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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