The Supreme Court unanimously ruled yesterday that isolated DNA is not patent eligible under 35 U.S.C. §101. See Association of Molecular Pathology v. Myriad Genetics. Or, put more precisely, the Court ruled that Myriad’s isolated DNA claims as written are not patent eligible. The Court further ruled that similar cDNA claims are for the most part patent eligible, seemingly because the information underlying the claimed molecule omits some content of the information which underlies the full gene.
Spoiler alert: If you are the type of person who enjoys reading about convoluted analogies to baseball bats, plucked leaves, mined gold and surgically removed livers, you are out of luck. Mercifully, and quite amazingly, the Court managed to avoid that morass.
A pivotal point is the question of whether Myriad was claiming information or a chemical compound. Of course, the unique thing about DNA is that it is both (i) a chemical compound comprised of carbon, oxygen, nitrogen, phosphorus and hydrogen, and can be bound to cellular proteins, and (ii) an informational blueprint for proteins which form the building blocks of every living thing.
So, which was Myriad claiming? Let’s take a look at the representative claims (from the ‘282 patent):
- An isolated DNA coding for a BRCA1 polypeptide, said polypeptide having the amino acid sequence set forth in SEQ ID NO:2.
- The isolated DNA of claim 1, wherein said DNA has the nucleotide sequence set forth in SEQ ID NO: 1.
- An isolated DNA having at least 15 nucleotides of the DNA of claim 1.
Unfortunately, no Markman hearing was ever done, and thus there was no claim construction at any the three previous proceedings (similar to what occurred in CLS Bank and Mayo). The claims are all quite brief, and their only real non-informational substance is wholly derived from the phrase “isolated DNA.” But what does “isolated” mean? If we look to the patents themselves, the specifications state that:
An “isolated” or “substantially pure” nucleic acid (e.g., an RNA, DNA or a mixed polymer) is one which is substantially separated from other cellular components which naturally accompany a native human sequence or protein, e.g., ribosomes, polymerases, many other human genome sequences and proteins. The term embraces a nucleic acid sequence or protein which has been removed from its naturally occurring environment, and includes recombinant or cloned DNA isolates and chemically synthesized analogs or analogs biologically synthesized by heterologous systems.
Although the claims would seem to recite a chemical structure specifically excluding structure found alongside the genomic DNA, the Court concluded that claim 1 of the ‘282 patent (an isolated DNA claim) “asserts a patent claim on the DNA code that tells a cell to produce the string of BRCA1 amino acids listed in SEQ ID NO: 2”. Page 5 (emphasis added). The Court further states that claim 5 (which recites a 15 nucleotide DNA) “claims a subset of the data in claim 1”. Page 6 (emphasis added). As to claim 2 of the ‘282 patent (a cDNA claim), the Court uses less strong language, but concludes that this claim “asserts a patent on the cDNA nucleotide sequence listed in SEQ ID NO: 1, which codes for the typical BRCA 1 gene.” Page 5.
The baffling aspect of the opinion is that the Court seems to agree that both the DNA of claim 1 and the DNA of claim 2 are man-made and do not occur in nature. Of claim 1, the Court states that “isolating DNA from the human genome severs chemical bonds and thereby creates a nonnaturally occurring molecule”. Page 14 (emphasis added). Of claim 2, the Court states that “the lab technician unquestionably creates something new when cDNA is made.” Page 17 (emphasis added). According to the way many patent attorneys (and Judge Rader) think, that should be sufficient to comply with §101. But the Court does not see things this way.
So there we have it: two molecules each having a structure which never before existed on the planet Earth prior to Myriad’s work, but one of them is not patent eligible under §101. However, for the Court, the structural argument does not appear to carry any weight, since the claims seem to be interpreted as lacking any significant structure. Rather, they say “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.” Justice Thomas states that Myriads claims are “concerned primarily with the information contained in the genetic sequence, not with the specific chemical composition of a particular molecule.” (italics in original, underlining added). Page 15. In other words, all of the claims are essentially interpreted as claiming only “code” or “data”.
And it is that “code” or “data” that appears to determine why one of the claims fails and one does not. As to the isolated DNA claims, the Court states that the claims “understandably focus on the genetic information encoded in BRCA1 and BRCA2 genes.” Pages 14-15 (emphasis added). In other words, the isolated DNA claims primarily recite information that existed in nature.
On the other hand, as to the cDNA claims, where introns are removed, the underlying information “is distinct from the DNA from which it was derived”. Page 17. But, the Court notes that isolated cDNA might be indistinguishable from natural DNA where it is too short of a sequence to have introns removed from it. In that case, the lab-made short cDNA molecule would be interpreted in the same manner as isolated DNA, it appears.
So where do we stand now? Patent owners and applicants can rest assured that any claims directed to cDNA are safe and can be written in the traditional way, at least where the cDNA represents a sequence where an intron was removed. Also, recombinant DNA claims are most likely also safe, since the Court refrains from considering the patentability of “DNA in which the order of the natural occurring nucleotides has been altered.” For similar reasons, a recombinant vector including naturally occurring DNA, as well as DNA having a radioactive tag or the like should also be safe.
But, perhaps there is still hope for isolated DNA claims, if they are written in a manner which more explicitly recites the chemical structure, and in particular recites structural features which distinguish over the genomic DNA. In its conclusion, the Court states that “we merely hold that genes and the information they encode” are not patent eligible. As noted above, the Court appears to interpret the claims such that the structural/chemical recitations in Myriad’s claims as written are trivial and can be ignored.
So, perhaps an isolated DNA claim could be written as follows:
An isolated and purified polymer consisting essentially of:
a plurality of guanine (G), adenine (A), thymine (T) and cytosine (C) molecules arranged in a chain having a sugar-phosphate backbone, the guanine (G), adenine (A), thymine (T) and cytosine (C) molecules being arranged in the order of SEQ ID NO: 1,
wherein said polymer is substantially separated from cellular proteins, and wherein said polymer is not bound by covalent bonds to another polymer.
Would this work? It is impossible to say until we can see how the USPTO would react, and furthermore how a court would interpret such claims. But, this would perhaps address the Court’s view that the claims “are simply not expressed in terms of chemical composition”. If rewriting the claims in this manner would be sufficient to save these claims, or at least give them a fighting chance, patent owners may consider filing a reissue in order to attempt to resurrect the type of claim which the Court has killed today.