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Biotechnology debate

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Monsanto to Allow Use of Seed After Patent. Patenting Life. The Case For Corporations. Who Owns Genes? Today the ACLU and the Public Patent Foundation filed a lawsuit challenging the U.S. government’s practice of granting patents on human genes – specifically, the BRCA1 and BRCA2 genes, which are associated with breast and ovarian cancer. That’s right: the U.S. Patent and Trademark Office issues patents on human genes – the segments of DNA that we all have in our cells – giving private corporations, individuals, and universities the exclusive rights to those genetic sequences, their usage, and their chemical composition.

Although many people are unaware of this practice, it has been going on for roughly 20 years, and at this point 20 percent of the human genome has been patented. This raises serious civil liberties concerns because the government is essentially giving patent holders a monopoly over the patented genes and all of the information contained within them. Patent holders have the right to prevent anyone else from testing, studying, or even looking at the genes. Patents Unlawful. (Originally posted on ACSBlog.) Last week the ACLU and the Public Patent Foundation filed a lawsuit challenging the U.S. government's practice of granting patents on human genes - specifically, the BRCA1 and BRCA2 genes, which are associated with breast and ovarian cancer. In the last 20 or so years the U.S. Patent and Trademark Office (PTO) has issued patents on thousands of human genes — the segments of DNA that we all have in our cells — giving private corporations, individuals, and universities the exclusive rights to those genetic sequences and their usage.

The patents on the BRCA genes are particularly broad and offensive. The lawsuit charges, as critics of gene patents have argued for years, that gene patents stifle biomedical research and interfere with patients' access to genetic testing. To be clear, the patent claims being challenged do in fact include claims on the genes themselves. What is claimed is: 1. More recently, the U.S. Hearing Held. Fittingly, on the eve of Breast Cancer Awareness Month, plaintiffs had their first hearing in federal court yesterday in their challenge to the breast cancer gene patents.

The government's granting of exclusive rights to the BRCA1 and 2 human genes and Myriad Genetics' aggressive enforcement of its patent rights means that some women cannot access genetic testing to find out if they are at increased risk for hereditary breast or ovarian cancer, and that no one can get a second opinion on their test results. It also means that Myriad controls whether scientific researchers can study the BRCA genes or develop new genetic tests.

For the 20 breast cancer and women's health groups, individual women, genetic counselors, researchers, and scientific associations consisting of approximately 150,000 geneticists, pathologists, and laboratory professionals the ACLU represents, patents on human genes unacceptably restrict scientific freedom and access to information about one's own genes. Civil Liberties. On Tuesday evening, Joanna Rudnick joined the ACLU at Tribeca Cinemas to screen her award-winning documentary film, In the Family, and discuss the patenting of human genes, a practice that has serious implications for women like Joanna who have a genetic predisposition to breast and ovarian cancer. You can see photos from the event here. In the film, Joanna tells her own story of learning that she has a mutation along one of the hereditary "breast cancer genes," as well as the stories of other women and families facing the heart-wrenching choices that this information forces them to make.

The film opened up a lively conversation about what it means for companies to own patents on human genes, how this impacts women’s access to information about their own bodies, and how scientific freedom is limited by gene patents. The ACLU filed a lawsuit challenging the patents on the BRCA1 and BRCA2 genes in May of this year. And please help spread the word about this issue! First Federal Hearing. The courtroom was packed for yesterday's hearing in the breast cancer gene patents case, a testament to the significance of our challenge. Both sides argued that the judge should rule in their favor without a trial. (You can read our motion for summary judgment here.) The lawsuit, Association for Molecular Pathology, et al. v. U.S. Patent and Trademark Office, et al., challenges the government's granting of and Myriad Genetics' control of patents on the BRCA1 and BRCA2 human genes, which are associated with breast and ovarian cancer.

Basically what was at issue in this hearing, and what is at the legal core of the case, is whether the challenged patent claims cover "products of nature" and "laws of nature" and are therefore invalid. There are actually many things that everyone involved in this case agrees on. Everyone also agrees that DNA in the body is a product of nature and therefore not patentable. We expect a ruling sometime in the next few months. Liberate Breast Cancer Genes. The ACLU has taken on a patent case for the first time in its nearly 90-year history. The government's been allowing private companies to patent human genes. The ACLU thinks that violates the First Amendment and patent law.

This is heady, complicated stuff. But when a patent creates a monopoly that restricts the free flow of information, a lot is at stake, and when we're talking about something like genes associated with breast and ovarian cancer, real women are hurt. "How can it be that a company controls genes? We hope this short video will inform and inspire. The results from Myriad's genetic test are a strong factor in women's decision to have children. Lisbeth Ceriani, a single mom, simply can't afford the more than $3,000 test. "I'd like to see my 8-year-old daughter go to college," Ceriani says. Dr. Limary had breast cancer at 28 and took Myriad's test to find out if it was likely to return and if ovarian cancer is a concern.