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Request for Comments on Patent Protection for Nucleic Acid Sequences

Art Purcell purcell at WindDancer.uspto.gov
Thu Nov 16 00:38:03 EST 1995


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 "sequences at uspto.gov."

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: sequences at uspto.gov).

FOR FURTHER INFORMATION CONTACT: Esther Kepplinger by telephone at (703)
306-2714, by facsimile transmission to (703) 308-6879, by electronic mail at
ekepplin at uspto.gov, 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 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 as 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.

_______________         _______________________________________
Date                            BRUCE A. LEHMAN
                                Assistant Secretary of Commerce and
                                  Commissioner of Patents and Trademarks



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