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Tuesday, March 30, 2010

Courts - Even more on "Cancer Patients Challenge the Patenting of a Gene"

Updating earlier ILB entries, GenomeWeb Daily News reports: "Federal Court Rules that Myriad's BRCA Patents are Invalid; Deems 'Isolated DNA' Unpatentable."

This is big. Currently, Myriad holds the patents on this test for hereditary breast cancer, and the last I checked, the test was $3,000 and frequently not covered by insurance. Some quotes from the story:

NEW YORK (GenomeWeb News) — A US District Court today sided with the American Civil Liberties Union and other plaintiffs in an ongoing anti-gene-patenting lawsuit by declaring Myriad Genetics' BRCA gene patents invalid.

The suit, filed last May by the ACLU and the Public Patent Foundation on behalf of several scientific organizations and women's health groups, charged that the BRCA gene patents held by the University of Utah Research Foundation and exclusively licensed to Myriad "stifle research that could lead to cures and limit women's options regarding their medical care."

The suit, while focused on Myriad's patents, essentially challenged the constitutionality of patenting all genetic sequences on First Amendment grounds.

The ACLU said in a statement today that the 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 2,000 human genes."

In the ruling, Judge Robert Sweet noted that the case hinged on the fact that the patents protect "isolated DNA," which is "premised on the view that DNA should be treated no differently from any other chemical compound and that its purification from the body, using well-known techniques, renders it patentable by transforming it into something distinctly different in character."

However, Sweet noted that because "DNA represents the physical embodiment of biological information, distinct in its essential characteristics from any other chemical found in nature … [its] existence in an 'isolated' form alters neither this fundamental quality of DNA as it exists in the body nor the information it encodes."

Therefore, he concluded, "the patents at issue directed to 'isolated DNA' containing sequences found in nature are deemed unpatentable subject matter."

The Wall Street Journal reports, in a story today by Nathan Koppel and Shirley Wang:
In a court ruling likely to be followed closely by the medical industry, a federal judge in Manhattan on Monday struck down some of a company's patents on two genes linked to breast and ovarian cancers.

The decision, which addresses questions about whether human genes should be subject to patent protection, could have ramifications for diagnostics and biotechnology companies that have relied heavily on gene-related patents to help them build their businesses. Many companies are trying to build revenue around exclusive licenses.

As much as 20% of the human genome, some scientists estimate, is subject to patents. But critics say that creates monopolies that block alternative tests and research that might yield better, and cheaper, care.

The ruling by U.S. District Judge Robert Sweet follows a lawsuit filed last year by the American Civil Liberties Union and the Public Patent Foundation against Myriad Genetics Inc. and the University of Utah Research Foundation. Myriad and the research foundation hold patents covering the BRCA1 and BRCA2 genes, which have been linked to hereditary cancers.

The ACLU, on behalf of cancer patients and women's health groups, claimed that Myriad's patents had blocked patients from getting the highest-quality testing for genetic breast cancer. * * *

Many geneticists say the BRCA1 and 2 patents were particularly important because the genes are powerful markers for diagnosis of breast cancer risk.

The best coverage I've seen is here, at the blog Singularity Hub. The reports by Aaron Saenz begins:
In what is sure to become a landmark case for genomics, a US District Court Judge in New York (Robert Sweet) has ruled that patents on human genes held by Myriad Genetics are invalid. These patents, on the BRCA1 and BRCA2 genes, were issued more than a decade ago and gave Myriad exclusive rights to examine those sections of DNA. Mutations in BRCA 1 and 2 carry important links to breast and ovarian cancer, and Myriad’s BRAC Analysis (Be Ready Against Cancer) genetic screening is used to provide patients with a better understanding of their risk for the diseases. The court decision effectively eliminates Myriad’s rights to solely market tests on the BRCA genes, which may lower costs (previously up to $3000) for those interested in the tests . The American Civil Liberties Union (ACLU) lead the attack against the Myriad patents which it shares equally with the University of Utah Research Foundation. This case has wide ranging implications for the entire genomics community. 20% of human genes are patented, often along with the process of identifying the genes, and these patents are now drawn into question. It is almost certain that this ruling will be appealed and eventually reach the US Supreme Court. It may take years before a final decision is made, but for now it seems like the human genome may no longer be up for grabs as intellectual property. Thank goodness.
The story inclues a link to the 156-page opinion.

[More] The NY Times has this story by John Schwartz and Andrew Pollack. A quote:

Myriad Genetics, the company that holds the patents with the University of Utah Research Foundation, asked the court to dismiss the case, claiming that the work of isolating the DNA from the body transforms it and makes it patentable. Such patents, it said, have been granted for decades; the Supreme Court upheld patents on living organisms in 1980. In fact, many in the patent field had predicted the courts would throw out the suit.

Judge Sweet, however, ruled that the patents were “improperly granted” because they involved a “law of nature.” He said that many critics of gene patents considered the idea that isolating a gene made it patentable “a ‘lawyer’s trick’ that circumvents the prohibition on the direct patenting of the DNA in our bodies but which, in practice, reaches the same result.”

The case could have far-reaching implications. About 20 percent of human genes have been patented, and multibillion-dollar industries have been built atop the intellectual property rights that the patents grant. * * *

Myriad sells a test costing more than $3,000 that looks for mutations in the two genes to determine if a woman is at a high risk of getting breast cancer and ovarian cancer. Plaintiffs in the case had said Myriad’s monopoly on the test, conferred by the gene patents, kept prices high and prevented women from getting a confirmatory test from another laboratory. * * *

One of the individual plaintiffs in the suit, Genae Girard, who has breast cancer and has been tested for ovarian cancer, applauded the decision as “a big turning point for all women in the country that may have breast cancer that runs in their family.” Chris Hansen, an A.C.L.U. staff lawyer, said: “The human genome, like the structure of blood, air or water, was discovered, not created. There is an endless amount of information on genes that begs for further discovery, and gene patents put up unacceptable barriers to the free exchange of ideas.”

And from the WSJ Law Blog, "Court Shoots Down Patents on Two Human Gene Sequences."

Posted by Marcia Oddi on March 30, 2010 08:18 AM
Posted to Courts in general