Biotechnology can be defined as any technological application that uses biological systems from living organisms or living organisms to produce or modify products designed for a specific application. Although a great deal of attention has been focused on biotechnology since the advent of genetic engineering, it has long been used in food processing, antibiotics development and agricultural processing. Lately, the term has been used more to refer to recombinant DNA based processes or production of specific compounds via cell culture and bacteriological culture means. Various methods have been used to effect gene transfer in living organisms via vectors to introduce unique DNA into a particular host resulting in production of a compound of interest. Currently, a major focus is to utilize biotechnology to produce “biofuels” for the energy industry from diverse biological material such as cellulose.
One of the most promising areas in the biotechnology arena is the production of biopharmaceuticals for prevention or treatment of specific diseases. Recombinant DNA derived vaccines and/or therapeutic proteins can be produced in high levels in bacterial and eukaryotic cell cultures and then purified for use by the medical community. Most of these processes involve unique procedures or molecules that have been developed through extensive research and development programs. This gives rise to a substantial amount of intellectual property that may be protected by patents or may be considered confidential information. In many cases, the intellectual property may be held by one group, but production of the product may be done by a separate contract manufacturing organization. Any product intended for parenteral use as a vaccine or therapeutic must be manufactured in compliant facilities under manufacturing guidelines developed by the FDA. Such manufacturing is done under a contract that establishes rigid specifications for the product and under a Quality Agreement that defines the responsibilities of both the manufacturer and the contracting group. All of this is intended to result in a non-adulterated product. Products intended for the veterinary industry similarly must be manufactured under the guidelines developed by the USDA.
Disputes concerning a product may arise when it does not meet the established specifications or when the contract manufacturer did not comply with the FDA regulations. This may be due to a myriad of reasons, but typically occurs when the specifications are open to interpretation. Such disputes then may result in a lawsuit between the two entities. Disputes also may arise when the intellectual property has been compromised or when patent infringement is suspected. Settlement of such disputes involving the biotechnology sector may be facilitated by a mediator familiar with the technology, the uses of the technology to produce products and the applicable FDA or USDA guidelines.