[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 comments-biotech@upsto.gov.'' 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 kushan@uspto.gov,
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
