Engineering and science has progressed rapidly over the last sixty years, specifically within the region of the life sciences. Disciplines such as biochemical engineering, proteomics, metabolic engineering, and biomolecular engineering have emerged as a result of engineering fundamentals being applied to biological systems and molecules. However, due the “natural” origin of the biological products that have been formulated, there is debate if such products should even be patentable. The landmark case of this debate, which also was the first controversy over what could be considered a genetic patent, was. Diamond v. Chakrabaty. The case has set the precedent for what can be considered a genetic patent, which inspired the rest of the biotechnology industry to file an enormous amount of patents over the past 33 years, where as of today, 47,000 patents involve genetic material.
In 1972, Dr. Ananda Chakrabarty, a microbiologist working for General Electric Co. filed a patent application for the invention of “a bacterium from the genus Pseudomonas containing therein at least two stable energy-generating plasmids, each of said plasmids providing a separate hydrocarbon degradative pathway.” This genetically engineered bacterium was capable of breaking down multiple components of crude oil, a property which no known naturally occurring bacterium was capable of. Chakrabaty’s had three different claims on why the bacterium were patentable: first, the process on how to produce the bacterium was novel; second, the inoculum comprised of carrier material cable of floating on water, and finally on the bateria themselves. The patent examiner accepted the first two claims, but ultimately rejected the third claim that the bacteria could not be patented because they were micro-organisms that were products of nature, and that living things are not patentable subject matter under 35 U.S.C. 101. However, on June 16, 1980, the Supreme Court overturned the decision of the patent examiner and ruled in favor of Chakrabaty on the following grounds: a live, engineered, human produced micro-organism is patentable subject matter, as the bacterium which Chakrabaty created could be considered a “manufacture” or a “composition of matter,” and that patent laws should be given a wide scope considering “any” composition of matter or manufacture is considered patentable. The court also noted that while genetic technology was unforeseen when 35 U.S.C. 101 was passed by congress, the language of the statue clearly embraced the invention of Dr. Chakrabaty.
Dr. Chakrabaty was clearly was within all his right to file the patent for his bacterium which he created and the Supreme Court made the right decision. However, with cases such as the Association for Molecular Pathology v. Myriad Genetics, it appears that maybe some people have taken the Chakrabaty decision too far. Pharmaceutical companies are trying to patent anything they can under the sun, including our on genes and even DNA sequences. For example, in the United States, 3,000-5,000 human genes have been granted patents. Simply isolating such biological materials (which exist naturally) is not innovative. Genetic patents such as those are purely money making schemes. If things as basic as DNA sequences and genes become patent , there leaves less for innovation, which is one of the main purposes of the patent laws, and IP laws in general (except for Trade Secrets). Imagine how much more innovation there would be in biomedical research if those 3,000-5,000 humans genes had not been patented? A line needs to be drawn somewhere, or perhaps all innovation may be lost in an exciting and upcoming field of research.
Cook, Robert D. “Gene Patents.” The Hastings Center. 2014. Web.
“Diamond v. Chahrakabty.” Fine Law. 16 May 2014. Web. 16 May 2014.
“Gene Patents Remain Controversial in Biomedical Research.” The Lancet. 2013. Web.