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Myriad Genetics has patented the genes BRCA1 and BRCA2 that help control the progression of breast cancer. Myriad is among the companies that curently "own" 20 percent of the human genome.  (Source: AU-KBC RESEARCH CENTRE)

Myriad makes breast cancer detection tests. It has blocked universities from researching the important gene, and blocked competitors from developing test kits, making it impossible to get a second opinion on the test. The ACLU is challenging the legality of patenting the human genome in a major court battle.  (Source: SureTouch)
Should biotech firms be able to patent genes, block medical tests and university research on grounds of "ownership"?

A pivotal lawsuit launched early 2009 when the American Civil Liberties Union sued biotech firm Myriad Genome.  Currently the precedent in U.S. patent law is that you can not patent natural phenomena.  You can not patent gold, you can not patent the force of gravity, you can not patent the formula energy equals mass times the speed of light squared.  And yet, 20 percent of the human genome has indeed been patented, in what critics argue is a further sign of the slippage of the U.S. patent and copyright system.

Genome patents began about 30 years in the U.S. (following an important 1980 ruling), and have also been ongoing in other nations, as well.  Basic rules state that the human genome itself should not be patentable; it must be transfected (take out of the cell) and modified to be sufficiently different from nature's designs before its patentable.

However, the U.S. Patent and Trademark Office lately has been slipping -- and that's where the ACLU comes in.  Myriad was granted patents in 1997 and 2000 on the breast cancer genes BRCA1 and BRCA2, genes also linked to ovarian cancer.  Myriad did virtually nothing to modify these genes -- it just took them out, observed them and filed a patent.

The ACLU's legal team is fired up about this.  Myriad manufactures kits to test for breast cancer based on genetic profiles -- it claims without the patent it would never have been able to finance these tests and bring them to market.  However, Myriad is also using its patent to legally blocking other companies from deploying similar tests, essentially making it impossible to get a second opinion or alternative to the somewhat expensive $4,000 test.  Myriad is also using the patent to block breast cancer research at a university level.

The ACLU asserts that this case illustrates the folly in patenting any of the human genome, a pivotal part of life.  It has called for both Myriad's patents to be undone and for a ruling that would essentially roll back all human genome patents.

The ACLU has many powerful allies in the case.  The American Medical Association, the association representing doctors across the U.S. backs the ACLU in this case.  Numerous university and research organizations, tired of having to pay licensing fees to research patented genes, also have offered support.  Some universities have been denied the right to research the naturally occurring gene.

States Kenneth I. Berns, M.D., Ph.D., Editor in Chief of the peer reviewed journal, Genetic Testing and Molecular Biomarkers,  "Patenting of human genes is a bad idea and that healthcare in the U.S. would be enhanced if the ACLU suit prevails."

John Sterling, Editor in Chief of Genetic Engineering & Biotechnology News (GEN), comments, "This is going to turn into one of the watershed events in the evolution of the bioindustry. The pros and cons of patenting genes have been an ongoing, and often acrimonious series of debates, since the in re Chakrabarty decision in 1980. But this particular case seems to have taken on a life of its own with over fifteen plaintiffs. For while the lawsuit specifically centers on the patentability of two cancer-related genes, the ACLU says it plans to challenge the entire concept of patenting genes. What we have here is one group, the ACLU and its allies, contending that gene patents stifle life science research and potentially harm the health of thousands of patients. On the other side are biotech companies who maintain that without gene patents research incentives are seriously diminished and innovation is smothered."

Mr. Sterling hits on a key point -- the ACLU is challenging all patents on the human genome, not just gunning for Myriad's.  The biotech industry is blasting this stance, stating that it would ruin them financially and punish companies who do significantly alter human genes for therapeutic purposes.  William Warren, partner at the Sutherland law firm supports this stance, stating, "The ACLU unexpectedly based its invalidity challenge on claims to unpatentable subject matter.  The ACLU might have instead considered challenging the Myriad patents for obviousness."

This week both the USPTO (which the ACLU is suing) and Myriad requested summary judgment -- for a judge to rule on the case before it reaches court.  The ACLU's lawyers had previously filed for summary judgment as well.  There's no guarantees, though, that the judge will grant both parties' request and deliver a ruling.

Regardless of the outcome, the ACLU says it plans to continue to fight the legality of patenting the human genome.  States Chris Hansen, one of the ACLU lawyers handling the case, "Gene patents defy common sense. If you’re at a cocktail party and you tell people human genes are patented, almost everyone will say that can’t be right."




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