[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] ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- SUMMARY: The Patent and Trademark Office (PTO) requests public comments on issues associated with the patenting of and use of patent rights related to biotechnological inventions. Interested members of the public are invited to testify at public hearings and to present written comments on any of the topics outlined in the supplementary information section of this notice. DATES: Public hearings will be held on Monday, October 17, 1994, at 9:00 a.m. Those wishing to present oral testimony at any of the hearings must request an opportunity to do so no later than October 12, 1994. Written comments on the topics presented in the supplementary information section of this notice will be accepted by the PTO until November 23, 1994. ADDRESSES: The public hearing will be held in the Copper Room of the San Diego Concourse, 202 C Street, San Diego, California. Those interested in presenting written comments on the topics presented in the supplementary information, or any other related topics, should address their comments to the Commissioner of Patents and Trademarks, marked to the attention of Jeff Kushan. Comments submitted by mail should be sent to Commissioner of Patents and Trademarks, Box 4, Patent and Trademark Office, Washington, DC 20231. Comments may also be submitted by telefax at (703) 305-8885 and by electronic mail through the Internet to ``[email protected].'' Written comments should include the following information: --Name and affiliation of the individual responding; --An indication of whether comments offered represent views of the respondent's organization or are the respondent's personal views; and --If applicable, information on the respondent's organization, including the type of organization (e.g., business, trade group, university, non-profit organization) and general areas of interest. Parties offering testimony or written comments should provide their comments in machine readable format. Such submissions may be provided by electronic mail messages sent over the Internet, or on a 3.5'' floppy disk formatted for use in either a Macintosh or MS-DOS based computer. Machine-readable submissions should be provided as unformatted text (e.g., ASCII or plain text), or as formatted text in one of the following file formats: Microsoft Word (Macintosh, DOS or Windows versions) or WordPerfect (Macintosh, DOS or Windows versions). Persons wishing to testify must request an opportunity to do so no later than October 12, 1994. Requests should be sent to Jeff Kushan by mail, phone or fax, at the addresses listed above. No requests for presenting oral testimony will be accepted through electronic mail. Written comments and transcripts of the hearings will be available for public inspection on or about December 1, 1994, in Room 902 of Crystal Park Two, 2121 Crystal Drive, Arlington, Virginia. In addition, transcripts of the hearings and comments provided in machine readable format will be available on or around December 1, 1994, through anonymous file transfer protocol (ftp) via the Internet (address: comments.uspto.gov). FOR FURTHER INFORMATION CONTACT: Jeff Kushan by telephone at (703) 305- 9300, by fax at (703) 305-8885, by electronic mail at [email protected], or by mail marked to his attention addressed to the Commissioner of Patents and Trademarks, Box 4, Washington, DC 20231. SUPPLEMENTARY INFORMATION: I. Background Since the Supreme Court established that non-naturally occurring organisms were eligible for patent protection, the patent system has played a crucial role in the development of the biotechnology industry. Exclusivity over novel, nonobvious biotechnology innovations through clearly identified and enforceable patent rights has greatly assisted the ability of companies to attract investments, undertake risks and devote human resources needed to develop and bring new biotechnology products to market. Patents have also facilitated the development of relationships between government, university and private sector partners by providing an impetus and a mechanism for commercializing advances at the cutting edge of biotechnology research. With the growth of the biotechnology industry has come significant changes in the process of research, development and commercialization of biotechnology inventions. For example, instead of working from a known protein sequence, many groups are now focusing on elucidating the significance of identified but uncharacterized cDNA sequences. Similarly, the greatly enhanced ability of scientists to identify and transfer useful genetically transmitted traits among different plant species has significantly changed the focus of modern plant breeding efforts. And the ability of scientists of discover and modify genetic links to previously untreatable illnesses is not only pushing back the frontiers of medicine, but challenging conventional assumptions regarding the feasibility of treating such illnesses. Technological changes such as these present challenges for the patent system. They not only affect decisions as to whether an invention is new and nonobvious, but even raise questions as to whether certain inventions are ``useful'' and therefore eligible for patent protection. Appropriate and well-reasoned policies must be maintained to address these challenges. As the agency charged with granting patents, the PTO has a special interest in developing and implementing such policies. For this reason, the PTO is interested in obtaining public input on a number of patent-related issues currently under debate in the biotechnology community. II. Issues for Public Comment Interested members of the public are invited to testify and/or present written comments on issues they believe to be relevant to the discussion topics outlined below. Questions following each topic are included to identify specific issues upon which the PTO is interested in obtaining public input. Information that is provided pursuant to this notice will be made part of a public record. In view of this, parties should not provide information that they do not wish to be publicly disclosed. Parties who would like to rely on confidential information to illustrate a point being made are requested to summarize or otherwise provide the information in a way that will permit its public disclosure. Individuals with questions regarding submission of such information may contact Jeff Kushan at the numbers listed above for further information. References to ``biotechnological inventions'' in the questions below refer to inventions involving nucleotide sequences, proteins, peptides, lipids, carbohydrates, microorganisms and multicelluar organisms, as well as processes for making or using these products A. Practical Utility for Biotechnological Inventions Under Section 101 of title 35, United State Code, an invention must be ``new and useful'' to be eligible to receive patent protection. This requirement, termed the utility requirement, has been part of the United States patent system for over two hundred years. The Supreme Court addressed the purpose of the modern utility requirement nearly thirty years ago in the case of Brenner v. Manson, 383 U.S. 519, 534- 535, 148 U.S.P.Q. 689 (1966): [T]he basic quid pro quo contemplated by the Constitution and the Congress for granting a patent monopoly is the benefit derived by the public from an invention with substantial utility. Unless and until a process is refined and developed to this point--where specific benefit exists in currently available form--there is insufficient justification for permitting an applicant to engross what may prove to be a broad field. Federal courts have interpreted the utility requirement to require that patent applicants identify a ``substantial'' or practical utility for the invention for which patent protection is sought. See, e.g. Brenner v. Manson, 383 U.S. at 536 (``But a patent is not a hunting license. It is not a reward for the search, but compensation for its successful conclusion.''); In re Ziegler, 992 F.2d 1197, 26 U.S.P.Q.2d 1600 (Fed. Cir. 1993); Cross v. Iizuka, 753 F.2d 1040, 1044, 224 U.S.P.Q. 739 (Fed. Cir. 1985). (``It is axiomatic that an invention cannot be considered `useful', in the sense that a patent can be granted on it, unless substantial or practical utility for the invention has been discovered and disclosed and disclosed where such utility would not be obvious.''); Nelson v. Bowler, 626 F.2d 853, 206 U.S.P.Q. 881 (C.C.P.A. 1980); In re Kirk, 376 F.2d 936, 153 U.S.P.Q. 48 (C.C.P.A. 1967) In re Joly, 376 F.2d 906, 153 U.S.P.Q. 45 (C.C.P.A. 1967); In re Nelson, 280 F.2d 172, 126 U.S.P.Q. 242 (C.C.P.A. 1960). Recently, concerns have been expressed in research communities and the biotechnology industry over the role and application of the ``practical utility'' requirement for certain biotechnological inventions. Such questions focus primarily on the patent-eligibility of technologies or innovations whose ultimate commercial significance or application is unclear or speculative. For example, some have raised ``practical utility''-type concerns over attempts by organizations to patent fragments of nucleotide sequences that are produced incident to expression of a human gene, where neither the sequence nor the gene has been characterized as to its physical biological or physiological significance. Such concerns echo earlier concerns in the chemical arts over the patent eligibility of intermediate compounds that could be used to yield an unidentified, yet commercially promising final product, or compounds claiming therapeutic utility based only on findings of in vitro biological activity. See, e.g., In re Krimmel, 292 F.2d 948, 130 U.S.P.Q. 215 (C.C.P.A. 1961); Carter-Wallace, Inc v. Riverton Laboratories, Inc., 433 F.2d 1034, 167 U.S.P.Q. 656 (2d Cir. 1970). The PTO is interested in ensuring that the practical utility requirement is governed by standards that promote research, development and commercialization of technological advances in the scientific fields that make up biotechnology. Public comments are invited to assist the PTO in identifying problems, if any, that exist in the law governing practical utility or its application by the PTO during examination. 1. Do you believe that the legal standards governing the requirement for identification of practical or substantial utility under 35 U.S.C. 101, as developed by the Federal courts, are sufficiently clear and appropriate for biotechnological inventions? If not, please: (a) identify aspects of the law that you believe lack clarity or are inappropriate, citing relevant cases; and (b) identify changes to legal standards you believe would be desirable. 2. Do you believe that the PTO is correctly and uniformly applying the legal standards governing the requirement for identification of practical or substantial utility under 35 U.S.C. 101 for biotechnological inventions? If not, please: (a) identify the basis for your belief that the PTO is not correctly or uniformly applying the legal standards governing practical utility; (b) identify changes you would like to see the PTO make in its application of this requirement during examination of patent applications; and (c) discuss the implications of such changes, not only with respect to patent applicants seeking protection but also for scientific research and development in general. 3. Do you believe legal standards and examining practices in foreign systems to assess the patent eligibility of biotechnological inventions (e.g. those governing industrial applicability and exclusions for patentability) provide a better framework than is available for in the United States? Please identify desirable and undesirable practices of foreign offices, particularly the Japanese Patent Office and European Patent Office, in this regard. B. Proof of Operability for Human Therapeutic Inventions To be eligible to receive patent protection, an invention must be operative (e.g., it must ``work as claimed''). Two statutory requirements govern this requirement. First, courts have interpreted the utility requirements of 35 U.S.C. 101 to require that an invention be operative to possess utility. See, eg., Raytheon Co. v. Roper Corp., 724 F.2d 951, 956, 220 U.S.P.Q. 592 (Fed. Cir. 1983), cert. denied, 469 U.S. 835, (1984); Stiftung v. Renishaw PLC, 945 F.2d 1173, 20 U.S.P.Q.2d 1094 (Fed. Cir. 1991); In re Gazave, 379 F.2d 973, 154 U.S.P.Q. 92 (C.C.P.A. 1967); In re Chilowsky, 229 F.2d 457, 108 U.S.P.Q. 321 (C.C.P.A. 1956). Second 35 U.S.C. 112, first paragraph, requires that an inventor provide a disclosure of the invention that will enable a person of skill in the art to make and use the claimed invention. Rejections that assert that an invention is inoperative and therefore lacking of utility under 35 U.S.C. 101 are often accompanied by rejections under Sec. 112 that assert that the specification is not enabling. See, In re Zeigler, 992 F.2d 1197, 1200-1201, 26 U.S.P.Q.2d 1600 (Fed. Cir. 1993)(``[t]he how to use prong of section 112 incorporates as a matter of law the requirement of 35 U.S.C. 101 that the specification disclose as a matter of fact a practical utility for the invention [...] If the application fails as a matter of fact to satisfy 35 U.S.C. 101, then the application also fails as a matter of law to enable one skilled in the art to use the invention under 35 U.S.C. 112.''). See also, In re Marzocchi, 439 F.2d 220, 169 U.S.P.Q.). 367 (C.C.P.A. 1971); In re Bundy, 642 F.2d 430, 209 U.S.P.Q. 48 (C.C.P.A. 1981); In re Fouche, 439 F.2d 1237, 169 U.S.P.Q. 429 (C.C.P.A. 1971). In assessing each of these requirements, the PTO must accept the assertions of the patent applicant that the invention is operable as true unless the PTO provides credible, scientifically based reasons to the contrary. See e.g., In re Jolles, 628 F.2d 1322, 1327, 206 U.S.P.Q. 885 (C.C.P.A. 1980) (``When utility as a drug, medicament, and the like in human therapy is alleged, it is proper for the examiner to ask for substantiating evidence unless one skilled in the art would accept the allegations as obviously correct.''). The vast majority of inventions for which patent protection is sought do not raise questions related to operability. In contrast, applications drawn to inventions whose sole identified use is the treatment of human disorders frequently require consideration of operability issues, particularly for inventions drawn to treatment of disorders presently considered ``incurable'' (e.g., cancer, HIV). While necessarily fact dependent, resolution of questions regarding operability has been aided by a number of decisions from the Federal courts and from the PTO Board of Patent Appeals and Interferences. These holdings have addressed such issues as whether a therapeutically related invention must be shown to be safe and effective in humans, the type of evidence an applicant must provide to demonstrate that the invention will work as claimed and under what circumstances the PTO may require an applicant to provide such evidence. See e.g., In re Langer, 503 F.2d 1380, 183 U.S.P.Q. 288 (C.C.P.A. 1974); In re Anthony, 414 F.2d 1383, 162 U.S.P.Q. 594 (C.C.P.A. 1969): In re Hartop, 311 F.2d 249, 135 U.S.P.Q. 419 ( C.C.P.A. 1962); In re Malachowiski, 530 F.2d 1402, 189 U.S.P.Q. 432 (C.C.P.A. 1976), Ex parte Balzarini, 21 U.S.P.Q.2d 1892 (B.P.A.I. 1991); Ex parte Rubin, 5 U.S.P.Q.2d 1461 (B.P.A.I. 1987). See also, Manual of Patent Examining Procedure, Sec. 608,01(p)(A)(5th Ed., Rev. 16 1994). Examination of patent applications claiming products and processes for treating human disorders, particularly those for which no known cure exists, can be challenging and controversial. For example, some have expressed concern over the nature of quantity of evidence required by the PTO during examination to support claims for inventions used to treat human disorders. Such requirements are cited as being an improper use of the utility or enablement requirements to assess the effectiveness or safety of a human therapeutic invention. Yet, others have identified important public policy justifications for the PTO to review operability of inventions to be used to treat human disorders. A patent provides the public with a high-quality technically accurate disclosure of a new, useful and nonobvious invention. However, with the imprimatur of the Federal Government, a patent can also affect the commercial prospects of the invention in question, and can raise or lower expectations of those afflicted with the illness the invention is designed to treat. The PTO, therefore, seeks public input on legal standards governing the requirement of operability of inventions under 35 U.S.C. 101 and 112, first paragraph, and their application during patent examination. 1. Do you believe that the legal standards governing proof of operability for inventions relating to treatment of human disorders under the utility requirement of 35 U.S.C. 101 and under the enablement requirement of 35 U.S.C. 112, first paragraph, as developed and interpreted by the Federal courts, are sufficiently clear and appropriate? If not, please: (a) identify aspects of the law that you believe lack clarity or are inappropriate, citing relevant cases; and (b) identify any changes to these legal standards you believe would be desirable. 2. Do you believe the PTO is correctly and uniformly applying the legal standards governing proof of operability under 35 U.S.C. Sec. 101 and Sec. 112, first paragraph, during examination of patent applications claiming inventions for treatment of human disorders? If not, please: (a) identify specific practices that you believe are inappropriate, particularly with respect to evidentiary requirements to establish operability, effectiveness or safety of a claimed human therapeutic product or process; (b) provide or summarize examples where you believe the PTO has incorrectly or inappropriately imposed or maintained an evidentiary requirement to support operability, under either Sec. 101, Sec. 112 or both, of an invention for use in treatment of a human disorder; (c) identify changes you would like to see the PTO make in examination of applications claiming inventions related to treatment of human disorders under 35 U.S.C. Sec. 101 or Sec. 112, first paragraph; and (d) discuss the implications of such changes, not only for patent applicants seeking protection, but also for scientific research and development related to treatment of human disorders as well as the public health and welfare. 3. Do you believe legal standards and examining practices in foreign systems provide a better framework than is available in the United States for assessing patentability questions related to operability of inventions for treating human disorders? Please identify desirable or undesirable practices of foreign offices, particularly the Japanese Patent Office and the European Patent Office, in this regard. C. Technical Standards Used in Measuring Nonobviousness and Enablement of Biotechnological Inventions The law governing nonobviousness for biotechnological inventions, particularly those involving manipulation of genetic material, has been refined through a series of decisions by the Court of Appeals for the Federal Circuit, and by the PTO Board of Patent Appeals and Interferences. See, e.g., Amgen, Inc. v. Chugai Pharmaceutical Co., 927 F.2d 1200, 18 U.S.P.Q.2d 1016 (Fed. Cir. 1991); In re Bell, 991 F.2d 781, 26 U.S.P.Q.2d 1529 (Fed. Cir. 1993); In re O'Farrell, 853 F.2d 894, 7 U.S.P.Q.2d 1673 (Fed. Cir. 1988); Ex parte Anderson, 30 U.S.P.Q.2d 1866 (B.P.A.I. 1993); Ex parte Deuel, 27 U.S.P.Q.2d 1360 (B.P.A.I. 1993); appeal docketed, No. 94-1202 (Fed. Cir. Feb. 25, 1994); Ex parte Movva, 31 U.S.P.Q.2d 1027 (B.P.A.I. 1993). Similarly, important questions regarding enablement of such inventions has been addressed in a number of decisions by the Federal Circuit. See, e.g., Amgen, 927 F.2d at 1212, 18 U.S.P.Q.2d at 1026; In re Wright, 999 F.2d 1557; 27 U.S.P.Q.2d 1510 (Fed. Cir. 1993); In re Wands, 858 F.2d 731, 8 U.S.P.Q.2d 1400 (Fed. Cir. 1988); In re Vaeck, 947 F.2d 488, 20 U.S.P.Q.2d 1438 (Fed. Cir. 1991); In re Goodman, 11 F.3d 1046, 29 U.S.P.Q.2d 2010 (Fed. Cir. 1993). This growing body of decisions has provided the patent bar and the PTO with much needed guidance on application of the statutory conditions of patentability for biotechnology inventions. However, the state of the art in the various fields of technology that make up biotechnology is advancing rapidly. Research, development and commercialization in the field of genetic engineering, in particular, has undergone significant changes over the past decade. For example, in the early 1980s, efforts to elucidate and isolate a gene sequence typically began with work on a known protein. If possible, one would sequence all or a portion of the amino acid sequence of the protein. Then, armed with this information, a researcher could design DNA probes and eventually identify and isolate the gene encoding the protein of interest. Today, scientists can sometimes identify a fragment of an expressed gene well before they know anything about the eventual whole gene or its expression product. While this makes it possible for researchers to easily gain access to genetic information, it can also create problems for an inventor concerned about gaining meaningful patent protection for the technology under development. Changes in the state of the art affect determinations as to the level of skill possessed by an individual working in the field of technology of an invention. And this assessment affects the PTO's application of two of the statutory requirements of patentability. Under 35 U.S.C. 103, nonobviousness of an invention is measured through reference to knowledge and experience of one of ordinary skill in the art. Under 35 U.S.C. 112, adequacy of disclosure of an application is measured from the perspective of one skilled in the art to which the invention pertains. Changes in the level of skill in the art thus directly affect how the PTO reaches conclusions regarding patentability of inventions, particularly where the state of the art is advancing rapidly. Some patent practitioners and biotechnology company representatives have expressed concerns related to how the PTO assesses the skill level of individuals working in the various fields of biotechnology. For example, some argue that it is inappropriate for the PTO to reject an invention involving genetic manipulation as being obvious over prior art disclosing conventional genetic engineering techniques while at the same time rejecting the application as not being in compliance with the enablement requirement under section 112. Similarly, some have criticized the PTO for rejecting claims to monoclonal antibodies as being obvious over disclosure of the antigen that serves as the basis for making the antibody in view of conventional hybridoma technology, while at the same time requiring an applicant to deposit samples of the hybridoma pursuant to the enablement requirement of section 112. Still others suggest that the PTO is imposing a ``per se'' rule of obviousness for inventions involving sequencing and expression of genes once ``any'' sequence information has been publicly disclosed, whether that sequence information takes the form of a partial amino acid sequence of a protein or DNA sequence information derived from the expression of the gene. It has been suggested that such an approach improperly attributes a much higher level of skill to the person of ``ordinary'' skill in the art than is appropriate at this time. It is difficult for the PTO to respond to these concerns, particularly when expressed anecdotally. To receive a patent, an invention for which patent protection is sought must comply with all statutory requirements of patentability. The PTO examines each patent application on its own merits and does not apply per se rules regarding obviousness, enablement or any other statutory requirement of petentability. Furthermore, the PTO strives to ensure that its examining practices reflect appropriate scientific and technological standards. The PTO thus seeks public input to help it ensure that it is properly construing and applying the statutory requirements of patentability, particularly those that depend upon evaluation of skill levels in the field of biotechnology. 1. Do you believe the legal standards governing assessment of the ordinary level of skill in the art for purposes of nonobviousness under 35 U.S.C. 103, as developed and interpreted by the Federal courts, are sufficiently clear and appropriate for biotechnology inventions? If not, (a) identify aspects of the law that you believe lack clarity or are inappropriate, citing relevant cases; and (b) identify any changes to these legal standards you believe would be desirable. 2. Do you believe the legal standards governing assessment of the level of skill attributable to a person ``skilled in the art'' in determinations made under 35 U.S.C. 112, first paragraph, as developed and interpreted by the Federal courts, are sufficiently clear and appropriate? If not, (a) identify aspects of the law that you believe lack clarity or are inappropriate, citing relevant cases; and (b) identify any changes to these legal standards you believe would be desirable. 3. Do you believe the PTO is correctly assessing the level of skill possessed by persons working in the field of biotechnology in determinations it makes regarding nonobviousness under 35 U.S.C. 103 and enablement under section 112, first paragraph? In particular: (a) Do you believe that PTO is properly assessing the level of ``ordinary skill'' in the art of biotechnology under 35 U.S.C. 103? If not, please provide examples and identify specific situations where determinations have not been made that reflect the appropriate standard. (b) Do you believe that PTO is properly assessing the level of skill possessed by biotechnology inventors in determining compliance of an application with 35 U.S.C. 112, first paragraph? If not, please provide examples and identify specific situations where determinations have not been made that reflect the appropriate standard. (c) Do you believe the PTO should equate the knowledge and experience of a person ``skilled in the art to which the invention pertains'' under section 112 to that possessed by a ``person of ordinary skill in the art'' under section 103? Please explain the basis for your conclusions. 4. Are there specific practices of the PTO with regard to determinations under 35 U.S.C. 103 or 112 for biotechnological inventions that you believe are inappropriate or inconsistent with legal precedent? If so, (a) please identify with specificity the practices in question, providing examples; (b) explain why the identified practices are inappropriate or inconsistent with relevant legal precedent; (c) suggest specific changes that would address your concerns; and (d) explain the implications of such changes, not only for inventors seeking patent protection, but for researchers and third parties engaged in biotechnology research and development. 5. Do you believe legal standards and examining practices in foreign systems provide a better framework for making patentability determinations that depend upon the level of skill in the relevant field of biotechnology than is utilized in the United States? Please identify desirable and undesirable practices of foreign offices, particularly the Japanese Patent Office and the European Patent Office, in this regard. D. Implications of Pending Legislative Patent Reform on PTO Operations and Examination Procedures Several patent reform initiatives are pending before or under consideration by the Congress. These include measures that would provide a 20-year patent term measured from the U.S. filing date of an application, establish a provisional patent application system, permit patent applicants to claim domestic priority to previously filed U.S. applications, and automatically publish patent applications 18 months after their earliest effective filing date. Implementation of these measures, should they be enacted into law, will require careful consideration of the objectives of the legislation and the special needs of users of the patent system, particularly those from the biotechnology and related industries. For this reason, the PTO seeks public input as to how to best implement changes to patent examining procedures and its operations that may be required if these legislative reforms are enacted. 1. Do you believe there are procedural steps that the PTO could adopt to facilitate use of a provisional application filing system by biotechnology inventors, particularly with respect to filing of DNA or amino acid sequence information? 2. The PTO is spending in excess of $2 million to obtain the special computer capability for storing and searching DNA sequence information. Do you believe this cost should be recovered from all patent applicants, or only applicants who file applications which require use of these special facilities? 3. Please identify changes, if any, to current restriction practices that you believe would be appropriate in a patent system that provides for automatic publication of applications and a 20-year patent term measured from filing. In discussing this, please: (a) indicate requirements or measures that would be appropriate for the PTO to impose on patent applicants to enable it to examine multiple patentably distinct inventions in a single application, and (b) identify practices of foreign offices, particularly the Japanese Patent Office and the European Patent Office, with regard to unity of invention for applications claiming inventions involving genetic material that would be appropriate or inappropriate for use by the PTO. 4. Please identify changes to other aspects of PTO examining practices or operations that could be made in implementing a 20-year patent term, provisional application filing, or 18-month publication that you believe would be desirable or beneficial for the biotechnology industry. If possible, please comment on procedures available in foreign systems that you believe would be desirable for the U.S. to adopt in implementing these changes. E. Experimental Use Defense to Patent Infringement Note: The PTO has previously solicited written comments on the experimental use defense to patent infringement. See, Public Hearings and Request for Comments on Economic Aspects of the U.S. Patent System, 58 FR 68394 (December 27, 1993); Cancellation of Public Hearings on Economic Aspects of the U.S. Patent System, 59 FR 1935 (January 13, 1994). Several individuals, in responding to this earlier request for public comment, expressed a desire to present oral remarks. Those individuals interested in testifying on the topics presented in the earlier Federal Register notice are invited to do so at this public hearing. In addition, those interested in offering written comments on the topics presented in the earlier notice may provide those comments in conformance with the guidelines outlined in this notice. F. Protection Afforded by Plant Patents Under section 163 of title 35, United States Code, a plant patent affords its holder only the right to exclude others from sexually reproducing the plant or using the plant so reproduced. As such, protection afforded by a plant patent does not extend to parts of the protected plant, such as harvested material (e.g., table fruit, cut flowers, etc.). This has enabled growers to reproduce and use, outside the United States, plants subject to a U.S. plant patent, and subsequently import products harvested from such plants, to the detriment of the U.S. plant patent owner. Legislation presently pending before Congress would, if enacted, permit the United States to adhere to the 1991 Act of the International Convention for the Protection of New Varieties of Plants (UPOV). In accordance with the provisions of that Convention, the United States would thus amend its laws to provide, among other things, protection for harvested material obtained from sexually reproduced plant varieties. Note: The most commonly used title of protection for sexually reproduced plant varieties is the Plant Variety Protection Act sections 2321-2582, title 7, United States Code, which is administered by the U.S. Department of Agriculture. As the agency charged with administration of the Plant Patent Act, the PTO is interested in obtaining public comments on the following question. 1. Do you believe that the Plant Patent Act should be amended to permit a holder of United States plant patent to exercise exclusive rights with respect to parts of a protected plant, such as material harvested from the plant? G. Other Issues Parties may address matters not specifically identified in the above sections. If this is done, parties are requested to: --Label that portion of their response as ``Other Issues''; --Clearly identify the matter being addressed; --Provide examples, where appropriate, that illustrate the matter addressed; --Identify any relevant legal authorities applicable to the matter being addressed; and --Provide suggestions regarding how the matter should be addressed by the PTO. III. Guidelines for Oral Testimony Individuals wishing to testify must adhere to the following guidelines: 1. Anyone wishing to testify at the hearings must request an opportunity to do so no later than October 12, 1994. Requests to testify may be accepted on the date of the hearing if sufficient time is available on the schedule. No one will be permitted to testify without prior approval. 2. Requests to testify must include the speaker's name, affiliation and title, phone number, fax number, mailing address, and Internet mail address (if available). Parties may include in their request and indication as to whether the party wishes to testify during the morning or afternoon session of the hearing. 3. Speakers will be provided between 7 and 15 minutes to present their remarks. The exact amount of time allocated per speaker will be determined after the final number of parties testifying has been determined. All efforts will be made to accommodate requests for additional time for testimony presented before the day of the hearing. 4. Speakers may provide a written copy of their testimony for inclusion in the record of the proceedings. These remarks should be provided no later that October 28, 1994. 5. Speakers must adhere to guidelines established for testimony. These guidelines will be provided to all speakers on or before October 14, 1994. A schedule providing approximate times for testimony will be provided to all speakers the morning of the day of the hearing. Speakers are advised that the schedule for testimony will be subject to change during the course of the hearings. IV. Other Information Questions regarding the Convention facilities or lodging in the San Diego area should be directed to the San Diego Convention Center Corporation, by phone to (619) 236-6500, or by fax to (619) 236-6849. Dated: August 25, 1994. Bruce A. Lehman, Assistant Secretary of Commerce and Commissioner of Patents and Trademarks. [FR Doc. 94-21485 Filed 8-31-94; 8:45 am] BILLING CODE 3510-16-M