[Federal Register Volume 60, Number 65 (Wednesday, April 5, 1995)]
[Notices]
[Pages 17366-17367]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-8356]



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INTERNATIONAL TRADE COMMISSION

[Investigation No. 337-TA-349]


Certain Diltiazem Hydrochloride and Diltiazem Preparations; 
Notice of Commission Decision to Review Portions of an Initial 
Determination

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 certain portions of the initial 
determination (ID) and Order No. 52 issued by the presiding 
administrative law judge (ALJ) on February 2, 1995, in the above-
captioned investigation.

FOR FURTHER INFORMATION CONTACT: Cynthia P. Johnson, Esq., Office of 
the General Counsel, U.S. International Trade Commission, telephone 
202-205-3098.

SUPPLEMENTARY INFORMATION: On February 1, 1995, the presiding ALJ 
issued his final ID finding that there was no violation of section 337. 
He found that claim 1 of U.S. Letters Patent 4,438,035 ('035 patent) 
was not infringed by any of respondents' processes, that claim 1 was 
invalid as obvious under 35 U.S.C. 103, and that the '035 patent was 
unenforceable because of complainants' inequitable conduct during 
reexamination proceedings before the U.S. Patent and Trademark Office. 
In a separate order (Order No. 52), issued on the same date, the ALJ 
granted respondents' motion for evidentiary sanctions. In that order, 
he stated that because there is a Commission preference for decisions 
on the merits based on all the evidence adduced, and because he 
believes that the same conclusions of law regarding infringement would 
be appropriate whether or not the sanctions of Order No. 52 are 
applied, he was imposing sanctions on complainants only as alternate 
relief, i.e., only if the Commission determines based on all the 
evidence of record that respondents have infringed claim 1 of the '035 
patent.
    On February 21, 1995, complainants filed a petition for review of 
the ALJ's final ID. They also filed a separate petition for review of 
Order No. 52. On the same day, the Commission investigative attorneys 
(IAs) filed a petition for review of the ALJ's finding that a domestic 
industry exists.
    On March 6, 1995, the IAs, the Fermion respondents, and the 
Profarmaco respondents filed oppositions to complainants' petition for 
review. Respondent Gyma Laboratories also filed an opposition to 
petition for review indicating that it principally relies on and 
concurs in the response filed by the Profarmaco respondents.
    Having examined the record in this investigation, including the ID 
and Order No. 52, the Commission has determined to review the issues of 
(1) claim interpretation, (2) whether claim 1 of the '035 patent is 
infringed by respondents' processes; (3) whether claim 1 of the '035 
patent is invalid as obvious under 35 U.S.C. Sec. 103; (4) whether the 
'035 patent is unenforceable; and (5) Order No. 52. The Commission has 
determined not to review the remainder of the ID. The Commission 
regards the ID as including Order No. 52. The Commission has also 
denied complainants' motion for leave to file the affidavit of James 
Gambrell, and denied complainants' request for an oral hearing. With 
regard to the Gambrell affidavit, the Commission believes that 
reopening the record to accept the affidavit at this late stage of the 
investigation would not be appropriate.
    On review, the Commission is particularly interested in answers to 
the following questions:
    (1) Is claim 1 of the '035 patent entitled to any range of 
equivalents? If not, why not? If so, does the range of equivalents 
cover (1) use of methyl ethyl ketone, the next higher homolog of 
acetone, as a solvent when used with potassium hydroxide as a base, or 
(2) use of potassium carbonate and toluene as the base-solvent 
combination? Why?
    (2) What is the status of the Abic group of respondents? Have they 
settled their differences with complainants? If so, will a motion to 
terminate the Abic group of respondents from the investigation be 
forthcoming?
    (3) Is there any suggestion or motivation in the prior art 
references as a whole applied in the ID to combine those references so 
as to render obvious under 35 U.S.C. 103 the invention claimed in claim 
1 of the '035 patent?
    (4) Was there a sale in the United States of the product produced 
by the Tanabe trade secret KOH/DMSO process within the meaning of 35 
U.S.C. 102(b)? Is there applicable case law relevant to complainants' 
contention that sales of a product for the sole purpose of FDA approval 
do not constitute an ``on sale'' bar within the meaning of 35 U.S.C. 
102(b)? The Commission is interested in an analysis, based on the 
evidence of record, of whether sales made solely for purposes of FDA 
approval constitute an ``on sale'' bar, taking into account the 
analysis set forth by the Federal Circuit in considering whether a 
prior use or sale is a statutory bar in, e.g., Pennwalt Corp. v. Akzona 
Inc. (and cases cited therein) 740 F.2d 1573 (Fed. Cir. 1984). The 
Commission is also interested in any evidence of record relevant to 
complainants' contention that the only sales in the United States of 
Tanabe's trade secret KOH/DMSO process were for purposes of FDA 
approval. If the Tanabe KOH/DMSO process is found to be prior art, what 
suggestion or motivation, if any, is there in the prior art that the 
use of DMSO as a solvent would have rendered the solvents of claim 1 of 
the '035 patent obvious under 35 U.S.C. 103? Finally, assuming that the 
Tanabe KOH/DMSO process is prior art, was it more pertinent than the 
references before the examiner during the reexamination proceedings?
    In connection with 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 [[Page 17367]] 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, 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 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 specific 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. Complainants 
and the Commission investigative attorneys are also requested to submit 
proposed remedial
orders for the Commission's consideration. The written submissions and 
proposed remedial orders must be filed no later than the close of 
business on April 13, 1995. Reply submissions must be filed no later 
than the close of business on April 20, 1995. 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 document and 14 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 C.F.R. 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 (19 U.S.C. 1337) and sections 210.54-.55 of the 
Commission's Interim Rules of Practice and Procedure (19 CFR 210.54-
.55).

    Copies of the public version of the ID and all other 
nonconfidential 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 S.W., Washington, D.C. 
20436, telephone 202-205-2000. Hearing-impaired persons are advised 
that information on the matter can be obtained by contacting the 
Commission's TDD terminal on 202-205-1810.

    Issued: March 30, 1995.


    By order of the Commission.

Donna R. Koehnke,

Secretary.

[FR Doc. 95-8356 Filed 4-4-95; 8:45 am]
BILLING CODE 7020-02-P