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A federal court has ruled that key patents held by Myriad Genetics, a diagnostics company based in Salt Lake City, UT, on the BRCA 1 and 2 genes are invalid. Specific mutations in these genes are responsible for the majority of hereditary forms of breast and ovarian cancers, and many women with a family history of these cancers undergo screening to help them make medical decisions around preventing the disease.

The suit, brought by the American Civil Liberties Union (ACLU), patients and medical groups, argued that the patents restricted research and patients’ access to healthcare. Myriad’s critics have long argued that they give the company a monopoly over this type of genetic screening, allowing it to keep prices high–the test costs more than $3000, despite continual decreases in the cost of genomic analysis tools–and preventing women from seeking confirmatory tests from other sources.

According to a statement from the ACLU, “The precedent-setting ruling marks the first time a court has found patents on genes unlawful and calls into question the validity of patents now held on approximately 2000 human genes.” That amounts to about 20 percent of human genes, including those associated with Alzheimer’s disease, colon cancer, asthma and other illnesses. “Because the ACLU’s lawsuit challenges the whole notion of gene patenting, its outcome could have far-reaching effects beyond the patents on the BRCA genes.”

Dan Vorhaus at the Genomics Law Report discusses the ruling in more detail:

Judge Sweet’s ruling invalidates both Myriad’s composition of matter claims (its patents on isolated DNA sequences to all or a portion of the breast cancer genes) and its method claims (those patent claims that relate to analyzing or comparing isolated DNA sequences in order to detect mutations in a patient’s BRCA1/2 genes that might cause breast cancer).

The overall tone of the Court’s ruling is best captured by this passage (from page 135):

The identification of the BRCA1 and BRCA2 gene sequences is unquestionably a valuable scientific achievement for which Myriad deserves recognition, but that is not the same as concluding that it is something for which they are entitled to a patent.

The ruling follows decades of debate over gene patenting. An article in the New York Times points out that such patents “have been granted for decades; the Supreme Court upheld patents on living organisms in 1980,” an argument Myriad made when asking the court to dismiss the case. The company is expected to appeal the decision

Many patent experts were surprised by the court’s decision and predict it will have a negative impact on young start-ups in the biotech industry. It’s not yet clear how it will affect the market for BRCA screening. “For the moment, however, we do not foresee this decision producing any radical changes in commercial, clinical or other activity surrounding Myriad’s BRCA patents, or gene patents more broadly,” Vorhaus wrote in his post.

In the broader policy debate surrounding gene and biotechnology patents, however, this decision is the latest, unmistakable shot across the bow of gene patent holders, particularly those such as Myriad Genetics that have developed businesses around patent-protected genetic tests supported by exclusive rights in underlying gene patents.

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Tagged: Biomedicine, breast cancer, gene patents

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