A material transfer agreement (MTA) is a contract that governs the transfer of tangible research materials between two organizations when the recipient intends to use it for his or her own research purposes. The MTA defines the rights of the provider and the rights and obligations of the recipient with respect to the materials and any progeny, derivatives, or modifications.
The material can be of any kind, from chemicals, electronics, biological, or any other material. Biological materials, such as cell lines, plasmids, and vectors, are the most frequently transferred materials. But MTAs are also used for other types of materials, such as chemical compounds, reagents, mouse models, and even some types of software.
Three types of MTAs are most common at academic institutions: transfer between academic or research institutions, transfer from academia to industry and transfer from industry to academia. Each calls for different terms and conditions. [1]
For simple transfers not involving intellectual property, in the US the National Institutes of Health (NIH) recommends a simple letter agreement. For materials that may be patented or for which more protection is desired, the NIH has developed a Uniform Biological Material Transfer Agreement (UBMTA). Many U.S. educational institutions have signed the UBMTA Master Agreement. [2] AUTM (previously the Association of University Technology Managers) serves as the repository for the original UBMTA Master Agreement and maintains the list of the signatories. [3] Signatories to the UBMTA Master Agreement only have to sign an implementing letter with the details of the particular transfer since they have already agreed to all the terms of the Master Agreement.
Bioprospecting is the exploration of natural sources for small molecules, macromolecules and biochemical and genetic information that could be developed into commercially valuable products for the agricultural, aquaculture, bioremediation, cosmetics, nanotechnology, or pharmaceutical industries. In the pharmaceutical industry, for example, almost one third of all small-molecule drugs approved by the U.S. Food and Drug Administration (FDA) between 1981 and 2014 were either natural products or compounds derived from natural products.
A microarray is a multiplex lab-on-a-chip. Its purpose is to simultaneously detect the expression of thousands of biological interactions. It is a two-dimensional array on a solid substrate—usually a glass slide or silicon thin-film cell—that assays (tests) large amounts of biological material using high-throughput screening miniaturized, multiplexed and parallel processing and detection methods. The concept and methodology of microarrays was first introduced and illustrated in antibody microarrays by Tse Wen Chang in 1983 in a scientific publication and a series of patents. The "gene chip" industry started to grow significantly after the 1995 Science Magazine article by the Ron Davis and Pat Brown labs at Stanford University. With the establishment of companies, such as Affymetrix, Agilent, Applied Microarrays, Arrayjet, Illumina, and others, the technology of DNA microarrays has become the most sophisticated and the most widely used, while the use of protein, peptide and carbohydrate microarrays is expanding.
As with all utility patents in the United States, a biological patent provides the patent holder with the right to exclude others from making, using, selling, or importing the claimed invention or discovery in biology for a limited period of time - for patents filed after 1998, 20 years from the filing date.
Cambia is an Australian-based global non-profit social enterprise focusing on open science, biology, innovation system reform and intellectual property. Its projects include The Lens, formerly known as Patent Lens, and the Biological Innovation for Open Society Initiative.
The Bayh–Dole Act or Patent and Trademark Law Amendments Act is United States legislation permitting ownership by contractors of inventions arising from federal government-funded research. Sponsored by senators, Birch Bayh of Indiana and Bob Dole of Kansas, the Act was adopted in 1980, is codified at 94 Stat. 3015, and in 35 U.S.C. § 200–212, and is implemented by 37 C.F.R. 401 for federal funding agreements with contractors and 37 C.F.R 404 for licensing of inventions owned by the federal government.
Stanley Norman Cohen is an American geneticist and the Kwoh-Ting Li Professor in the Stanford University School of Medicine. Stanley Cohen and Herbert Boyer were the first scientists to transplant genes from one living organism to another, a fundamental discovery for genetical engineering. Thousands of products have been developed on the basis of their work, including human growth hormone and hepatitis B vaccine. According to immunologist Hugh McDevitt, "Cohen's DNA cloning technology has helped biologists in virtually every field". Without it, "the face of biomedicine and biotechnology would look totally different." Boyer cofounded Genentech in 1976 based on their work together, but Cohen was a consultant for Cetus Corporation and declined to join. In 2022, Cohen was found guilty of having committed fraud in misleading investors into a biotechnology company he founded in 2016, and paid $29 million in damages.
Science Commons (SC) was a Creative Commons project for designing strategies and tools for faster, more efficient web-enabled scientific research. The organization's goals were to identify unnecessary barriers to research, craft policy guidelines and legal agreements to lower those barriers, and develop technology to make research data and materials easier to find and use. Its overarching goal was to speed the translation of data into discovery and thereby the value of research.
BiOS is an international initiative to foster innovation and freedom to operate in the biological sciences. BiOS was officially launched on 10 February 2005 by Cambia, an independent, international non-profit organization dedicated to democratizing innovation. Its intention is to initiate new norms and practices for creating tools for biological innovation, using binding covenants to protect and preserve their usefulness, while allowing diverse business models for the application of these tools.
ATCC or the American Type Culture Collection is a nonprofit organization which collects, stores, and distributes standard reference microorganisms, cell lines and other materials for research and development. Established in 1925 to serve as a national center for depositing and distributing microbiological specimens, ATCC has since grown to distribute in over 150 countries. It is now the largest general culture collection in the world.
A biopharmaceutical, also known as a biological medical product, or biologic, is any pharmaceutical drug product manufactured in, extracted from, or semisynthesized from biological sources. Different from totally synthesized pharmaceuticals, they include vaccines, whole blood, blood components, allergenics, somatic cells, gene therapies, tissues, recombinant therapeutic protein, and living medicines used in cell therapy. Biologics can be composed of sugars, proteins, nucleic acids, or complex combinations of these substances, or may be living cells or tissues. They are isolated from living sources—human, animal, plant, fungal, or microbial. They can be used in both human and animal medicine.
Biotechnology is the application of scientific and engineering principles to the processing of materials by biological agents to provide goods and services. From its inception, biotechnology has maintained a close relationship with society. Although now most often associated with the development of drugs, historically biotechnology has been principally associated with food, addressing such issues as malnutrition and famine. The history of biotechnology begins with zymotechnology, which commenced with a focus on brewing techniques for beer. By World War I, however, zymotechnology would expand to tackle larger industrial issues, and the potential of industrial fermentation gave rise to biotechnology. However, both the single-cell protein and gasohol projects failed to progress due to varying issues including public resistance, a changing economic scene, and shifts in political power.
Ananda Mohan Chakrabarty, PhD was an Indian American microbiologist, scientist, and researcher, most notable for his work in directed evolution and his role in developing a genetically engineered organism using plasmid transfer while working at GE, the patent for which led to landmark Supreme Court case, Diamond v. Chakrabarty.
Biotechnology consulting refers to the practice of assisting organizations involved in research and commercialization of biotechnology in improving their methods and efficiency of production, and approaches to R&D. This assistance is usually provided in the form of specialized technological advice and sharing of expertise. Both start-up and established organizations would hire biotechnology consultants mainly to receive an independent and professional advice from key opinion leaders, individuals with extensive knowledge and experience in a particular area of biotechnology or biological sciences, and, often, to outsource their projects for implementation by well qualified individuals. Large management consulting firms would often be able to provide technological advice as well, depending on the qualifications of their consulting team. With the growth of pharmaceutical companies, biotechnology consulting has recently developed into an industry of its own and separated from the management consulting industry that traditionally also provides technological advice on R&D projects to various industries. This has also been fueled by the impact various conflicts of interests can have on commercialization when biotechnology organizations contract services from academic institutions or government scientists
The United States Army Combat Capabilities Development Command Chemical Biological Center is the United States Department of Defense's principal research and development resource for non-medical chemical and biological defense (CB). As a critical national asset in the CB defense community, CBC supports all phases of the acquisition life-cycle ― from basic and applied research through technology development, engineering design, equipment evaluation, product support, sustainment, field operations and demilitarization ― to address its customers’ unique requirements.
The NIH Office of Technology Transfer (OTT) plays a strategic role by supporting the patenting and licensing efforts of our NIH ICs. OTT protects, monitors, markets and manages the wide range of NIH discoveries, inventions, and other intellectual property as mandated by the Federal Technology Transfer Act and related legislation.
On 29 March 2010, the US District Court for the Southern District of New York found several of the patent claims on the BRCA1 and BRCA2 breast cancer genes held by Myriad Genetics to be invalid. The patents were initially issued on the basis that the genes were isolated and purified to a non-naturally occurring state, however the court found, amongst other things, that the purification was not markedly different from a product of nature and thus was not patentable. The ruling may have implications for holders of other gene patents and the patentability of other naturally occurring substances. It has the potential to directly affect the operation of the healthcare and medical research industries, particularly with regards to cancer treatment and prevention, and may alter the accessibility of such therapies to patients.
Stanford University v. Roche Molecular Systems, Inc., 563 U.S. 776 (2011), was a United States Supreme Court case in which the Court held that title in a patented invention vests first in the inventor, even if the inventor is a researcher at a federally funded lab subject to the 1980 Bayh–Dole Act. The judges affirmed the common understanding of U.S. constitutional law that inventors originally own inventions they make, and contractual obligations to assign those rights to third parties are secondary.
Victor Golla (1939–2021) was a linguist who specialized in the indigenous languages of California and Oregon, especially the Pacific Coast Athabaskan subgroup of the Athabaskan language family and the languages of the region that belong to the Penutian phylum. He was emeritus professor of anthropology at Humboldt State University and lived in Trinidad, California.
A biological patent is a patent on an invention in the field of biology that by law allows the patent holder to exclude others from making, using, selling, or importing the protected invention for a limited period of time. The scope and reach of biological patents vary among jurisdictions, and may include biological technology and products, genetically modified organisms and genetic material. The applicability of patents to substances and processes wholly or partially natural in origin is a subject of debate.
Aaron Michael Streets is an African American bioengineer and associate professor in the Department of Engineering at the University of California, Berkeley in Berkeley, California. He is the principal investigator at the Streets Lab, where he and his team use tools from mathematics, physics, and engineering to study biology. Streets is currently developing microfluidic technology for single-cell measurements due to its high-resolution imaging.