Notice2021-22814
Certain Laparoscopic Surgical Staplers, Reload Cartridges, and Components Thereof; Final Determination Finding a Violation of Section 337 and Issuance of Remedial Orders; Suspension of Enforcement of the Remedial Orders Pending Final Resolution of a Final Written Decision by the Patent Trial and Appeal Board; and Termination of the Investigation
Primary source
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Published
October 20, 2021
Issuing agencies
International Trade Commission
Abstract
Notice is hereby given that the U.S. International Trade Commission (the ``Commission'') has determined that: (i) The respondents have violated section 337 of the Tariff Act of 1930, as amended, by importing, selling for importation, or selling in the United States after importation certain laparoscopic surgical staplers, reload cartridges, and components thereof that infringe complainants' U.S. Patent No. 9,844,379 (``the '379 patent''); (2) the appropriate remedies are a limited exclusion order and cease and desist orders; and (3) enforcement of said remedial orders will be suspended pending final resolution of a Final Written Decision by the Patent Trial and Appeal Board (``PTAB'') that the asserted claims of the '379 patent are unpatentable. This investigation is terminated.
Full Text
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<title>Federal Register, Volume 86 Issue 200 (Wednesday, October 20, 2021)</title>
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[Federal Register Volume 86, Number 200 (Wednesday, October 20, 2021)]
[Notices]
[Pages 58100-58101]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-22814]
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INTERNATIONAL TRADE COMMISSION
[Investigation No. 337-TA-1167]
Certain Laparoscopic Surgical Staplers, Reload Cartridges, and
Components Thereof; Final Determination Finding a Violation of Section
337 and Issuance of Remedial Orders; Suspension of Enforcement of the
Remedial Orders Pending Final Resolution of a Final Written Decision by
the Patent Trial and Appeal Board; and 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 (the ``Commission'') has determined that: (i) The
respondents have violated section 337 of the Tariff Act of 1930, as
amended, by importing, selling for importation, or selling in the
United States after importation certain laparoscopic surgical staplers,
reload cartridges, and components thereof that infringe complainants'
U.S. Patent No. 9,844,379 (``the '379 patent''); (2) the appropriate
remedies are a limited exclusion order and cease and desist orders; and
(3) enforcement of said remedial orders will be suspended pending final
resolution of a Final Written Decision by the Patent Trial and Appeal
Board (``PTAB'') that the asserted claims of the '379 patent are
unpatentable. This investigation is terminated.
FOR FURTHER INFORMATION CONTACT: Benjamin S. Richards, Office of the
General Counsel, U.S. International Trade Commission, 500 E Street SW,
Washington, DC 20436, telephone (202) 708-5453. Copies of non-
confidential documents filed in connection with this investigation may
be viewed on the Commission's electronic docket (EDIS) at <a href="https://edis.usitc.gov">https://edis.usitc.gov</a>. For help accessing EDIS, please email
<a href="/cdn-cgi/l/email-protection#7f3a3b362c4c371a130f3f0a0c160b1c51181009"><span class="__cf_email__" data-cfemail="85c0c1ccd6b6cde0e9f5c5f0f6ecf1e6abe2eaf3">[email protected]</span></a>. General information concerning the Commission may
also be obtained by accessing its internet server at <a href="https://www.usitc.gov">https://www.usitc.gov</a>. Hearing-impaired persons are advised that information on
this matter can be obtained by contacting the Commission's TDD terminal
on (202) 205-1810.
SUPPLEMENTARY INFORMATION: The Commission instituted this investigation
on July 5, 2019, based on a complaint filed by Ethicon LLC of Guaynabo,
PR; Ethicon Endo-surgery, Inc. of Cincinnati, OH; and Ethicon US, LLC
of Cincinnati, OH (collectively, ``Ethicon''). 84 FR 32220 (July 5,
2019); see also 84 FR 65174 (Nov. 26, 2019) (amending the caption). The
complaint alleged violations of section 337 of the Tariff Act of 1930,
as amended, 19 U.S.C. 1337, based on the importation into the United
States, the sale for importation, and the sale within the United States
after importation of certain laparoscopic surgical staplers, reload
cartridges, and components thereof by reason of infringement of one or
more claims of U.S. Patent Nos. 9,844,379; 9,844,369 (``the '369
patent''); 7,490,749 (``the '749 patent''); 8,479,969 (``the '969
patent''); and 9,113,874 (``the '874 patent''). 84 FR at 32220. The
Commission's notice of investigation named the following as
respondents: Intuitive Surgical Inc., of Sunnyvale, CA; Intuitive
Surgical Operations, Inc., of Sunnyvale, CA; Intuitive Surgical
Holdings, LLC, of Sunnyvale, CA; and Intuitive Surgical S. De R.L. De
C.V. of Mexicali, Mexico (collectively, ``Intuitive''). Id. The Office
of Unfair Import Investigations is not participating in this
investigation. Id.
On October 23, 2020, the Chief Administrative Law Judge (``CALJ'')
granted Ethicon's motion for leave to amend the complaint, case
caption, and notice of investigation to reinstate the original plain
English statement of the category of accused products, as well as the
original case caption, and to reincorporate Intuitive's laparoscopic
surgical staplers and components thereof as articles to be excluded.
Order No. 14, unreviewed by Comm'n Notice (Nov. 21, 2019). As initially
instituted, the investigation covered reload cartridges for those
staplers, but not the staplers themselves. See id.
[[Page 58101]]
On October 29, 2019, the CALJ conducted a Markman hearing.
Thereafter, on January 7, 2020, the CALJ issued Order No. 15, which
construed various terms in the asserted patents.
On March 5, 2020, the CALJ granted Ethicon's motion to terminate
claim 1 of the '379 patent and all claims of the '749 patent from the
investigation. See Order No. 21, unreviewed by Comm'n Notice (Mar. 25,
2020).
On April 21, 2020, Ethicon moved for leave to file a second amended
complaint to include the Certificate of Correction for the '379 patent.
The CALJ granted Ethicon's motion on May 6, 2020, and Ethicon filed its
second amended complaint on May 7, 2020. See Order No. 36; Doc. ID
709878.
On June 8, 2021, the CALJ issued the subject ID on violation, which
found a violation of section 337 based on infringement of the asserted
claims of the '369 and '379 patents by Intuitive. The ID found no
violation based on the '969 and '874 patents. Also, on June 8, 2021,
the CALJ issued his recommended determination on remedy and bonding.
The CALJ recommended, upon a finding of violation, that the Commission
issue a limited exclusion order, issue cease and desist orders, and
impose a bond in the amount of zero percent (0%) of the entered value
of any covered products imported during the period of Presidential
review.
On June 21, 2021, Ethicon and Intuitive submitted petitions seeking
review of the subject ID. Intuitive's petition included a request for
suspension of enforcement of any remedial orders directed to the '379
patent based on a Final Written Decision by the PTAB, in which the PTAB
found all claims of the '379 patent unpatentable. See Intuitive
Surgical, Inc. v. Ethicon LLC, IPR2020-00050, IPR2020-00051, Patent
9,844,379, Final Written Decision Determining All Challenged Claims
Unpatentable (Mar. 26, 2021). On June 29, 2021, Ethicon and Intuitive
submitted responses to the other's petitions.
On June 9, 2021, the Commission issued a notice soliciting public
comments on the public interest factors, if any, that may be implicated
if a remedy were to be issued in this investigation. 85 FR 30735 (May
20, 2020). The Commission received twelve submissions from the public
in response to its notice.
On August 16, 2021, issued notice of its determination to review
the ID in part with respect to (1) the ID's findings on claim
construction, infringement, anticipation, obviousness, and
enforceability for the '969 patent; and (2) the ID's findings on claim
construction, infringement, and obviousness for the '369 patent. The
Commission determined not to review the remainder of the ID, including
the ID's determination that a violation of section 337 had occurred
with respect to the '379 patent and that no violation occurred with
respect to the '874 patent. In connection with its review of the ID,
the Commission sought briefing from the parties on several questions
germane to the issues on review and on remedy, bonding, and the public
interest.
The parties filed their initial response to the Commission's review
questions on August 23, 2021, and their respective reply briefs on
August 30, 2021.
Having considered the parties' submissions, the ID, and the record
in this investigation, the Commission has determined that Intuitive has
violated section 337 by importing into the United States, selling for
importation, or selling in the United States after importation certain
laparoscopic surgical staplers, reload cartridges, and components
thereof that infringe claims 2 and 3 of the '379 patent. The Commission
has further determined to affirm, reverse, and take no position on
certain portions of the ID, as explained in the Commission's opinion
issued concurrently herewith.
The Commission has determined that the appropriate remedy is: (a) A
limited exclusion order prohibiting the importation of certain
laparoscopic surgical staplers, reload cartridges, and components
thereof that infringe claims 2 and 3 of the '379 patent; and (b) cease
and desist orders against Intuitive. The Commission has determined that
the public interest factors enumerated in section 337(d)(1) and (f)(1)
do not preclude issuance of the limited exclusion order or cease and
desist orders. The Commission has also determined to set a bond in the
amount of zero percent (0%) (i.e., no bond) of the entered value of the
excluded products imported during the period of Presidential review (19
U.S.C. 1337(j)).
The Commission has also determined to suspend enforcement of its
remedial orders, including the bond provision, pending final resolution
of a Final Written Decision issued by the PTAB on March 26, 2021,
finding all claims of the '379 patent to be unpatentable. See 35 U.S.C.
318(b); Intuitive Surgical, Inc. v. Ethicon LLC, IPR2020-00050,
IPR2020-00051, Patent 9,844,379, Final Written Decision Determining All
Challenged Claims Unpatentable (Mar. 26, 2021).
The Commission's orders and opinion were delivered to the President
and United States Trade Representative on the day of their issuance.
The Commission vote for this determination took place on October
14, 2021.
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
210).
By order of the Commission.
Issued: October 14, 2021.
Lisa Barton,
Secretary to the Commission.
[FR Doc. 2021-22814 Filed 10-19-21; 8:45 am]
BILLING CODE 7020-02-P
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