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  • No more gene patents

    Fri, 2010-10-29 21:29 -- John Hawks

    This is a surprise: The U.S. federal government's position now opposes gene patents:

    The new position was declared in a brief filed late Friday by the Justice Department in relation to a lawsuit challenging the validity of patents held on two genes that are used to judge whether a woman has an unusually high risk of breast cancer.

    “We acknowledge that this conclusion is contrary to the longstanding practice of the Patent and Trademark Office, as well as the practice of the National Institutes of Health and other government agencies that have in the past sought and obtained patents for isolated genomic DNA,” the brief said.

    This is a natural consequence of technological advance. Today there's little novelty in isolating a gene sequence. It is still work to associate a gene with a disease, but it has become very easy to add a genotype to a chip that contains hundreds of thousands of other genotypes. It's pretty hard to argue that anything having to do with testing genotypes today is deserving of patent protection. In fact, a group of geneticists have published a do-it-yourself workaround to the Myriad patents on BRCA1 and BRCA2.

    The story is brief and does not discuss whether the administration still considers some other applications of genetic information to be patent eligible. The new position is based on the idea that gene sequences are "products of nature". Since the BRCA1 and BRCA2 patents are at issue, the "natural products" idea must be construed to include rare mutational variants and tests that include combinations of rare natural variants. These have been aspects of the testing procedure that the government formerly held to be worthy of protection.

    If personalized genomic medicine has much hope, it will be because systematic relations are discovered between common diseases and combinations of variants at many genes. Could there by any combinatorial test sufficiently novel for patent protection?

    And to what extent would RNA silencing and other methods that may use natural sequences be patentable?

    The area may now be wide open.

    Tags: 
    biotech
    patents

  • Gene patents at risk

    Tue, 2010-03-30 00:17 -- John Hawks

    A Federal court has thrown out Myriad Genetics' patents on tests for BRCA1 and BRCA2 mutations, risk factors in breast and ovarian cancer:

    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.”

    That's huge and surprising news for the biotech industry. Probably it benefits companies positioned to do genome-wide tests of various kinds, which due to the advance of technology are presently much cheaper than Myriad has been charging for its tests.

    Tags: 
    testing
    patents
    biotech

  • Microsoft tries to patent the comparative method

    Sun, 2009-08-09 11:31 -- John Hawks

    Elizabeth Pennisi writes in Science about a case where computer scientists and their lawyers are bumbling through biology:

    Patent 20090030925 was filed by Microsoft researcher Stuart Ozer, an expert in databases, in July 2007. Ozer says he wanted to apply database technologies to complex problems in biological sciences: "I saw an opportunity to create a new approach in analyzing sequence data when phylogenetic information was available," he says.

    The patent application describes a way to use biological data that has been organized according to evolutionary relatedness. It includes methods for counting evolutionary events and grouping positions within molecules. However, "this patent is written in such broad language that it appears to swallow up any activity that involves understanding biodiversity through phylogenetics," says William Piel, a phylogeneticist at Yale University. He points out that such analyses date back to Charles Darwin, who sketched the first evolutionary tree; today, more than 350 phylogeny software packages are available on the Web. "Microsoft might as well patent the multiplication tables," Piel says.

    The only novelty in this case is that systematists are likely to take it personally. Biomedical researchers already work in a patent-rich environment, museum researchers in taxonomy do not -- at least, not yet. But with genomics and bioinformatics, the field is ripe for colonization by enterprising software developers whose companies' lawyers will be looking to protect their time. And let's not forget that universities have been stomping into the patent game.

    Seems to me that somebody needs to fund a few systematists to outline prior art in the area, so that the field is protected from overly broad patents that might stifle the development of new research methods.

    Maybe there's a bright side: There's no way that Microsoft could develop anything worse than the ICZN.

    References:

    Pennisi E. 2009. Systematics researchers want to fend off patents. Science 325:664. doi:10.1126/science.325_664

    Tags: 
    bioinformatics
    patents
    biotech
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