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At least 19 recordsLinked to original sources
PubMed1986

University-industry research relationships in biotechnology: implications for the university.

The growth of university-industry research relationships in biotechnology has raised questions concerning their effects, both positive and negative, on universities. A survey of over 1200 faculty members at 40 major universities in the United States reveals that biotechnology researchers with industrial support publish at higher rates, patent more frequently, participate in more administrative and professional activities and earn more than colleagues without such support. At the same time, faculty with industry funds are much more likely than other biotechnology faculty to report that their research has resulted in trade secrets and that commercial considerations have influenced their choice of research projects. Although the data do not establish a causal connection between industrial support and these faculty behaviors, our findings strongly suggest that university-industry research relationships have both benefits and risks for academic institutions. The challenge for universities is to find ways to manage these relationships that will preserve the benefits while minimizing the risks.

Antibodies, Monoclonal↗
PubMed1994

Ethnobotany and intellectual property rights.

Contemporary intellectual property law permits only the patenting of an identified active principle from a plant, not the plant or folk information relating to medicinal properties of a plant. The most significant rights of indigenous peoples are those deriving from physical control of the plants and the knowledge pertaining to their use. This control can provide the basis for trade secret protection. Such agreements are enforceable in developed nations and should become so in developing nations. There have been recent efforts to strengthen indigenous peoples' rights over genetic resources and relevant folk knowledge but the most far-reaching of these are not yet a part of international law. Pharmaceutical patents combined with trade secrecy can allow firms to develop and market products and ensure that the nation and/or people from which the material or information was derived are properly rewarded. This does not provide protection from competition or with respect to derived knowledge nor does it act retrospectively. At present, rights under the United Nations Convention on Biodiversity are prospective only. These rights belong to the nation and there is little legal pressure for recompense to be shared with indigenous peoples. A uniform agreement that deals in a balanced way with the relative rights of indigenous peoples and of their governments should be developed by non-governmental organizations.

Drug Industry↗
PubMed1984

Access to data on chemical composition of products used in auto repair and body shops.

Some information on chemical composition of products used in the workplace can be obtained by requesting composition data from product marketers. Workers in auto repair and body shops identified 253 products used in their shops. Full disclosure of composition was obtained for approximately 20% of the 174 products marketed by companies which answered our letters. Composition was partially disclosed for approximately 40% of the products, and about 10% of the product formulations were claimed to be trade secret or confidential. The study reported in this paper was carried out in New York State in 1980, before the effective date of the New York State right-to-know law. The results of this study can be used as a benchmark to judge the effectiveness of worker right-to-know laws and product labeling regulations.

Air Pollutants, Occupational↗
PubMedDate not supplied

Life forms protectable as subjects of US patents--microbes to animals (perhaps).

Scientists, businessmen, universities, and industries with fundamental or peripheral interests in technology as applied to life processes will be keenly interested in recent US Patent Office decisions. These decisions indicate that new higher life forms, animal or plant, are proper subjects of patents if they are not naturally occurring (and are not human, in the case of animals). In contrast to plants and other organisms, genetically modified animals have had no mode of protection as intellectual property except possibly as trade secrets or utility patents. The Ex parte Allen decision, reached by the Patent Office Board of Appeals and Interferences, directly addressed the issue of animal patentability in view of the broad reading of 35 U.S.C. section 101 by the US Supreme Court in the Chakrabarty decision. The subject invention concerned polyploid oysters. Claims directed toward polyploid oysters produced by a particular process were rejected under 35 U.S.C. section 103 and section 101. The Board, reversing the 35 U.S.C. section 101-based rejection in view of the Chakrabarty decision, indicated that the claimed polyploid oysters were non-naturally occurring manufactures or compositions of matter within the confines of patentable subject matter under 35 U.S.C. section 101. A similar decision affecting the patentable status of plants or segments thereof had previously been reached by the Patent and Trademark Office in the case of Ex parte Hibberd, 227 U.S.P.Q. 443 (Bd. Pat. App. 1985). The Hibberd utility patent application concerned "genetically engineered" maize which had high levels of the tryptophan.

Animals↗
PubMed1992

Industry-funded dermatologic research within academia in the United States: fiscal and ethical considerations.

Private-sector funding of biomedical research within academia may come from industry, foundations, the dermatologists themselves, and the public at large. Industry-funding is of benefit to both academia and industry. Industry may fund clinical and basic research and product testing. Industry is more willing to fund product testing and clinical research than basic research. Funds for dermatologic research may be obtained from manufacturers of drugs, medical devices, cosmetics, soaps, and detergents. Questions of academic freedom arise when research is funded by industry. The results of academic research are in the public domain; the results of intramural industry research are often proprietary, i.e., "trade secrets." When there is industry funding within academia, any restraints on publication should be held to a minimum and be temporary. Publication should occur in a timely fashion, although recognizing the need for delayed publication if the results concern patentable material. When there is a consultantship, pre-arranged terms of agreement may restrict communication. Patents usually are held by the investigator's institution. The funding company may be granted world-wide, royalty-bearing licenses. Conflicts of interest may arise during any research endeavor; this warrants close attention when the research is industry funded. Stock ownership, speaker fees, blind contracts, etc., should be avoided. In any communication, funding agreements should be stated. Indirect costs are a "necessary evil." There are non-research expenditures associated with all research projects for which the institution is justified in requesting compensation. Indirect costs must have definite connections to a project. As industrial funding of research within academia increases, various facets of the academia-industry relationship are receiving increasing attention. Several aspects of conflicts of interest and indirect costs must yet be resolved. When faced openly and directly, all of these issues are manageable and need not reduce the benefits to both industry and academia that are inherent in this relationship. Federal funding of academic research uses tax dollars; industry funding comes from private capital. Academia will benefit from the funding of academic biomedical research by industry. The ultimate beneficiary of the funding of academic research by industry, however, will be society at large as the medical advances derived from sound biomedical research and carefully controlled clinical trials aid patients. A solidly established academia-industry relationship is essential to the effective funding by industry of biomedical research within academia.

Biomedical Research↗
PubMed1977

Cutting fluids and their effects on the skin of mice. An experimental study with special reference to carcinogenicity.

Reports of skin malignancies due to occupational exposure have decreased since the introduction of solvent-refining of mineral oil fraction in the manufacture of oil based cutting fluids. Commercial mineral oil based cutting fluids caused local and general pathological changes after repeated application to the skin of mice in the present study. Forty-eight per cent of the mice exposed to oils showed severe dysplasia or malignancy of the skin on histological examination. The corresponding figure for the control group, where various additives were used was 8 per cent. The frequency of papillomas was also increased in the mice exposed to oils. The systemic lesions included focal necrosis of the liver, associated with amyloid deposition, as well as amyloidosis of the skin, spleen and kidneys. The substances responsible for these apparent carcinogenic properties of the complex mixtures may be polycyclic hydrocarbons; the latter are still present in the commercial products despite solvent refining; on the other hand the carcinogens may be additives to the cutting oils the composition of which is generally a trade secret.

Amyloidosis↗
PubMed1989

Life forms protectable as subjects of U.S. patents -- microbes to animals (perhaps).

Scientists, businessmen, universities and industries with fundamental or peripheral interests in technology as applied to life processes will be keenly interested in recent U.S. Patent Office decisions. These decisions indicate that new higher life forms, animal or plant, are proper subjects of patents if they are not naturally occurring (and are not human in the case of animals). In contrast to plants and other organisms, genetically modified animals have had no mode of protection as intellectual property except possibly as a trade secret or utility patent. The Ex parte Allen decision, reached by the Patent Office Board of Appeals and Interferences, directly addressed the issue of animal patentability in view of the broad reading of 35 U.S.C. section 101 by the U.S. Supreme Court in the Chakrabarty decision. The subject invention concerned polyploid oysters. Claims directed toward polyploid oysters produced by a particular process were rejected under 35 U.S.C. section 103 and section 101. The Board, reversing the 35 U.S.C. section 101 - based rejection in view of the Chakrabarty decision, indicated that the claimed polyploid oysters were non-naturally occurring manufactures or compositions of matter within the confines of patentable subject matter under 35 U.S.C. section 101. A similar decision affecting the patentable status of plants or segments thereof had previously been reached by the Patent and Trademark Office in the case of Ex parte Hibberd, 227 U.S.P.Q. 443 (Bd. Pat. App. 1985). The Hibberd utility patent application concerned "genetically engineered" maize which had high levels of the tryptophan.

Animals↗
PubMed1975

Relations between sales authorisation and pharmacopoeia.

At a time when the production and distribution of drugs and drug products is no longer confined within the national boundaries of particular countries, many thoughtful people are concerning themselves with the idea of standardisation of quality control procedures and specifications. For medicines currently marketed in different countries, a multitude of standards and specifications for both the raw materials and finished products exists. Plans for the regionalisation of drug standards have been put into operation but realistic estimates of progress agree that it will be measured and dignified. In one area there is the possibility for earlier action in reaching agreement on adequate specifications. The process of registration of a new drug substance for the first time presents an opportunity to make known to drug regulation authorities, academic and industrial pharmaceutical specialists, and other interested parties, the qualities and characteristics of the newly proposed agent and its dosage forms. A wide range of information will be needed on the chemical, physical, biological and physicochemical properties of the dosage forms as well as the raw materials of the active and inactive ingredients. Many of these requirements have already been described (3). There may be apprehension that the disclosure of some of this information could imperil the confidentiality of certain manufacturing processes or trade secrets, and adequate steps would be demanded to prevent this happening. The promulgation of a standard, at or shortly after the time of registration, should have been preceded by experimental tests, in the laboratories of the Authority, to verify the robustness of the analytical methodology. In some cases more extensive confirmation by collaborative study may be warranted. The elaboration of these concepts will be presented and examples brought forward of problems that have occurred in the past, and means to prevent them in the future.

Legislation, Pharmacy↗
PubMed1988

The dermatologist and the right to know.

Recently the Federal Occupational Safety and Health Administration has promulgated a Hazard Communication Standard, as have many states and local governments. Regulations give physicians access to Material Safety Data Sheets and also to trade-secret information regarding chemical substances that their patients may come into contact with at work. This article describes how to access and interpret this information.

Allergens↗
PubMed1986

Genetically-engineered microorganisms: I. Identification, classification, and strain history.

We have argued that accurate identification of the microorganism will form a cornerstone of the assessment of potential hazard. Appropriate methodology for identification exists, and is continually under development and refinement. Organizations such as the American Type Culture Collection will perform certified identifications for relatively low cost. Thus there appears to be little reason that an organism should not be identified insofar as current microbiology allows prior to submission for PMN review. We suggest that a complete microbiological characterization be considered an essential element of an acceptable PMN. To accomplish this, however, current institutional arrangements for the protection of trade secret information needed in the process of identification may need to be improved. An accurate identification of the strain will often provide access to important information with which to evaluate its ecology, pathogenicity, biochemistry, and genetics. Specialized texts, the scientific literature, and professional consultation are ready sources of such information. However, a major effort should be made to establish a data base that can specifically address the needs of biohazard evaluation. This could be done, in part, by collecting information about the construction, and about the behavior in the environment of genetically-engineered microorganisms that are now under development and will soon be tested or used. Identification information may also eventually be useful for the formulation of hypotheses about possible modes of harm or about relative safety, based on phylogenetic relationships. This is a very difficult undertaking at present, however. Microbial taxonomy is currently in a process of radical reevaluation as new macromolecular sequence information reveals previously unsuspected phylogenetic relationships, and disturbs categorizations based on older types of traits such as morphology, etc. This means that both inferences about relative safety and about possible modes of harm from taxonomic relationships must be highly tentative based on current information. Regulatory authorities may wish to consider requesting confirmatory DNA hybridization data or other macromolecular sequence comparisons in cases where strong arguments related to safety must be made from taxonomic information in relatively poorly studied groups of organisms. Detailed strain histories would provide valuable information for safety evaluations.(ABSTRACT TRUNCATED AT 400 WORDS)

Bacteria↗
PubMed1987

A patent law primer for clinical chemists and other scientists.

Patenting and commercialization by academic scientists, despite potential drawbacks, are on balance highly desirable if technology is to be transferred from the laboratory to the public use, and if the scientist and his institution are to be encouraged to participate in this transfer. If that premise is accepted, there is much that academic institutions can do to foster utilization of their biotechnological discoveries. Such institutions should have a patent policy that is known to all and that includes a professional patent administrator and clear administrative procedures for carrying out such policy. Scientists should be trained to recognize and protect their inventions and to appropriately disclose their inventions to their patent officers. Ideally, scientists should know the rudiments of the patent statutes of their own country and should be aware of what constitutes trade secrets. Scientists should be given guidance in working with patent attorneys in the preparation and prosecution of patent applications. Finally, given human nature, institutions should see to it that their scientists are provided with a suitable environment in which to invent, and appropriate incentives to do so.

Chemistry, Clinical↗