From the Editors

Death of Gene Patents?

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It took more than a decade to expose this legal monstrosity; all patents on DNA sequences natural or synthetic should be banned on the ground that they usurp the ‘laws of nature’ embodied in the DNA coding mechanisms that have evolved through billions of years of evolution

US Government rejects gene patents

The US federal government dropped a bombshell on 29 October 2010 when it reversed a longstanding policy. It said that patents should not be granted for genomic DNA as it is a product of nature even when isolated from the organism. However, recombinant DNA, or new combinations of DNA for making genetically modified organisms, or gene therapy, or ‘synthetic life’ (see Synthetic Life? Not By a Long Shot, SiS 47) remain patentable.

The opinion was expressed in the amicus (friend of the court) brief from the Justice Department in response to the ongoing legal battle over US patents for the breast and ovarian cancer-predisposing genes BRCA1 and BRCA2.

“The chemical structure of native human genes is a product of nature, and it is no less a product of nature when that structure is ‘isolated’ from its natural environment than are cotton fibers that have been separated from cotton seeds or coal that has been extracted from the earth,…

 “We acknowledge that this conclusion is contrary to the longstanding practice of the Patent and Trademark Office, as well as the practice of the National Institutes of Health and other government agencies that have in the past sought and obtained patents for isolated genomic DNA,” the brief said.

Is this a major reversal of policy?

“It’s major when the United States, in a filing, reverses decades of policies on an issue that everyone has been focused on for so long,” said Edward Reines, a patent attorney who represents biotechnology companies.

Dr. James P. Evans, a professor of genetics and medicine at the University of North Carolina and head of a government advisory task force on gene patents, referred to the government’s brief “a bit of a landmark, kind of a line in the sand.” He pointed out that although gene patents had been issued for decades, the patentability of genes had never been examined in court.

As of 2010 approximately 40 000 US patents exist that relate to an estimated 2 000 human genes, or about 20 percent of the human genome. Patents have been issued for isolated genes, methods of using the isolated genes, and methods to diagnose a disease based on an association between a gene and a disease.

Legal battle over breast cancer genes

This major reversal in US policy came in the midst of a legal battle over patents on the breast cancer genes. In March 2010, a US District court ruled that claims in seven patents supporting a widely used genetic test for breast and ovarian cancer susceptibility are invalid. This was in stark contrast to a 2008 decision by the appeals board of the European Patent Office, which supported the patents. The US ruling was delivered as the result of a lawsuit brought in May 2009 against Myriad Genetics, Salt Lake City, Utah, and the University of Utah Research Foundation, which hold the patents on the BRCA1 and BRCA2 genes.

The company charges more than US$3 000 for a test. In 2009, Myriad’s revenues from molecular diagnostics grew by 47 percent to $326.5 million, with BRCAnalysis accounting for the lion’s share of the revenues.

The plaintiffs in the case included individual physicians and patients as well as the Association for Molecular Pathology and the American College of Medical Genetics; they were represented by the American Civil Liberties Union (ACLU) and the New York–based Public Patent Foundation.

The plaintiffs called the patents illegal on the basis that they restrict both scientific research and patients’ access to medical care, and claim that patents on human genes violate patent law because genes are products of nature. In his written opinion, Judge Robert Sweet of the US District Court for the Southern District of New York ruled that both Myriads' composition and method claims are invalid under the law, disagreeing, for instance, with Myriad’s argument that the purification of a natural product like a gene necessarily renders it patentable,

“The summary judgment is a first step but a very important one," says Mary-Claire King, a geneticist at the University of Washington in Seattle, who discovered BRCA1 in 1990. “Opening genetic testing for BRCA1 and BRCA2 to the competitive marketplace of new genomic technologies would be good for breast and ovarian cancer patients, their families, and their physicians.”

Apart from the steep price of the test, the plaintiffs raised of the points raised in the Myriad case, was that Myriad made efforts to prevent clinical trials on their test and the patents denied patients from receiving second opinions on their test results.

Specific claims, though not all claims, in seven of Myriad’s 23 patents on BRCA1 and BRCA2 were challenged in the complaint, covering the isolated genes as well as diagnostic methods.

In his decision handed down 29 March 2010, the judge rejected the legal equivalency between chemical compositions such as purified adrenaline and DNA.

Judge Sweet said: “The information encoded in DNA is not information about its own molecular structure incidental to its biological function, as is the case with adrenaline or other chemicals found in the body...this informational quality (of DNA) is unique among the chemical compounds found in our bodies, and it would be erroneous to view DNA as ‘no different’ than other chemicals previously the subject of patents....DNA, in particular the ordering of its nucleotides, therefore serves as the physical embodiment of laws of nature - those that define the construction of the human body…the preservation of this defining characteristic of DNA in its native and isolated forms mandates the conclusion that the challenged composition claims are to unpatentable products of nature.”

Myriad announced that it would appeal the decision, and did so 16 June 2010.

In September 2010, Melissa Parke, a Member of Parliament in Australia, announced that she intends to call for amendments to the Patents Act so gene patents would no longer be recognized for reasons similar to those in the Myriad case.

Division within the US government

On 1November 2010, David Kappos, Undersecretary of Commerce for Intellectual Property and Director of the United States Patent and Trademark Office  told the press: “The USPTO at the present time is maintaining the status quo. We’re continuing with current procedures as they are.”

This presages a public policy battle between the United States Department of Commerce and the United States Department of Justice.

ISIS has called for a ban on gene patents since 1999 (see Open Letter from World Scientists to all Governments Concerning Genetically Modified organisms (GMOs), http://www.i-sis.org.uk/list.php); and argued time and again Why Biotech Patents Are Patently Absurd (ISIS-TWN Report). We are obviously gratified by these new developments, and look forward to a ban on all patents on DNA sequences, synthetic or natural on ground that humans are usurping the laws of nature embodied in the DNA coding mechanisms (as Judge Robert Sweet had pointed out in his ruling against Myriad), which have evolved through billions of years of evolution.

Fully referenced versions of all articles including this editorial are available on ISIS members’ website

Fully referenced versions of this editorial and all articles are available on ISIS members website: http://www.i-sis.org.uk/sismembers.php

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