By Jason Rantanen
Association for Molecular Pathology v. Myriad (2013) Download 12-398_8njq
In an unanimous opinion, this morning the Supreme Court drew a sharp line between isolated DNA (not patentable subject matter) and cDNA [synthetic versions of DNA that omit non-coding portions] (patentable). There is a curious concurrence by Justice Scalia that I'll post about separately.
The Court's basic rationale is similar to Judge Bryson's dissent in the Federal Circuit opinion. DNA is really about information, Myriad's patent claim treats it as if it's about information, and that's how the Court treats it as well. Because the minor chemical differences between naturally occurring DNA and isolated DNA don't change the informational component of DNA relative to its naturally ocurring state, isolated DNA is not patentable. However, the creation of cDNA in the laboratory does affect this informational component by removing the non-expressing portion of the DNA sequence, thus producing a non-naturally ocurring DNA sequence. This change in the informational content is sufficient to render the cDNA sequence patentable.
The 101 Standard: The court applied an incentive/preemption framework for analyzing the patentable subject matter issue:
As we have recognized before, patent protection strikes a delicate balance between creating “incentives that lead to creation, invention, and discovery” and “imped[ing] the flow of information that might permit, indeed spur, invention.” (quoting Mayo v. Prometheus, at 23)
Isolated DNA: Simlar to its approach in other patentable subject matter cases, the Court first looked to the essence of what Myriad had done. "Myriad’s principal contribution was uncovering the precise location and genetic sequence of the BRCA1 and BRCA2 genes within chromosomes 17 and 13. The question is whether this renders the genes patentable….In this case,  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." Slip Op. at 12.
In reaching its conclusion as to the unpatentability of isolated DNA, the Court adopted an information-centric view of DNA as opposed to a chemical-structural approach:
Nor are Myriad’s claims saved by the fact that isolating DNA from the human genome severs chemical bonds and thereby creates a nonnaturally occurring molecule. 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 focuson 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 (such as claims 1 and 2 of the ’282 patent) 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 withthe information contained in the genetic sequence, not with the specific chemical composition of a particular molecule.
Slip Op. at 14-15.
cDNA Patentable: The Court reached a different result for cDNA:
cDNA does not present the same obstacles to patentability as naturally occurring, isolated DNA segments. As already explained, creation of a cDNA sequence from mRNA results in an exons-only molecule that is not naturally occurring. Petitioners concede that cDNA differs from natural DNA in that “the non-coding regions have been removed.” Brief for Petitioners 49. They nevertheless argue that cDNA is not patent eligible because “[t]he nucleotide sequence of cDNA is dictated by nature, not by the lab technician.” Id., at 51. 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 under §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.
Slip Op. at 16-17 (emphasis added). Note that under the last bit, a cDNA sequence may not be patent eligible subject matter in some circumstances.
What are the consequences? My immediate reaction is that for most practical applications, the Court's holding means that even though the broadest possible biotechnology product claims (to the isolated DNA itself) aren't going to be patentable, the key elements in making and using a biotechnology-based invention are still going to be protectable via patents (Part III of the Court's opinion makes this especially clear). This will allow researchers and competitors a little bit of wiggle room to design around biotechnology patents because they can use the basic isolated sequence but there will still be substantial limitations on what they can do with that isolated sequence. For this reason, I'm skeptical that the Court's opinion will have a negative effect on the incentives for creating biotechnology-based applications. To the contrary: by affirming that cDNA can be patented, it may strengthen the incentives for investing in research in this area.
In terms of the effects on my friends here at the University, I can see at least two consequences. First, it may allow researchers more freedom to engage in whole-genome sequencing because they won't need to deal with a multitude of isolated DNA patents for individual sequences. On the other hand, because early-stage research on newly discovered DNA sequences cannot be patented, it may encourage companies – and perhaps universities – to pursue greater secrecy over those early stage discoveries. Social research norms may cut against this – particularly in universities – but there may be some increased pressure, particularly at the margins, towards secrecy of potentially valuable inventions.
Update: In the short term, this case may have an immediate impact on BRCA testing. Via Brian Love at Santa Clara, Hank Greely just tweeted that: "Ambry announces its own BRCA 1/2 sequence test. $2200, a 30%+ cut from Myriad. They'll do deletes/dups for $500. Price hemorrhaging begins!"