Sponsored by the U.S. Department of Energy Human Genome Program
Human Genome News Archive Edition
Human Genome News, March 1994; 5(6)
The following article was written by Robert Cook-Deegan (Institute of Medicine, National Academy of Sciences) and Rebecca Eisenberg (University of Michigan Law School). The authors use topics discussed at the conference to illustrate issues relating to patenting of genome discoveries, government patenting policies, and technology transfer. Some basic information on patents is given in the article Staking a Claim on Biotechnology.
A conference on Maximizing the Return from Genome Research was convened by the Franklin Pierce Law Center (FPLC) in Manchester, New Hampshire, on July 23-24, 1993. The meeting was organized by Thomas Field and Gianna Julian-Arnold (FPLC) and funded in part by the Ethical, Legal, and Social Issues component of the DOE Human Genome Program.
Presentation topics included the genesis of the genome project; relevant intellectual property protections; technology transfer law; practical considerations in technology transfer, especially from national laboratories to the private sector; and policies governing research administration and technology transfer at NIH and DOE. Discussion was facilitated by the relatively small size of the group and the expertise of participants.
The conference addressed questions about which genome discoveries can and should be patented and who should own and control patent rights to federally funded research. These are crucial questions not only for genome research but for all biomedical research. Congress has expressed interest in technology transfer law; patent law; and operation of technology transfer offices at universities, government laboratories, and private firms (see OTA Study).
The controversy surrounding large-scale patenting of expressed sequence tags (ESTs) has brought intense scrutiny to the relationship between genome research and intellectual property. Although this attention has not always been welcome to those involved, it has nonetheless generated interest in the way technology transfer works, particularly in biotechnology. The debate has also highlighted contradictory federal policies that promote commercial applications of research on one hand and prompt disclosure of all map and sequence data on the other.
Data sharing, a major concern in the Human Genome Project since its inception, has been a topic at each annual sequencing meeting and on many other occasions. Because maps and databases are more useful when they are comprehensive, immediate and complete sharing of data seems desirable. Some investigators are eager to publish new data as soon as possible, particularly if multiple research groups are competing for scientific priority. Others may wish to protect data until they file a patent application and satisfy the legal requirements of novelty and nonobviousness. Once an application is filed, the applicant can release data without compromising patent rights. The U.S. Patent and Trademark Office (PTO) will keep the information confidential until a patent is issued and invention information is publicly disclosed, but some foreign patent offices disclose patent applications 6 months after they receive them. Because inventors may take up to 1 year to file foreign patent applications, the period of nondisclosure is typically 18 months. Thus patent considerations may lead to interim delays, but they should not prevent full disclosure in the long run.
Indeed, two purposes of the patent system are to (1) promote disclosure by offering exclusive rights to inventors and (2) encourage new inventions by conferring profitable exclusive rights that will foster private investment in research and development. During the 1980s, Congress passed several statutes aimed at furthering technology transfer, including the Bayh-Dole Act (1980), the Stephenson-Wydler Act (1980), and the Federal Technology Transfer Act (1986). These and other related statutes and executive orders assumed that patenting the results of government-sponsored research and vesting patent rights in research institutions would accelerate commercial applications, produce more jobs, and strengthen the competitive position of U.S. firms in the global economy.
While this is generally true, some patent rights held by research institutions performing government-funded basic research could interfere with, rather than encourage, private-sector product development. Instead of providing industry with otherwise unavailable exclusive rights, government- and university-held patents might burden firms with obligations toward institutions whose product-development contributions seem remote and inconsequential. How much control should a partial gene sequence's discoverer, who may not know its biological function or other uses, have over subsequent systematic investigations of that gene and its products?
Another conference topic was whether or not patents should be allowed on discoveries that are useful mainly as research tools, even if they have commercial value. Such patents could present obstacles to commercial product development by increasing costs and slowing research progress. Grantees might be forced to build licensing fees and transaction costs into grant applications, and commercial firms might have to negotiate a complex network of licenses to avoid the threat of infringement liability. As the number of patents and the complexity of relationships among patent holders increase, "patent clutter" could defeat the very goals that patent law is intended to promote.
Some potential harm might be mitigated by what Marilyn Hartig (Warner-Lambert) characterized as a de facto period of research exemption arising from the delay between application filing and patent issuance. Patent rights are not enforceable during this interim period, thus creating an opportunity to use a research tool without risking infringement liability. The lengthy process of issuing biotechnology patents, coupled with rapid progress in the field, may allow time for researchers and firms to learn all they need to know from a research tool before a patent is granted. Users incur no obligations to the eventual patent holder before the patent is granted, but a license is required thereafter.
Views differ about whether EST patent applications, now abandoned by NIH and the British Medical Research Council but still being pursued by other entities, would help future commercial interests or hinder them. Some say that patenting such discoveries is inappropriate because the effort to find any given EST is small compared with the work of isolating and characterizing a gene and gene product, finding out what it does, and developing a commercial product. They feel that allowing holders of such "gatekeeper" patents to exercise undue control over the commercial fruits of genome research would be unfair. Others say that patents on ESTs preserve the commercial options of future inventors whose discoveries may be rendered obvious (and therefore unpatentable) by prior publication of partial sequence information. In such a situation, the inventor could enjoy market exclusivity under a license from the EST patent holder. The validity of this view depends on the accuracy of the prediction that inventors will be unable to obtain their own patent rights and on the scope of patent protection available to EST discoverers. If EST patents do not cover the entire gene and gene product, for example, they may not offer effective commercial protection to firms seeking to market these products.
Patentability standards depend on the state of knowledge in the field at the time of the invention, thus limiting the precedential value of earlier cases. For example, an invention that was novel and nonobvious in 1985 might well be familiar and unpatentable in 1991. Patent attorney Kate Murashige (Morrison and Foerster) discussed one case in which a biotechnology patent application had been pending for over a decade. If litigation over infringement were to follow, many more years would be consumed. Moreover, patent laws are national in scope, so fundamental issues may be resolved differently in different countries. Decisions must be made in the face of necessarily incomplete information.
The discussions did not resolve these questions but helped clarify the complexity and interdependence among several areas of law and science.
The Spring issue of Risk: Health, Safety, & Environment will be devoted to this conference. Copies of Risk can be ordered, but only before May 1, from Carol Ruh, Managing Editor; Risk; Franklin Pierce Law Center; 2 White Street; Concord, NH 03301 (603/228-1541, Fax: -0388). The set of papers prepared before the conference can be obtained from the same address.
The electronic form of the newsletter may be cited in the following style:
Human Genome Program, U.S. Department of Energy, Human Genome News (v5n6).
The Human Genome Project (HGP) was an international 13-year effort, 1990 to 2003. Primary goals were to discover the complete set of human genes and make them accessible for further biological study, and determine the complete sequence of DNA bases in the human genome. See Timeline for more HGP history.
Published from 1989 until 2002, this newsletter facilitated HGP communication, helped prevent duplication of research effort, and informed persons interested in genome research.