The sky is falling! Those who feel the Supreme Court’s decision in Mayo Collaborative Services v. Prometheus Laboratories, Inc. is terrible are right, although many won’t likely fully apprehend the gravity of the situation at first. Those in the biotech, medical diagnostics and pharmaceutical industries have just been taken out behind the woodshed and summarily executed by the Supreme Court this morning. An enormous number of patents will now have no enforceable claims. Hundreds of billions of dollars in corporate value has been erased. But that might be a good thing. Immediate attention now must turn to Congress. Thank goodness that the technical amendments to the America Invents Act are outstanding. This will provide a perfect opportunity for Congress to save an industry that employs many millions of people, while at the same time undoing a pathetic, narrow-minded decision of the Supreme Court.
What is all the fuss about? Earlier today the United States Supreme Court issued its decision in Mayo v. Prometheus, holding that the process claims at issue in the case are not patent eligible subject matter. To make matters worse, Justice Breyer, writing for a unanimous Court, continually acknowledged that the claims at issue did not specifically cover a law of nature because there were “administering” and “determining” steps. Yet, he and the other Justices determined that those “administering” and “determining” steps were well known and conventional, thus meaning that the claims lacked patent eligible subject matter. Come again? Did all nine of the Supreme Court Justices just conflate patent eligibility with novelty and non-obviousness? Yes they did! But it gets worse — they explicitly admitted doing so! The Supreme Court also further specifically ignored the Government’s objective, reasonable and until today correct assertion that any step beyond a statement of a law of nature transforms the claim into one that displays patent eligible subject matter, with issues of whether those steps are known to be properly resolved by 102 and 103.
Where to begin? Let’s start with the holding as explained by Justice Breyer:
We find that the process claims at issue here do not satisfy [the conditions for patent eligibility]. In particular, the steps in the claimed processes (apart from the natural laws themselves) involve well-understood, routine, conventional activity previously engaged in by researchers in the field. At the same time, upholding the patents would risk dis proportionately tying up the use of the underlying natural laws, inhibiting their use in the making of further discoveries.
If a student were to write such nonsense in a patent law paper or on a patent law final exam they would receive little, if any, credit. It is shocking that all 9 Justices of the Supreme Court know so little about patent law, yet the collective fate of the industry rests on those with only a cursory understanding of patent law — and that is at best! Justice Breyer and all of the others conflate novelty and non-obviousness with patent eligibility when they base a patentable subject matter determination on the fact that the claimed processes are “well-understood, routine, convention activity previously engaged in by researchers in the field.” Under a PROPER understanding of patent law that does not in any way, shape or form have any bearing on patent eligibility. This rationale directly implicates the question of whether the invention is novel and non-obvious, which are two other wholly distinct patentability inquiries.
In Mayo v. Prometheus the Supreme Court took claim 1 of U.S. Patent No. 6,355,623 to be the primary claim for purposes of analysis. Claim 1 of the ’623 patent covers:
A method of optimizing therapeutic efficacy for treatment of an immune-mediated gastrointestinal disorder, comprising:
(a) administering a drug providing 6-thioguanine to a subject having said immune-mediated gastrointestinal disorder; and
(b) determining the level of 6-thioguanine in said subject having said immune-mediated gastrointestinal disorder,
wherein the level of 6-thioguanine less than about 230 pmol per 8×108 red blood cells indicates a need to increase the amount of said drug subsequently administered to said subject and
wherein the level of 6-thioguanine greater than about 400 pmol per 8×108 red blood cells indicates a need to decrease the amount of said drug subsequently ad ministered to said subject.
Justice Breyer explained that this claim sets forth a law of nature “namely, relationships between concentrations of certain metabolites in the blood and the likelihood that a dosage of a thiopurine drug will provide ineffective or cause harm.” This lead Breyer to define the question facing the Court: “The question before us is whether the claims do significantly more than simply describe these natural relations. To put the matter more precisely, do the patent claims add enough to their statements of the correlations to allow the processes they describe to qualify as patent-eligible processes that apply natural laws?”
Justice Breyer acknowledged that the claims each recite an “administering” step, a “determining” step, and a “wherein” step. Breyer admitted: “These additional steps are not themselves natural laws…” He still went on to say that they do not transform the nature of the claim, which is puzzling. Breyer and the other Justices admit that the claims do not cover a law of nature but then find the claims to be patent ineligible on a subject matter basis because they do cover a law of nature. This is repeated over and over again. Talk about intellectual dishonesty!
Breyer went on to say:
To put the matter more succinctly, the claims inform a relevant audience about certain laws of nature; any additional steps consist of well understood, routine, conventional activity already engaged in by the scientific community; and those steps, when viewed as a whole, add nothing significant beyond the sum of their parts taken separately.
Plain and simple, the Supreme Court missed the boat here in Mayo v. Prometheus.
In fact, it isn’t until page 21 of the decision that Breyer quotes the famous 1952 legislative history, which says that anything made by man under the sun is patentable. In a parenthetical quote citing the legislative this is said:
A person may have ‘invented’ a machine or a manufacture, which may include anything under the sun that is made by man, but it is not necessarily patentable under section 101 unless the conditions of the title are fulfilled.”
(emphasis provide by Justice Breyer).
For crying out loud Justice Breyer makes the argument perfectly for the contrary decision. The quote he inserts in parenthesis, likely so he didn’t have to discuss it or deal with the fact that it supports the contrary outcome, explains it all. You are not entitled to a patent unless all of the patentability requirements are satisfied. Patent eligible subject matter is but one of those requirements! The legislative history, which has routinely been slavishly applied by the Supreme Court, mandates that if there is human interaction then there is patent eligible subject matter. Whether a patent can or should issue on claims then becomes a matter of whether the claim covers a useful invention, the claim covers something that is novel and non-obvious and whether the invention has been adequately described to satisfy U.S. patent law requirements, specifically those in 35 U.S.C. 112.
But wait, there is more! With respect to mixing the 101 patent eligibility inquiry with the 102 novelty inquiry, Breyer admits that is exactly what he is doing! He wrote:
We recognize that, in evaluating the significance of additional steps, the §101 patent-eligibility inquiry and, say, the §102 novelty inquiry might sometimes overlap.
So not only does the Supreme Court get an “F” on patent law today, but they get an “F”, or at least a “D-” on statutory interpretation. Interpreting different parts of the statute to cover the same thing when for the last 200+ years that has been absolutely prohibited is extraordinarily arrogant. Imagine the gall! Breyer went on to say:
These considerations lead us to decline the Government’s invitation to substitute §§102, 103, and 112 inquiries for the better established inquiry under §101.
The arrogance. The ignorance to say “invitation to substitute §§102, 103, and 112 inquiries…” The Supreme Court is well aware that the other sections of the Patent Act are intended to address the sole issue they raise — that what is covered in the claim is well known. Nevertheless, they would rather resort to section 101 and PRETEND that section 101 is the proper place for the entirety of the patent inquiry to reside. In other words, and more succinctly — the Supreme Court decision in Mayo v. Prometheus has nullified §§102, 103, and 112. They are of no concern any more whatsoever in determining whether a claim is patentable. The entire inquiry collapses down to section 101, in a “know it when you see it” kind of way I guess.
Clearly the claims at issue in this case are patent eligible subject matter. The Supreme Court is wrong, and the fact that they have either through ignorance or intent conflated patent eligibility with novelty and non-obviousness will be a plague on the entire patent system for years to come. In courts where this decision is applied it there will not be patent eligible subject matter where the claim covers something well known. I wonder whether claims will be determined to be valid or allowable as a matter of law when section 101 is satisfied? Something tells me that this will be only a one-way street. If you don’t have something the court believes is new then no patent for you. If you have something that clearly satisfies 101 patent eligibility we will then go through and inquire about §§102, 103, and 112. Said another way, and more succinctly, patentees and patent applicants get screwed!
How long will it take the Federal Circuit to overrule this inexplicable nonsense? The novice reader may find that question to be ignorant, since the Supreme Court is the highest court of the United States. Those well acquainted with the industry know that the Supreme Court is not the final word on patentability, and while the claims at issue in this particular case are unfortunately lost, the Federal Circuit will work to moderate (and eventually overturn) this embarrassing display by the Supreme Court. This will eventually be accomplished the same as it was after the Supreme Court definitively ruled software is not patentable in Gottschalk v. Benson, and the same as the ruling in KSR v. Teleflex will be overruled. I have taken issue with Chief Judge Rader’s statements that nothing has changed in Federal Circuit jurisprudence as a result of KSR, which is not technically true. What is true, however, is that the Federal Circuit continues to refine the KSR “common sense test,” narrowing the applicability in case after case and tightening the ability for “common sense” to be used against an application. We are almost 5 years post KSR and there is still a lot of work left to be done by the Federal Circuit to finally overrule the Supreme Court’s KSR decision. It took almost 10 years to overrule Gottschalk v. Benson, so we are likely in for a decade of work to moderate the nonsense thrust upon the industry this morning.
Indeed, Breyer’s decision is the most intellectually dishonest decision I have ever read, which is saying a lot given the utter contemptuous understanding of patent law displayed by the Supreme Court over the years. It is truly troubling that all 9 of the Justices concurred in what history will regard as one of the worst decisions in the patent space EVER!
Yes, Congress will be asked to step in and rectify this absurd ruling, and they should. Knowing how the legislative branch operates I cringe at the thought of Congress coming to the rescue. The only thing that gives me solace is that the industries summarily executed this morning have an A+ lobbying game, which in Washington, DC means everything.
To arms… to arms… the Supreme Court has come! Rally all the lawyers, collect all the lobbyists and march on Congress!- - - - - - - - - -
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Posted in: Biotechnology, Federal Circuit, Gene Quinn, IP News, IPWatchdog.com Articles, Medical Devices & Methods, Patentability, Patents, 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.