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Human Gene Patents in Limbo

By March 27, 2011

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Should human genes be patented? More than 2,000 human genes have been sequenced and patented, the majority of them after completion of the Human Genome Project in 2001. When New York Federal District Court Judge Robert Sweet invalidated patents for inherited breast and ovarian cancer genes, and a diagnostic test for them a year ago (March 2010), it put those patents into question.

Human DNA Sequence
DNA sequencing output. Each vertical lane shows the sequence of bases in a given stretch of DNA. Image courtesy The Sanger Institute, Wellcome Images

The American Civil Liberties Union (ACLU) brought suit against the U.S. Patent Office and the patent holders, Myriad Genomics, of Salt Lake City, Utah, and the University of Utah Research Foundation. Researchers at the university discovered the gene sequence and the university licensed it to Myriad. The ACLU claimed that the challenged patents violate the First Amendment and patent law because genes are "products of nature" and therefore not patentable. The ACLU also claimed that when Myriad exercised its exclusive right over the diagnostic test, it limited womens' access to the test and the right to obtain a second opinion.

The ACLU was pleased with the ruling. Chris Hansen, a staff attorney with the ACLU First Amendment Working Group, called the ruling "a victory for the free flow of ideas in scientific research."

Myriad has appealed the decision and the case may be heard by the federal appeals court as early as this summer. "While we are disappointed that Judge Sweet did not follow prior judicial precedent or Congress's intent that the Patent Act be broadly construed and applied, we are very confident that the Court of Appeals for the Federal Circuit will reverse this decision and uphold the patent claims being challenged in this litigation," said Peter Meldrum, president and CEO of Myriad Genetics.

The case took an interesting turn last December when the Department of Justice submitted a legal brief to the court in support of the invalidation. The DoJ wrote that only genes that have been modified should be eligible for patents. The litigation puts investors, drug developers and researchers on unsteady ground in terms of their rights and obligations.

The issue of gene patenting was stuck on the back burner until Myriad began exercising its right as sole provider of the test, and the ACLU filed suit. The majority of genes have been discovered in academic institutions, and researchers patent the genes so their institutions can license them to private companies. Patenting is an important step in handing off or "translating" research discoveries into new therapies, diagnostic tests and related technologies, which in the United States (and most other countries) is the purview of private industry.

Health law experts I spoke with expect the federal appeals court will bump the case up to the Supreme Court for a decision. If that's the case, it may be a year to 18 months before there is a decision on whether genes are patentable -- or not.

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