[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
