Appeals Court Overturns Ruling Invalidating Gene Patents

On July 29, a federal appeals court ruled that individual genes may be patented, overturning a lower court decision that had reached the opposite conclusion. The case centered on the question of whether genes were inherently products of nature.  In its ruling, the court found that genes were isolated DNA, having “been manipulated chemically so as to produce a molecule that is markedly different from that which exists in the body,” thus making them unique from “naturally-occurring” DNA.

The case revolved around patents held by Myriad Inc. for the BRCA1 and BRCA2 genes that are often mutated in breast cancer. The plaintiffs in the case, which included several researchers and the American Civil Liberties Union, challenged the right of the company to hold exclusive rights to what they felt were products of nature.  While upholding the right of companies to patent individual genes, the appeals court actually invalidated Myriad’s BRCA patents, stating that the patents… “are directed to the abstract mental processes of comparing two nucleotide sequences” and therefore unpatentable.

The ruling reaffirms the judicial standard regarding gene patenting that had, until last year, held since 1980, when the first gene patents were approved by the Supreme Court.  The U.S. Department of Justice upset this standard by filing a brief last fall in support of the plaintiffs in the case, thus awkwardly pitting the administration against the U.S. Patent and Trademark Office. The current ruling restored the previous standard, stating that “an entire industry [had] developed in the decades since the Patent Office first granted patents to isolated DNA,” and warning that “disturbing the biotechnology industry’s settled expectations now risks impeding, not promoting, innovation.”

An appeal to the Supreme Court is likely. ASBMB will continue to monitor the case.

Gene Patents Back in Court

On Monday, the U.S. Federal Appeals Court in Washington D.C. heard testimony in a case that may well set legal precedent on the ability of companies to obtain patents on natural materials. The case centers on two patents held by Myriad Genetics that cover the BRCA1 and BRCA2 genes, mutations in which are highly linked to breast cancer. The company is being sued by a consortium of research and patient advocates who argue that the patents illegally allow Myriad to develop exclusive genetic tests for the mutations, thus limiting diagnosis and treatment options.

The majority of Monday’s hearing centered on whether the act of identifying and isolating a gene is a patentable act of human ingenuity, or whether a gene is a product of nature, regardless of whether it has been isolated or not. The three-judge panel peppered lawyers on both sides with highly technical questions on the science behind genetic manipulation, but offered no hint as to how they intended to rule.

The case has produced the extremely unusual circumstance of having the government argue against itself.  The U.S. Patent Office was named a defendant along with Myriad, as government policy has, actively or not, allowed patenting of genetic material ever since the Supreme Court ruled in Diamond v. Chakrabarty that products of genetic engineering were eligible for protection.  However, the Department of Justice has now taken a stand against that position, first filing an amicus brief in favor of the plaintiffs back in November, and then testifying on their behalf in front of the Appeals Court.

The Appeals Court is expected to deliver their decision over the summer.

Government Opposes Patenting of Individual Genes

Stepping into a case that could have wide-ranging effects on scientific researchers, the U.S. Department of Justice on Friday filed a brief that opposes the patentability of genes.  The filing represents a reversal of position for the government, which for decades has allowed the U.S. Patent and Trademark Office to grant patents on individual genes.

In May 2009, the American Civil Liberties Union organized a lawsuit on behalf of four breast cancer patients, scientific researchers and professional societies that challenged the patents held by Myriad Genetics on the BRCA1 and BRCA2 genes.  Mutations in these two genes are highly correlated with development of breast cancer, and Myriad used its patents to develop exclusive tests that determined cancer risks.

In March, a New York District Court judge ruled in favor the plaintiffs, arguing that, as products of nature, genes are not patentable.  The defendants appealed, and, while a final ruling is being contemplated, the Justice Department decided to file an amicus brief stating its position.  While the brief itself was not filed in support of either party, its contents favor the plaintiffs’ point of view concerning the ability to patent genes.  The government agreed that forms of recombinant DNA, including vectors, cDNA and various other genetically modified materials, were “in every meaningful sense the fruits of human ingenuity,” thus qualifying them as “‘human-made inventions’ eligible for patent protection.”  By contrast, it said that “genomic DNA that has merely been isolated from the human body, without further alteration or manipulation, is not patent-eligible.”

The ability to patent genetic material dates to 1980, when the U.S. Supreme Court, ruling in Diamond v. Chakrabarty, held that products of genetic engineering were patentable, as they represented significant modifications to an existing “product.”  Researchers and companies interpreted the ruling to pertain to all genetic-related material (whether “natural” or modified) and seized upon this decision to gain patent protection for their experimental discoveries, resulting in nearly 20 percent of the 23,000 human genes being covered under patents.  Basic researchers long have argued that such an arrangement restrains scientific discovery, though in 2006 the National Research Council issued a report indicating that such patents “rarely impose significant burdens on biomedical research.”  The report did warn that “there are reasons to be apprehensive about their future impact on scientific advances in this area.”

 

What are your thoughts on the case?  Do you agree with the government?