Abstract
Patenting gene and its nucleotide sequence has been a controversial subject since the release of working draft of the Human Genome Project. A number of US Supreme Court judgments pronounced in the recent past and accordingly revised patent examination strategies of the United States Patent and Trademark Office (USPTO) created a huge confusion in the field of biotechnology. The present article explores the volatile nature of judicial decision-making in modern biotechnology arena and attempts to analyze and gauge the practical impact of the landmark judgment of Association for Molecular Pathology v. Myriad genetics Inc. The present article also reveals how the Myriad judgment changed the USPTO’s long-standing practice of granting patents on isolated DNA molecules and set a new patent-eligibility standard for genes and DNA related innovations. The present article also endeavors to investigate the challenges and possibilities of patenting isolated proteins, sequence homology and protein three-dimensional structure based innovations in post- Myriad US patent regime.
Highlights
After the release of working draft of the Human Genome Project, the US Patent and Trademark Office (USPTO) received a number of letters from stakeholders including the NHGRI1 director Francis Collins arguing a revision of its acceptability norms for gene and DNA sequence related patent applications
In 2001, USPTO issued a guideline raising the bar on patent-eligibility standard for DNA related patent applications stating that identification of gene sequence alone is not patentable, but that discoveries directed to genes isolated from their natural environment might be patentable if they possessed “specific, substantial and credible utility”.2USPTO clarified in its revised guidelines that even if a gene was discovered from its natural source but “isolated” and “purified” from other molecules naturally associated with it would be patent-eligible as long as the requirements of title 35 of the US code were met
There is no objection in granting patents for such genes as „composition of matter‟ or „a matter of manufacture‟.4Patent applications directed to isolated gene never faced unavoidable challenge at the USPTO, the scenario dramatically changed in 2013 when the US Supreme Court invalidated three disputed patents of Myriad Genetics Inc. related to BRCA gene
Summary
Ph.D. Candidate (Patents Law and Biotechnology Innovations), The West Bengal National University of Juridical Myriad genetics Inc. The present article reveals how the Myriad judgment changed the USPTO‟s long-standing practice of granting patents on isolated DNA molecules and set a new patent-eligibility standard for genes and DNA related innovations.
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