So, Your Genes Cannot be Patented in the US, Why Should You Care?

CURRENT SOCIETAL CONCERNS
Elpidio V. Peria
15 June 2013

Last Thursday, 13 June 2013, the US Supreme Court issued a unanimous ruling in a long-awaited case involving the legality of patenting human genes, in Association for Molecular Pathology, et.al. v. Myriad Genetics, Inc., et.al., holding that a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated, but complementary or cDNA, (a synthesized analogue of the same DNA), is patent eligible because it is not naturally occurring.

This case involved the BRCA1 and BRCA2 breast cancer genes that were isolated by Myriad Genetics of Salt Lake City, Utah, in the US, and is now being used to test women for breast cancer, something made familiar by news reports of Hollywood star Angelina Jolie’s decision to remove her breasts and ovary as a preemptive action to prevent being afflicted with such disease.

The immediate impact of this decision is the lowering of the costs of similar breast cancer test kits in the US and perhaps also in the developing world, like in the Philippines, which kits are now coming out, as a result of the decision. This is now possible since with the invalidation of Myriad’s patents on the BRCA1 and BRCA2 genes, other companies who may work on these genes will no longer be stopped by Myriad from doing so.

This will also encourage researchers in the developing world, including the Philippines, as they will no longer worry about being sent demand letters ordering them to stop their research activities, or else negotiate a hefty licensing fee from Myriad, the owner of the patent in these genes. Of course, we may also ask if there are Filipino research groups who may have the funding and the facilities to work on these types of genes. For Filipinos in the US, they can avail of these lowered costs for detecting cancer diseases, which, the sooner it can be done, should result in early detection and treatment. For those in the Philippines, the effects of the lower price of the breast cancer tests means there are a lot more people who may be able to afford it.

As to whether the legal principles used to invalidate these patents can be used to invalidate patents on non-human, i.e., animal, plant or other living matter, genes, this remains to be seen if groups working on this issue will mount these types of expensive cases.

Perhaps in their revision of the Patent Manual, the Philippine Intellectual Property Office, even if US cases are not directly applicable here but merely have a persuasive application, may want to use this case as a key principle to guide their patent examiners, to exact a higher level of effort from researchers, who now doesn’t just need to show they have isolated certain living cells or chemical compounds, but also show that they have put certain amount of effort in synthesizing it, in order that it can be owned.

oOo

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