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A Slice Of BRCA - Busting The Gene Monopoly

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The long-running litigation over patents for two genes associated with hereditary breast and ovarian cancers - BRCA1 and BRCA2 (pronounced bracka-1 and bracka-2), granted to Myriad Genetics Inc. (MYGN) ended Thursday with the Supreme Court issuing a mixed ruling in the case.

While unanimously invalidating the patents on the two genes - ruling that gene is a segment of DNA, a product of nature, and therefore is not patent eligible, the Supreme Court noted that synthetically created DNA known as complementary DNA (cDNA) can be patented because they are not naturally occurring.

The legal spat began in 2009 when the American Civil Liberties Union and the Public Patent Foundation, a not-for-profit patent reform organization, filed a lawsuit, questioning the U.S. Patent and Trademark Office's issuance of patents to Myriad for the BRCA genes.

The lawsuit alleged that the patents granted to Myriad gave the company monopoly on providing tests or performing research on the BRCA genes. This monopoly stifled research because the patents prevented others from studying, testing or even examining a gene, and also restricted women's options regarding their medical care, according to the plaintiffs.

Being the first to sequence the BRCA-1 gene, Myriad filed for a patent on the BRCA1 gene in 1994 and for a patent on the BRCA2 gene in 1995. By 1999, Myriad gained exclusive rights over the BRCA genes.

Since Myriad has been controlling patents on the BRCA1 and BRCA2 genes, it has been the only company to offer the commercially available BRCA test in the U.S., charging over $3,000 - a cost unaffordable for many without insurance. Myriad's BRCA gene test is marketed as BRACAnalysis.

The BRCA gene test helps in identifying mutations in BRCA1 and BRCA2. If the test results are positive, it means that the individual has inherited mutations in these genes and therefore has a much higher risk of developing breast cancer and ovarian cancer compared to the general population.

Last month, actress Angelina Jolie announced that she underwent a preventive double mastectomy earlier this year after BRCAnalysis screening revealed that she was positive for a mutation of the BRCA1 gene.

The Supreme Court's decision on gene patents has been hailed as a victory by the plaintiffs, which according to them represents a major shift in patent law and overturns current Patent Office policy.

Welcoming the verdict, Sandra Park, senior staff attorney with the American Civil Liberties Union Women's Rights Project and co-counsel in the case said that the ruling will help patients have greater access to genetic testing, and scientists to engage in research on these genes without fear of being sued.

However, supporters of Myriad like National Venture Capital Association and Biotechnology Industry Organization have a different view on the ruling.

According to Kelly Slone of the National Venture Capital Association, the Supreme Court's decision would make the climate for venture capital investment in new nucleic-acid based technologies, such as molecular diagnostics, gene therapies and alternative energy sources, more difficult.

Jim Greenwood, President and CEO of the Biotechnology Industry Organization is of the view that the Supreme Court's decision on gene patents represents a troubling departure from decades of judicial and Patent and Trademark Office precedent supporting the patentability of DNA molecules that mimic naturally-occurring sequences.

The verdict offers urgently-needed certainty for research-driven companies that rely on cDNA patents for investment in innovation but could unnecessarily create business uncertainty for a broader range of biotechnology inventions, says Greenwood.

Industry experts believe that the Supreme Court's decision paves way for other companies too to offer the BRCA testing, thereby breaking the monopoly and bringing down the cost of the test.

Barely hours after the Supreme Court's verdict, California-based Ambry Genetics Corp. and Houston-based DNATraits, a subsidiary of Gene By Gene Ltd., announced the launch of BRCA1/2 genetic testing. Quest Diagnostics will also be offering a BRCA1 and BRCA2 test service later this year, say reports.

Guess what?

DNATraits reportedly would offer testing for the BRCA1 and BRCA2 genes in the U.S. for $995.

And this is what Myraid had to say about the ruling...

"We believe the Court appropriately upheld our claims on cDNA, and underscored the patent eligibility of our method claims, ensuring strong intellectual property protection for our BRACAnalysis test moving forward. While we are confident that Myriad offers the highest quality genetic tests in the world, we also support patients' rights to seek second opinion tests from any of the many laboratories conducting BRCA testing for the purpose of confirming the Myriad test result."

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