By Robert on Tuesday, 30 March 2010
Category: Uncategorised

Judge Invalidates Human Gene Patent

Looks as though the practise of patenting genes may be at an end (at least in the USA) Judge Invalidates Human Gene Patent - NYTimes.com.  It's always seemed odd to me that patents of natural objects suc as genes were allowed in the first place - this case concerns patents held by Myriad Genetics on the use of BRCA1 and BRCA2.
A federal judge on Monday struck down patents on two genes linked to breast and ovarian cancer. The decision, if upheld, could throw into doubt the patents covering thousands of human genes and reshape the law of intellectual property.
The case was brought jointly by the American Civil Liberties Union and the Public Patent Foundation.  This case has been interesting - my memory of events is that Myriad knew where the genes were, but that it was the public human genome sequencing projects which provided the raw data that enabled Myriad to determine the gene sequences. The implication of this ruling, if it's upheld, may be interesting.  I suppose smaller biotech companies with principal IP assets in the form of gene patents might find themselves in trouble.  The NYT article continues:
Judge Sweet, however, ruled that the patents were “improperly granted” because they involved a “law of nature.” He said that many critics of gene patents considered the idea that isolating a gene made it patentable “a ‘lawyer’s trick’ that circumvents the prohibition on the direct patenting of the DNA in our bodies but which, in practice, reaches the same result.” The case could have far-reaching implications. About 20 percent of human genes have been patented, and multibillion-dollar industries have been built atop the intellectual property rights that the patents grant.
I notice from a quick Google search that John Sulston released a statement back in 2009 supporting the ACLU case (BRCA - Statement of Support: Sir John Sulston):
I applaud the efforts of the ACLU and the Public Patent Foundation in challenging the patenting of human genes, and in particular the patents on BRCA1 and BRCA2. A patent on a gene specifically bestows the right to prevent others from using that gene. Rather than fostering innovation – one of the primary goals of the patent system – gene patents can have a chilling impact on research, obstruct the development of new genetic tests, and interfere with medical care. Genes are naturally occurring things, not inventions, and the heritage of humanity. Like a mountain or a river, the human genome is a natural phenomenon that existed, if not before us, then at least before we became aware of it.
Sulston's statement also illustrates the chilling effect of gene patents on research and development, specifically citing the chain of events which led to Myriad's patent application. Of course there are differing views on this: the NYT report quotes various individuals from the patent/legal/business side of the affair who clearly believe that medical research progress will be dented if individuals or companies are prevented from profiting financially from gene discovery (rather than inventing some application based upon gene discovery). This decision is to be welcomed, although the NYT reports that the decision is likely to be appealed.

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