SCOTUS: DNA is information, not a chemical

Should DNA be subject to copyright law, rather than patent law?

Section 101 of Title 35 U.S.C. sets out the subject matter that can be patented:

Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.

Today SCOTUS ruled that naturally occurring genes cannot be patented [PDF].  The ruling was made in the lawsuit against Myriad Genetics and their patent on BRCA1/2.  The decision comes on the heels of Angelina Jolie’s decision to have a preventative double mastectomy, when she discovered she had a BRCA1 mutation that gave her an 87% chance of developing breast cancer before the age of 90. The decision was hailed as beneficial to patients and healthcare, and will help reduce the costs of genetic tests and cancer screening, removing the monopoly that human gene patents have granted.

In a nutshell SCOTUS’s decision is elegantly summarized here (all quotes from now on are from the above ruling):

Finding the location of the BRCA1 and BRCA2 genes does not render the genes patent eligible “new . . . composition[s] of matter,”

So the gene itself cannot be patented, as is any product of nature. That defeats Myriad’s blanket hold on any procedure involving BRCA1/2 or any of its naturally occurring mutations. But in the same ruling, the judges made it clear that synthetic DNA constructs are patentable. This would mean that the PCR primers and the resulting cDNA product are patentable. The judges have talked about that specifically (p. 2 in the decision)

cDNA is not a “product of nature,” so it is patent eligible … cDNA does not present the same obstacles to patentability as naturally occurring, isolated DNA segments. Its creation results in an exons-only molecule, which is not naturally occurring. Its order of the exons may be dictated by nature, but the lab technician unquestionably creates something new when introns are removed from a DNA sequence to make cDNA….

So under this ruling Myriad can conceivably patent the primers used for creating the cDNA and the cDNA itself.   Such patents have been filed before (thanks Leighton Pritchard), so I am not sure how this decision will play out in the health-care market, and whether we will see more patent trolling on high-profit medical testing.  SCOTUS was very clear that there is no method patent here though:

…there are no method claims before this Court. Had Myriad created an innovative method of manipulating genes while searching for the BRCA1 and BRCA2 genes, it could possibly have sought a method patent. But 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 fora gene would likely have utilized a similar approach,” 

But what is really interesting is that SCOTUS  treats DNA as a vehicle of information, rather than as a chemical construct:

Myriad’s claims are simply not expressed in terms of chemical composition, nor do they rely in any way on the chemical changes that result from the isolation of a particular section of DNA. Instead, the claims understandably focus on the genetic information encoded in the BRCA1 and BRCA2 genes. If the patents depended upon the creation of a unique molecule, then a would-be infringer could arguably avoid at least Myriad’s patent claims on entire genes … by isolating a DNA sequence that included both the BRCA1 or BRCA2 gene and one additional nucleotide pair. Such a molecule would not be chemically identical to the molecule “invented” by Myriad. But Myriad obviously would resist that outcome because its claim is concerned primarily with the information contained in the genetic sequence, not with the specific chemical composition of a particular molecule.

SCOTUS’s judges ruled: DNA is information. This ruling stands in contrast to the earlier ruling in the same matter, made by the Federal Circuit Court in which opinions were split,  treating DNA primarily  as a chemical, rather than a vehicle of information. As a result the Circuit Court’s decision held that isolated DNA (but not natural DNA) is patentable:

With respect to the merits, the [circuit] court held that both isolated DNA and cDNA were patent eligible…

Judge Lourie relied on the fact that the entire DNA molecule is held together by chemical bonds and that the covalent bonds at both ends of the segment must be severed in order to isolate segments of DNA. This process technically creates new molecules with unique chemical compositions… Accordingly, he [Lourie] rejected petitioners’ argument that isolated DNA was ineligible for patent protection as a product of nature.

On the other hand, in the same circuit court ruling, Judge Bryson viewed DNA as information, rather than as a chemical, and came to a different conclusion:

[T]here is no magic to a chemical bond that requires us to recognize a new product when a chemical bond is created or broken.” … Instead, he [Bryson] relied on the fact that “[t]he nucleotide sequences of the claimed molecules are the same as the nucleotide sequences found in naturally occurring human genes.”

Eventually the circuit court ruled that naturally occurring DNA cannot be patented, but isolated DNA can, based on the ruling (dissented by Bryson) that isolated DNA is new matter (a chemical), and as such is patentable.

But this whole confusion (which SCOTUS has attempted to settle now) comes from treating DNA as a chemical. Should DNA be even subject to patent laws? For the purposes of “ownership”, treating DNA as deoxyribonucleic acid  is like treating books as collection of cellulose sheets and ink splotches. Nobody does that, and ownership and reproduction rights for books lie within the realm of copyright law, rather than patent law. Copyright law talks about creative works and information: who can reproduce what, under what conditions.

Perhaps it is time to separate the DNA/RNA as a chemical from DNA/RNA as information, and move the legal treatment of DNA intellectual property from the patent to the copyright realm. In that way we won’t get such a strange decision in which the cDNA is patentable, but the gene from which it was transcribed is not.

Say that copyright law applied to genetic material. What then?  BRCA1/2 would obviously be in public domain, since under copyright law, the intellectual property rights are inapplicable: no human created BRCA1/2, or any other gene for that matter. Th einformation is in the public domain. Since cDNA is an obvious copy of the DNA, then the cDNA should fall under the same t category as the gDNA it is based upon: public domain. Furthermore, when someone does create a synthetic gene, they will be granted copyright, and may choose to  license the information in the same way one licenses any written material.

Because when you think about it,  most known  DNA sequences that we can access and use* are not chemicals kept in freezers, but magnetic dipoles kept on disk drives. These are data, not chemical.

(*Note that most DNA sequences are actually out there in nature, and most of them are inaccessible and unknown to us).

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5 Responses to “SCOTUS: DNA is information, not a chemical”

  1. While a particular set of primers might be patentable, it would be stunningly broad to allow a claim on ALL primers capable of amplifying a given region. In most cases, a huge number of possible primers are available, so a patent on primers is unlikely to be blocking.

    Similarly, I’d be bothered if one could make a blanket claim on capture oligos for a given region.

  2. Iddo says:

    Keith: you’re probably right about using a primer / oligos as blanket claim. What bothers me more is that cDNA RT’d from genes is patentable, creating “something new” simply by virtue of removing the introns. The circuit court ruled that DNA is not patentable, but the islolation process is, and therefore isolated DNA is patentable. SCOTUS ruled that isolated DNA is not patentable, but reversed-transcribed DNA is patentable. I may be missing something here (and would love to be corrected) but to me it seems like they robbed Peter to pay Paul.

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  5. jytdog says:

    Myriad has broad, issued claims to primers, and has had them from the get-go. These claims were not challenged in the litigation. It will be interesting to see whether those specific claims (or others’ PCR primer claims) will be challenged in the future based on this SCOTUS decision. On the one hand, the primers are “isolated, naturally occurring sequences”. On the other hand, it takes a lot of trial and error to identify optimal primers, and that trial and error is a hallmark of invention. It will be “interesting”, which is a terrible thing for business, which craves predictability.