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Gene therapy: patents

The gene is out of the bottle


Landmark judgement will prevent firms from patenting individual genes
SAYAN GHOSH | Issue Dated: July 14, 2013, Delhi
Tags : The gene is out of the bottle |

The US Supreme Court judge Justice Clarence Thomas declared in a landmark judgment on patenting human DNA, "We hold that a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated." The judgment was an outcome of a legal battle between American Civil Liberties Union (ACLU) vs Myriad Genetics Inc, where the latter had isolated a couple of gene types from the human body called BRCA genes and patented it in its own name, thus controlling any kind research and testing on them. The BRCA genes are particularly important for treating many kinds of illness, and in the cure of breast and ovarian cancer. Justice Thomas and several other watchdogs are concerned that patenting genes by individual corporations would stifle the spread of research, testing and invention of drugs that would be a “considerable danger” to intellectual protection in the fields of medical science and biotechnology. "Myriad", Justice Thomas said, “did not create anything. To be sure, it found an important and useful gene, but separating that gene from its surrounding genetic material is not an act of invention.”

There is another side to this judgment. The investment of billions of dollars that goes into research would be affected for want of a motivation as the road to recoup the invested funds would be blurred. However, the court has allowed patenting synthetic DNA and complementary DNA (cDNA), which are manufactured in laboratories. Complementary DNAs are created by manipulating something unfound in nature and it means “the lab technician unquestionably creates something new when a cDNA is made.” The latter ruling is made keeping in mind the importance of patenting for the genetic research firms and their recovery prospects of the investments made.

The ruling also signifies the price factor for genetic testing, which is often tagged at more than $3,000, and is likely to plummet considerably. This is because competition, as against monopoly, is likely to push the price down. And that will help several middle class women who cannot afford, unlike Angelina Jolie (whose genetic problem was instrumental in attracting media spotlight on the issue), an exorbitant price tag for gene therapy like the one charged by Myriad. Dr. Harry Ostrer, one of the defendants in the case, pointed out that the effect of price “will have an immediate impact on people’s health.”

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Issue Dated: Feb 5, 2017