Human Genes Can't Be Patented Unless They're Custom Made

In one of the most important rulings on its calendar, the Supreme Court today ruled that human genes, even those isolated by biotech companies, cannot be patented. The unanimous decision hinged on the fact that while a company can develop the process to isolate a gene, it didn't create it in the first place, which makes patenting them impossible.

It's a nuanced decision that has huge implications for researchers and medical patients, and still leaves open the possibility that custom genes could still be patented.

Justice Clarence Thomas wrote the Court's opinion for Association for Molecular Pathology v. Myriad Genetics, Inc., which pitted patient advocates against Myriad Genetics. Myriad held patents for the location and sequence of a pair of genes that, when mutated, can be a precursor to breast and ovarian cancer.

The key point in the case was the difference between naturally occurring DNA and complimentary DNA, or cDNA, which is synthetically created. Stating that "groundbreaking, innovative, or even brilliant discovery" doesn't by itself satisfy patent requirements, Thomas wrote, "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." Essentially, the Court held genes to the same patent standards as anything else: You can patent something only if you created it.

It seems like a simple distinction, but the ruling is profound. In the immediate term, Myriad will no longer have sole control over the genes it patented, known as BRCA genes, which in time will bring down the costs of genetic testing for breast and ovarian cancer.

"The court struck down a major barrier to patient care and medical innovation," Sandra Park, senior staff attorney with the ACLU Women's Rights Project, told USA Today. "Myriad did not invent the BRCA genes and should not control them."

"Because of this ruling, patients will have greater access to genetic testing, and scientists can engage in research on these genes without fear of being sued," Park continued.

As Reuters notes, it's not a massive blow to Myriad, whose patents were set to expire in 2015 anyway. Plus, the Court's ruling will have huge ramifications in the biotech community. The ruling over gene patenting has been awaited for a long time, and while the Court allowing gene patenting has been a constant worry for activists, the opposite outcome—that genes of any type could not be banned—was a big question in biotech.

Now, the Court has ruled that custom genes are indeed patent eligible, which is key to development of the gene therapy industry. The argument about cDNA was pretty fascinating: Plaintiffs argued that cDNA could not be patented because “the nucleotide sequence of cDNA is dictated by nature, not by the lab technician.” In other words, because even a custom gene has to work with the rules set by the human body, it's still a natural force, which can't be patented.

In the Court's opinion, Thomas replied, "That may be so, but the lab technician unquestionably creates something new when cDNA is made. cDNA retains the naturally occurring exons of DNA, but it is distinct from the DNA from which it was derived. As a result, cDNA is not a 'product of nature' and is patent eligible." The one exception Thomas noted was in the case that a cDNA sequence is so short that it's indistinguishable from natural DNA, which could make for interesting legal battles in the future.

(One scenario I can imagine is a biotech firm swapping out nonessential parts of a gene in order to make it patentable. The Court's opinion suggests that such a move would be ineligible for patents, but it is open to argument.)

It's hard to understate the significance of the ruling. Giving a clear ruling on the patentability of custom genes is the exact type of guidance and stability needed to bring forth heavier innovation on the gene front. This could mean more funds aimed at gene therapy, since companies have a better idea of what returns they can get on investment, and also means sci-fi fantasies like custom gene treatments just got a little bit closer.

Sure, they're still a long ways off, but imagine there's a gene that can be modified to cure male pattern baldness. A patent on that would be worth billions, and now the Court has ruled that such a patent would actually be valid. Expect more money to flow into gene research now that biotech firms have a better idea of how they can actually monetize that research.

The US Patent and Trademark Office has issued some 40,000 patents related to human genes since 1984, and it's currently unclear what's going to happen following the Court's ruling. In Myriad's case, its exclusive control over BRCA testing—which USA Today says runs $3,340 for the initial test—will be no more, which will hopefully bring down the cost over time as other companies over similar testing. Expanding throughout the healthcare industry, the Court's ruling could lead to significantly more competition in genetic testing, which will bring down costs.

Philosophically, the ruling is a double-edged sword. It's rather nice to hear that your and my genes can't be owned by some outside agency, which always felt like a fundamentally absurd situation. At the same time, custom gene therapy just got a big shot in the arm. Are we nearing a future in which cures—or, if you want to get really out there, genetic upgrades—are controlled and sold to the highest bidder? Well, as we've seen with pharmaceuticals, that's already happening now. But hey, at least the DNA you were born with is still yours, right?

@derektmead