[Federal Register Volume 60, Number 219 (Tuesday, November 14, 1995)]
[Notices]
[Pages 57223-57224]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-28053]



-----------------------------------------------------------------------

DEPARTMENT OF COMMERCE
Patent and Trademark Office


Notice of Hearings and Request for Comments on Issues Relating to 
Patent Protection for Nucleic Acid Sequences

AGENCY: Patent and Trademark Office, Commerce.

ACTION: Notice of hearings and request for comments.

-----------------------------------------------------------------------

SUMMARY: The Patent and Trademark Office (PTO) will hold public 
hearings, and it requests comments, on issues relating to patent 
protection for nucleic acid sequences. Interested members of the public 
are invited to testify at public hearings and to present written 
comments on any of the topics outlined in the supplementary information 
section of this notice.

DATES: Public hearings will be held on Wednesday, November 29, 1995, 
from 9:00 a.m. until 1:00 p.m., and Thursday, December 7, 1995, from 
9:00 a.m. until 1:00 p.m.
    Those wishing to present oral testimony at any of the hearings must 
request an opportunity to do so no later than Monday, November 27, 
1995, for the November 29 hearing, or Tuesday, December 5, 1995, for 
the December 7 hearing.
    Speakers may provide a written copy of their testimony for 
inclusion in the record of the proceedings no later than Monday, 
December 18, 1995.
    Written comments will be accepted by the PTO until December 18, 
1995.
    Written comments and transcripts of the hearings will be available 
for public inspection on or about Monday, January 22, 1996.

ADDRESSES: The November 29 hearing will be held from 9:00 a.m. until 
1:00 p.m. at the University of California, San Diego, The Mandeville 
Auditorium/Recital Hall, Muir Campus, La Jolla, California.
    The December 7 public hearing will be held from 9:00 a.m. until 
1:00 p.m. in Suite 912, Commissioner's Conference Room, Crystal Park 
Building No. 2, 2121 Crystal Drive, Arlington, Virginia.
    Requests to testify should be sent to Esther Kepplinger by 
telephone at (703) 306-2714, by facsimile transmission at (703) 308-
6879, or by mail marked to her attention addressed to the Assistant 
Commissioner for Patents, Box DAC, Washington, D.C. 20231. No request 
for oral testimony will be accepted through electronic mail.
    Written comments should be addressed to the Assistant Commissioner 
for Patents, Box DAC, Washington, D.C. 20231, marked to the attention 
of Esther Kepplinger. Comments may also be submitted by facsimile 
transmission at (703) 308-6879, with a confirmation copy mailed to the 
above address, or by electronic mail over the Internet to 
``[email protected].''
    Written comments and transcripts of the hearings will be maintained 
for public inspection in Suite 520 of Crystal Park One, 2011 Crystal 
Drive, Arlington, Virginia. Transcripts and comments provided in 
machine readable format will also be available through anonymous file 
transfer protocol (ftp) via the internet (address: 
[email protected]).

FOR FURTHER INFORMATION CONTACT: Esther Kepplinger by telephone at 
(703) 306-2714, by facsimile transmission to (703) 308-6879, by 
electronic mail at [email protected], or by mail marked to her 
attention addressed to the Assistant Commissioner for Patents, Box DAC, 
Washington, D.C. 20231.

SUPPLEMENTARY INFORMATION:

I. Background

    With the growth of the biotechnology industry have come significant 
changes in the process of research, development and commercialization 
of biotechnology inventions. For at least a decade, patent applications 
claiming nucleic acid sequences, such as genes composed of 
deoxyribonucleic acid (``DNA''), have been examined and granted patent 
rights by the PTO. These sequences typically encode known proteins or 
proteins for which applicant discovered a function. Scientific and 
technological advances have permitted researchers to identify large 
numbers of gene fragments rapidly. Armed with databases containing the 
sequences of known genes, they can identify a novel sequence. The ease 
of sequencing large numbers of random nucleic acid fragments has 
resulted in the filing of a growing number of patent applications each 
claiming thousands of nucleic acid sequences. This is a serious problem 
for the PTO. While the PTO has recently acquired sophisticated and 
costly hardware and software necessary to search applications 
containing such sequences, their examination will significantly burden 
the existing system and may necessitate the acquisition of many 
additional, expensive, massively parallel processor computers to 
complete examination in a reasonable time.
    PTO estimates that the computer search time for one hundred 
sequences is about fifteen hours and the examiner time for evaluating 
the sequence search results is about sixty-five hours. The estimated 
cost for computer search time for one hundred sequences is $1500. 
Although the number of cases involving large numbers of sequences 
presently before the PTO is small, it is estimated that the cost to 
search and examine these cases will be $8 million. These estimates 
represent searches by a massively parallel processor computer of 
commercially available databases.
    Applications that claim excessively long sequences present similar 
challenges, since the claimed sequence must be broken up into numerous 
smaller sequences in order to be searched.
    An additional issue has been raised relating to what is known as 
the Human Genome Initiative (HGI).
    The HGI is a project to obtain the entire DNA sequence in the human 
genome. Many of the benefits expected from the HGI are due to the 
characterization of expressed nucleic acid sequences in the human 
genome and their protein products.
    Some individuals believe that expressed nucleic acid sequences in 
the human genome should not be patentable because of the possibility 
that a patent to a gene fragment could preclude future use of the gene 
or its protein product. This, it is argued, could inhibit future 
research efforts to isolate the entire gene or to develop medically 
beneficial protein compounds. Others believe that 

[[Page 57224]]
the benefits of the patent system should not be withheld from this area 
of technology, because research and development would be drastically 
curtailed due to the inability to protect capital investments or to 
reap financial rewards from those investments. Appropriate policies 
must be established to address these challenges.

II. Issues for Public Comment

    Interested members of the public are invited to testify or to 
present written comments related to the above topics, including the 
following issues:
    1. Is there a more cost-effective way to examine applications 
containing large numbers of sequences or excessively long sequences, in 
view of the PTO's limited human and computer resources?
    2. How should the significantly higher cost associated with 
searching applications claiming large numbers of sequences or 
excessively long sequences be underwritten? For example:
    (a) By fees from all applications?
    (b) By fees from the biotechnology industry applications only?
    (c) By fees from those specific applications involving large 
numbers of sequences or extraordinarily long sequences?
    3. Will the patenting of a complete genome of an organism inhibit 
rather than promote advancement of the biotechnology arts? If so, why?
    4. Will the patenting of human genome fragments inhibit rather than 
promote advancement of the biotechnology arts? If so, why?

III. Guidelines for Oral Testimony

    Individuals wishing to testify at the hearings must adhere to the 
following guidelines:
    1. Requests to testify must include the speaker's name, 
affiliation, title, phone number, fax number, mailing address, and 
Internet mail address (if available).
    2. Speakers will be provided between seven and fifteen minutes to 
present their remarks. The exact amount of time allocated per speaker 
will be determined after the final number of parties testifying has 
been determined. All efforts will be made to accommodate requests for 
additional time for testimony presented before the day of the hearing.
    3. Requests to testify may be accepted on the date of the hearing 
if sufficient time is available on the schedule. No one will be 
permitted to testify without prior approval.
    A schedule providing approximate times for testimony will be 
provided to all speakers the morning of the day of the hearing.
    Speakers are advised that the schedule for testimony may be subject 
to change during the course of the hearings.

IV. Guidelines for Written Comments

    Written comments should include the following information:
    1. Name and affiliation of the individual responding.
    2. If applicable, an indication of whether comments offered 
represent views of the respondent's organization or are the 
respondent's personal views.
    3. If applicable, information on the respondent's organization, 
including the type of organization (e.g., business, trade group, 
university, non-profit organization) and general areas of interest.
    Information that is provided pursuant to this notice will be made 
part of the public record. In view of this, parties should not provide 
information they do not wish publicly disclosed. Parties who would like 
to rely on confidential information to illustrate a point being made 
are requested to summarize or otherwise provide the information in a 
way that will permit its public disclosure.
    Parties offering testimony or written comments should provide their 
comments in machine readable format, if possible. Such submissions 
should be provided by electronic mail messages over the Internet, or on 
a 3.5'' floppy disk formatted for use in either a Macintosh or MS-DOS 
based computer. Machine readable submissions should be provided as 
unformatted text (e.g., ACSII or plain text), or formatted text in one 
of the following file formats: Microsoft Word (Macintosh, DOS or 
Windows versions) or WordPerfect (Macintosh, DOS or Windows versions).

V. Guidelines for Comments via Internet

    Comments received via the Internet should include the same 
information requested in the guidelines set out for written comments.

VI. Other Information

    Questions regarding the facilities and lodging in the La Jolla, 
California, area should be directed to the University of California, 
San Diego, Special Events, by phone at (619) 534-6386, or by fax to 
(619) 534-0905. Parking permits are required for on-campus parking and 
may be purchased in advance through the Parking Office or on November 
29 at Information booths at the university. Questions regarding parking 
should be directed to the Special Events Parking Office at (619) 534-
9682, or by fax to (619) 534-9685.

    Dated: November 8, 1995.
Bruce A. Lehman,
Assistant Secretary of Commerce and Commissioner of Patents and 
Trademarks.
[FR Doc. 95-28053 Filed 11-13-95; 8:45 am]
BILLING CODE 3510-16-M