Personalized Medicine and the Gene Patenting Debate

15 April 2013 Personalized Medicine Bulletin Blog

The transcript for today’s Supreme Court oral argument in The Association for Molecular Pathology v. Myriad Genetics, Inc., No. 12-398 (2013) has been released, and the importance of the gene patenting debate to personalized medicine was discussed. The Court was well briefed on the issues and questioned the parties and U.S. government regarding why isolated genes should or should not be patent-eligible, the distinctions between DNA probes or primers and claims to full length sequences (isolated genomic DNA and cDNA) and the difficulty in crafting a test that would exclude broadly claimed inventions under Section 101 of the patent act rather than limiting broadly claimed inventions as failing under Section 102 (novelty) and/or Section 103 (obviousness).

Gregory A. Castanias noted the importance of gene patents in general to the evolving business of personalized medicine. Justice Kagan questioned Mr. Castanias regarding the application of the product of nature doctrine to the patent-eligibility of isolated naturally occurring materials. Justice Kagan asked:

“Well, the plant in the forest can’t be used for any purpose either. It only has a use when it’s taken out – you know, when it’s uprooted and taken out of the forest. But it’s still the same thing. And I guess what you haven’t gotten me to understand is how this is different than that. It’s still the same thing, but now that you’ve isolated it, it in fact has lots of great uses.”

Mr. Castanias replied:

“Well, I think there are two ways – two ways to look at that. First of all, if you want to look at it from the – the perspective of the so-called product of nature doctrine, which I think has some very dangerous consequences if it’s not cabined and understood correctly – but if you look at it strictly from a product of nature doctrine, you could say, well, that’s the same plant and it says in the 1930 legislative history of the Plant Patent Act that plants that are unmanipulated by the hand of man are not eligible for patents, and that’s fine, in terms of their breeding and genetics and that sort of thing.

But the product of nature doctrine is troublesome for this reason: Modern medicine – go beyond just the isolated DNA patents here. Modern medicine, particularly the area of personalized medicine, is trying to get to a point where what we are administering to individual patients is giving them the opportunity to mimic the actions of the body. And – so actually, the goal of medicine is to get closer to nature, rather than farther away. And anything that takes the product of nature doctrine beyond the simple truism that the product of nature is something that is not a human invention, then that’s very dangerous, not just for our case…”

A decision from the Court is expected this summer.

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