION

[Federal Register Volume 81, Number 192 (Tuesday, October 4, 2016)]
[Notices]
[Page 68454]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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]
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