10/17/94 - US Patent Office Hearing on Biotechnology - San Diego, CA
merlin
merlin at neuro.usc.edu
Thu Sep 8 15:53:16 EST 1994
I would not ordinarily post a formal legal federal open hearing announcement
in this technical newsgroup. However, the very serious issue of current and
future problems in application of monopoly patent protection to biotechnology
processes and products generated in academic, government, and commercial labs
merits careful review and comment by senior representatives of our community.
The federal government invites oral testimony and machine readable written
submissions regarding problems in the current biotechnology patent process.
Hearings will be held on October 17, 1994 in San Diego, CA. Deadlines are:
o October 12, 1994 -- if you prefer to testify at the hearing
o November 23, 1994 -- if you prefer to submit a written statement
Please do not submit any materials or requests to me. I am simply making a
copy of the Federal Register hearing announcement available via the network
to the molecular biology research community. I would suggest making a copy
of this announcement available to the senior researcher in your group, your
technology transfer office, and general counsel office as soon as possible.
Please submit your request to testify or any formal written materials to the
US Patent and Trademark Office as described in the full text of the article.
A. J. Annala
Department of Biological Sciences
University of Southern California
Los Angeles, CA 90089-2520
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09/01/94 [59 FR 45267 - 45271]
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.
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 at 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 at 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
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