And now, patents for genes1 min read . Updated: 07 Apr 2013, 08:31 PM IST
India must quickly tighten its position on patenting genes and explicitly defining incremental innovation
While the polemical dust kicked up after the apex court ruling that upheld a lower court decision to deny Novartis India a patent on Glivec may be slowly settling, the Supreme Court in the US will begin hearings to settle—hopefully once and for all—the issue of whether human genes may be patented. The case involves the Utah-based biotechnology company Myriad Genetics that was granted patents in 1998 on a series of genes that claim to determine the risk of breast cancer unprecedentedly early and accurately.
While on the surface it may seem absurd to grant patents on genes in the first place—most countries explicitly bar natural substances from being patented—the controversy surrounding these patents exists on grounds if genes that are isolated and purified outside of the body, or inventively reconfigured for developing new diagnostic steps, may qualify as patentable products or processes. That there are patents on bacteria modified to treat oil spills and adrenaline, a trademark and artificially purified form of naturally produced epinephrine, laid the grounds to grant these patents to Myriad. Challenges to these patents are based on issues such as thwarting of research and advances in breast cancer detection and treatment. However, it is time India seriously considered legal implications of gene patents.
This is because the future of medicine lies in designing complex biological molecules that will increasingly depend on factoring the effects of genes and other biological components. Manufacturing the generic equivalent of such medicines is far more daunting, as well as less profitable. It is also likely that Indian drug companies will move to seek patent protection—even within India—to recoup their investments. The nature of biomedical research now means that several incremental innovations are necessary for big breakthrough medicines. India has great expertise in chemical formulations but almost nothing in discovering new drugs. It has to go through a painful process of several incremental finds before hitting on substantial inventions. The laws as they stand, though designed to keep prices of drugs low are predicated on limiting incremental innovations. To address its responsibilities to patients and industry, India must quickly tighten its position on patenting genes and explicitly defining incremental innovation.
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