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Supreme Court Rules Unanimously That Human Genes Cannot Be Patented

But some questions still remain unanswered.


Today the U.S. Supreme Court issued a unan­imous decision on the Myriad Patent case, having to do with the company’s own­ership of BRCA-​​1 and BRCA-​​2 gene sequences. The main opinion, authored by Justice Thomas, says this:

A nat­u­rally occurring DNA segment is a product of nature and not patent eli­gible merely because it has been iso­lated, but cDNA is patent eli­gible because it is not nat­u­rally occurring.

At first glance, this is ter­rific news for patients worldwide. It means that no company, uni­versity, other entity or indi­vidual can patent human genes.

Keep in mind, the case doesn’t just apply to BRCA and eval­u­ating a person’s risk for breast and ovarian cancers. Rather, there are hun­dreds of human genes impli­cated in cancer that are potential targets for treatment that might be eval­uated, and thou­sands linked to other dis­eases. The decision continues:

Myriad did not create or alter either the genetic infor­mation encoded in the BCRA1 and BCRA2 genes or the genetic structure of the DNA. It found an important and useful gene, but ground­breaking, inno­v­ative, or even bril­liant dis­covery does not by itself satisfy the ... patent law.

What’s clear is that gene sequences, as they occur in human cells, can’t be owned just because they’re found, no matter how important they are. This cir­cum­stance should allow other researchers and firms to create cDNA from the natural sequences to develop new (com­peting and poten­tially less costly) assays and, even better, do their own work—tan­ta­mount to pro­viding “second” and “third” opinions, necessary research to under­stand how the genes lead to disease in some people and might be tar­geted for therapy. Great.

But the decision sug­gests that many lab-​​generated com­ple­mentary DNA (cDNA) strands remain patentable, or up for grabs once created—which may be the reason some biotech stocks have rising values today. I’m neither a lawyer nor an analyst, but I do know from my expe­rience as a researcher that it’s essen­tially trivial to gen­erate cDNA from short segments of DNA. So how might the cDNA be patented, if anyone who has access to the original genetic sequence might form the cDNA using routine lab methods?

Near the end of the opinion, the justice writes:

[B]ut 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 under patent law §101, except insofar as very short series of DNA may have no inter­vening introns to remove when cre­ating cDNA. In that situation, a short strand of cDNA may be indis­tin­guishable from natural DNA.

The doc­ument clar­ifies the cDNA issue just slightly:

It is important to note what is not impli­cated by this decision. First, there are no method claims before this Court ... the processes used by Myriad to isolate DNA were well under­stood by geneti­cists at the time of Myriad’s patents ... were well under­stood, widely used, and fairly uniform insofar as any sci­entist engaged in the search for a gene would likely have uti­lized a similar approach....

Nor do we con­sider the patentability of DNA in which the order of the nat­u­rally occurring nucleotides has been altered. Sci­en­tific alteration of the genetic code presents a dif­ferent inquiry, and we express no opinion about the appli­cation of patent law §101 to such endeavors.

How I interpret this is that if a researcher gen­erates a short cDNA segment based on a gene, that’s not patentable, but if it’s a long strand involving lots of clipped introns, that might be patentable.

Taking in all this, which is far from simple, I have a question and a wider point:

What goes unad­dressed by the jus­tices is the patentability of cDNA based on common genetic variants in cancer. Those are “nat­u­rally occurring” muta­tions, inasmuch as they arise in humans. But the cDNA gen­erated from those sequences might remain patentable. There are loads of examples in this regard: Con­sider the genetic muta­tions in EGFR, and ALK that are used in lung cancer diag­nosis, treatment deci­sions, and devel­opment of new tar­geted drugs. In the current issue of the New England Journal of Med­icine, doctors report on SALL4, a gene that occurs in some liver cancers and might be a good, useful target for therapy in that disease.

The point is that the Supremes—and those would-be lawyers—need to know about biology. Justice Scalia, sadly in my view, wrote his own opinion not because he dis­agreed with the others, but because he felt there was too much science in the decision. From the Scotus Blog today:

Many readers no doubt will share the view of Justice Antonin Scalia, in a short, sep­arate opinion refusing to join in a section “going into the fine details of mol­e­cular biology,” of which he said he had neither knowledge nor belief. Scalia said he did under­stand enough....

This scares me, that one of the jus­tices, our most accom­plished lawyers who might make deci­sions on cloning, and stem cells, and who knows what in the future, copped out because he lacks science edu­cation—what should be required high school biology in U.S. schools, public and private—to form an opinion that matters so much.