In the Matter of Certain Products and Pharmaceutical Compositions Containing Recombinant Human Erythropoietin;, 18548-18549 [2010-8205]

Agencies

• INTERNATIONAL TRADE COMMISSION

[Federal Register Volume 75, Number 69 (Monday, April 12, 2010)]
[Notices]
[Pages 18548-18549]
From the Federal Register Online via the Government Printing 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 
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 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