[Federal Register Volume 76, Number 203 (Thursday, October 20, 2011)]
[Notices]
[Pages 65210-65211]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-27167]


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INTERNATIONAL TRADE COMMISSION

[Investigation No. 337-TA-568]


Certain Products and Pharmaceutical Compositions Containing 
Recombinant Human Erythropoetin; Termination of Investigation on the 
Basis of Settlement

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 terminate the above-captioned 
investigation on the basis of settlement between the private parties.

FOR FURTHER INFORMATION CONTACT: Sidney A. Rosenzweig, Office of the 
General Counsel, U.S. International Trade Commission, 500 E Street, 
SW., Washington, DC 20436, telephone (202) 708-2532. 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: This investigation was instituted on May 12, 
2006, based on a complaint filed by Amgen Inc. (``Amgen'') of Thousand 
Oaks, California. 71 FR 27,742 (May 12, 2006). The complaint alleged a 
violation of section 337 of the Tariff Act of 1930 (19 U.S.C. 1337) 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 various claims of six United States 
patents: U.S. Patent Nos. 5,441,868; 5,547,933 (``the '933 patent''); 
5,618,698 (``the '698 patent''); 5,621,080 (``the '080 patent''); 
5,756,349; and 5,955,422. The complaint 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.
    After separate remands by the Court of Appeals for the Federal 
Circuit of this investigation and a parallel civil action involving 
many of the same patents asserted in this investigation, on December 
18, 2009, the private parties executed a settlement agreement that 
allows Roche to begin selling accused products in the United States in 
mid-2014. Form 10-K, Amgen Inc., at 8 (Mar. 1, 2010); see also 
Settlement Agreement (Dec. 18, 2009). On December 21, 2009, Amgen and 
Roche submitted a proposed consent order to the district court in that 
parallel civil action, and on December 22, 2009, the district court 
entered judgment.
    On December 22, 2009, Amgen moved to withdraw certain patent claims 
from this investigation that had not been asserted in the district 
court. Unopposed Compl't Amgen Inc.'s Mot. to Terminate Investigation 
as 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 (Dec. 22, 2009). The 
Commission granted that motion. 75 FR 18,548 (Apr. 12, 2010).
    Also on December 22, 2009, Amgen moved the Commission to terminate 
this investigation by entry of an exclusion order based on preclusion 
caused by the district court judgment. Addendum to August 24, 2009 
Stipulation (Dec. 22, 2009). Two Amgen motions regarding claim 7 of the 
'349 patent followed. By notice on April 6, 2010, the Commission sought 
clarification from the parties about, among other things, the effect of 
the stipulated district court judgment on this investigation. 75 FR 
18,548 (Apr. 12, 2010).
    On March 11, 2011, the Commission issued an order to show cause why 
the investigation should not be terminated in view of the parties' 
settlement. In response, Amgen and Roche declined to pursue their 
request for an exclusion order and instead requested the issuance of a 
consent order. In support of their proposed consent order, Amgen and 
Roche stated that ``the Commission has previously terminated 
investigations when there is both a settlement agreement and an 
executed consent order stipulation.'' Joint Response of Complainant and 
Respondents to the Commission's Order to Show Cause and Request for 
Termination on the Basis of a Consent Order 2-3 (Apr. 21, 2011) 
(``Joint Response'') (citing Notices, Certain Digital Multimeters and 
Products with Multimeter Functionality, Inv. No. 337-TA-588 (May 31, 
2007 and July 3, 2007)). In a corrected response that the Commission 
hereby grants leave to file, the Commission investigative attorney did 
not object to the issuance of a consent order.
    As will be discussed further in an accompanying opinion, the facts 
of the 588 investigation are readily distinguished from the facts here. 
Amgen and Roche have offered no basis, in law or policy, to support the 
Commission's issuance of a consent order under the unusual facts of 
this investigation. Nor is the Commission itself aware of any such 
basis. Accordingly, the Commission terminates this investigation on the 
basis of the settlement agreement between the private parties. 19 
U.S.C. 1337(c); 19 CFR 210.21(b), 210.41.
    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).

    Issued: October 14, 2011.


[[Page 65211]]


    By order of the Commission.
James R. Holbein,
Secretary to the Commission.
[FR Doc. 2011-27167 Filed 10-19-11; 8:45 am]
BILLING CODE 7020-02-P