Justice Department: Genes Are Not Patentable

In the reversal of a decades-long government position, the U.S. Justice Department says genes aren't patentable.
In the reversal of a decades-long government position, the U.S. Justice Department says genes aren't patentable.

The U.S. Department of Justice has reversed its stance on the longstanding practice of patenting genes, now saying that genes should not be patentable. If the new position ends up taking effect at the Patent and Trademark Office, it could have wide implications for the biotech industry and for medicine development, potentially invalidating thousands of patents that have been issued over decades.

Already, an estimated 20% of the human genome has been patented, according to The New York Times, which broke the news late Friday. And yet, the issue of whether gene patenting is legal had never been examined in court. Until last year.

Patenting Nature

That's when the American Civil Liberties Union and the Public Patent Foundation, along with various individuals, medical researchers and societies, filed a lawsuit challenging patents held by Myriad Genetics (MYGN) and the University of Utah Research Foundation. The patents cover two genes, BRCA1 and BRCA2, which are linked to breast and ovarian cancer. Myriad developed a diagnostic test, which costs nearly $4,000, used to identify women with higher risk.

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In their complaint, the plaintiffs challenge the legality of granting such patents, saying they restrict patient access to their own genetic information and slow research. A judge already ruled the patents invalid in March, but Myriad has appealed his decision. The Justice Department declared its new position in an amicus brief, filed late Friday, related to the case.

Acknowledging the reversal from previous government positions, the brief states the U.S. "has concluded that isolated but otherwise unaltered genomic DNA is not patent-eligible subject matter." Unmodified genomic DNA is a product of nature and "isolation" does not transform it into a human-made invention, according to the brief. On the other hand, the Justice Department says that engineered DNA molecules are human-made investments and should be eligible for patent protection.

What's Best for Science?

Unsurprisingly, opinions differ on whether the news is good or bad. In a scathing criticism, Kevin Noonan of Patent Docs claims the new stance is "is disturbing as well as contrary to sound patent policy." The brief, he adds, "ignores and trivializes the nature of what it takes to isolate human DNA that encode particular genes." He also suggested it could be dangerous. "What will be the effect on the economics of producing vaccines for the next pathogenic outbreak if the DNA comprising the vaccine cannot be protected?"

Biotech companies claim that genes isolated from the body are different from those found in the body and therefore should be eligible for patents. They say the genetic research into new tests, drugs and more personalized medicine would stall without patents protecting the discoveries (and guaranteeing a share in future revenues from such discoveries).

Meanwhile, opponents say that patenting basic genetic information makes medical development harder, not easier, and that the information should be accessible to anyone. As Steven Salzberg, director of the Center for Bioinfomatics at the University of Maryland, writes in Forbes: "It seems absurd that, having your own DNA in hand ... you wouldn't be allowed to check your own genes for mutations without first paying a license fee to a company."