Comments on: This is Personal: A Legislative Attack on Personalized Medicine

By: David Resnick

David Resnick — Mon, 10 Dec 2007 01:18:53 +0000

I’m not sure I get your point. There are thousands of patents that claim methods to produce nuclear energy that directly result from Einstein’s theory. A theory can’t be patented. As Chief Justice Burger stated in his majority opinion to Diamond v Chakrabarty: “The laws of nature, physical phenomena, and abstract ideas have been held not patentable. [cites omitted] Thus, a new mineral discovered in the earth or a new plant found in the wild is not patentable subject matter. Likewise, Einstein could not patent his celebrated law that E=mc2.; nor could Newton have patented the law of gravity. Such discoveries are “manifestations of . . . nature, free to all men and reserved exclusively to none.”

By: Cheuk Tam

Cheuk Tam — Thu, 06 Dec 2007 02:19:21 +0000

Thanks for clarifying your position, but I still question the nature of the patent. If the patent is for the application of the discovery, why does the discovery itself hold patent status? Claiming the possible application of the association between a gene and a disease would be like patenting E=MC2 as a method of producing (nuclear)energy. Shouldn’t the inventor of the application of the discovery be granted a patent, and not the discoverer of the association?

By: David Resnick

David Resnick — Sun, 25 Nov 2007 21:41:45 +0000

You stated that “[a] direct link between a gene polymorphism and a disease state is not “invented” by the researcher, it is discovered.” However, you have an invention if that discovery is applied to a method to diagnose a disease or to predict a patient’s response to a drug and that method meets the requirements of the law, e.g., it’s non-obvious, novel and useful. There are some, including a few members of the US Supreme Court, that believe that a correlation between a biomarker and disease state is not patentable subject matter because it’s a “natural phenomenon.” Take a look at the decision this year in LabCorp v. Metabolite. In that case the Supreme Court looked at the issue but dismissed the case as not having a proper record. Given the current anti-patent enviroment, this issue will be back.

By: Mollie Roth

Mollie Roth — Fri, 23 Nov 2007 15:39:57 +0000

Thanks for your thoughts on this issue. While direct research has perhaps not been impeded, I would agree with you that commercialization of innovative products, which is to some extent the beneficial outcome we are looking for from such research, has been impeded.

I looked at Lita’s presentation, which was quite good, but I still question whether a patent is appropriate for something not invented. A direct link between a gene polymorphism and a disease state is not “invented” by the researcher, it is discovered. Discovering the means to replicate a gene snp in the lab, invention. Inventing the means to discover the correlation, invention. The person who discovered the correlation between a tendon contricting and the corresponding movement of the muscle to which it attached did not invent that. Unless I am very mistaken, (which is posisble) the patent system was created for invention, not discovery.

By: David Resnick

David Resnick — Fri, 23 Nov 2007 14:46:52 +0000

There is little evidence that “gene” patents have an affect on scientific research. In close to 20 years of practice I have never seen research stop as a result of a DNA patent or a patent directed to a biomarker/disease correlation. However, a problem could arise if one wishes to commercialize a product that results from such research. This is a problem for any technology and is not unique to diagnostics. Some suggest that the roadblock to commercialization is exclusive patent licensing of such innovations by institution that make these discoveries, mainly universities and research hospitals. At the conference noted above, Lita Nelsen, director of technology transfer at MIT, gave an excellent overview of the issue and provided some potential solutions. If you are interested, her slides can be found at the conference web page.
http://www.nixonpeabody.com/events/personalizedMedicine/presentations.asp

(The views expressed in this column represent only those of the author and not of Nixon Peabody or its clients.)

By: Hannah Koyfman

Hannah Koyfman — Wed, 21 Nov 2007 03:38:29 +0000

I agree 100% that laws of nature should not be patentable – and they’re not patentable. A gene, however, is something else entirely. A gene is a physical object that can be made by humans. And an isolated gene in a test tube is something novel, and patentable. A gene in its natural habitat (that is, a normal cell) has clearly been around for years or millennia, and is not patentable.
I spent the better part of a decade doing academic research in molecular biology. In that time I never had to forgo an experiment because of patent issues. I’m curious whether there are any readers out there who had to. I would guess that this happens in more often in companies than in universities.
(My opinions are my own; I don’t speak for my current or past employers.)

By: Mollie Roth

Mollie Roth — Tue, 20 Nov 2007 15:41:56 +0000

I wonder if you would comment on how to prevent people from being squeezed out of using patented gene sequences for research based on exorbitant licensing fees if we continue to allow gene sequences to be patented. How do you prevent that from happening while still allowing for patent protection (or some other vehicle) to encourage this sort of research?

Further, patents are for inventions, not finds. No one is inventing these sequences they are simply finding that they are important and doing the research to understand and characterize what they do. They should get something for being the first to characterize the find but should they really get to put a lock on the use of it through a patent? Newton discovered gravity and characterized it, he did not invent it so a patent would not have been appropriate right? What’s the difference here that justifies patents other than the potentially enormous profits to be made? Isn’t this the worst example of the use of the patenting system? Restricting access to naturally occurring phenomenon simply because it costs a lot to undertake the research?