Intellectual-property law, which provides a personal property interest in the work of the mind, is of increasing importance to people using biotechnology to create new inventions. Intellectual property involves several areas of the law: patent, copyright, trademark, trade secret, and plant variety protection. All affect emerging high-technology industries because they provide incentives for individuals and organizations to invest in and carry out R&D. Many see protection of intellectual property as a paramount consideration when discussing a nation’s competitiveness in industries fostered by the new biology.
Broad patent protection exists for all types of biotechnology-related inventions in the United
States. The Supreme Court decision in Diamond v. Chakrabarty, that a living organism was patentable, along with action by Congress and the executive branch changing Federal policy to increase opportunities for patenting products and processes resulting from federally funded research have spurred biotechnology- related patent activity. Internationally,several agreements (e.g., the Paris Union Convention,the Patent Cooperation Treaty, the Budapest
Treaty, the Union for the Protection of New Varietiesof Plants, and the European Patent Convention) provide substantive and procedural protection for inventions created through the use of biotechnology.
Despite a generally favorable international climate,a number of elements affect U.S. competitivenessin protecting intellectual property. The patent application backlog at the Patent and Trademark Office (PTO), domestic and international uncertainties regarding what constitutes patentable subject matter, procedural distinctions in U.S. law (e.g.,first-to-invent versus frost-to-file, priority dates, grace periods, secrecy of patent applications, and deposit considerations), uncertainties in interpreting process patent protection, and the spate of patent infringement litigation, all constitute unsettled areas that could affect incentives for developing new inventions.
The backlog of patent applications at PTO is frequently cited as the primary impediment to commercialization of biotechnology-related processes and products. Recent studies reveal that
the pendency period for biotechnology patent applications is longer than that of any other technology.