DOJ Responds To BRCA Gene Patent Dispute With Proposed Rule Change

DOJ Responds To BRCA Gene Patent Dispute With Proposed Rule Change
Main Category: Genetics
Also Included In: Litigation / Medical Malpractice; Pharma Industry / Biotech Industry
Article Date: 06 Nov 2010 - 0:00 PDT


In a "surprising" move, the Department of Justice last week proposed to reverse three decades of legal precedent by imposing limits on gene patents, NPR's "Morning Edition" reports. DOJ made the proposal in a filing for a court dispute that has reinvigorated debate on "where to draw the line in patenting parts of nature," according to "Morning Edition."

The case began in 2009, when Myriad Genetics attempted to patent two genes, BRCA 1 and BRCA 2, which are targeted in widely used tests related to breast and ovarian cancers (Harris, "Morning Edition," NPR, 11/4). The American Civil Liberties Union and the Public Patent Foundation filed a case against Myriad claiming the patents hindered patients' ability to secure high-quality genetic breast cancer testing. In March, U.S. District Judge Robert Sweet ruled that the patents were "improperly granted" because they involved the "law of nature," which prohibits the patenting of human DNA (Women's Health Policy Report, 3/30).

Myriad appealed Sweet's ruling and asked DOJ to give its opinion, assuming that the government would defend its 30-year-old position on gene patents, "Morning Edition" reports. However, DOJ's filing was largely against Myriad's position. The U.S. Patent and Trademark Office said it will not change its rules in the near future.

The company's tests for the genes would still be protected by other patents if the court were to rule against its appeal, according to Myriad general counsel Richard Marsh. The case "is not going to have any material impact" on Myriad, he said, adding, "What we're concerned about is, we're part of the biotech industry, and we believe, as to the biotech industry, this will have a very, very significant impact" ("Morning Edition," NPR, 11/4).

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DOJ Responds To BRCA Gene Patent Dispute With Proposed Rule Change