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@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@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@uspto.gov, or by mail marked to her attention addressed to the Assistant Commissioner for Patents, Box DAC, Washington, D.C. 20231.
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.
Speakers are advised that the schedule for testimony may be subject to change during the course of the hearings.
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).
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Date
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BRUCE A. LEHMAN
Assistant Secretary of Commerce and
Commissioner of Patents and Trademarks