In the last several years‚ the biotechnology field has experienced rapid growth‚ becoming one of the hottest markets in applied science. Biotechnology is the application of live microorganisms and biological processes to the fields of medicine‚ engineering‚ agriculture‚ and other technology. Biotechnology includes‚ among other things‚ genetic engineering‚ the creation of proteins‚ and the culturing of cells and tissues. Rather than purely researching biological processes and living organisms‚ biotech companies strive to utilize these processes and organisms to create products‚ compositions‚ or other processes. Examples of biotechnology patents include medical insulin‚ adrenaline‚ and genetically modified organisms.
History of Biological Patents
With the proliferation of modern genetic engineering came the desire to protect man-made‚ or recombinant‚ DNA sequences. In the 1970’s‚ geneticists began applying for and receiving patents for recombinant DNA. Landmark achievements in the field of genetic research‚ such as successful animal cloning and the completion of the Human Genome Project‚ have spurned growth in both the amount of genetic research undertaken and the amount of gene related patents requested each year.
The next major development in biotechnology patents began with the 1980 Supreme Court case Diamond v. Chakrabarty. There‚ the Supreme Court determined that a patent could be granted for a living micro-organism. In that case‚ a General Electric employee developed a bacteria that could break down crude oil‚ hoping to develop that bacteria for use in cleaning up oil spills. After being initially denied a patent by the examiner on the grounds that a living thing was not patentable‚ the United States Court of Customs and Patent Appeals ruled in favor of Chakrabarty. The Supreme Court affirmed its decision‚ reasoning that the organism was truly man-made and fit under the composition of matter category of a utility patent‚ making it eligible for patent protection. Since this decision‚ viruses‚ plants‚ seeds‚ and animals have been the subjects of biotechnology patents issued by the USPTO.
Requirements for Biotechnology Patents
A biotechnology patent requires basically the same elements as a common utility patent. First‚ the process‚ gene‚ or organism must be new‚ useful‚ and non-obvious. Second‚ the patent must sufficiently describe the process‚ organism‚ or gene sequence and enable others to recreate it.
The novelty and non-obvious requirements pose unique challenges on inventors seeking biotechnology patents. In order to obtain a patent on a biological process or organism‚ the subject of the patent must be sufficiently distinct from its naturally occurring form to be considered novel and non-obvious.
For example‚ it is unlikely that one could obtain a patent for the now internationally trendy “fish pedicure‚” a skin treatment process involving Doctor Fish or Garra Rufa who eat the dead skin off the feet of patients while leaving the live skin intact. This is because these organisms will naturally perform this task without any biological modification. Instead‚ to obtain a patent‚ the subject of the patent must amount to a sufficiently new gene‚ organism‚ or process not found in nature. Attempting to patent a naturally occurring organism or process would likely fail as such a patent application would not satisfy the novelty and non-obviousness requirements for a utility patent.
Furthermore‚ as with other utility patents‚ those applying for biotechnology patents must sufficiently enable others to create the patented material. For a biotechnology patent to issue‚ others skilled in the art must be able to replicate the organism or process without undue further experimentation. While the law recognizes the unpredictable nature of biology and reproduction‚ the claims must sufficiently enable those skilled in the art to recreate the virus‚ bacteria‚ process‚ or plant sought to be patented. Therefore‚ the enablement requirement for a biotechnology patent is arguably higher than that of a general utility patent.
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