On 13th June 2013, in one of the most important case in the area of Biotechnology Patents between “Association For Molecular Pathology” and “Myriad Genetics”, the United States Supreme Court ruled that “A naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated, whereas cDNA (Complimentary DNA) is patent eligible because it is not naturally occurring,”
A brief background on the case, Myriad Genetics developed tests that predict a woman’s genetic tendency to particular cancer. Its research identified two human genes BRCA 1 and BRCA 2 that are associated with an increased risk of breast or ovarian cancer. If these genes mutate, it results in high risk for developing breast and ovarian cancer. “Myriad Genetis” developed a test to screen for these mutated genes. Myriad’s Patent Application claim focused on the genetic information encoded in the BRCA1 and BRCA2 genes. When“Myriad Genes” patented its discovery, it prevented other diagnostics from testing to identify mutated genes. Thus, also making the test very costly for patients.
In the said case “Association For Molecular Pathology” argued in favour of declaring said claims of “Myriad Genetic’s” Patent Application invalid and emphasized that although Myriad researched and discovered the said genes but the contained genetic sequence were made by nature, not by Myriad. It further argued that when you lock up a product of nature, it prevents industry from innovating and making new discoveries.
The U.S Supreme Court in this matter held that although “Myriad Genetics” discovered cancer-associated genes, merely discovering the location and genetic sequence of the genes does not render the same patent-eligible, as separating that gene from its surrounding genetic material is not an act of invention.
Hopefully this decision will help in lowering the prices for said tests as patients will have greater access to genetic testing with increase in number of test providers. It is to be seen now how this decision shall effect patent related processes and litigation. For any suggestions/query you can email me at securingip@gmail.com or please drop in your comments.
Vidhik-Vishleshan (Decoding The Law & More) 