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Are Human Genes Patentable?
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Myriad Genetics, pioneer in molecular diagnostics lost its long fought battle to retain its patent protection on the gene BRCA1 and BRCA2 in June 2013 following the Supreme Court’s judgment stating that the isolated gene or gene sequences are not patentable for they are all naturally occurring. The verdict also stated that the synthetic DNA/ manmade DNA like cDNA and genetically engineered gene sequences are patentable.

The link between breast cancer and the genes BRCA 1 and BRCA2 was established in early 90’s by Myriad genetics and the company got its patent protection over these two genes from US patent and Trade Office. This triggered a legal battle between Myriad genetics, US Patent and Trade office, University of Utah Research Foundation on the one side and many associations like American Civil Liberties Union, Public patent foundation, Association for Molecular Pathology, ACMG, Breast cancer Action and Women’s Health Collective groups as opponents with the later groups appealing to the court to remove the patent protection of Myriad genetics over the BRCA1 and BRCA2 genes claiming that genes cannot be patented.

Starting in May 2009 over several appeals in Court of Appeals for Federal Circuit and hearings in the following years the verdict of Supreme Court in June 2013 “Naturally present human gene or gene sequences cannot be patented just because it is identified and isolated”, proves to have severe impact on industries and organizations involved in the development of innovative medicine, science and technology, biotechnology community and its principles of patenting. Though denied US patent protection on BRCA1 and BRCA 2 genes, Myriad genetics still possess the patents of the genes approved by Canadian IPO.

A similar verdict appeared in the district court of California on 3rd November 2013, in a case filed by Ariosa diagnostics against Sequenom diagnostics for its patent over its gene testing facility for Down’s syndrome. The verdict “natural phenomenon are not patentable” is not in favor of Sequenom diagnostics impacting the stocks held by the firm initiating the company to appeal in Court of Appeals for Federal Circuit.

The ultimate verdict that human genes cannot be patented will definitely be a game changer in the future prospects of biotechnology.
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