[Federal Register Volume 85, Number 78 (Wednesday, April 22, 2020)]
[Notices]
[Pages 22443-22444]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-08480]
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INTERNATIONAL TRADE COMMISSION
[Investigation No. 337-TA-1116]
Certain Blood Cholesterol Testing Strips and Associated Systems
Containing the Same; Commission's Final Determination Finding a
Violation of Section 337; Issuance of a Limited Exclusion Order;
Termination of 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 found a violation of section 337 of the Tariff Act of
1930, as amended, by ACON Biotech (Hangzhou) Co., Ltd. of Hangzhou,
China, and ACON Laboratories, Inc., of San Diego, California, and has
determined to issue a limited exclusion order. The investigation is
terminated.
FOR FURTHER INFORMATION CONTACT: Robert Needham, Office of the General
Counsel, U.S. International Trade Commission, 500 E Street SW,
Washington, DC 20436, telephone (202) 708-5468. Copies of non-
confidential documents filed in connection with this investigation may
be viewed on the Commission's electronic docket (EDIS) at https://edis.usitc.gov. For help accessing EDIS, please email
[email protected]. General information concerning the Commission may
also be obtained by accessing its internet server (https://www.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: The Commission instituted this investigation
on June 5, 2018, based on a complaint filed by Polymer Technology
Systems, Inc. of Indianapolis, Indiana (``PTS''). 83 FR 26087-88. The
complaint alleges violations of section 337 in the importation into the
United States, the sale for importation, and the sale after importation
within the United States after importation of certain blood cholesterol
testing strips and associated systems containing the same by reason of
infringement of one or more claims of U.S. Patent Nos. 7,087,397 (``the
'397 patent''); 7,625,721 (``the '721 patent''); and 7,494,818 (``the
'818 patent''). Id. at 26087. The notice of investigation named as
respondents ACON Laboratories, Inc. of San Diego, California (``ACON
Labs''), and ACON Biotech (Hangzhou) Co., Ltd. of Hangzhou, China
(``ACON Bio'') (collectively, ``ACON''). The Office of Unfair Import
Investigations is not a party to the investigation. Id. at 26088.
The Commission subsequently terminated the investigation with
respect to claims 10, 13, 14, and 20 of the '397 patent based on PTS's
withdrawal of those allegations. See Order. No. 7 (Sept. 10, 2018), not
reviewed, Notice (Sept. 25, 2018); Order No. 10 (Jan. 31, 2019), not
reviewed, Notice (Feb. 21, 2019). The Commission also terminated the
investigation for infringement purposes with respect to claim 17 of the
'397 patent; claims 2, 3, 13, and 14 of the '721 patent; and claim 10
of the '818 patent based on PTS's withdrawal of allegations. Order No.
14 (Feb. 14, 2019), not reviewed, Notice (Mar. 5, 2019). Finally, the
Commission terminated the investigation with respect to claims 1-3, 5,
and 18 of the '397 patent and claims 5, 7, and 9 of the '721 patent
based on PTS's withdrawal of allegations. Order No. 15 (Mar. 12, 2019),
not reviewed, Notice (April 9, 2019). Accordingly, at the time of the
Final ID, PTS asserted for infringement claim 19 of the '397 patent;
claims 1, 4, 6, 8, and 15 of the '721 patent; and claims 8, 9, and 11
of the '818 patent. Final ID at 43.
On February 13, 2019, the presiding administrative law judge
(``ALJ'') issued an initial determination (``ID'') granting a summary
determination that PTS satisfied the economic prong of the domestic
industry requirement for each of three asserted patents under section
337(a)(3)(A), (B), and (C). Order No. 13 (Feb. 13, 2019). No party
petitioned for review of the ID, and the Commission declined to review
the ID. Notice (Mar. 12, 2019).
On June 4, 2019, the ALJ issued a final ID finding a violation of
section 337 with respect to the '397 and '721 patents, and no violation
with respect to the '818 patent. The ALJ found that ACON infringed
claim 19 of the '397 patent and claims 1, 4, 6, 7, and 15 of the '721
patent, but did not infringe claims 8, 9, and 11 of the '818 patent.
The ALJ also found that PTS satisfies the domestic industry requirement
with respect to all three asserted patents, and that no asserted claims
were shown to be invalid by clear and convincing evidence.
On June 17, 2019, ACON petitioned for review of the final ID with
respect
[[Page 22444]]
to the '397 and '721 patents, and contingently petitioned for review of
the final ID with respect to the '818 patent. PTS did not file a
petition for review, and, on June 25, 2019, PTS filed a response to
ACON's petition.
On August 13, 2019, the Commission determined to review the Final
ID in part. Specifically, the Commission determined to review the
following issues: (1) Whether ACON Labs' use of the accused products in
the United States constitutes a violation of 19 U.S.C.
1337(a)(1)(B)(i); (2) the final ID's construction of ``reacting HDL . .
. without precipitating said one or more non-selected analytes'' in the
'721 patent, as well as related findings on infringement, the domestic
industry, and invalidity; and (3) the final ID's finding that all of
the asserted claims of the '721 patent are not shown to be invalid for
a lack of enablement. The Commission did not review any other findings
presented in the final ID.
The Commission also sought briefing from the parties on four issues
and on remedy, bonding, and public interest. On August 27, 2019, PTS
and ACON filed their initial submissions in response to the
Commission's request for briefing. On September 3, 2019, PTS and ACON
filed their reply submissions in response to the Commission's request
for briefing. No third-party submissions on remedy, bonding, or the
public interest were received.
Having examined the record of this investigation, including the
Final ID, the petition, response, and other submissions from the
parties, the Commission has determined that PTS has shown a violation
of section 337 by ACON Bio and ACON Labs with respect to the '397 and
'721 patents. The Commission has also determined to construe the term
``precipitating'' to mean ``separating a solid substance or material
from a solution by a chemical reaction,'' and finds that, under this
construction, PTS established infringement and the domestic industry
requirement with respect to claims 1, 4, 6, 8, and 15 of the '721
patent, and that ACON failed to show that any claim is invalid by clear
and convincing evidence. The Commission's determinations are explained
more fully in the accompanying Opinion. All other findings in the ID
under review that are consistent with the Commission's determinations
are affirmed.
The Commission has determined that the appropriate form of relief
in this investigation is a limited exclusion order with respect to ACON
Bio and ACON Labs prohibiting the importation of imported blood
cholesterol testing strips and associated systems containing the same
that are covered by one or more of claim 19 of the '397 patent and
claims 1, 4, 6, 8, and 15 of the '721 patent. The Commission has
further determined that the public interest factors enumerated in
subsection 337(d)(1) (19 U.S.C. 1337(d)(1)) do not preclude the
issuance of the limited exclusion order. Finally, the Commission has
determined that the bond for importation during the period of
Presidential review shall be in the amount of zero percent of the
entered value of such articles.
The Commission's notice, order, and opinion were delivered to the
President and to the United States Trade Representative on the day of
their issuance. The Commission has also notified the Secretary of the
Treasury and Customs and Border Protection of the order. The
investigation is hereby 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: April 16, 2020.
Lisa Barton,
Secretary to the Commission.
[FR Doc. 2020-08480 Filed 4-21-20; 8:45 am]
BILLING CODE 7020-02-P