All living things have genes that act as their foundation. Characteristics such as the colour of the hair and eyes, the likelihood to contract cancer, etc. are all controlled by genes. Their omnipotence is, therefore, a given. Gene patents are highly sought after owing to the ability of companies to make the best use of this omnipotence. Keeping other requirements of being patentable aside, various cases have tested the eligibility of human genes to be treated as ‘inventions’ that are valuable enough to be protected by patents under 35 U.S.C. § 101. The Federal Circuit held Human genes to be patentable in the landmark case of Association for Molecular Pathology v. U.S. Patent and Trademark Office (the Myriad decision).
An approach based purely on structure has been chosen by the majority over the biological importance of the informational contents of the deoxyribonucleic acid (DNA) molecule. By holding that a DNA molecule, in isolation, is “markedly different from a natice DNA molecule, owing to slight differences in structure, the court has made an error in judgement. By doing so, the court has accidentally failed to acknowledge that both an isolated DNA molecule and the relevant portion of native DNA contain identical biological information due to their same sequence of nucleotides. The Federal Circuit ‘s approach reeks of bigotry. However, there exists an alternative, more comprehensive approach that perceives the structure of a DNA molecule by considering the two significant properties of DNA together.
By taking a totality-of-the-circumstances approach, this paper aims to analyse biological molecules under § 101 for both aspects, the structure and the information underlying in it. Germane precedents of patent law have been discussed and critically analysed in Part A. Part B digs deeper into the Federal Circuit’s decision in the landmark Myriad Case. Part C explores the after effects of the recent Supreme Court judgement in Mayo Collaborative Services v. Prometheus Laboratories. Part D, lastly, solves the conundrum revolving around the eligibility of the human gene. Eyeing the issue through the lens of a totality-of-the-circumstances approach, this paper ultimately concludes that human genes are, in fact, not patentable.