82 FR 37898 - Certain Recombinant Factor IX Products; Institution of Investigation
INTERNATIONAL TRADE COMMISSION Federal Register Volume 82, Issue 155 (August 14, 2017)
Federal Register Volume 82, Issue 155 (August 14, 2017)
| Page Range | 37898-37899 | |
| FR Document | 2017-17058 |
[Federal Register Volume 82, Number 155 (Monday, August 14, 2017)] [Notices] [Pages 37898-37899] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-17058] ======================================================================= ----------------------------------------------------------------------- INTERNATIONAL TRADE COMMISSION [Investigation No. 337-TA-1066] Certain Recombinant Factor IX Products; Institution of Investigation 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 July 7, 2017, under section 337 of the Tariff Act of 1930, as amended, on behalf of Bioverativ Inc. of Waltham, Massachusetts; Bioverativ Therapeutics Inc. of Waltham, Massachusetts; and Bioverativ U.S. LLC of Waltham, Massachusetts. A supplement to the complaint was filed on July 14, 2017. 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 IX products by reason of infringement of certain claims of U.S. Patent No. 9,670,475 (``the '475 patent''); U.S. Patent No. 9,623,091 (``the '091 patent''); and U.S. Patent No. 9,629,903 (``the '903 patent''). The complaint further alleges that an industry in the United States exists as required by the applicable Federal Statute. 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 SW., Room 112, Washington, DC 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 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. FOR FURTHER INFORMATION CONTACT: Pathenia M. 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 CFR 210.10 (2017). Scope of Investigation: Having considered the complaint, the U.S. International Trade Commission, on August 8, 2017, 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 IX products by reason of infringement of one or more of claims 1, 2, 4-19, 24, 25, 29, and 34 of the '475 patent; claims 1-7, 11-16, 18, 19, 21, and 23-27 of the '091 patent; and claims 1-10, 13-15, and 17-28 of the '903 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 CFR 210.50(b)(1), the presiding Administrative Law Judge shall take evidence or other information and hear arguments from the parties or 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: Bioverativ Inc., 225 Second Avenue, Waltham, MA 02451. Bioverativ Therapeutics Inc., 225 Second Avenue, Waltham, MA 02451. Bioverativ U.S. LLC, 225 Second Avenue, Waltham, MA 02451. (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: CSL Behring LLC, 1020 First Avenue, King of Prussia, PA 19406. CSL Behring GmbH, Emil-von-Behring-Strasse 76, Marburg, Hessen 35041 Germany. CSL Behring Recombinant Facility AG, Wankdorfstrasse 10, Bern, Bern 3014 Switzerland. (c) The Office of Unfair Import Investigations, U.S. International Trade Commission, 500 E Street SW., Suite 401, Washington, DC 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 CFR 210.13. Pursuant to 19 CFR 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 [[Page 37899]] and desist order or both directed against the respondent. By order of the Commission. Issued: August 8, 2017. Lisa R. Barton, Secretary to the Commission. [FR Doc. 2017-17058 Filed 8-11-17; 8:45 am] BILLING CODE P
![37898 Federal Register / Vol. 82, No. 155 / Monday, August 14, 2017 / Notices
the ESA by conducting an intra-Service and, after the investigation, issue a the public interest in this investigation,
section 7 consultation on anticipated limited exclusion order and cease and as appropriate, and provide the
ITP actions. We will use the results of desist orders. Commission with findings of fact and a
this consultation, in combination with ADDRESSES: The complaint, except for recommended determination on this
the above findings, in our final analysis any confidential information contained issue, which shall be limited to the
to determine whether to issue the ITP. therein, is available for inspection statutory public interest factors set forth
If we determine that all requirements during official business hours (8:45 a.m. in 19 U.S.C. 1337(d)(1), (f)(1), (g)(1);
are met, we will issue an ITP under to 5:15 p.m.) in the Office of the (3) For the purpose of the
section 10(a)(1)(B) of the ESA to the Secretary, U.S. International Trade investigation so instituted, the following
applicant for the take of the covered Commission, 500 E Street SW., Room are hereby named as parties upon which
species, incidental to otherwise lawful 112, Washington, DC 20436, telephone this notice of investigation shall be
covered activities. We will make the (202) 205–2000. Hearing impaired served:
final permit decision no sooner than 30 individuals are advised that information (a) The complainants are: Bioverativ
days after the date of this notice. on this matter can be obtained by Inc., 225 Second Avenue, Waltham, MA
contacting the Commission’s TDD 02451. Bioverativ Therapeutics Inc., 225
Authority Second Avenue, Waltham, MA 02451.
terminal on (202) 205–1810. Persons
We provide this notice in accordance with mobility impairments who will Bioverativ U.S. LLC, 225 Second
with the requirements of section 10 of Avenue, Waltham, MA 02451.
need special assistance in gaining access
the ESA and NEPA and their (b) The respondents are the following
to the Commission should contact the
implementing regulations (50 CFR 17.32 entities alleged to be in violation of
Office of the Secretary at (202) 205– section 337, and are the parties upon
and 40 CFR 1506.6, respectively). 2000. General information concerning which the complaint is to be served:
Dated: June 20, 2017. the Commission may also be obtained CSL Behring LLC, 1020 First Avenue,
Theresa E. Rabot, by accessing its internet server at King of Prussia, PA 19406. CSL Behring
Deputy Regional Director, Pacific Region, U.S. https://www.usitc.gov. The public GmbH, Emil-von-Behring-Strasse 76,
Fish and Wildlife Service, Portland, Oregon. record for this investigation may be Marburg, Hessen 35041 Germany. CSL
[FR Doc. 2017–17082 Filed 8–11–17; 8:45 am] viewed on the Commission’s electronic Behring Recombinant Facility AG,
BILLING CODE 4333–15–P
docket (EDIS) at https://edis.usitc.gov. Wankdorfstrasse 10, Bern, Bern 3014
FOR FURTHER INFORMATION CONTACT: Switzerland.
Pathenia M. Proctor, The Office of (c) The Office of Unfair Import
INTERNATIONAL TRADE Unfair Import Investigations, U.S. Investigations, U.S. International Trade
COMMISSION International Trade Commission, Commission, 500 E Street SW., Suite
telephone (202) 205–2560. 401, Washington, DC 20436; and
[Investigation No. 337–TA–1066] (4) For the investigation so instituted,
SUPPLEMENTARY INFORMATION:
Certain Recombinant Factor IX Authority: The authority for the Chief Administrative Law Judge,
Products; Institution of Investigation institution of this investigation is U.S. International Trade Commission,
contained in section 337 of the Tariff shall designate the presiding
AGENCY: U.S. International Trade Act of 1930, as amended, 19 U.S.C. 1337 Administrative Law Judge.
Commission. and in section 210.10 of the Responses to the complaint and the
ACTION: Notice. Commission’s Rules of Practice and notice of investigation must be
Procedure, 19 CFR 210.10 (2017). submitted by the named respondents in
SUMMARY: Notice is hereby given that a Scope of Investigation: Having accordance with section 210.13 of the
complaint was filed with the U.S. considered the complaint, the U.S. Commission’s Rules of Practice and
International Trade Commission on July International Trade Commission, on Procedure, 19 CFR 210.13. Pursuant to
7, 2017, under section 337 of the Tariff August 8, 2017, ordered that— 19 CFR 201.16(e) and 210.13(a), such
Act of 1930, as amended, on behalf of (1) Pursuant to subsection (b) of responses will be considered by the
Bioverativ Inc. of Waltham, section 337 of the Tariff Act of 1930, as Commission if received not later than 20
Massachusetts; Bioverativ Therapeutics amended, an investigation be instituted days after the date of service by the
Inc. of Waltham, Massachusetts; and to determine whether there is a Commission of the complaint and the
Bioverativ U.S. LLC of Waltham, violation of subsection (a)(1)(B) of notice of investigation. Extensions of
Massachusetts. A supplement to the section 337 in the importation into the time for submitting responses to the
complaint was filed on July 14, 2017. United States, the sale for importation, complaint and the notice of
The complaint alleges violations of or the sale within the United States after investigation will not be granted unless
section 337 based upon the importation importation of certain recombinant good cause therefor is shown.
into the United States, the sale for Factor IX products by reason of Failure of a respondent to file a timely
importation, and the sale within the infringement of one or more of claims 1, response to each allegation in the
United States after importation of 2, 4–19, 24, 25, 29, and 34 of the ’475 complaint and in this notice may be
certain recombinant Factor IX products patent; claims 1–7, 11–16, 18, 19, 21, deemed to constitute a waiver of the
by reason of infringement of certain and 23–27 of the ’091 patent; and claims right to appear and contest the
claims of U.S. Patent No. 9,670,475 1–10, 13–15, and 17–28 of the ’903 allegations of the complaint and this
(‘‘the ’475 patent’’); U.S. Patent No. patent; and whether an industry in the notice, and to authorize the
administrative law judge and the
sradovich on DSK3GMQ082PROD with NOTICES
9,623,091 (‘‘the ’091 patent’’); and U.S. United States exists as required by
Patent No. 9,629,903 (‘‘the ’903 patent’’). subsection (a)(2) of section 337; Commission, without further notice to
The complaint further alleges that an (2) Pursuant to Commission Rule the respondent, to find the facts to be as
industry in the United States exists as 210.50(b)(1), 19 CFR 210.50(b)(1), the alleged in the complaint and this notice
required by the applicable Federal presiding Administrative Law Judge and to enter an initial determination
Statute. shall take evidence or other information and a final determination containing
The complainants request that the and hear arguments from the parties or such findings, and may result in the
Commission institute an investigation other interested persons with respect to issuance of an exclusion order or a cease
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![Federal Register / Vol. 82, No. 155 / Monday, August 14, 2017 / Notices 37899
and desist order or both directed against terminal on (202) 205–1810. Persons this notice of investigation shall be
the respondent. with mobility impairments who will served:
By order of the Commission. need special assistance in gaining access (a) The complainant is: Qualcomm
Issued: August 8, 2017.
to the Commission should contact the Incorporated, 5775 Morehouse Drive,
Office of the Secretary at (202) 205– San Diego, CA 92121.
Lisa R. Barton,
2000. General information concerning
Secretary to the Commission. the Commission may also be obtained (b) The respondent is the following
[FR Doc. 2017–17058 Filed 8–11–17; 8:45 am] by accessing its internet server at entity alleged to be in violation of
BILLING CODE P https://www.usitc.gov. The public section 337, and is the party upon
record for this investigation may be which the complaint is to be served:
viewed on the Commission’s electronic Apple Inc., 1 Infinite Loop, Cupertino,
INTERNATIONAL TRADE docket (EDIS) at https://edis.usitc.gov. CA 95014.
COMMISSION
FOR FURTHER INFORMATION CONTACT: (c) The Office of Unfair Import
[Investigation No. 337–TA–1065] Pathenia M. Proctor, The Office of Investigations, U.S. International Trade
Unfair Import Investigations, U.S. Commission, 500 E Street SW., Suite
Certain Mobile Electronic Devices and International Trade Commission, 401, Washington, DC 20436; and
Radio Frequency and Processing telephone (202) 205–2560.
Components Thereof; Institution of (4) For the investigation so instituted,
SUPPLEMENTARY INFORMATION:
Investigation the Chief Administrative Law Judge,
Authority: The authority for
U.S. International Trade Commission,
AGENCY: U.S. International Trade institution of this investigation is
shall designate the presiding
Commission. contained in section 337 of the Tariff
Act of 1930, as amended, 19 U.S.C. 1337 Administrative Law Judge.
ACTION: Notice.
and in section 210.10 of the Responses to the complaint and the
SUMMARY: Notice is hereby given that a Commission’s Rules of Practice and notice of investigation must be
complaint was filed with the U.S. Procedure, 19 CFR 210.10 (2017). submitted by the named respondent in
International Trade Commission on July Scope of Investigation: Having accordance with section 210.13 of the
7, 2017, under section 337 of the Tariff considered the complaint, the U.S. Commission’s Rules of Practice and
Act of 1930, as amended, on behalf of International Trade Commission, on Procedure, 19 CFR 210.13. Pursuant to
Qualcomm Incorporated of San Diego, August 8, 2017, ordered that— 19 CFR 201.16(e) and 210.13(a), such
California. A supplement was filed on (1) Pursuant to subsection (b) of responses will be considered by the
July 7, 2017. The complaint, as section 337 of the Tariff Act of 1930, as Commission if received not later than 20
supplemented, alleges violations of amended, an investigation be instituted days after the date of service by the
section 337 based upon the importation to determine whether there is a Commission of the complaint and the
into the United States, the sale for violation of subsection (a)(1)(B) of notice of investigation. Extensions of
importation, and the sale within the section 337 in the importation into the time for submitting responses to the
United States after importation of United States, the sale for importation,
certain mobile electronic devices and complaint and the notice of
or the sale within the United States after
radio frequency and processing investigation will not be granted unless
importation of certain mobile electronic
components thereof by reason of devices and radio frequency and good cause therefor is shown.
infringement of U.S. Patent No. processing components thereof by Failure of the respondent to file a
8,633,936 (‘‘the ’936 patent’’); U.S. reason of infringement of one or more of timely response to each allegation in the
Patent No. 8,698,558 (‘‘the ’558 patent’’); claims 1–27, 29, 38, 49, 55–60, 67, and complaint and in this notice may be
U.S. Patent No. 8,487,658 (‘‘the ’658 68 of the ’936 patent; claims 1 and 6– deemed to constitute a waiver of the
patent’’); U.S. Patent No. 8,838,949 (‘‘the 20 of the ’558 patent; claims 9, 10, 12, right to appear and contest the
’949 patent’’); U.S. Patent No. 9,535,490 14, and 20–22 of the ’658 patent; claims allegations of the complaint and this
(‘‘the ’490 patent’’); and U.S. Patent No. 1–8, 10–14, 16, 20, and 22 of the ’949 notice, and to authorize the
9,608,675 (‘‘the ’675 patent’’). The patent; claims 1–6, 8, 10, 16, 17, and 31 administrative law judge and the
complaint further alleges that an of the ’490 patent; and claims 1–3 and Commission, without further notice to
industry in the United States exists as 7–14 of the ’675 patent; and whether an the respondent, to find the facts to be as
required by the applicable Federal industry in the United States exists as alleged in the complaint and this notice
Statute. required by subsection (a)(2) of section and to enter an initial determination
The complainant requests that the 337; and a final determination containing
Commission institute an investigation (2) Pursuant to Commission Rule
and, after the investigation, issue a such findings, and may result in the
210.50(b)(1), 19 CFR 210.50(b)(1), the
limited exclusion order and a cease and issuance of an exclusion order or a cease
presiding Administrative Law Judge
desist order. and desist order or both directed against
shall take evidence or other information
ADDRESSES: The complaint, except for and hear arguments from the parties or the respondent.
any confidential information contained other interested persons with respect to By order of the Commission.
therein, is available for inspection the public interest in this investigation, Issued: August 8, 2017.
during official business hours (8:45 a.m. as appropriate, and provide the Lisa R. Barton,
to 5:15 p.m.) in the Office of the Commission with findings of fact and a
sradovich on DSK3GMQ082PROD with NOTICES
Secretary to the Commission.
Secretary, U.S. International Trade recommended determination on this
[FR Doc. 2017–17057 Filed 8–11–17; 8:45 am]
Commission, 500 E Street SW., Room issue, which shall be limited to the
112, Washington, DC 20436, telephone statutory public interest factors set forth BILLING CODE 7020–02–P
(202) 205–2000. Hearing impaired in 19 U.S.C. 1337(d)(1), (f)(1), (g)(1);
individuals are advised that information (3) For the purpose of the
on this matter can be obtained by investigation so instituted, the following
contacting the Commission’s TDD are hereby named as parties upon which
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Document Created: 2018-10-24 11:50:20
Document Modified: 2018-10-24 11:50:20
| 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 | Pathenia M. Proctor, The Office of Unfair Import Investigations, U.S. International Trade Commission, telephone (202) 205-2560. | |
| FR Citation | 82 FR 37898 |
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