Monday, June 10, 2013

DNA Patents

Deoxyribonucleic acid …. Most of us can’t even say that let alone try to understand even the basics, but we do know that DNA is the molecule that encodes the genetic instructions used in the development and functioning of all known living organisms, and, according to Wikipedia, and many viruses. Along with RNA and proteins, DNA is one of the three major macromolecules essential for all known forms of life. End of game – but wait, now there’s more, and while most of us will never go there, you still never know...

Association for Molecular Pathology v. Myriad Genetics is a patent law case that’s made it all the way to the U.S. Supreme Court. Justices heard oral arguments back on April 15th.; we’re passing it along as an offset to illustrate the breadth of DNA testing & research.

“It is a natural human trait, “Lyle Denniston at ScotusBlog wrote in recapping those arguments “— of judges, too — when one doesn’t quite grasp a very complex idea, to reach for something commonplace for comparison. For the nine Justices of the Supreme Court, imperfectly versed in biochemistry, it was most useful to talk about how a baseball bat gets created, and how the sap of a plant in a forest in the Amazon might be analyzed for its powers to cure human disease. But those very analogies strongly suggested that an inventor probably cannot get a patent for taking something out of the human body, and manipulating it without changing its nature.”

“Biotechnology innovators have secured thousands of U.S. patents on genes for some 30 years, defining the legal rights to medical and agricultural products worth hundreds of billions of dollars,” Greg Stohr and Susan Decker Bloomberg, also at ScotusBlog, wrote the day before. “Now the U.S. Supreme Court is considering whether that was all a big mistake with the debate on whether human genes can be patented, and hearing arguments from doctors, patients and scientists who say patents are stifling clinical testing and research.”

Myriad Genetics Inc.’s patents on genes linked to breast and ovarian cancer are what’s being challenged, Stohr and Bloomberg’s article continues, saying “a decision against gene patenting would ripple across a host of industries — including biotechnology, agriculture, industrial microbiology and pharmaceuticals., the case having implications for the growing field of personalized medicine and efforts to map the human brain and discover new uses for embryonic stem cells, and potentially barring patents on discoveries outside the DNA context.”

They quote Robert Cook-Deegan, a public-policy professor at Duke University and its Institute for Genome Sciences and Policy. As saying “the intellectual framework that comes out of this decision could have an impact on other patents, and affect agricultural biotechnology, environmental biotechnology, green-tech, the use of organisms to produce alternative fuels and other applications.”

One perhaps illustration of these possibilities might be the Court’s recent, May 13th., Bowman v. Monsanto Co., 11-796 case in which an Indiana farmer was sued for patent infringement when he saved and replanted seed genetically engineered by Monsanto and sold subject to a licensing agreement that permits farmers to plant the purchased seed in one, and only one, growing season. Growers may consume or sell the resulting crops, but may not save any of the harvested soybeans for replanting. While the farmer had the defense of patent exhaustion, which gives the purchaser of a patented article, or any subsequent owner, the right to use or resell that article, the courts consistently disagreed.

Federal Circuit Court's decision

Petition for a writ of certiorari
Brief of respondents Myriad Genetics, Inc., et al. in opposition

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