In an earlier post, I wrote about the consternation surrounding patents on genes and the potential implications to the developing realm of nanotechnology. Recently, an amicus brief was filed with the Federal Circuit by the Department of Justice (DOJ) opposing the patents that were issued to Myriad regrding the testing for breast and ovarian cancer. Interestingly, the United States Patent and Trademark Office (USPTO) did not join the DOJ, which indicates an idealogical rift in the Obama administration. It was reported that Mr. Kappos, current director of the USPTO, ”seemed chagrined that the Department of Justice was taking a viewpoint very different from the patent office.”
The following is an excerpt from the amicus brief Table of Contents which is rather revealing and informative regarding the government’s opinion on the matter:
A. Section 101 Embraces Only “Human-Made Inventions”
B. Engineered DNA Molecules, Including cDNAs, are Human-Made Inventions Eligible For Patent Protection
C. Isolated But Otherwise Unmodified Genomic DNA Is Not A Human-Made Invention
1. Unmodified Genomic DNA Is A Product Of Nature
2. “Isolation” Does Not Transform A Product Of Nature Into A Man-Made Invention
3. Isolated Genomic DNA Is Not Patent-Eligible Merely Because It Is A Literal Composition Of Matter
4. Isolated Genomic DNA Is Not Rendered Patentable On The Theory That It Is “Pure”
5. Isolated Genomic DNA Is Not Patent-Eligible Merely Because It Is Useful Or Requires Investment To Identify
It is important to note that the DOJ is not advocating an all-out ban on patents on genes, just those that are ‘unmodified.’ Initially, this will allow for further development of the information contained in the genomic code. It seems as though the big argument revolves around the pieces of the code that are isolated, but not changed in any way. Proponents assert that there should not be the reward of patent protection based solely on finding that which already naturally occurs. Opponents argue that invention and development of specified uses for these segments of DNA would be stiffled, and the United States’ position as a global leader in the life sciences would be severely compromised.
It will be interesting to watch the development of the subject matter as it works its way through the Federal Circuit, and presumably the Supreme Court. Not only for the impact it will have on the biotechnology arena, but also on nanotech. As mentioned before, many argue that the majority of inventions involving nanotechnology do not qualify for patent protection because they are not far enough removed from the naturally occurring material they are comprised of. We shall see.
Link to the DOJ brief:
http://graphics8.nytimes.com/packages/pdf/business/genepatents-USamicusbrief.pdf
Why the long wait? this could help us in the future but they keep restricting everything