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New DNA Patent Ruling Could Improve Access to Genetic Testing and Research Posted: April 14th, 2010

Judge: No patents on genes linked to cancer

In a move hailed as a "strong advance for women's health and for science," a U.S. District court judge has struck down patents on two genes linked to breast and ovarian cancer. The decision could have far-reaching implications for genomics research and the biotechnology industry, potentially affecting patents held on 20 percent of the human genome.

DNA Patents: Medical Monopoly or Innovation Incentive?

Expanding access to isolated DNA is a clear victory for the broader scientific community and patients seeking diagnostic testing. But some biotechnology firms warn that removing patent protection will reduce the incentive to invest in costly genomics research.

Patents are designed to reward innovation without impeding future development. When it comes to genomics research, the test for patents appears straightforward; as policy analyst Jesse Reynolds puts it, "Natural things aren't patentable; inventions are."  Currently, DNA as it occurs in the body is not patentable, but isolated sequences can be.

The new ruling rejects this distinction, arguing that "isolated DNA is not markedly different from native DNA." District Judge Robert Sweet cited Supreme Court opinion rejecting patents on purified products of nature. In short, the decision undercuts the ability of companies to limit researchers' and testers' access to basic genetic building blocks.

What the Ruling Means for You

The decision is a victory for patients and the scientific community, argue proponents of the decision. Mary-Claire King, the scientist who discovered the breast cancer predisposition gene BRCA-1, called the ruling "very good news for women who are potential carriers" of the cancer gene.

  • Access to Diagnostic Testing. First, the ruling removes the monopoly of a single company over testing for a particular gene. Myriad's patents on the isolated form of the BRCA-1 gene, for example, has afforded the company exclusive rights to mutation testing. This exclusivity has driven the price of this important diagnostic test to nearly $4000, according to one expert. Removing patent protection should spur competition in the testing market, bringing more affordable access to this and other genetic tests.
  • New Research Opportunities. More broadly, the scientific community will have access to these key DNA sequences, supporting future research. "This is going to speed up genetic mutation research," commented patent attorney Barbara Caulfield, who filed an amicus brief on behalf of the March of Dimes arguing against the Myriad patents.
    If the ruling is upheld in higher courts, it could invalidate other human gene patents. Such a development could create a more hospitable environment for gene-based research, supporting early detection, prevention, and more effective treatment of genetic diseases.

Clare Kaufman