!020194 PTO seeking comments on experimental use patent rights Apparently the Patent and Trademark Office is seeking comments on the experimental use defense to patent infringement. Anyone with an interest in this topic can submit comments to the USPTO. (And for those of us in San Jose last week, this announcement which appeared in the January 18, 1994 Official Gazette is very baffling. Most repositories and law firms didn't receive their Jan 18 OGs until the 25th). Anyways, if anyone has some commentary on this issue, please send it to me, and I will distribute it over the news service. I hadn't realized that this was an issue of importance. DEPARTMENT OF COMMERCE Patent and Trademark Office Economics and Statistics Administration Technology Administration Docket #: 931234-3334 Notice of Public Hearings and Request for Comments on Economic Apsects of the U.S. Patent System Agencies: Patent and Trademark Office; Economics and Statistics Administration; Technology Administration; Department of Commerce Action: Notice of hearings and request for public comments Summary: The Patent and Trademark Office (PTO), the Economics and Statistics Administration (ESA), and the Technology Administration (TA) of the Department of Commerce are conducting a review of certain aspects of domestic and foreign intellectual property systems. As part of their review, these agencies are interested in obtaining public input on issues associated with the balance of rights between patent owners and the public with regard to research-oriented use of patented technology. 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: A public hearing will be held on January 25,1994, at the San Jose Convention Center, 408 Almaden, Ave., San Jose, Calif. Those wishing to present oral testimony at the hearing must request an opportunity to do so no later than January 20, 1994. Written comments on topics presented in the supplementary information section of this notice should be received by the PTO on or before March 1,1994. Addresses: Those interested in presenting written comments on the topics contained in the supplementary information, or any other related topic, 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, D.C. 20231. Comments can be sent by electronic mail to Internet address "comments-exp-use@uspto.gov." Comments may also be submitted by telefax at (703) 305-8885. Written comments should include the following information: - name and affiliation of the individual responding; - an indication of whether comments offered represent views of the individual's organization or are the respondent's personal views; and - if applicable, the nature of the respondent's organization, including the size, type of organization (e.g., business, trade group, university, non-profit organization) and principal areas of business or research activity. Parties offering testimony or written comments are asked to provide their comments in machine readable fotmat in one of the following file formats: ASCII test, WordPerfect for DOS version 4 2 or 5.x, WordPerfect for Windows version 5.x, Word for Windows version 1.0 or 2.0, Word for DOS version 5.0, Word for Macintosh version 3.0, 4.0 or 5.x, or WordPerfect for Macintosh version 2.x. Persons wishing to testify must notify Jeff Kushan no later than January 20, 1994. Mr. Kushan can be reached by mail sent to his attention addressed to the Commissioner of Patents and Trademarks, Box 4, Washington, D.C. 20231; by phone at (703) 305-9300; or by telefax at (703) 305-8885. No requests to testify will be accepted through electronic mail. Written comments and transcripts of the hearings will be available for public inspection no later than January 30,1994, in Room 902 of Crystal Park Two, 2121 Crystal Drive, Arlington, VA. Persons wishing to obtain a machine readable copy of the transcripts and public comments should contact Jeff Kushan at the address listed below. For Further Information Contact: Jeff Kushan by telephone at (703) 305-9300, by fax at (703) 305-8885, by electronic mail at kushan@uspto.gov, or by mail marked to his attention addressed to the Commissioner of Patents and Trademarks, Box 4, Washington, D.C. 20231. Supplementary Inforrnation 1. Background The intellectual property systems in the United States have been designed to promote innovation, creative expression and fair competition. These systems of protection, including patents, copyrights, trademarks and trade secret protection, have proven flexible enough to handle rapid advances in technology and dramatic changes in business practices. However, periodic adjustments to certain aspects of these intellectual property systems have been necessary to ensure their continued usefulness in promoting the respective fields of activity each type of protection was designed to encourage. A question that has attracted much recent attention is the balance of rights between holders of patent rights and the general public regarding research-oriented use of patent protected technology. The question has become complicated by the increasingly close relationships that are developing between industry, Govemment and universities. Adding to this is the increased pace of innovation, which brings with it an increasingly compressed period between groundbreaking or landmark innovations. The question of balance, however, is central to the basic objectives of the patent system. A primary objective of the patent system is the promotion not only of innovation but also of public disclosure of inventions. The patent system functions by providing a seventeen-year period of exclusive rights authorizing the patent holder to prohibit others from making, using or selling the patented invention, as it is defined in the patent, in exchange for a full public disclosure of the invention. This grant of exclusivity serves as the primary incentive for inventors to publicly disclose their inventions. The public benefits through this arrangement immediately via the publication of information regarding the invention and eventually through dedication to the public of the right to use the invention described in the patent. Thus, a key aspect of the public value of patent disclosures is the immediate public access to information contained in the patent document for purposes of further research and development in the field of technology of the patented invention. Implicit in the public disclosure role of the patent system is the idea that the public will not only be able to use, in some fashion, the information contained in the patent document, but will also be given some discretion in using the patented invention itself so that it can be fully understood. Yet, other than limited provisions allowing for testing of patented pharmaceutical products for purposes of regulatory approval (e.g., 271(e)(1) of title 35, United States Code), existing law does not provide a general, statutory defense against a charge of infringement for experimental use of patented technology. Despite this, the Federal courts have recognized a limited defense to a charge of patent infringement based on use of the patented technology for experimental purposes. This defense, referred to as the experimental use defense, has been raised infrequently, and when considered has been construed very narrowly. There are few cases elaborating the nature of the defense, primarily because patent rights are not frequently enforced against members of the public that use the patented technology for purely experimental purposes. In these cases, the courts have not recognized the defense where the accused infringer has engaged in use of the patented invention for purposes of commercially exploiting the invention, rather than for increasing their understanding of the invention. In cases where the defense has been raised successfully, the experimental use in question was to ascertain how the invention functioned or for purely philosophical or academic reason. [Note: a good summary of the experimental use exception can be found in Section IV, Part 2 Chapter 9 of House Report 100-888 (100th Congress, 2d Session).] The increasingly close relationships between industrial governmental and university researchers has heightened sensitivity to the commercial implications of basic, as opposed to applied, research. This, in turn, has led to questions regarding the use of patented technology in a research context. This has special implications in research-intensive industries like the pharmaceutical and biotechnological industries, which tend to be high-risk capital intensive and intensely competitive. Many companies in these industries view clearly defined and understood patent rights as being critical to their commercial success. As a result, such companies aggressively pursue and enforce patent rights to protect their often significant financial investments. However, central to the success of these industries is access to and use of information regarding both significant and incremental advances in science and technology. Experimentation on patented products and processes in these industries often is essential to understanding the nature and significance of these advances. These factors have led to some degree of uncertainty in the research communities regarding use of information and technology disclosed in and protected by patents. This, in turn has led to calls for a better understanding and possible clarification of the basic balance of rights with respect to research-oriented use of patented technology. II. Topics for Discussion The hearing will address the following topics: - Justifications and rationale for or against an experimental use defense to patent infringement; - Desirable characteristics of an experimental use defense to patent infringement; and - Justifications for or against a statutory experimental use defense to patent infringement. The topics will be explored through a series of questions to which interested members of the public are invited to respond. [Note: The following questions have been developed with the intent of framing in a neutral fashion a discussion of research-oriented use of patented inventions. The topics have been selected to provide an opportunity for members of academia industry, Government and the bar to provide their input on the treatment of research activity under current patent law as well as their ideas and suggestions for changes, if viewed as necessary, to the current patent system. Parties responding to these questions are asked to provide the basis for their conclusions offered and, where possible, to provide their actual experiences in dealing with patent enforcement in the context of research-oriented use of patented technology.] Topic A. Justifications and rationale for or against an experimental use defense to patent infringement. 1. Considering the goals of the patent system of encouraging innovation and public disclosure of inventions, what economic rationale can be cited in support of or against recognizing a defense to a claim of patent infringement based on experimental use of a patented invention? 2. What gains or losses to levels of basic research, inventive activity and investment in research-intensive industries, if any would you expect to occur if the nature of the present experimental use defense to infringement was modified? [Note: Parties commenting on this question are invited to comment on the effect of the current patent system on research and development activities, and then to comment on possible effects to a more expansive or restrictive experimental use defense on these activities.] Topic B. Desirable characteristics of an experimental use defense to patent infringement. 1. What activities by an entity conducting research involving a patented invention should not require the authorization of the patent owner? 2. What activities by an entity conducting research involving a patented invention should give rise to liability for infringment? [Note: for questions B-1 and B-2, please consider: - the implications of your conclusions for patented products and processes that are to be used primarily as research tools, and - whether a distinction should be made between commercially-oriented research (e.g., directed at production of a specific commercial product or process) and non-commercially-oriented research (e.g., basic academic research with no specified commercial target) regarding the availability of the defense?] Topic C. Justifications for or against a statutory experimental use defense to patent infringement. 1. Is there a need for a statutory exception to liability for patent infringement based on experimental use of a patented invention? 2. If your answer to question 1 is "yes', how would you define such an exception? 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 January 20, 1994. No one will be permitted to testify without prior approval. 2. Requests to testify must include the speaker's name, affiliation (if any), phone number, fax number (if available), mailing address, and the questions in each topic that the speaker intends to address in his or her testimony. 3. Time allocated to each speaker will be determined after the final number of speakers has been determined. 4. Speakers must provide a written copy of their testimony for inclusion in the record of the proceedings no later than January 25, 1994. 5. Speakers must adhere to guidelines established for testimony. These guidelines will be provided to all speakers no later than January 21, 1994. A schedule providing approximate times for testimony will be provided to all speakers no later than the morning of January 25, 1994. Speakers are advised that the schedule for testimony will be subject to change during the course of the hearings. Greg Aharonian Internet Patent News Service