Rethinking Healthcare

Will gene patent reversal slow search for cures?

Will gene patent reversal slow search for cures?

Posting in Cancer

The brief admits this is a wholesale reversal of previous positions. Thousands of human gene patents have already been issued, covering 20 percent of the genome.

In a startling brief before the nation's highest patent court, the U.S. Justice Department has come out forthrightly against patenting human genes.

The brief admits this is a wholesale reversal of previous positions. Thousands of human gene patents have already been issued, covering 20 percent of the genome.

The case is the Association for Molecular Pathology vs. the U.S. Patent and Trademark Office and Myriad Genetics. The issue involves a widely-used test to develop breast cancer, and genes called BRCA-1 and BRCA-2.

The ACLU had taken the side of plaintiffs, arguing that genetic patents are not inventions,and that if a woman wanted to examine her own genes she had to pay Myriad up to $4,000 for the privilege.

The blog PatentDocs puts the case for patentability.

The very property the government's brief argues makes isolated genomic DNA patent-ineligible applies with even greater force for all those other valuable and useful "products of nature." ...Simply put, the government's position will prevent protection (and thus retard commercialization) of any useful compound found in plants, microrganisms, animals, etc.

IP Watchdog Gene Quinn predicted after the initial decision the ruling would be overturned, in a post filled with anti-liberal rhetoric. But he also made the good point that "the biotechnology industry...happens to be one of the growth industries in the US at a time when growth, and jobs, are scarce."

The Biotechnology Industry Organization, which calls the case the ACLU vs. Myriad Genetics, filed a brief in support of Myriad, noting that courts have long upheld patents on naturally-occurring substances:

The claimed isolated DNA molecules differ in structure, function, utility, and information content from natural BRCA1 and BRCA2 sequences. So significant are these differences that the claimed DNAs have qualities that make them differ in kind from native sequences and are more than sufficient to confer patent eligibility.

Human genes are inside all of us, but isolating them and making them useful in cures is hard work. If the genes can't be patented, the industry asks, why would anyone use them?

Maybe because, while the genes themselves may not be subject to patent, the cures created using them certainly are.

What is your view? Can we have genetic cures without gene patents? And should your genes be subject to patent, once they are isolated and purified, identified and transcribed?

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Dana Blankenhorn

Contributing Editor

Contributing Editor Dana Blankenhorn has written for the Chicago Tribune, Advertising Age's "NetMarketing" supplement and founded the Interactive Age Daily for CMP Media. He holds degrees from Rice and Northwestern universities. He is based in Atlanta. Follow him on Twitter. Disclosure