It seems to me that anyone who tries to convince themselves that Myriad is anything other than a disaster is just fooling themselves. It does no good to put our heads in the sand and ignore what the Supreme Court said as if by doing so it will make a difference. Anyone who is honest with themselves knows how the district courts will interpret Myriad, and it will not be in a patentee friendly manner.
But before going to far, let me conclusively demonstrate with the Supreme Court’s own explicit language why those who are trying to convince themselves, and others, that the decision is workable are wrong.
First, with respect to cDNA, it has been widely reported and believed that the Supreme Court said cDNA is patent eligible. In fact, what the Supreme Court said is that some cDNA is specifically not patent eligible, which is a far cry from the blanket statement that some suggest is found in the decision. For example, the Supreme Court wrote:
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.
This clearly and unambiguously means that short strands of cDNA are not patent eligible. So can we please dispense with the inaccurate and rather ridiculous interpretation of this case as being a blanket endorsement of cDNA as patent eligible? Clearly that is not what the Supreme Court said. The opinion goes to great length to explain that cDNA is nonnaturally occurring, is not a product of nature, but still some cDNA sequences that are created by man are not going to be patent eligible if they are “indistinguishable from natural DNA.”
This also offers our first clue as to why the Myriad decision overrules Chakrabarty. In Diamond v. Chakrabarty the Supreme Court held that living matter is patentable eligible if it is created by man. The Supreme Court in Chakrabarty explained:
[R]espondent’s micro-organism plainly qualifies as patentable subject matter. His claim is not to a hitherto unknown natural phenomenon, but to a nonnaturally occurring manufacture or composition of matter – a product of human ingenuity…
The Chakrabarty decision revolutionized the biotechnology industry in the United States. Chakrabarty was quite clearly the turning point for the biotech industry. The fact that the biotech industry has flourished in the United States and languished elsewhere shows the importance of an expansive view of what is patentable subject matter.
But in Myriad the Supreme Court turned their back on the fundamental holding in Chakrabarty. This is objectively and quite clearly true because Justice Thomas, writing for a unanimous Court, explained that the isolated DNA claimed by Myriad was nonnaturally occurring. Justice Thomas wrote:
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.
Thus, the Supreme Court quite directly contradicts the reasoning of Chakrabarty in Myriad. Thomas explains that it is a fact that isolated DNA is nonnaturally occurring, but still nevertheless not patent eligible.
Whether we like it or not, the very foundation of the Supreme Court’s decision in Chakrabarty has been overruled, or at the very least significantly cut back. Arguments to the contrary are simply wishful thinking and ignore the explicit language of the Myriad decision.
I think anyone who is honest knows how this passage will be used by defendants and challengers at the USPTO and in the district courts. If the PTAB decision on covered business methods is any indication the PTAB is quite anti-patent. See Did the PTAB Kill Software? We also know that many, if not a majority, of district court judges are anti-patent. We also know that many judges on the CAFC are increasingly taking anti-patent positions. See, for example, Federal Circuit Nightmare in CLS Bank. This will be offered by challengers and accepted by judges who do not like patents as meaning that something that is nonnaturally occurring and man-made is not necessary patent eligible. That fundamentally undercuts the ruling in Chakrabarty.
Soon we will see these arguments made and adopted. So patent owners had better figure out a response. It won’t be persuasive in court to simply pretend the Supreme Court didn’t say what they clearly said, or that such a viewpoint is “the sky is falling” paranoid nonsense. Likewise, it will not be persuasive to attempt to distinguish these cases based on the fact that Chakrabarty related to a genetically modified bacteria and Myriad related to isolated DNA. The fundamental holding in Chakrabarty was that if what is claimed is nonnaturally occurring it is patent eligible. After Myriad the fact that it is nonnaturally occurring does not mean that what is claimed is patent eligible. Thus, there must be more than something that is nonnaturally occurring to be patent eligible.
Patent attorneys and clients need to wake up and stop fooling themselves. The landscape has significantly changed. Wishing things were different and pretending that the Myriad ruling doesn’t say things that are clearly stated is not a winning strategy. A winning strategy is to engage. That means pushing forward and forcing the discussion both with Members of Congress and with the Courts. That means engaging in lobbying efforts and filing amicus briefs. If you pretend that nothing has changed eventually you will wake up one day and very little will be patent eligible. So who is fooling who exactly?
In the meantime, strategies need to be designed to put applications in the most favorable light. That means that claims need to closely track the language of 35 USC 101, which means that for software you need to claim “a machine comprising…” and for biotechnology innovations such as isolated DNA you must claim the invention as “a composition of matter comprising…” Additionally, a variety of claiming techniques can and should be used. We can’t know where the law is ultimately going to wind up, and by the time that we do know it will be to late to go back and add disclosure and vary the claims.
The pendulum will likely swing back at some point because if it does not there will be nothing left to the patent system. Interpreted to the extreme the Supreme Court’s decisions in Mayo and Myriad render a great many things patent ineligible. If that message didn’t get driven home by the PTAB’s decision in the first ever covered business method decision I don’t know what else could possibly cut through to prove the point.
All is not well, the erosion of patent rights continues, and we do no favors by trying to tell clients everything is fine. We need to enlist clients, explain to them that it is unfathomable that at the end of the day these decisions will be interpreted as they are actually written, but that in the meantime we must engage on a variety of fronts, both at the USPTO, in the halls of Congress and by speaking up and participating in important litigations and appeals even when our own patents are not at stake.
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Posted in: Biotechnology, Gene Patents, Gene Quinn, IP News, IPWatchdog.com Articles, Patents, Pharmaceutical, US Supreme Court
About the Author
Gene Quinn is a Patent Attorney and the founder of the popular blog IPWatchdog.com, which has for three of the last four years (i.e., 2010, 2012 and 2103) been recognized as the top intellectual property blog by the American Bar Association. He is also a principal lecturer in the PLI Patent Bar Review Course. As an electrical engineer with a computer engineering focus his specialty is electronic and computer devices, Internet applications, software and business methods.