[Federal Register Volume 71, Number 229 (Wednesday, November 29, 2006)]
[Notices]
[Pages 69143-69144]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-20178]


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INTERNATIONAL TRADE COMMISSION

[Investigation No. 337-TA-550]


In the Matter of Certain Modified Vaccinia Ankara (``MVA'') 
Viruses and Vaccines and Pharmaceutical Compositions Based Thereon; 
Notice of Commission Decision To Review the Final Initial 
Determination; Extension of the Target Date for Completion of the 
Investigation; Schedule for Briefing on the Issues on Review and 
Remedy, 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 review in its entirety the final initial 
determination (``final ID'') issued by the presiding administrative law 
judge (``ALJ'') in the above-captioned investigation and to extend the 
target date for completion of the investigation.

FOR FURTHER INFORMATION CONTACT: James A. Worth, Office of the General 
Counsel, U.S. International Trade Commission, 500 E Street, SW., 
Washington, DC 20436, telephone (202) 205-3065. 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 
(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 
September 23, 2005, based on a complaint filed by Bavarian Nordic A/S 
(``Bavarian Nordic'') of Denmark. The complaint alleged violations of 
section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337, in 
the importation into the United States, the sale for importation, and 
the sale within the United States after importation of certain modified 
vaccinia ankara (``MVA'') viruses and vaccines and pharmaceutical 
compositions based thereon by reason of infringement of various claims 
of United States Patent Nos. 6,761,893 (``the '893 patent'') and 
6,913,752 (``the '752 patent''). The complaint also alleged violations 
of section 337 in the importation of certain MVA viruses and vaccines 
and pharmaceutical compositions based thereon or in the sale of such 
articles by reason of misappropriation of trade secrets, the threat or 
effect of which is to destroy or substantially injure an industry in 
the United States. The complaint named a single respondent, Acambis PLC 
(``Acambis'') of the United Kingdom.
    On November 30, 2005, the ALJ issued an order (Order No. 10) 
denying Acambis' motion to terminate the investigation on the basis of 
28 U.S.C. 1498.
    On April 14, 2006, the ALJ issued an ID (Order No. 26) terminating 
the trade secret portion of this investigation based on an agreement to 
arbitrate between Bavarian Nordic and Acambis. On May 9, 2006, the 
Commission declined to review this ID.
    On April 17, 2006, the ALJ issued an ID (Order No. 27) granting in 
part respondent's motion for summary determination with regard to the 
conversion claim, on the basis, inter alia, that it was insufficiently 
pled. In a separate notice issued on May 9, 2006, the Commission 
reviewed the ID on the conversion claim, affirming the dismissal of the 
conversion claim and taking no position on the ALJ's finding of no 
jurisdiction over the conversion claim.
    After a hearing and post-hearing briefing, the ALJ issued a final 
initial determination (``final ID'') on September 6, 2006, finding no 
violation of section 337. The ALJ held that the patents were infringed 
but invalid.
    Bavarian Nordic, Acambis, and the Commission investigative attorney 
filed petitions for review of the final ID. By notice of October 20, 
2006, the Commission extended the deadline for determining whether to 
review the final ID to Wednesday, November 22, 2006 and extended the 
target date for completion of the investigation to Monday, January 8, 
2007.
    Having examined the relevant portions of the record in this 
investigation, including the final ID, the petitions for review, and 
the responses thereto, the Commission has determined to review the 
final ID in its entirety, as well as Order No. 10. The Commission has 
also determined to extend the target date for completion of the 
investigation to January 31, 2007.
    The Commission requests briefing based on the evidentiary record on 
the issues on review. The Commission is particularly interested in 
responses to the following questions:

Regarding Both the '893 and '752 Patents

    (1) Does 28 U.S.C. 1498(a) constitute an affirmative defense 
available in section 337 investigations? If so, has Acambis properly 
and timely raised and maintained this defense? What are the 
consequences of having successfully raised and maintained this 
defense in a section 337 proceeding?

Regarding the '893 Patent

    (1) As a matter of claim construction, does ``virus deposited'' 
in claim 1 refer to an isolated, purified virus?
    (2) Can the virus deposited be identified by sequence alone or 
is replication behavior a limitation of the virus deposited? If two 
viruses contain identical DNA coding region sequences, are the viral 
genomes necessarily identical? If not, e.g., if viruses contained 
different inverted terminal repeats, is replication behavior 
necessarily the same? What are the consequences of replication 
behavior for determining anticipation and infringement of ``virus 
deposited * * * and derivatives'' in claim 1?
    (3) May a mixture of viruses containing the claimed virus 
anticipate claim 1 regardless of the replication behavior of the 
mixture? Does MVA-572 or MVA-575 inherently anticipate claim 1 even 
if those prior art viruses were not homogenous?
    (4) Is MVA-F6 homogenous and does MVA-F6 directly anticipate 
claim 1?

Regarding the '752 Patent

    (1) Is there any evidence that the terms ``non-replicative'' and 
``not capable of reproductive replication'' have different meanings, 
despite the use of different words? Should the terms ``non-
replicative'' and ``permit replication'' as they appear in the 
asserted claims of the '752 patent be construed in conformance with 
the teaching from the specification that ``the term `not capable of 
reproductive replication' means that the virus of the present 
invention

[[Page 69144]]

exhibits an amplification ratio of less than 1 in human cell lines, 
such as 293 (ECACC No. 85120602), 143B (ECACC No. 91112502), HeLa 
(ATCC No. CCL-2) and HaCat (Boukamp et al. 1988, J Cell Biol 106(3): 
761-71) under the conditions outlined in Example 1 of the present 
specification''? '752 patent, col. 2, lines 53-59.
    (2) Would a virus be considered to replicate if it sometimes 
replicated and other times did not? Is a person of ordinary skill in 
the art only concerned with mean values to the exclusion of standard 
error analysis? Would a person of ordinary skill in the art find 
viral replication if the mean value were above 1 even if the 
confidence intervals straddled 1? Would a person of ordinary skill 
in the art find no replication if the mean value were below 1 and 
the confidence intervals straddled 1?
    (3) Is there evidence that MVA-575 possesses a replication ratio 
of 1 or greater in HaCaT and other human cells? Is there clear and 
convincing evidence that MVA-575 possesses a replication ratio less 
than 1 in HaCaT and other human cells?
    (4) Given the claim construction in Order No. 31 regarding 
``replication,'' would it matter to enablement, written description, 
infringement, or domestic industry of the '752 patent whether MVA-BN 
replicated less than MVA-575 if MVA-575 still possessed a 
replication ratio less than 1 in human cells? Is the ALJ's claim 
construction of this term correct to a person of ordinary skill in 
the art? Answers to the above should give precise citations to the 
record and should take into account the confidence interval.
    (5) Figure 1A indicates that the replication rates for certain 
MVA viruses are different. This is especially apparent at higher 
replication rates. Does the difference in replication rates indicate 
that these viruses are not identical? Would the lack of identity be 
reflected in the genome? If so, what part of the genome would 
reflect the lack of identity? The coding region? The noncoding 
region? Both?

    In connection with the final disposition of this investigation, the 
Commission may issue (1) An order that could result in the exclusion of 
the subject articles from entry into the United States, and/or (2) 
cease and desist orders that could result in respondents 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 are likely to do so. For background 
information, see the Commission Opinion, In the Matter of Certain 
Devices for Connecting Computers via Telephone Lines, Inv. No. 337-TA-
360.
    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 President has 60 
days to approve or disapprove the Commission's action. During this 
period, the subject articles would be entitled to enter the United 
States under a bond, in an amount to be 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.
    Written Submissions: The parties to the investigation are requested 
to file written submissions on the issues under review. The submissions 
should be concise and thoroughly referenced to the record in this 
investigation, including references to exhibits and testimony. 
Additionally, the parties to the investigation, interested government 
agencies, and any other interested persons are encouraged to file 
written submissions on the issues of remedy, the public interest, and 
bonding. Such submissions should address the ALJ's September 6, 2006, 
recommended determination on remedy and bonding. Complainant and the 
Commission investigative attorney are also requested to submit proposed 
remedial orders for the Commission's consideration. Complainant is 
requested to supply the expiration dates of the patents at issue and 
the HTSUS numbers under which the accused products are imported. The 
written submissions and proposed remedial orders must be filed no later 
than the close of business on December 12, 2006. Reply submissions must 
be filed no later than the close of business on December 22, 2006. No 
further submissions will be permitted unless otherwise ordered by the 
Commission.
    Persons filing written submissions must file with the Office of the 
Secretary the original and 12 true copies thereof on or before the 
deadlines stated above. Any person desiring to submit a document (or 
portion thereof) 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 201.6. Documents for which confidential treatment 
is granted by the Commission will be treated accordingly. All 
nonconfidential written submissions will be available for public 
inspection at the Office of the Secretary.
    This action is taken under the authority of section 337 of the 
Tariff Act of 1930, as amended (19 U.S.C. 1337), and under sections 
210.42-.46, .51(a) of the Commission's Rules of Practice and Procedure 
(19 CFR 210.42-.46, .51(a)).

    By order of the Commission.

    Issued: November 22, 2006.
Marilyn R. Abbott,
Secretary to the Commission.
[FR Doc. E6-20178 Filed 11-28-06; 8:45 am]
BILLING CODE 7020-02-P