As many of you may have already heard, the U.S. Supreme Court recently issued a ruling on whether human genes could be patented. We had covered this issue at the stage of arguments in two guest posts, over here and here. One of our regular guest bloggers, Chris Ohly, a partner at a leading U.S. law firm has been kind enough to send us a guest post, analysing the latest opinion of the U.S. Supreme Court in this case. The full version of this post along with footnotes can be accessed over here. The Court’s opinion can be accessed over here.
The Common Heritage of Mankind:
Isolated Genes
By D. Christopher Ohly[1]
“The human genome underlies the fundamental unity of all members of the human family, as well as the recognition of their inherent dignity and diversity. In a symbolic sense, it is the heritage of humanity.”[2]
On June 13, 2013, the United States Supreme Court authoritatively answered the question “Are human genes patentable?”[3] and, in doing so, affirmed that at least in the United States the human genome is the common heritage of mankind.[4]
Phrased more precisely, the question before the Supreme Court was “Whether human genes are patent-eligible subject matter under 35 U.S.C. § 101.”[5]
In a unanimous opinion in Association for Molecular Pathology, et al., v. United States Patent and Trademark Office, No. 12-398 (S.Ct. 2012), the United States Supreme Court held that an isolated segment of naturally occurring DNA segment is a product of nature and is not patent eligible merely because it has been isolated. In contrast, the Court held that, because “creation of a cDNA sequence from mRNA results in an exons-only molecule that is not naturally occurring,” it “does not present the same obstacles to patentability as naturally occurring, isolated DNA segments,” and is eligible for patenting in the United States.[6]
Myriad has been the subject of attention since its commencement in 2010.[7] In the Federal Circuit decision in Myriad, which the Supreme Court reviewed, the majority opinion was founded on a “chemical” definition of genetic materials, in determining its eligibility for patenting, found that isolated DNA “is a free-standing portion of a native DNA molecule, frequently a single gene.” Isolated DNA, the Federal Circuit majority said, “has been cleaved (i.e., had covalent bonds in its backbone chemically severed) or synthesized to consist of just a fraction of a naturally occurring DNA molecule. …” The intermediate court held that, as a result of the severing of covalent bonds in the DNA backbone in order to obtain “isolated DNA,” that form of DNA is a “chemical species” that markedly differs from “native DNA,” and is therefore patent eligible subject matter. [8]
The Supreme Court disagreed. “In this case,” the Court said, “Myriad did not create anything. To be sure, it found an important and useful gene,” the Court added, “but separating that gene from its surrounding genetic material is not an act of invention.”[9] In more sweeping language, the Court said that “Groundbreaking, innovative, or even brilliant discovery does not by itself satisfy the §101 inquiry.”[10]
Myriad’s claims were not saved, the Court said, “by the fact that isolating DNA from the human genome severs chemical bonds and thereby creates a non-naturally occurring molecule.” Indeed, “Myriad’s claims are simply not expressed in terms of chemical composition,” the Court noted, “nor do they rely in any way on the chemical changes that result from the isolation of a particular section of DNA.” Instead, the Court said, “the claims understandably focus on the genetic information encoded in the BRCA1 and BRCA2 genes.” The Court continued:
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 with the information contained in the genetic sequence, not with the specific chemical composition of a particular molecule.[11]
The Supreme Court also rejected the argument, relied on by Judge Moore in the Federal Circuit, that “the PTO’s past practice of awarding gene patents is entitled to deference,” ultimately agreeing with the position of the United States Solicitor General, as amicus curiae, that ” PTO’s practice [is] not ‘a sufficient reason to hold that isolated DNA is patent-eligible.’”[12]
The Supreme Court went to some length to describe what was not “implicated” in its decision. First, the decision said nothing about method claims, since the method claims at issue in Myriad were not before the Supreme Court.[13] Second, the Court noted that Myriad did “not involve patents on new applications of knowledge about the BRCA1 and BRCA2 genes.” Some of Myriad’s “unchallenged claims were limited to such applications.”[14] Third, the Court did not “consider the patentability of DNA in which the order of the naturally occurring nucleotides has been altered.”[15]
As narrow as the Court may have intended its holding in Myriad to be, the decision will undoubtedly have significant implications, both jurisprudentially and practically. The decision will provide additional basis, in future cases, for distinguishing between “invention” and “mere discovery.” As a practical matter, the decision will affect the manner in which patent claims are written and examined,[16] and may well impact patent claims that might have been asserted in future litigation over biosimilar medical products. There are still a myriad of possibilities.
[1] NOTE: The views expressed in this article are entirely my own and do not necessarily reflect the views of my law firm, or of any of its other attorneys or clients. Nothing in this article is intended to provide any form of legal advice.
Could someone please comment as to how difficult or easy is to invalidate a cDNA only based patent.
SCOTUS explicitly says that cDNA is patent eligible but patentability is altogether a different analysis (they were not concerned with it in Myriad).
We have 103 which says:
“Patentability shall not be negated by the manner in which the invention was made”
In my opinion Myriad ruling does leave cDNAs vulnerable to attack.
I am eager to understand the following aspects:
If it is only the c-DNAs of a naturally existing gene sequence which is patent-eligible…what could be the defence when these claims are attacked for invalidation on the basis of obviousness… saying that naturally occurring gene sequence can be converted into a c-DNA (axon alone sequences)by the process known in the art and would have the predictable impact.
Even otherwise, assuming that the patent is granted….how strong the protection would be in terms of designing around possibilities.
DAB
DAB:
Once you know the mRNA sequence you already know what cDNA would look like. Making a cDNA is a routine laboratory job. 103 might rescue you – as obviousness of a method doesn’t necessarily mean the obviousness of the product. But the case here is a cDNA. You know what mRNA is and you can exactly predict the sequence of a cDNA. This is the problem with Myriad ruling. It ignores the basic tenets of molecular biology………well the Judges might say that were only deciding on whether “isolated DNA” is a “product of nature” or not, and in doing so they created more uncertainties and left people guessing the impact this might have.
I noted in my earlier message (10:34 pm) that it might make cDNAs vulnerable to attack. This is based upon the fact that court concluded that myriad was not interested in the DNA as a chemical molecule but was concerned in the genetic information the DNA encoded – “the claims understandably focus on the genetic information encoded in the BRCA1 and BRCA2 genes”. What this might imply is that every time you make a cDNA you are not interested in it as a chemical, but in the “encoded information” in the cDNA sequence which simply existed in mRNA, although with a variation in one base.
Another adverse impact of this ruling is that (implied from the decision probably the Judges were not aware what they are doing) – it has made cDNAs of all bacteria and viruses “product of nature” because their DNAs do not have non-coding sequences! oops!!!
The middle ground should have been holding the isolated DNA sequences patentable only to the uses reasonably anticipated from the description. It would have at least given incentive for the highly capital intensive the biotech industry.
BTW, you find “axons” in nerve cells, not in DNA (they are exons, the coding sequence).
Anon @10:34 pm
Isolated DNA is “product of nature” hence cannot be patented. Next in line of attack will be cDNA because it is obvious.
Dear Anon @10:34 pm
Thanks for your response and the correction.
If the process of preparing a c-DNA is routine and the effect and composition of a c-DNA (as a product) is predictable/ obvious…coupled with clear motivation to arrive at c-DNA as a functional counterpart of m-RNA. How would 103 rescue me?
It was interesting to note that there wont be any difference(!) in the c-DNA and naturally existing DNAs of viruses and bacteria.
I agree that this decision has added more uncertainities (by holding “c-DNAs” patent-eligible) rather than imparting clarify (by holding naturally existing gene sequence non-eligible).
To note your suggestion that the isolated DNA sequences with anticipated uses should be allowable…will that not mean you isolate something that is already existing in nature and claim monopoly on it (be it limited by the uses you can describe)?.
Additionally I still have following questions
Since the composition is known…
which is the toughest (not just time consuming)/non-predictable step in arriving at an isolated gene sequence for a trait/disease condition??
identification,
isolation
use?
– if the natural sequences are not patentable and would promote further research and safe harbour in the field of concerned area, will the protection on C-DNAs limit the above to any extent??
DAB
DAB:
“If the process of preparing a c-DNA is routine and the effect and composition of a c-DNA (as a product) is predictable/ obvious…coupled with clear motivation to arrive at c-DNA as a functional counterpart of m-RNA…”
It is not so predictable/easy/obvious to get to the mRNA. So cDNA made from it would also be non-obvious. The threshold of non-obviousness in US had always been very flexible compared to other jurisdictions. Under the Myriad ruling now mRNA is also a “product of nature” which was not the case earlier. According to Myriad no amount of scientific ingenuity would make it overcome this barrier. Even if one might like to make the argument that obviousness of a method need not necessarily make the product obvious – in the context of cDNA it is less likely to hold water given the decision in Myriad which makes your mRNA product of nature. This is what I emphasized in my previous comment taking into account its nature and went about explaining why it would be so. You might like to read some decisions about obviousness issues in biotech arts (eg reDeuel, reKubin, reMayo etc).
“To note your suggestion that the isolated DNA sequences with anticipated uses should be allowable…”
At least this has been the case in Europe. In Monsanto v Cefetra the court rejected absolute protection to product and interpreted Art 9 of the biotech directive only to closely linked functionality of the DNA sequence. A similar approach in US should have been beneficial to everyone.
“….will that not mean you isolate something that is already existing in nature and claim monopoly on it..”
The EPO practice is that if you have isolated a substance from nature you can not only obtain a patent for the process of isolation but also a patent to the product if you can sufficiently characterize it.
“Additionally I still have following questions………………”
I am not sure I fully understand your query here, but I can say that it is not so predictable to identify desired gene and find ways of using it for prophylactic/therapeutic/diagnostic purpose.
– if the natural sequences are not patentable and would promote further research and safe harbour in the field of concerned area, will the protection on C-DNAs limit the above to any extent??
The argument is moot as safe harbor is always available whether it is an isolated sequence or modified sequence and there is nothing that will prevent further research even if a patent exists on such sequences.
Dear Anon @10:34 pm/ 11:27 PM,
Thanks a lot. I will definitely read the judgements.
I recollect that in case of Monsanto the function of the gene was to protect the plant and the court held that once the plant is processed into a dead material having the residues of the gene concerned can not infringe the patent (focused on the gene sequence responsible for protection of the weed) since in the final product, the residual sequence is not performing the desired function. I will have to read the judgement further it in detail to understand that the differences /similarities of the two cases.
You are right about the safe harbour thing. However, what I had in my mind was that will such protection on C-DNA be worth anything?..or it could just be a free lunch for the competitors
Thanks again
DAB