A magnificent win with long-term implications

Saturday June 15, 2013

The most amazing thing about the U.S. Supreme Court decision regarding the patenting of human genes is the fact that the discussion even made it to the nation’s highest court.

The 9 to 0 decision implicitly affirms that it’s simple common sense that you just can’t patent nature.

Writing for the court, Justice Clarence Thomas stated "Myriad did not create anything. To be sure, it found an important and useful gene, but separating that gene from its surrounding genetic material is not an act of invention."

In case you’re new to this story, the American Civil Liberties Union and the Public Patent Foundation had sued Myriad Genetics after the company was granted patents on two genes related to the hereditary breast and ovarian cancer.

The patents allowed Myriad to limit access to the two genes and to control the terms and costs of testing for the genes.

"The court rightfully found that patents cannot be awarded for something so fundamental to nature as DNA," stated Daniel B. Ravicher, executive director of the Public Patent Foundation.

Immediately following the decision striking down Myriad’s monopoly, companies and universities began offering cheaper and broader genetic testing for breast cancer risk. Prior to the ruling, the testing cost as much as $4,000.

While 348,000 U.S. women carry at least one of the genes, noted Robert Langreth and Shannon Pettypiece, writing for Bloomberg, fewer than 50,000 have been identified through testing.

"With the publicity surrounding the Supreme Court case and actress Angelina Jolie’s announcement that gene testing led to her double mastectomy, many doctors and genetic counselors say they have been flooded with calls from women asking whether they need to be tested," wrote Langreth and Pettypiece.

Also following the ruling, the U.S. Patent and Trademark Office issued a notice that stated the decision "significantly changes the office’s examination policy." While new guidelines are developed, the notice ordered patent examiners to reject all claims on isolated DNA.

The decision goes far beyond BRCA1 and BRCA2, the genes Myriad had patented, because, as Brian Resnick, writing for The National Journal, noted, genetic medicine is "about to explode," with costs expected to reach $25 billion by 2021.

It also means current patents on genes are no longer valid.

However, the decision wasn’t a total loss for Myriad and other companies that have patented genes; the Supreme Court said those companies can keep patents on synthetic versions of the genes and on the techniques they use to isolate those genes.

"The whole idea of patenting a gene -- a piece of all of us, me and you -- just doesn’t feel right," wrote Slate’s Emily Bazelon. "You can find something ‘important and useful’ in nature, as (Justice) Thomas puts it, without having the right to own it. The Supreme Court got it right today."

Not only did the court get it right, it got it right unanimously. That’s something to be celebrated.


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