Certain Microfluidic Devices; Notice of the Commission's Final Determination Finding a Violation of Section 337; Issuance of a Limited Exclusion Order and Cease and Desist Order; Termination of the Investigation, 70999-71000 [2019-27759]

Download as PDF khammond on DSKJM1Z7X2PROD with NOTICES Federal Register / Vol. 84, No. 247 / Thursday, December 26, 2019 / Notices desist order within a commercially reasonable time; and (v) Explain how the LEO and CDO would impact consumers in the United States. Written submissions from the public must be filed no later than the close of business on Friday, January 17, 2020. Persons filing written submissions must file the original document electronically on or before the deadline stated above and submit eight (8) true paper copies to the Office of the Secretary by noon the next day pursuant to section 210.4(f) of the Commission’s Rules of Practice and Procedure (19 CFR 210.4(f)). Submissions should refer to the investigation number (‘‘Inv. No. 337–TA–1118’’) in a prominent place on the cover page and/or first page. (See Handbook for Electronic Filing Procedures, https://www.usitc.gov/ documents/handbook_on_filing_ procedures.pdf.). Persons with questions regarding filing should contact the Secretary (202–205–2000). Any person desiring to submit a document to the Commission in confidence must request confidential treatment. All such requests should be directed to the Secretary to the Commission and must include a full statement of the reasons why the Commission should grant such treatment. See 19 CFR 201.6. Documents for which confidential treatment by the Commission is properly sought will be treated accordingly. All information, including confidential business information and documents for which confidential treatment is properly sought, submitted to the Commission for purposes of this Investigation may be disclosed to and used: (i) By the Commission, its employees and Offices, and contract personnel (a) for developing or maintaining the records of this or a related proceeding, or (b) in internal investigations, audits, reviews, and evaluations relating to the programs, personnel, and operations of the Commission including under 5 U.S.C. Appendix 3; or (ii) by U.S. government employees and contract personnel, solely for cybersecurity purposes. All contract personnel will sign appropriate nondisclosure agreements. All non-confidential written submissions will be available for public inspection at the Office of the Secretary and on EDIS. 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). VerDate Sep<11>2014 16:53 Dec 23, 2019 Jkt 250001 By order of the Commission. Issued: December 18, 2019. Lisa Barton, Secretary to the Commission. [FR Doc. 2019–27712 Filed 12–23–19; 8:45 am] BILLING CODE 7020–02–P INTERNATIONAL TRADE COMMISSION [Investigation No. 337–TA–1068] Certain Microfluidic Devices; Notice of the Commission’s Final Determination Finding a Violation of Section 337; Issuance of a Limited Exclusion Order and Cease and Desist Order; Termination of the Investigation U.S. International Trade Commission. ACTION: Notice. AGENCY: Notice is hereby given that the U.S. International Trade Commission (‘‘Commission’’) has found a violation of section 337 in the abovecaptioned investigation. The Commission has determined to issue tailored remedial orders that permit researchers to continue their work in ongoing research projects using the infringing microfluidic devices as explained in the accompanying opinion. These remedial orders include: (1) A limited exclusion order (‘‘LEO’’) prohibiting the unlicensed entry of infringing microfluidic devices covered by certain claims of U.S. Patent Nos. 9,500,664 (‘‘the ’664 patent’’); 9,636,682 (‘‘the ’682 patent’’); and 9,649,635 (‘‘the ’635 patent’’) that are manufactured abroad for or on behalf of, or imported by or on behalf of 10X Genomics, Inc. of Pleasanton, California (‘‘10X’’) or any of its affiliated companies, parents, subsidiaries, or other related business entities, or its successors or assigns; and (2) a cease and desist order (‘‘CDO’’) directed against 10X and its affiliated companies, parents, subsidiaries, or other related business entities, or its successors or assigns. This investigation is terminated. FOR FURTHER INFORMATION CONTACT: Ron Traud, Office of the General Counsel, U.S. International Trade Commission, 500 E Street SW, Washington, DC 20436, telephone 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, telephone 202–205–2000. General information concerning the Commission SUMMARY: PO 00000 Frm 00072 Fmt 4703 Sfmt 4703 70999 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. Hearing-impaired persons are advised that information on this matter can be obtained by contacting the Commission’s TDD terminal, telephone 202–205–1810. SUPPLEMENTARY INFORMATION: On September 6, 2017, the Commission instituted this investigation based on a complaint filed by Bio-Rad Laboratories, Inc. of Hercules, California; and Lawrence Livermore National Security, LLC of Livermore, California. 82 FR 42115 (Sept. 6, 2017). The complaint (and supplement thereto) alleges violations of section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337 (‘‘section 337’’) based upon the importation into the United States, the sale for importation, or the sale within the United States after importation of certain microfluidic devices by reason of infringement of one or more claims of the ’664 patent, the ’682 patent, the ’635 patent, and U.S. Patent Nos. 9,089,844 (‘‘the ’844 patent’’) and 9,126,160 (‘‘the ’160 patent). Id. The Commission’s notice of investigation named as the sole respondent 10X. Id. The Office of Unfair Import Investigations was also named as a party to this investigation. Id. Prior to the issuance of the final initial determination (‘‘ID’’) by the presiding administrative law judge (the ‘‘ALJ’’), the investigation was terminated as to the ’844 patent in its entirety and as to certain claims of the ’160, ’664, ’682, and ’635 patents. See Order No. 12, unreviewed, Notice (Mar. 6, 2018); Order No. 16, unreviewed, Notice (Mar. 26, 2018); Order No. 19, unreviewed, Notice (Apr. 16, 2018); Order No. 29, unreviewed, Notice (June 1, 2018). The ALJ’s final ID addressed the following claims: (i) Claim 20 of the ’160 patent; (ii) claims 1, 2, 14, and 15 of the ’664 patent; (iii) claims 14, 16, and 17 of the ’682 patent; and (iv) claims 1, 13, 14, 16, and 21 of the ’635 patent. On September 20, 2018, the ALJ issued the final ID, which finds 10X in violation of section 337 as to the remaining asserted claims of the ’664, ’682 patent, and ’635 patents. On September 28, 2018, the ALJ issued her recommendations on remedy, bond, and the public interest. The ALJ recommended that the Commission issue a limited exclusion order directed to 10X’s infringing products and a cease and desist order directed to 10X. The ALJ also recommended a bond of 100 percent of entered value during the E:\FR\FM\26DEN1.SGM 26DEN1 khammond on DSKJM1Z7X2PROD with NOTICES 71000 Federal Register / Vol. 84, No. 247 / Thursday, December 26, 2019 / Notices period of Presidential review. See 19 U.S.C. 1337(j)(3). The private parties petitioned for the Commission to review certain of the ALJ’s determinations. On December 4, 2018, after considering the parties’ petitions and responses thereto, the Commission determined to review the following issues: (1) Whether 10X indirectly infringes the ’682 and ’635 patents; (2) Whether 10X’s Chip GB infringes claims 1 and 14 of the ’664 patent; and (3) Whether 10X’s Chip SE infringes claim 20 of the ’160 patent and claim 1 of the ’664 patent. 83 FR 63672 (Dec. 11, 2018). The Commission thereafter requested briefing only on remedy, the public interest, and bonding. On June 10, 2019, the Commission requested supplemental briefing on the public interest. 84 FR 27802 (June 14, 2019); 84 FR 31912 (July 3, 2019) (modifying briefing schedule). Thereafter, the parties, members of the public, and a government agency submitted public interest briefing. On review, and consistent with the simultaneously-issued Commission opinion, the Commission has determined to affirm with modification the final ID’s finding of a violation of section 337 with respect to claims 1, 2, 14, and 15 of the ’664 patent, claims 14, 16, and 17 of the ’682 patent, and claims 1, 13, 14, 16, and 21 of the ’635 patent. The Commission has further determined that the public interest factors enumerated in subsections (d)(l) and (f)(1) (19 U.S.C. 1337(d)(l), (f)(1)) do not preclude issuance of the abovereferenced remedial orders. However, the Commission has determined to tailor the LEO and CDO to allow research studies using the infringing articles at issue as of the date of issuance of the remedial orders to continue to use those infringing articles. The Commission has determined to impose a bond of three (3) percent of entered value of the covered products during the period of Presidential review (19 U.S.C. 1337(j)). This investigation is terminated. This action is taken under the authority of 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: December 18, 2019. Lisa Barton, Secretary to the Commission. [FR Doc. 2019–27759 Filed 12–23–19; 8:45 am] BILLING CODE 7020–02–P VerDate Sep<11>2014 16:53 Dec 23, 2019 Jkt 250001 DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–562] Bulk Manufacturer of Controlled Substances Application: Bulk Manufacturers of Marihuana: Stanley Brothers Bio Tec Inc. ACTION: Notice of application. The Drug Enforcement Administration (DEA) is providing notice of an application it has received from an entity applying to be registered to manufacture in bulk basic classes of controlled substances listed in schedule I. Prior to making decisions on this and other pending applications, DEA intends to promulgate regulations that govern the program of growing marihuana for scientific and medical research under DEA registration. DATES: Registered bulk manufacturers of the affected basic classes, and applicants therefore, may file written comments on or objections to the issuance of the proposed registration on or before February 24, 2020. SUMMARY: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DPW 8701 Morrissette Drive, Springfield, Virginia 22152. To ensure proper handling of comments, please reference Docket No. DEA–562 in all correspondence, including attachments. SUPPLEMENTARY INFORMATION: The Controlled Substances Act (CSA) prohibits the cultivation and distribution of marihuana except by persons who are registered under the CSA to do so for lawful purposes. In accordance with the purposes specified in 21 CFR 1301.33(a), DEA is providing notice that the entity identified below has applied for registration as a bulk manufacturer of schedule I controlled substances. In response, registered bulk manufacturers of the affected basic classes, and applicants therefore, may file written comments on or objections of the requested registration, as provided in this notice. This notice does not constitute any evaluation or determination of the merits of the application submitted. The applicant plans to manufacture bulk active pharmaceutical ingredients (APIs) for product development and distribution to DEA registered researchers. If its application for registration is granted, the registrant would not be authorized to conduct other activity under this registration aside from those coincident activities specifically authorized by DEA regulations. DEA will evaluate the application for registration as a bulk manufacturer for compliance with all applicable laws, treaties, and regulations and to ensure adequate safeguards against diversion are in place. As this applicant has applied to become registered as a Bulk Manufacturer of Marihuana, the application will be evaluated under the criteria of 21 U.S.C. 823(a) as described in 84 FR 44920, published on August 27, 2019. In accordance with 21 CFR 1301.33(a), DEA is providing notice that on October 31, 2019, STANLEY BROTHERS BIO TECH INC., 66 South Logan Street, Suite 209, Denver, Colorado 80209–1809 applied to be registered as a bulk manufacturer of the following basic class of controlled substances: Controlled substance Drug code Marihuana ............... Tetrahydrocannabinols. 7360 7370 Schedule I I ADDRESSES: PO 00000 Frm 00073 Fmt 4703 Sfmt 4703 The applicant noticed above applied to become registered with DEA to grow marihuana as a bulk manufacturer subsequent to a 2016 DEA policy statement that provided information on how it intended to expand the number of registrations, and described in general terms the way it would oversee those additional growers. Before DEA completes the evaluation and registration process for applicants to grow marihuana, DEA intends to propose regulations in the near future that would supersede the 2016 policy statement and govern persons seeking to become registered with DEA to grow marihuana as bulk manufacturers, consistent with applicable law, as described in 84 FR 44920. Dated: December 6, 2019. William T. McDermott, Assistant Administrator. [FR Doc. 2019–27782 Filed 12–23–19; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–561] Bulk Manufacturer of Controlled Substances Application: Kinetochem LLC ACTION: E:\FR\FM\26DEN1.SGM Notice of application. 26DEN1

Agencies

[Federal Register Volume 84, Number 247 (Thursday, December 26, 2019)]
[Notices]
[Pages 70999-71000]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-27759]


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INTERNATIONAL TRADE COMMISSION

[Investigation No. 337-TA-1068]


Certain Microfluidic Devices; Notice of the Commission's Final 
Determination Finding a Violation of Section 337; Issuance of a Limited 
Exclusion Order and Cease and Desist Order; Termination of the 
Investigation

AGENCY: U.S. International Trade Commission.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: Notice is hereby given that the U.S. International Trade 
Commission (``Commission'') has found a violation of section 337 in the 
above-captioned investigation. The Commission has determined to issue 
tailored remedial orders that permit researchers to continue their work 
in ongoing research projects using the infringing microfluidic devices 
as explained in the accompanying opinion. These remedial orders 
include: (1) A limited exclusion order (``LEO'') prohibiting the 
unlicensed entry of infringing microfluidic devices covered by certain 
claims of U.S. Patent Nos. 9,500,664 (``the '664 patent''); 9,636,682 
(``the '682 patent''); and 9,649,635 (``the '635 patent'') that are 
manufactured abroad for or on behalf of, or imported by or on behalf of 
10X Genomics, Inc. of Pleasanton, California (``10X'') or any of its 
affiliated companies, parents, subsidiaries, or other related business 
entities, or its successors or assigns; and (2) a cease and desist 
order (``CDO'') directed against 10X and its affiliated companies, 
parents, subsidiaries, or other related business entities, or its 
successors or assigns. This investigation is terminated.

FOR FURTHER INFORMATION CONTACT: Ron Traud, Office of the General 
Counsel, U.S. International Trade Commission, 500 E Street SW, 
Washington, DC 20436, telephone 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, 
telephone 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. Hearing-impaired persons are advised that information 
on this matter can be obtained by contacting the Commission's TDD 
terminal, telephone 202-205-1810.

SUPPLEMENTARY INFORMATION: On September 6, 2017, the Commission 
instituted this investigation based on a complaint filed by Bio-Rad 
Laboratories, Inc. of Hercules, California; and Lawrence Livermore 
National Security, LLC of Livermore, California. 82 FR 42115 (Sept. 6, 
2017). The complaint (and supplement thereto) alleges violations of 
section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337 
(``section 337'') based upon the importation into the United States, 
the sale for importation, or the sale within the United States after 
importation of certain microfluidic devices by reason of infringement 
of one or more claims of the '664 patent, the '682 patent, the '635 
patent, and U.S. Patent Nos. 9,089,844 (``the '844 patent'') and 
9,126,160 (``the '160 patent). Id. The Commission's notice of 
investigation named as the sole respondent 10X. Id. The Office of 
Unfair Import Investigations was also named as a party to this 
investigation. Id.
    Prior to the issuance of the final initial determination (``ID'') 
by the presiding administrative law judge (the ``ALJ''), the 
investigation was terminated as to the '844 patent in its entirety and 
as to certain claims of the '160, '664, '682, and '635 patents. See 
Order No. 12, unreviewed, Notice (Mar. 6, 2018); Order No. 16, 
unreviewed, Notice (Mar. 26, 2018); Order No. 19, unreviewed, Notice 
(Apr. 16, 2018); Order No. 29, unreviewed, Notice (June 1, 2018). The 
ALJ's final ID addressed the following claims: (i) Claim 20 of the '160 
patent; (ii) claims 1, 2, 14, and 15 of the '664 patent; (iii) claims 
14, 16, and 17 of the '682 patent; and (iv) claims 1, 13, 14, 16, and 
21 of the '635 patent.
    On September 20, 2018, the ALJ issued the final ID, which finds 10X 
in violation of section 337 as to the remaining asserted claims of the 
'664, '682 patent, and '635 patents. On September 28, 2018, the ALJ 
issued her recommendations on remedy, bond, and the public interest. 
The ALJ recommended that the Commission issue a limited exclusion order 
directed to 10X's infringing products and a cease and desist order 
directed to 10X. The ALJ also recommended a bond of 100 percent of 
entered value during the

[[Page 71000]]

period of Presidential review. See 19 U.S.C. 1337(j)(3).
    The private parties petitioned for the Commission to review certain 
of the ALJ's determinations. On December 4, 2018, after considering the 
parties' petitions and responses thereto, the Commission determined to 
review the following issues:
    (1) Whether 10X indirectly infringes the '682 and '635 patents;
    (2) Whether 10X's Chip GB infringes claims 1 and 14 of the '664 
patent; and
    (3) Whether 10X's Chip SE infringes claim 20 of the '160 patent and 
claim 1 of the '664 patent.

83 FR 63672 (Dec. 11, 2018). The Commission thereafter requested 
briefing only on remedy, the public interest, and bonding.
    On June 10, 2019, the Commission requested supplemental briefing on 
the public interest. 84 FR 27802 (June 14, 2019); 84 FR 31912 (July 3, 
2019) (modifying briefing schedule). Thereafter, the parties, members 
of the public, and a government agency submitted public interest 
briefing.
    On review, and consistent with the simultaneously-issued Commission 
opinion, the Commission has determined to affirm with modification the 
final ID's finding of a violation of section 337 with respect to claims 
1, 2, 14, and 15 of the '664 patent, claims 14, 16, and 17 of the '682 
patent, and claims 1, 13, 14, 16, and 21 of the '635 patent.
    The Commission has further determined that the public interest 
factors enumerated in subsections (d)(l) and (f)(1) (19 U.S.C. 
1337(d)(l), (f)(1)) do not preclude issuance of the above-referenced 
remedial orders. However, the Commission has determined to tailor the 
LEO and CDO to allow research studies using the infringing articles at 
issue as of the date of issuance of the remedial orders to continue to 
use those infringing articles.
    The Commission has determined to impose a bond of three (3) percent 
of entered value of the covered products during the period of 
Presidential review (19 U.S.C. 1337(j)).
    This investigation is terminated.
    This action is taken under the authority of 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: December 18, 2019.
Lisa Barton,
Secretary to the Commission.
[FR Doc. 2019-27759 Filed 12-23-19; 8:45 am]
 BILLING CODE 7020-02-P