[Federal Register Volume 75, Number 69 (Monday, April 12, 2010)]
[Notices]
[Pages 18548-18549]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-8205]
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INTERNATIONAL TRADE COMMISSION
[Investigation No. 337-TA-568]
In the Matter of Certain Products and Pharmaceutical Compositions
Containing Recombinant Human Erythropoietin;
Notice of Commission Decision to Grant Amgen Inc.'s Motion for
Partial Termination; Notice of Request for Written Submissions Relating
to Summary Determination and to Remedy, the Public Interest, and
Bonding
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 Amgen Inc.'s motion for partial
termination of the above-referenced investigation and that the
Commission is requesting briefing on issues relating to summary
determination and to remedy, the public interest, and bonding.
FOR FURTHER INFORMATION CONTACT: Michelle Walters Klancnik, 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 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
http://www.usitc.gov. The public record for this investigation may be
viewed on the Commission's electronic docket (EDIS) at http://edis.usitc.gov. 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: On May 12, 2006, the Commission instituted
an investigation under section 337 of the Tariff Act of 1930 (19 U.S.C.
1337) based on a complaint filed by Amgen, Inc. (``Amgen'') of Thousand
Oaks, California. 71 FR 27742 (May 12, 2006). The complaint asserted a
violation of section 337 in the importation into the United States,
sale for importation, or sale within the United States after
importation of certain products and pharmaceutical compositions
containing recombinant human erythropoietin by reason of infringement
of claims 1 and 2 of U.S. Patent No. 5,441,868 (``the '868 patent''),
claims 3, 4, 5, and 11 of U.S. Patent No. 5,547,933 (``the '933
patent''), claims 4-9 of U.S. Patent No. 5,618,698 (``the '698
patent''), claims 4 and 6 of U.S. Patent No. 5,621,080 (``the '080
patent''), claim 7 of U.S. Patent No. 5,756,349 (``the '349 patent''),
and claim 1 of U.S. Patent No. 5,955,422 (``the '422 patent''). The
notice of investigation named Roche Holding Ltd. of Basel, Switzerland;
F. Hoffman-La Roche, Ltd. of Basel, Switzerland; Roche Diagnostics GmbH
of Mannheim, Germany; and Hoffman La Roche, Inc. of Nutley, New Jersey
(collectively, ``Roche'') as respondents.
On August 31, 2009, after a remand of the original investigation
from the United States Court of Appeals for the Federal Circuit, Amgen
moved for summary determination that Roche violated section 337 by
importing and using a pegylated erythropoietin product, which according
to Amgen infringes claims 1 and 2 of the '868 patent, claim 3 of the
'933 patent, claims 6-9 of the '698 patent, and claim 1 of the '422
patent. Amgen also requested a limited exclusion order that would
preclude importation of Roche's product regardless of the party seeking
to import such product. Roche does not oppose Amgen's motion for
purposes of this investigation. The Commission investigative attorney
(``IA'') also does not oppose Amgen's motion, but indicated that the
motion does not resolve asserted claim 7 of the '349 patent or asserted
claims 4, 5, and 11 of the '933 patent.
On December 22, 2009, Amgen moved to terminate the investigation
with respect to claims 4, 5, and 11 of the `933 patent, claims 4 and 6
of the `080 patent, and claims 4 and 5 of the `698 patent. In addition,
on December 31, 2009, Amgen filed a supplemental motion for summary
determination with respect to claim 7 of the `349 patent. Roche does
not oppose these motions. The IA also does not oppose Amgen's motion to
terminate the investigation in part, but does oppose Amgen's
supplemental motion for summary determination.
The Commission has determined to grant Amgen's motion to terminate
the investigation with respect to claims 4, 5, and 11 of the `933
patent, claims 4 and 6 of the `080 patent, and claims 4 and 5 of the
`698 patent. The Commission has determined that further briefing is
necessary to decide the motion for summary determination.
The parties are requested to brief their positions on the following
issues with reference to the applicable law and evidence:
1. How does the United States Court of Appeals for the Federal
Circuit's decision in Amgen Inc. v. F. Hoffman-La Roche Ltd, 580 F.3d
1340 (Fed. Cir. 2009), vacating certain aspects of the decision by the
United States District Court of Massachusetts in Amgen Inc. v. F.
Hoffman-La Roche, Ltd., No. 05-12237-WGY (D. Mass. Oct. 2, 2008),
affect Amgen's original motion for summary determination filed on
August 31, 2009, for each asserted claim? Please address the
Commission's February 3, 2009 opinion in Certain Semiconductor
Integrated Circuits Using Tungsten Metallization and Products
Containing Same, Inv. No. 337-TA-648.
2. If the Commission can proceed with respect to any claim(s),
please explain whether the Commission should apply the principles of
claim or issue preclusion to the district court case and what standard
the Commission should apply.
3. Can the Commission apply claim or issue preclusion to the
permanent injunction order issued by the district court on December 22,
2009, and if so, to what effect? Does the stipulation, which is signed
by the parties and which appears before the permanent injunction, form
part of the district court's judgment? If so, does Amgen rely on the
stipulation for claim or issue preclusion? Please provide case law
supporting your positions.
4. If the Commission denies Amgen's motions for summary
determination with respect to any claims, how should the Commission
proceed with respect to those claims?
[[Page 18549]]
In connection with the final disposition of this investigation, the
Commission may (1) issue an order that could result in the exclusion of
the subject articles from entry into the United States, and/or (2)
issue one or more cease and desist orders that could result in the
respondent being required to cease and desist from engaging in unfair
acts in the importation and sale of such articles. Accordingly, the
Commission is interested in receiving written submissions that address
the form of remedy, if any, that should be ordered. If a party seeks
exclusion of an article from entry into the United States for purposes
other than entry for consumption, the party should so indicate and
provide information establishing that activities involving other types
of entry either are adversely affecting it or likely to do so. For
background, see In the Matter of Certain Devices for Connecting
Computers via Telephone Lines, Inv. No. 337-TA-360, USITC Pub. No. 2843
(December 1994) (Commission Opinion).
If the Commission contemplates some form of remedy, it must
consider the effects of that remedy upon the public interest. The
factors the Commission will consider include the effect that an
exclusion order and/or cease and desist orders would have on (1) the
public health and welfare, (2) competitive conditions in the U.S.
economy, (3) U.S. production of articles that are like or directly
competitive with those that are subject to investigation, and (4) U.S.
consumers. The Commission is therefore interested in receiving written
submissions that address the aforementioned public interest factors in
the context of this investigation.
If the Commission orders some form of remedy, the U.S. Trade
Representative, as delegated by the President, has 60 days to approve
or disapprove the Commission's action. See Presidential Memorandum of
July 21, 2005, 70 FR. 43251 (July 26, 2005). During this period, the
subject articles would be entitled to enter the United States under
bond, in an amount determined by the Commission and prescribed by the
Secretary of the Treasury. The Commission is therefore interested in
receiving submissions concerning the amount of the bond that should be
imposed if a remedy is ordered.
Written Submissions: The parties to the investigation are requested
to file written submissions on the issues identified in this notice.
Parties to the investigation, interested government agencies, and any
other interested parties are encouraged to file written submissions on
the issues of remedy, the public interest, and bonding. Complainants
and the Commission investigative attorney are also requested to submit
proposed remedial orders for the Commission's consideration.
Complainants are also requested to state the dates that the patents
expire and the HTSUS numbers under which the accused products are
imported. The written submissions and proposed remedial orders must be
filed no later than close of business on May 7, 2010. Reply submissions
must be filed no later than the close of business on May 21, 2010. No
further submissions on these issues will be permitted unless otherwise
ordered by the Commission.
Persons filing written submissions must file the original document
and 12 true copies thereof on or before the deadlines stated above with
the Office of the Secretary. Any person desiring to submit a document
to the Commission in confidence must request confidential treatment
unless the information has already been granted such treatment during
the proceedings. All such requests should be directed to the Secretary
of the Commission and must include a full statement of the reasons why
the Commission should grant such treatment. See 19 CFR *210.6.
Documents for which confidential treatment by the Commission is sought
will be treated accordingly. All nonconfidential written submissions
will be available for public inspection at the Office of the Secretary.
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 sections 210.18, 210.21, and 210.50 of the Commission's Rules of
Practice and Procedure (19 CFR *210.18, 210.21, and 210.50).
By order of the Commission.
Issued: April 6, 2010.
Marilyn R. Abbott,
Secretary to the Commission.
[FR Doc. 2010-8205 Filed 4-9-10; 8:45 am]
BILLING CODE 7020-02-P