Patents traditionally have been perceived as the domain of industry and basic science the province of academia. Some separation of basic intellectual and commercial interest is desirable, but when science technologies mature to the point that they yield inventions of commercial interest, desegregation becomes inevitable. Over the past few decades, the boundaries between basic science and invention have blurred, prompting opposing cries of assault on basic research by crass commercialism and for more strategic science to directly benefit society. Science and invention are strongly rooted in one another and are sometimes considered synonymous, yet they represent two distinct processes. Science seeks knowledge and is largely based on formal customs and conventions, whereas the patent system strives to reward invention and is founded on law and precedent.
Applied science often incorporates basic research concepts or technologies to seek information with potential applications that are useful to society and thus have "utility." For an inventor to obtain U.S. patent protection through the Patent and Trademark Office (PTO), an idea must be not only new or original, but also useful and novel to the point that it could not be easily anticipated by others "skilled in the art."
The higher standards of utility and novelty are required for a patent; however, "conception" of the idea and the data to demonstrate the "reduction to practice" of an invention can be considerably less stringent than in science. Science tends to recognize the first to publish, whereas assigning priority to the person or "creative entity" who is first to conceive the idea for an invention is a cornerstone of U.S. patent law. (Most nations recognize the first to file.)
The U.S. Court of Appeals for the Federal Circuit has restated and clarified that intellectual-property rights are exclusively assigned to the individuals who conceive inventions and conception is complete when the inventors have a "definite and permanent idea of the complete and operative invention" (Burroughs Wellcome Co. v. Barr Laboratories Inc., July 1993). Although data to prove the reduction to practice of the invention may later be required for issue of a patent, conception--a separate legal process--can take place without the inventor even being certain whether the invention will work. Finally, U.S. patent law grants inventors entitlement to claim the "full scope" of their inventions. This includes hypothetical uses that do not require "extensive further experimentation" and may sometimes cover protection on closely related or "equivalent" concepts not described in a patent.
Patent law is fluid by design and is subject to constant revisions. Such changes can result from additions of new patent laws by Congress or the setting of precedents because of new interpretations of existing patent law by PTO or the courts. These forces are all subordinate to the constitutional provisions for patents as interpreted by the U.S. Supreme Court. Under U.S. patent law, if an invention is sold, published, or presented, a patent application must be filed within one year before this public disclosure negates any right to patent protection. (Most other patent systems allow no such grace period.) Until 1995, the life of a U.S. patent was 17 years from the date of issue. This has been changed by law to 20 years from the date of filing.
Developing data for patenting a drug usually requires demonstrating pharmacological activity in an animal model. However, until recently a higher standard of human clinical studies was required for conditions that have proved refractory to treatment, such as cancer and AIDS. In a case brought by researchers claiming drug utility for an anti-leukemia drug tested in mice, the Court of Appeals for the Federal Circuit set a new precedent, criticizing PTO for confusing the "requirements under the law for obtaining a patent with the requirements for obtaining [Food and Drug Administration] approval" (In re Brana 931393). The standard for drug utility for cancer treatment is now pharmacological activity in an animal model, and because of lack of an animal model, in vitro testing is accepted for AIDS.
Currently, broad patents on basic technologies, such as recombinant DNA or monoclonal antibodies, that can affect scientific research and progress and even patient care are being hotly debated. It is argued that the reward to investors of basic technologies "is attained at the expense of subsequent innovators, who must first obtain a license to use the patented technology before bringing it to the next step [toward commercialization]" (P. Ducor, Nature, 387:13, 1997). Thus, patents on basic technologies create a paradox for the patent system. To deny inventors reward for intellectual property violates the rationale for granting patents. On the other hand, inventors or companies that control basic technologies in a way that stifles future development may violate the primary directive of the patent system to stimulate innovation and commerce. This paradox will in time be resolved by legal precedent and perhaps changes in the patent laws.
Questions as to how science and medical research are prioritized are central concerns of granting agencies, members of the research community, and lawmakers. The answer as to the worth of most science studies resides in the future; thus, the potential significance of a research proposal can defy contemporary peer review and "expert" analysis (D. Horrobin, New Scientist, 94:842, June 1982). Too much emphasis on the hierarchy of premier investigators and institutions, along with publications in a few dozen prestigious journals, can exclude innovative ideas that are often created at the margins of science (F. Cowan, The Scientist, 9:11, Nov. 27, 1995). Furthermore, the current system of peer review may select against high-risk, high-yield research (D. Horrobin, Lancet, 348:1293, 1996). In recognition of this problem, the Defense Advanced Research Projects Agency (DARPA), the originator of the Internet, seeks out and funds potentially revolutionary ideas in the physical and, more recently, the biological sciences (E. Marshall, Science, 275:744-6, 1997). In view of the inherent difficulties of assessing the other criterion, selection of innovative and original ideas is an imperative. Therefore, in the information age, the use of broad computer search engines for evaluation of originality of grant proposals becomes critical to quality control in research.
Patent searches are broader in scope than scientific literature searches, encompassing both domestic and foreign patents and potentially any other information in the public domain. The European Commission in Brussels has assessed technology transfer program research proposals using "Quick Scan," a customized form of the 30-million-document database used as a standard novelty search by the European Patent Office (Nature, 387:542, 1997). Out of 100 proposals, 30 were deemed innovative, but the originality of 57 others was questioned. As a result of the study, two of the projects were rejected outright, resulting in savings of 10 times the cost of the search. The use of such patent-search technologies might facilitate and streamline initial research grant evaluations. This could promote originality, ensure the appropriate citation of related work, and identify the originators of ideas, all of which are requirements for any future patents.
A major canon of the peer review of science publications, of science ethics, and of the patent system is the importance of acknowledging the originators of ideas and inventions. The courtesy of science citation in the peer-reviewed literature is an excellent method for acknowledging the contributions of others but is dependent on the diligence, judgment, integrity, and good manners of each scientist. Thus, citation in the scientific literature is not solely adequate to establish priority for intellectual-property rights.
Patent systems, as previously discussed, use exhaustive literature searches to discern the chronological evolution of ideas and information that result in an invention. Patent law demands accurate and complete "disclosure" of all related material; conspiring to rob others of their priority of discovery is not just the bad manners of failure to cite, but a crime. If an inventor has knowledge of prior art and fails to disclose it, the right to patent protection for the invention is in grave danger; moreover, such subterfuge can be a felony. Furthermore, prior art that an investigator is unaware of and fails to cite can affect the validity of a patent application, and even an issued patent will be judged in light of discovered prior art. Indeed, PTO recently withdrew a patent on the use of the Indian herb turmeric powder to heal wounds for lack of "novelty." Revocation of the patent was based not only on prior art in scientific publications, but also on books on home remedies and an authorized translation of ancient Ayurvedic Sanskrit texts on Indian systems of medicine (K.S. Jayaraman, Nature, 389:6, 1997; E. Marshall, P. Bagla, Science, 277:1429, 1997).
Basic science research is the foundation of discovery, invention, and commerce. Bridging the abyss from science ideas to market requires players from different organizational cultures, including academia, government, and industry. Patents provide the financial incentives vital for linking the different cultures necessary for technology transfer from scientific R&D to the market. Patenting and commercial development of technologies generated by scientific research are the natural extension of decades of support for basic science achieving the fulfillment of the promise to promote discoveries that benefit society.
The U.S. patent and science systems have coexisted for nearly two centuries without losing their respective identities. However, a period of some adjustment of patent law, and to a lesser degree of science conventions, is inevitable as the "endless frontiers" of science converge with invention and commerce. As the machine age and industrial revolution shaped the last century, the success of science in creating the information age and high-technology revolution is shaping the next. Ultimately as in the past, the future will favor those individuals, organizations, and nations that can proficiently effect the transition of scientific discoveries into useful and marketable inventions.
Fred M. Cowan is a research biologist at the U.S. Army Medical Research Institute of Chemical Defense, Aberdeen Proving Ground, Md. He holds the U.S. patent on the use of Fc receptors for immunotherapy.