[Federal Register Volume 59, Number 169 (Thursday, September 1, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-21485]


[[Page Unknown]]

[Federal Register: September 1, 1994]


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DEPARTMENT OF COMMERCE
Patent and Trademark Office

 

Notice of Public Hearings and Request for Comments on Patent 
Protection for Biotechnological Inventions

AGENCY: Patent and Trademark Office, Commerce.

ACTION: Notice of hearings and request for public comments.

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SUMMARY: The Patent and Trademark Office (PTO) requests public comments 
on issues associated with the patenting of and use of patent rights 
related to biotechnological inventions. 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 Monday, October 17, 1994, at 
9:00 a.m. Those wishing to present oral testimony at any of the 
hearings must request an opportunity to do so no later than October 12, 
1994. Written comments on the topics presented in the supplementary 
information section of this notice will be accepted by the PTO until 
November 23, 1994.

ADDRESSES: The public hearing will be held in the Copper Room of the 
San Diego Concourse, 202 C Street, San Diego, California. Those 
interested in presenting written comments on the topics presented in 
the supplementary information, or any other related topics, should 
address their comments to the Commissioner of Patents and Trademarks, 
marked to the attention of Jeff Kushan. Comments submitted by mail 
should be sent to Commissioner of Patents and Trademarks, Box 4, Patent 
and Trademark Office, Washington, DC 20231. Comments may also be 
submitted by telefax at (703) 305-8885 and by electronic mail through 
the Internet to ``[email protected].'' Written comments 
should include the following information:

--Name and affiliation of the individual responding;
--An indication of whether comments offered represent views of the 
respondent's organization or are the respondent's personal views; and
--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.

    Parties offering testimony or written comments should provide their 
comments in machine readable format. Such submissions may be provided 
by electronic mail messages sent 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., ASCII 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).
    Persons wishing to testify must request an opportunity to do so no 
later than October 12, 1994. Requests should be sent to Jeff Kushan by 
mail, phone or fax, at the addresses listed above. No requests for 
presenting oral testimony will be accepted through electronic mail.
    Written comments and transcripts of the hearings will be available 
for public inspection on or about December 1, 1994, in Room 902 of 
Crystal Park Two, 2121 Crystal Drive, Arlington, Virginia. In addition, 
transcripts of the hearings and comments provided in machine readable 
format will be available on or around December 1, 1994, through 
anonymous file transfer protocol (ftp) via the Internet (address: 
comments.uspto.gov).

FOR FURTHER INFORMATION CONTACT: Jeff Kushan by telephone at (703) 305-
9300, by fax at (703) 305-8885, by electronic mail at [email protected], 
or by mail marked to his attention addressed to the Commissioner of 
Patents and Trademarks, Box 4, Washington, DC 20231.

SUPPLEMENTARY INFORMATION:

I. Background

    Since the Supreme Court established that non-naturally occurring 
organisms were eligible for patent protection, the patent system has 
played a crucial role in the development of the biotechnology industry. 
Exclusivity over novel, nonobvious biotechnology innovations through 
clearly identified and enforceable patent rights has greatly assisted 
the ability of companies to attract investments, undertake risks and 
devote human resources needed to develop and bring new biotechnology 
products to market. Patents have also facilitated the development of 
relationships between government, university and private sector 
partners by providing an impetus and a mechanism for commercializing 
advances at the cutting edge of biotechnology research.
    With the growth of the biotechnology industry has come significant 
changes in the process of research, development and commercialization 
of biotechnology inventions. For example, instead of working from a 
known protein sequence, many groups are now focusing on elucidating the 
significance of identified but uncharacterized cDNA sequences. 
Similarly, the greatly enhanced ability of scientists to identify and 
transfer useful genetically transmitted traits among different plant 
species has significantly changed the focus of modern plant breeding 
efforts. And the ability of scientists of discover and modify genetic 
links to previously untreatable illnesses is not only pushing back the 
frontiers of medicine, but challenging conventional assumptions 
regarding the feasibility of treating such illnesses.
    Technological changes such as these present challenges for the 
patent system. They not only affect decisions as to whether an 
invention is new and nonobvious, but even raise questions as to whether 
certain inventions are ``useful'' and therefore eligible for patent 
protection. Appropriate and well-reasoned policies must be maintained 
to address these challenges. As the agency charged with granting 
patents, the PTO has a special interest in developing and implementing 
such policies. For this reason, the PTO is interested in obtaining 
public input on a number of patent-related issues currently under 
debate in the biotechnology community.

II. Issues for Public Comment

    Interested members of the public are invited to testify and/or 
present written comments on issues they believe to be relevant to the 
discussion topics outlined below. Questions following each topic are 
included to identify specific issues upon which the PTO is interested 
in obtaining public input.
    Information that is provided pursuant to this notice will be made 
part of a public record. In view of this, parties should not provide 
information that they do not wish to be 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. 
Individuals with questions regarding submission of such information may 
contact Jeff Kushan at the numbers listed above for further 
information.
    References to ``biotechnological inventions'' in the questions 
below refer to inventions involving nucleotide sequences, proteins, 
peptides, lipids, carbohydrates, microorganisms and multicelluar 
organisms, as well as processes for making or using these products

A. Practical Utility for Biotechnological Inventions

    Under Section 101 of title 35, United State Code, an invention must 
be ``new and useful'' to be eligible to receive patent protection. This 
requirement, termed the utility requirement, has been part of the 
United States patent system for over two hundred years. The Supreme 
Court addressed the purpose of the modern utility requirement nearly 
thirty years ago in the case of Brenner v. Manson, 383 U.S. 519, 534-
535, 148 U.S.P.Q. 689 (1966):

    [T]he basic quid pro quo contemplated by the Constitution and 
the Congress for granting a patent monopoly is the benefit derived 
by the public from an invention with substantial utility. Unless and 
until a process is refined and developed to this point--where 
specific benefit exists in currently available form--there is 
insufficient justification for permitting an applicant to engross 
what may prove to be a broad field.

    Federal courts have interpreted the utility requirement to require 
that patent applicants identify a ``substantial'' or practical utility 
for the invention for which patent protection is sought. See, e.g. 
Brenner v. Manson, 383 U.S. at 536 (``But a patent is not a hunting 
license. It is not a reward for the search, but compensation for its 
successful conclusion.''); In re Ziegler, 992 F.2d 1197, 26 U.S.P.Q.2d 
1600 (Fed. Cir. 1993); Cross v. Iizuka, 753 F.2d 1040, 1044, 224 
U.S.P.Q. 739 (Fed. Cir. 1985). (``It is axiomatic that an invention 
cannot be considered `useful', in the sense that a patent can be 
granted on it, unless substantial or practical utility for the 
invention has been discovered and disclosed and disclosed where such 
utility would not be obvious.''); Nelson v. Bowler, 626 F.2d 853, 206 
U.S.P.Q. 881 (C.C.P.A. 1980); In re Kirk, 376 F.2d 936, 153 U.S.P.Q. 48 
(C.C.P.A. 1967) In re Joly, 376 F.2d 906, 153 U.S.P.Q. 45 (C.C.P.A. 
1967); In re Nelson, 280 F.2d 172, 126 U.S.P.Q. 242 (C.C.P.A. 1960).
    Recently, concerns have been expressed in research communities and 
the biotechnology industry over the role and application of the 
``practical utility'' requirement for certain biotechnological 
inventions. Such questions focus primarily on the patent-eligibility of 
technologies or innovations whose ultimate commercial significance or 
application is unclear or speculative. For example, some have raised 
``practical utility''-type concerns over attempts by organizations to 
patent fragments of nucleotide sequences that are produced incident to 
expression of a human gene, where neither the sequence nor the gene has 
been characterized as to its physical biological or physiological 
significance. Such concerns echo earlier concerns in the chemical arts 
over the patent eligibility of intermediate compounds that could be 
used to yield an unidentified, yet commercially promising final 
product, or compounds claiming therapeutic utility based only on 
findings of in vitro biological activity. See, e.g., In re Krimmel, 292 
F.2d 948, 130 U.S.P.Q. 215 (C.C.P.A. 1961); Carter-Wallace, Inc v. 
Riverton Laboratories, Inc., 433 F.2d 1034, 167 U.S.P.Q. 656 (2d Cir. 
1970).
    The PTO is interested in ensuring that the practical utility 
requirement is governed by standards that promote research, development 
and commercialization of technological advances in the scientific 
fields that make up biotechnology. Public comments are invited to 
assist the PTO in identifying problems, if any, that exist in the law 
governing practical utility or its application by the PTO during 
examination.
    1. Do you believe that the legal standards governing the 
requirement for identification of practical or substantial utility 
under 35 U.S.C. 101, as developed by the Federal courts, are 
sufficiently clear and appropriate for biotechnological inventions? If 
not, please:
    (a) identify aspects of the law that you believe lack clarity or 
are inappropriate, citing relevant cases; and
    (b) identify changes to legal standards you believe would be 
desirable.
    2. Do you believe that the PTO is correctly and uniformly applying 
the legal standards governing the requirement for identification of 
practical or substantial utility under 35 U.S.C. 101 for 
biotechnological inventions? If not, please:
    (a) identify the basis for your belief that the PTO is not 
correctly or uniformly applying the legal standards governing practical 
utility;
    (b) identify changes you would like to see the PTO make in its 
application of this requirement during examination of patent 
applications; and
    (c) discuss the implications of such changes, not only with respect 
to patent applicants seeking protection but also for scientific 
research and development in general.
    3. Do you believe legal standards and examining practices in 
foreign systems to assess the patent eligibility of biotechnological 
inventions (e.g. those governing industrial applicability and 
exclusions for patentability) provide a better framework than is 
available for in the United States? Please identify desirable and 
undesirable practices of foreign offices, particularly the Japanese 
Patent Office and European Patent Office, in this regard.

B. Proof of Operability for Human Therapeutic Inventions

    To be eligible to receive patent protection, an invention must be 
operative (e.g., it must ``work as claimed''). Two statutory 
requirements govern this requirement. First, courts have interpreted 
the utility requirements of 35 U.S.C. 101 to require that an invention 
be operative to possess utility. See, eg., Raytheon Co. v. Roper Corp., 
724 F.2d 951, 956, 220 U.S.P.Q. 592 (Fed. Cir. 1983), cert. denied, 469 
U.S. 835, (1984); Stiftung v. Renishaw PLC, 945 F.2d 1173, 20 
U.S.P.Q.2d 1094 (Fed. Cir. 1991); In re Gazave, 379 F.2d 973, 154 
U.S.P.Q. 92 (C.C.P.A. 1967); In re Chilowsky, 229 F.2d 457, 108 
U.S.P.Q. 321 (C.C.P.A. 1956). Second 35 U.S.C. 112, first paragraph, 
requires that an inventor provide a disclosure of the invention that 
will enable a person of skill in the art to make and use the claimed 
invention. Rejections that assert that an invention is inoperative and 
therefore lacking of utility under 35 U.S.C. 101 are often accompanied 
by rejections under Sec. 112 that assert that the specification is not 
enabling. See, In re Zeigler, 992 F.2d 1197, 1200-1201, 26 U.S.P.Q.2d 
1600 (Fed. Cir. 1993)(``[t]he how to use prong of section 112 
incorporates as a matter of law the requirement of 35 U.S.C. 101 that 
the specification disclose as a matter of fact a practical utility for 
the invention [...] If the application fails as a matter of fact to 
satisfy 35 U.S.C. 101, then the application also fails as a matter of 
law to enable one skilled in the art to use the invention under 35 
U.S.C. 112.''). See also, In re Marzocchi, 439 F.2d 220, 169 U.S.P.Q.). 
367 (C.C.P.A. 1971); In re Bundy, 642 F.2d 430, 209 U.S.P.Q. 48 
(C.C.P.A. 1981); In re Fouche, 439 F.2d 1237, 169 U.S.P.Q. 429 
(C.C.P.A. 1971). In assessing each of these requirements, the PTO must 
accept the assertions of the patent applicant that the invention is 
operable as true unless the PTO provides credible, scientifically based 
reasons to the contrary. See e.g., In re Jolles, 628 F.2d 1322, 1327, 
206 U.S.P.Q. 885 (C.C.P.A. 1980) (``When utility as a drug, medicament, 
and the like in human therapy is alleged, it is proper for the examiner 
to ask for substantiating evidence unless one skilled in the art would 
accept the allegations as obviously correct.'').
    The vast majority of inventions for which patent protection is 
sought do not raise questions related to operability. In contrast, 
applications drawn to inventions whose sole identified use is the 
treatment of human disorders frequently require consideration of 
operability issues, particularly for inventions drawn to treatment of 
disorders presently considered ``incurable'' (e.g., cancer, HIV). While 
necessarily fact dependent, resolution of questions regarding 
operability has been aided by a number of decisions from the Federal 
courts and from the PTO Board of Patent Appeals and Interferences. 
These holdings have addressed such issues as whether a therapeutically 
related invention must be shown to be safe and effective in humans, the 
type of evidence an applicant must provide to demonstrate that the 
invention will work as claimed and under what circumstances the PTO may 
require an applicant to provide such evidence. See e.g., In re Langer, 
503 F.2d 1380, 183 U.S.P.Q. 288 (C.C.P.A. 1974); In re Anthony, 414 
F.2d 1383, 162 U.S.P.Q. 594 (C.C.P.A. 1969): In re Hartop, 311 F.2d 
249, 135 U.S.P.Q. 419 ( C.C.P.A. 1962); In re Malachowiski, 530 F.2d 
1402, 189 U.S.P.Q. 432 (C.C.P.A. 1976), Ex parte Balzarini, 21 
U.S.P.Q.2d 1892 (B.P.A.I. 1991); Ex parte Rubin, 5 U.S.P.Q.2d 1461 
(B.P.A.I. 1987). See also, Manual of Patent Examining Procedure, 
Sec. 608,01(p)(A)(5th Ed., Rev. 16 1994).
    Examination of patent applications claiming products and processes 
for treating human disorders, particularly those for which no known 
cure exists, can be challenging and controversial. For example, some 
have expressed concern over the nature of quantity of evidence required 
by the PTO during examination to support claims for inventions used to 
treat human disorders. Such requirements are cited as being an improper 
use of the utility or enablement requirements to assess the 
effectiveness or safety of a human therapeutic invention. Yet, others 
have identified important public policy justifications for the PTO to 
review operability of inventions to be used to treat human disorders. A 
patent provides the public with a high-quality technically accurate 
disclosure of a new, useful and nonobvious invention. However, with the 
imprimatur of the Federal Government, a patent can also affect the 
commercial prospects of the invention in question, and can raise or 
lower expectations of those afflicted with the illness the invention is 
designed to treat.
    The PTO, therefore, seeks public input on legal standards governing 
the requirement of operability of inventions under 35 U.S.C. 101 and 
112, first paragraph, and their application during patent examination.
    1. Do you believe that the legal standards governing proof of 
operability for inventions relating to treatment of human disorders 
under the utility requirement of 35 U.S.C. 101 and under the enablement 
requirement of 35 U.S.C. 112, first paragraph, as developed and 
interpreted by the Federal courts, are sufficiently clear and 
appropriate? If not, please:
    (a) identify aspects of the law that you believe lack clarity or 
are inappropriate, citing relevant cases; and
    (b) identify any changes to these legal standards you believe would 
be desirable.
    2. Do you believe the PTO is correctly and uniformly applying the 
legal standards governing proof of operability under 35 U.S.C. Sec. 101 
and Sec. 112, first paragraph, during examination of patent 
applications claiming inventions for treatment of human disorders? If 
not, please:
    (a) identify specific practices that you believe are inappropriate, 
particularly with respect to evidentiary requirements to establish 
operability, effectiveness or safety of a claimed human therapeutic 
product or process;
    (b) provide or summarize examples where you believe the PTO has 
incorrectly or inappropriately imposed or maintained an evidentiary 
requirement to support operability, under either Sec. 101, Sec. 112 or 
both, of an invention for use in treatment of a human disorder;
    (c) identify changes you would like to see the PTO make in 
examination of applications claiming inventions related to treatment of 
human disorders under 35 U.S.C. Sec. 101 or Sec. 112, first paragraph; 
and
    (d) discuss the implications of such changes, not only for patent 
applicants seeking protection, but also for scientific research and 
development related to treatment of human disorders as well as the 
public health and welfare.
    3. Do you believe legal standards and examining practices in 
foreign systems provide a better framework than is available in the 
United States for assessing patentability questions related to 
operability of inventions for treating human disorders? Please identify 
desirable or undesirable practices of foreign offices, particularly the 
Japanese Patent Office and the European Patent Office, in this regard.

C. Technical Standards Used in Measuring Nonobviousness and Enablement 
of Biotechnological Inventions

    The law governing nonobviousness for biotechnological inventions, 
particularly those involving manipulation of genetic material, has been 
refined through a series of decisions by the Court of Appeals for the 
Federal Circuit, and by the PTO Board of Patent Appeals and 
Interferences. See, e.g., Amgen, Inc. v. Chugai Pharmaceutical Co., 927 
F.2d 1200, 18 U.S.P.Q.2d 1016 (Fed. Cir. 1991); In re Bell, 991 F.2d 
781, 26 U.S.P.Q.2d 1529 (Fed. Cir. 1993); In re O'Farrell, 853 F.2d 
894, 7 U.S.P.Q.2d 1673 (Fed. Cir. 1988); Ex parte Anderson, 30 
U.S.P.Q.2d 1866 (B.P.A.I. 1993); Ex parte Deuel, 27 U.S.P.Q.2d 1360 
(B.P.A.I. 1993); appeal docketed, No. 94-1202 (Fed. Cir. Feb. 25, 
1994); Ex parte Movva, 31 U.S.P.Q.2d 1027 (B.P.A.I. 1993). Similarly, 
important questions regarding enablement of such inventions has been 
addressed in a number of decisions by the Federal Circuit. See, e.g., 
Amgen, 927 F.2d at 1212, 18 U.S.P.Q.2d at 1026; In re Wright, 999 F.2d 
1557; 27 U.S.P.Q.2d 1510 (Fed. Cir. 1993); In re Wands, 858 F.2d 731, 8 
U.S.P.Q.2d 1400 (Fed. Cir. 1988); In re Vaeck, 947 F.2d 488, 20 
U.S.P.Q.2d 1438 (Fed. Cir. 1991); In re Goodman, 11 F.3d 1046, 29 
U.S.P.Q.2d 2010 (Fed. Cir. 1993). This growing body of decisions has 
provided the patent bar and the PTO with much needed guidance on 
application of the statutory conditions of patentability for 
biotechnology inventions.
    However, the state of the art in the various fields of technology 
that make up biotechnology is advancing rapidly. Research, development 
and commercialization in the field of genetic engineering, in 
particular, has undergone significant changes over the past decade. For 
example, in the early 1980s, efforts to elucidate and isolate a gene 
sequence typically began with work on a known protein. If possible, one 
would sequence all or a portion of the amino acid sequence of the 
protein. Then, armed with this information, a researcher could design 
DNA probes and eventually identify and isolate the gene encoding the 
protein of interest. Today, scientists can sometimes identify a 
fragment of an expressed gene well before they know anything about the 
eventual whole gene or its expression product. While this makes it 
possible for researchers to easily gain access to genetic information, 
it can also create problems for an inventor concerned about gaining 
meaningful patent protection for the technology under development.
    Changes in the state of the art affect determinations as to the 
level of skill possessed by an individual working in the field of 
technology of an invention. And this assessment affects the PTO's 
application of two of the statutory requirements of patentability. 
Under 35 U.S.C. 103, nonobviousness of an invention is measured through 
reference to knowledge and experience of one of ordinary skill in the 
art. Under 35 U.S.C. 112, adequacy of disclosure of an application is 
measured from the perspective of one skilled in the art to which the 
invention pertains. Changes in the level of skill in the art thus 
directly affect how the PTO reaches conclusions regarding patentability 
of inventions, particularly where the state of the art is advancing 
rapidly.
    Some patent practitioners and biotechnology company representatives 
have expressed concerns related to how the PTO assesses the skill level 
of individuals working in the various fields of biotechnology. For 
example, some argue that it is inappropriate for the PTO to reject an 
invention involving genetic manipulation as being obvious over prior 
art disclosing conventional genetic engineering techniques while at the 
same time rejecting the application as not being in compliance with the 
enablement requirement under section 112. Similarly, some have 
criticized the PTO for rejecting claims to monoclonal antibodies as 
being obvious over disclosure of the antigen that serves as the basis 
for making the antibody in view of conventional hybridoma technology, 
while at the same time requiring an applicant to deposit samples of the 
hybridoma pursuant to the enablement requirement of section 112. Still 
others suggest that the PTO is imposing a ``per se'' rule of 
obviousness for inventions involving sequencing and expression of genes 
once ``any'' sequence information has been publicly disclosed, whether 
that sequence information takes the form of a partial amino acid 
sequence of a protein or DNA sequence information derived from the 
expression of the gene. It has been suggested that such an approach 
improperly attributes a much higher level of skill to the person of 
``ordinary'' skill in the art than is appropriate at this time.
    It is difficult for the PTO to respond to these concerns, 
particularly when expressed anecdotally. To receive a patent, an 
invention for which patent protection is sought must comply with all 
statutory requirements of patentability. The PTO examines each patent 
application on its own merits and does not apply per se rules regarding 
obviousness, enablement or any other statutory requirement of 
petentability. Furthermore, the PTO strives to ensure that its 
examining practices reflect appropriate scientific and technological 
standards. The PTO thus seeks public input to help it ensure that it is 
properly construing and applying the statutory requirements of 
patentability, particularly those that depend upon evaluation of skill 
levels in the field of biotechnology.
    1. Do you believe the legal standards governing assessment of the 
ordinary level of skill in the art for purposes of nonobviousness under 
35 U.S.C. 103, as developed and interpreted by the Federal courts, are 
sufficiently clear and appropriate for biotechnology inventions? If 
not,
    (a) identify aspects of the law that you believe lack clarity or 
are inappropriate, citing relevant cases; and
    (b) identify any changes to these legal standards you believe would 
be desirable.
    2. Do you believe the legal standards governing assessment of the 
level of skill attributable to a person ``skilled in the art'' in 
determinations made under 35 U.S.C. 112, first paragraph, as developed 
and interpreted by the Federal courts, are sufficiently clear and 
appropriate? If not,
    (a) identify aspects of the law that you believe lack clarity or 
are inappropriate, citing relevant cases; and
    (b) identify any changes to these legal standards you believe would 
be desirable.
    3. Do you believe the PTO is correctly assessing the level of skill 
possessed by persons working in the field of biotechnology in 
determinations it makes regarding nonobviousness under 35 U.S.C. 103 
and enablement under section 112, first paragraph? In particular:
    (a) Do you believe that PTO is properly assessing the level of 
``ordinary skill'' in the art of biotechnology under 35 U.S.C. 103? If 
not, please provide examples and identify specific situations where 
determinations have not been made that reflect the appropriate 
standard.
    (b) Do you believe that PTO is properly assessing the level of 
skill possessed by biotechnology inventors in determining compliance of 
an application with 35 U.S.C. 112, first paragraph? If not, please 
provide examples and identify specific situations where determinations 
have not been made that reflect the appropriate standard.
    (c) Do you believe the PTO should equate the knowledge and 
experience of a person ``skilled in the art to which the invention 
pertains'' under section 112 to that possessed by a ``person of 
ordinary skill in the art'' under section 103? Please explain the basis 
for your conclusions.
    4. Are there specific practices of the PTO with regard to 
determinations under 35 U.S.C. 103 or 112 for biotechnological 
inventions that you believe are inappropriate or inconsistent with 
legal precedent? If so,
    (a) please identify with specificity the practices in question, 
providing examples;
    (b) explain why the identified practices are inappropriate or 
inconsistent with relevant legal precedent;
    (c) suggest specific changes that would address your concerns; and
    (d) explain the implications of such changes, not only for 
inventors seeking patent protection, but for researchers and third 
parties engaged in biotechnology research and development.
    5. Do you believe legal standards and examining practices in 
foreign systems provide a better framework for making patentability 
determinations that depend upon the level of skill in the relevant 
field of biotechnology than is utilized in the United States? Please 
identify desirable and undesirable practices of foreign offices, 
particularly the Japanese Patent Office and the European Patent Office, 
in this regard.

D. Implications of Pending Legislative Patent Reform on PTO Operations 
and Examination Procedures

    Several patent reform initiatives are pending before or under 
consideration by the Congress. These include measures that would 
provide a 20-year patent term measured from the U.S. filing date of an 
application, establish a provisional patent application system, permit 
patent applicants to claim domestic priority to previously filed U.S. 
applications, and automatically publish patent applications 18 months 
after their earliest effective filing date. Implementation of these 
measures, should they be enacted into law, will require careful 
consideration of the objectives of the legislation and the special 
needs of users of the patent system, particularly those from the 
biotechnology and related industries. For this reason, the PTO seeks 
public input as to how to best implement changes to patent examining 
procedures and its operations that may be required if these legislative 
reforms are enacted.
    1. Do you believe there are procedural steps that the PTO could 
adopt to facilitate use of a provisional application filing system by 
biotechnology inventors, particularly with respect to filing of DNA or 
amino acid sequence information?
    2. The PTO is spending in excess of $2 million to obtain the 
special computer capability for storing and searching DNA sequence 
information. Do you believe this cost should be recovered from all 
patent applicants, or only applicants who file applications which 
require use of these special facilities?
    3. Please identify changes, if any, to current restriction 
practices that you believe would be appropriate in a patent system that 
provides for automatic publication of applications and a 20-year patent 
term measured from filing. In discussing this, please:
    (a) indicate requirements or measures that would be appropriate for 
the PTO to impose on patent applicants to enable it to examine multiple 
patentably distinct inventions in a single application, and
    (b) identify practices of foreign offices, particularly the 
Japanese Patent Office and the European Patent Office, with regard to 
unity of invention for applications claiming inventions involving 
genetic material that would be appropriate or inappropriate for use by 
the PTO.
    4. Please identify changes to other aspects of PTO examining 
practices or operations that could be made in implementing a 20-year 
patent term, provisional application filing, or 18-month publication 
that you believe would be desirable or beneficial for the biotechnology 
industry. If possible, please comment on procedures available in 
foreign systems that you believe would be desirable for the U.S. to 
adopt in implementing these changes.

E. Experimental Use Defense to Patent Infringement

    Note: The PTO has previously solicited written comments on the 
experimental use defense to patent infringement. See, Public 
Hearings and Request for Comments on Economic Aspects of the U.S. 
Patent System, 58 FR 68394 (December 27, 1993); Cancellation of 
Public Hearings on Economic Aspects of the U.S. Patent System, 59 FR 
1935 (January 13, 1994). Several individuals, in responding to this 
earlier request for public comment, expressed a desire to present 
oral remarks. Those individuals interested in testifying on the 
topics presented in the earlier Federal Register notice are invited 
to do so at this public hearing. In addition, those interested in 
offering written comments on the topics presented in the earlier 
notice may provide those comments in conformance with the guidelines 
outlined in this notice.

F. Protection Afforded by Plant Patents

    Under section 163 of title 35, United States Code, a plant patent 
affords its holder only the right to exclude others from sexually 
reproducing the plant or using the plant so reproduced. As such, 
protection afforded by a plant patent does not extend to parts of the 
protected plant, such as harvested material (e.g., table fruit, cut 
flowers, etc.). This has enabled growers to reproduce and use, outside 
the United States, plants subject to a U.S. plant patent, and 
subsequently import products harvested from such plants, to the 
detriment of the U.S. plant patent owner.
    Legislation presently pending before Congress would, if enacted, 
permit the United States to adhere to the 1991 Act of the International 
Convention for the Protection of New Varieties of Plants (UPOV). In 
accordance with the provisions of that Convention, the United States 
would thus amend its laws to provide, among other things, protection 
for harvested material obtained from sexually reproduced plant 
varieties.

    Note: The most commonly used title of protection for sexually 
reproduced plant varieties is the Plant Variety Protection Act 
sections 2321-2582, title 7, United States Code, which is 
administered by the U.S. Department of Agriculture. As the agency 
charged with administration of the Plant Patent Act, the PTO is 
interested in obtaining public comments on the following question.

    1. Do you believe that the Plant Patent Act should be amended to 
permit a holder of United States plant patent to exercise exclusive 
rights with respect to parts of a protected plant, such as material 
harvested from the plant?

G. Other Issues

    Parties may address matters not specifically identified in the 
above sections. If this is done, parties are requested to:

--Label that portion of their response as ``Other Issues'';
--Clearly identify the matter being addressed;
--Provide examples, where appropriate, that illustrate the matter 
addressed;
--Identify any relevant legal authorities applicable to the matter 
being addressed; and
--Provide suggestions regarding how the matter should be addressed by 
the PTO.

III. Guidelines for Oral Testimony

    Individuals wishing to testify must adhere to the following 
guidelines:
    1. Anyone wishing to testify at the hearings must request an 
opportunity to do so no later than October 12, 1994. 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.
    2. Requests to testify must include the speaker's name, affiliation 
and title, phone number, fax number, mailing address, and Internet mail 
address (if available). Parties may include in their request and 
indication as to whether the party wishes to testify during the morning 
or afternoon session of the hearing.
    3. Speakers will be provided between 7 and 15 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.
    4. Speakers may provide a written copy of their testimony for 
inclusion in the record of the proceedings. These remarks should be 
provided no later that October 28, 1994.
    5. Speakers must adhere to guidelines established for testimony. 
These guidelines will be provided to all speakers on or before October 
14, 1994.
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 will be subject to change 
during the course of the hearings.

IV. Other Information

    Questions regarding the Convention facilities or lodging in the San 
Diego area should be directed to the San Diego Convention Center 
Corporation, by phone to (619) 236-6500, or by fax to (619) 236-6849.

    Dated: August 25, 1994.
Bruce A. Lehman,
Assistant Secretary of Commerce and Commissioner of Patents and 
Trademarks.
[FR Doc. 94-21485 Filed 8-31-94; 8:45 am]
BILLING CODE 3510-16-M