Judges' Views Key in Gene Patenting Battle

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Despite a federal court recently upholding a company’s rights to patent two genes linked to breast and ovarian cancer, the debate surrounding when and how genes should be patented rages on.

It’s likely the case will be considered by the Supreme Court after the American Civil Liberties Union announced last week it would appeal the ruling, according to one Inter Press Service article. Myriad Genetics, Inc., a company that patented two isolated genes, BRAC1 and BRAC2, won suit earlier this year. The court ruled that the genes, once removed from the body and analyzed, were fundamentally different than their previous states inside the body. Thus, they were worthy of patenting.

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Researchers, doctors, lawyers and even a judge revisited the case at a panel session for the American Society of Human Genetics in Montreal, Canada, last week.

Robert Sweet, a U.S. district judge who was involved in reviewing the case, offered insight into why Myriad retained rights over its patents in court. Judges’ perspectives, or the prisms they use to view gene patenting, affected the outcomes of the case. On one hand, judges siding with the majority argument held a more chemistry-based mindset, holding that the structural changes to the genes were enough to warrant a patent. On the other hand, many judges — including Sweet — looked at the case through a genetic science lens, viewing a gene as a fundamental piece of nature that stores information, which can’t be claimed on its own.

“We are at a threshold of this revolution of biotechnology, health and human affairs,” Sweet told a crowd at the American Society for Human Genetics conference on Friday. “…This topic — owning the genome — will be a subject of deep concern for years to come.”

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But gene patents, especially ones with diagnostic value, raise several questions, including whether the given method is truly the best one available. For instance, some research questions whether Myriad’s emphasis on cancers with high penetrance is worthy of its sole focus, especially considering the fact that other mutations can cause breast cancer. Even then, cancers can spread through the blood, too, and aren’t always noticed by tumors alone.

Then comes the question of getting a second opinion. When a company holds a monopoly over finding a mutation of a gene, it becomes more difficult to get a second opinion from another doctor or lab. Also, since there’s little competition, patients will probably pay higher prices, too.

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Patents, which reward and protect innovation, aren’t in need of change, some say. Instead, it’s the licensing, or terms of use, that accompany them, that are in need of refining. For instance, are researchers claiming rights to an entire process or the end result? How much money are they charging other labs in exchange for using the method or technology?

With some 20 percent of the protein-coding genes already patented, the Myriad case may challenge the status quo if the case reaches and is overturned by the Supreme Court.

Photo by bloomsberries/Flickr.com

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