The Supreme Court of the United States of America recently released the much anticipated judgment in the case of Association Molecular Pathology v. Myriad Genetics case. This case involved the issue of whether it is right for human genes to be patentable. In this case, the Supreme Court was of the opinion that isolating a gene as separating it from the surrounding genetic material was not in itself an act of invention. In the reasoning of the court, this is because the structure of the gene is not new as it already exists in nature. However, the Supreme Court was of the view that synthetic DNA or cDNA was patentable as it is a molecule that does not occur ordinarily or naturally but made in the lab, and this makes it patentable (Resnik 112).
The law on patents was introduced several centuries ago in the United States of America with two primary purposes. First is to provide temporary financial incentives for those individuals or companies for inventive products such as X-ray machine and combustible engine among others. Second is to ensure that an individual or a company do not control or hold a lifetime monopoly which might discourage consumer affordability and competition (Somsen 67). As a result, all patent submissions must distinguish between abstract principles and ideas and tangible scientific principles and discoveries as well as relying on reading of the relevant laws. It was a case brought by medical researchers and cancer patients on the question on whether human genes are patentable. It was a case to challenge a family of patents related to BRCA1 and BRCA2, isolated human genes owned by Myriad. Myriad Genetics used the isolated genes to identify a predisposition of developing ovarian and breast cancer. These genetic tests consequently gained publicity for being the motivation behind public election of Angelina Jolie's for preventive surgery (Bouchoux 23).
In several other nations or jurisdictions across the world such as Germany and France, human genes which can be isolated are patentable. This resulted to the argument that isolated genes should also be patentable in the United States of America but for a particular usage. In the case of Harvard College, the court noted that judicially developed exception from patentability of human genes that does not sufficiently address issues like whether the human body or its parts, would be patentable. In Canada, the Patent Office allows for patents on proteins, human genes, DNA sequences, and cells. As stated in the case of Monsanto Canada Inc. v Schmeiser, this is because the Patent Act allows for genetic modification of cells and genes (Kraepelin 51).
There is great importance in a biotechnology industry to allow human genes to be patentable as data derived from genetic screening tools are a potential proprietary information source which should be protected by trade secrets. For instance, several laboratories nowadays do not publish results for researches they conduct simply because of the impact of some mutations to the genes identified through their screening tools. This is because they want to maintain and conceal these results as trade secrets. Human genes should also be patentable because by extracting such genes from body of a human being, an individual or a company invents an isolated DNA from the native DNA and should hence be patentable (Richards, Julia, and Hawley 89).
On the other hand, arguments against patenting human genes were also presented and one it that it negatively affects the health sector in both the United States and Canada. According to a report published by Canadian Biotechnology Advisory Committee (CBAC) in October 2005, human genetic material should not be patented as it exists in nature. The committee was also of the opinion that chemicals that are isolated from nature by human intervention should be patented (Malik, Chitra, and Kaur 246). From the evolving jurisprudence on patents, the issue of patenting human genes is primarily an issue of inventiveness and subject matter. It is because technology is evolving and permitting rapid and automated genetic sequencing, and the issue of identifying human genes is a natural thing and not inventive skill (Kraepelin 54). As such a claim for genetic sequence should only be allowed in the event that the identification of such as sequence is represented a technical achievement. This means that a claim to a human gene would likely be ineligible for patent protection because the identification of such a sequence is no longer an invention. Human genes should also not be patentable because they are not materially distinct from genes prior to extraction, and if it is permitted, it will result to patenting of nature which will in turn be costly for medical treatment, patients, and scientific research (Richards, Julia, and Hawley 89).
In conclusion, isolated human genes should not be patentable where they have significant potential of hindering innovation (Somsen 67). Moreover, economic policy considerations or settled expectations only should not be enough to make isolated human genes patentable. It is essential that nature should not be patented but full claims of coding or identification of sequence that is patentable construct. However, end products from nature should be patentable so that it can significantly spur innovation in several areas of human or medical research (Bouchoux 43).
Work Cited
Bouchoux, Deborah E. Intellectual Property for Paralegals: The Law of Trademarks, Copyrights, Patents, and Trade Secrets. Clifton Park, NY: Delmar Cenage Learning, 2009. Print.
Kraepelin, Emil. Patenting of Human Genes and Living Organisms. S.l.: Springer, 2012. Print.
Malik, C P, Chitra Wadhwani, and Kaur Bhavneet. Crop Breeding and Biotechnology. Jaipur, Raj., India: Pointer Publishers, 2009. Print.
Resnik, David B. Owning the Genome: A Moral Analysis of Dna Patenting. Albany: State University of New York Press, 2004. Internet resource.
Richards, Julia E, and R S. Hawley. The Human Genome: A User's Guide. Burlington: Elsevier Science, 2010. Internet resource.
Somsen, Han. The Regulatory Challenge of Biotechnology: Human Genetics, Food and Patents. Cheltenham, UK: Edward Elgar, 2007. Internet resource.
