It will likely come as a surprise to many, but I really don’t think the ACLU victory in the Myriad Genetics litigation is a big deal. Hakuna Matada is what I say. It’s actually a wonderful phrase. It means no worries for the rest of your days, and is a problem-free philosophy… blah blah blah… Picture begins to wiggle out of focus and fades to black in three… two… one… You are about to begin a journey through space and time, into another dimension. On this odyessy into a wondrous land whose boundaries are that of the surreal, the vastness of the timeless infinity forms a middle ground between light and dark, between science and superstition, and it lies at the heart of humanity’s fears and the pinnacle of understanding. You are about to enter the Twilight Zone…
As most undoubtedly know by now, Judge Robert W. Sweet, the 88 year old liberal jurist from the United States District Court for the Southern District of New York, on Monday issued an opinion that invalidated Myriad’s gene patent claims, and the decision was the lead case in the Docket Report e-mail sent out earlier today. Essentially the opinion says gene patents, pretty much all of them, are not patentable subject matter because genes exist in nature. Never mind that the genes that exist in nature are not isolated, the isolation step is really of no consequence (and I mean that literally). If you can believe it, the term “isolated” was interpreted through one of the most tortured claim constructions I have ever seen to mean nothing. Yes, the word apparently has no meaning whatsoever, almost as if it were a null set or the linguistic equivalent of a black hole. Sadly, you can’t make this stuff up!
Unfortunately, the outcome in the case now styled Association for Molecular Pathology v. United States Patent and Trademark Office, which is likely known as ACLU v. Myriad Genetics by most observers, was foreseeable and predictable. Anyone who has followed the case knew Judge Sweet would rule against Myriad, and many predicted that gene patents and perhaps the entire patent system would be ruled unconstitutional. At least we should commend Judge Sweet for not ruling the entire patent system unconstitutional and only finding the claims at issue invalid. The fact that all of the evidence demanded a different ruling and the fact that there was no standing be damned! At least Judge Sweet deferred, finding it unnecessary to reach a constitutional issue after shooting the gene patent claims dead under 35 USC 101.
In Act I, which begins some 92 pages into the decision after an enormously long identification of the parties and recitation of the facts, in construing the claims Judge Sweet explained:
The term “isolated DNA” is defined by Plaintiffs as “a fragment of DNA substantially separated from other cellular components and other DNA.” Myriad disputs Plaintiff’s definition insofar as it implies that fragments of DNA exist free-floating in the cell, separate from other components, such as proteins and the other DNA in the chromosome. The patent specifications expressly define “isolated DNA” as a DNA molecule “which is substantially separated from other cellular components which naturally accompany a native human sequence [such as] human genome sequences and proteins’ and “includes recombinant or cloned DNA isolates and chemically synthesized analogs or analogs biologically synthesized by heterologous systems.
“Isolated DNA” is therefore construed to refer to a segment of DNA nucleotides existing separate from other cellular components normally associated with native DNA, including proteins and other DNA sequences comprising the remainder of the genome, and includes both DNA originating from a cell as well as DNA synthesized through chemical or heterologous biological means.
Of course, the handwriting was on the wall well before this point, but once Judge Sweet construed “isolated DNA” to mean “DNA originating from a cell” the fat lady was already warmed up and well into the chorus. To break this down to its most basic level, this construction by Judge Sweet was this: the term “isolated DNA” means “DNA.” As it turns out the word “isolated” was just superfluous and Myriad was just trying to patent DNA, which happens to naturally occur, so that must mean they were trying to patent humans and exercise exclusive control over every human within the geographical boundaries of the United States. Give me a break!
In any event, once again, Judge Sweet went through all the right paces and at the end engaged in almost unfathomable intellectual dishonesty. Why kill so many trees with a 152 page decision just to analyze things, take the time to carefully set everything up and then so obviously ignore facts, law and logic? Environmentalists everywhere should be appalled! He could have just issued a one page decision, or one paragraph decision that said:
La la la la la la la… I’m not listening… la la la la la la… I’m not listening… this invention is far to fundamentally important and valuable to allow for a patent to stand… la la la la la la… there are people who need a second opinion and want a second laboratory to run the test… la la la la la la… so we need to confiscate this patent and ensure that no biotech company will ever seek to commercialize an invention that would become free to the public once the patent term runs out… la la la la la la… we are better off without innovation and better off had there been no economic incentive… la la la la la… I’m not listening… la la la la la la la… the patent is invalid… la la la la la la… I mean the claims are all invalid… la la la la la la… I understand patent law… I’m not listening!
Even with the case heading this would have used only one page and killed far less trees, proving that Judge Sweet is a proper environmentalist.
Yes, I am in rare form, but wait… there’s more! If you can believe it things get even more comically tragic. It wasn’t enough to spit on the biotechnology industry, which happens to be one of the growth industries in the US at a time when growth, and jobs, are scarce. Judge Sweet couldn’t help himself. He had to point out that the depths of his intellectual dishonesty directly and specifically. To set up the sad but true punchline, on page 121 Judge Sweet summaries his position on patentable subject matter by explaining:
In sum, the clear line of Supreme Court precedent and accompanying lower court authorities, stretching from American Wood-Paper through to Chakrabarty, establishes that purification of a product of nature, without more, cannot transform it into patentable subject matter. Rather, the purified product must possess “markedly different characteristics” in order to satisfy the requirements of § 101.
This ignores at least one CCPA case, and Federal Circuit precedent on point, but like so many of the things Judge Sweet has said in this case, that statement is largely unassailable as a naked and disembodied statement of law, at least with respect to Supreme Court precedent. What Judge Sweet refused to acknowledge, however, was that the isolated genes in question do indeed “possess markedly different characteristics” because they do not exist in isolated form in nature. You see that is where the human interaction comes in, and pursuant to Supreme Court precedent interpreting the 1952 legislative history of the patent act anything made by man under the sun is patentable. So Judge Sweet selectively applies the law and carefully words things as if he were an advocate, not a judge, which allows him make correct statements of law while still reaching a tortured conclusion. That is advocacy 101 and unbecoming of a member of the Federal Judiciary.
Now the punchline — Judge Sweet acknowledged his own bias and intellectual dishonest on page 125 when he admits his “conclusion is driven by the overriding importance of DNA’s nucleotide sequence to both its natural biological function as well as the utility associated with DNA in its isolated form.” So in other words, this Myriad invention is far too important and fundamentally innovative to award a patent on. You’ve got to be kidding me! Really?
Let us be honest with each other, shall we? Many in the liberal elite have never liked patents, exclusive rights and/or capitalism. Add to that Judge Sweet’s view that an invention that is of “overriding importance” cannot be patented under 35 USC 101, and it is easy to see the real agenda of many liberal activists, like Judge Sweet. This was supposed to be a judicial opinion, not a magnum opus or swan song!
The reality, however, is this is NOT a liberal left only problem. The conservative leaning Supreme Court just a few years ago gave us the KSR monstrosity, which is anti-business, anti-invention and just plain ridiculous. Taken as written, under KSR if you set out to solve a problem that is proof that the resulting invention is obvious, because the problem defines the solution and if it weren’t obvious you wouldn’t have been successful. So in order to be an inventor you need to expect to fail, but nevertheless proceed. For crying out loud, that doesn’t even make sense in the different dimension of the Twilight Zone! Thank goodness the Federal Circuit and the Patent Office (for the most part) are not interpreting KSR as written, more focusing on the spirit of what they must have meant instead.
When you combine the liberal anti-patent view, with Judge Sweet’s intellectual dishonesty and the patently clueless Supreme Court, you are left with this sad state of affairs — You can’t have a patent if it is not important enough to be considered anything but trivial, you cannot have a patent if you actually set out to invent something because what results would be common sense and you cannot have a patent if your invention is enormously important and foundational. This last point was obviously taken from Judge Sweet’s opinion, but it could have just as easily been taken from the Supreme Court decision in Gottschalk v. Benson, where the invention was too important to be patentable subject matter because it would be used in every digital computer. Now you see why there is great concern over the imminent Bilski decision.
Newsflash!!!!!!!!!!!!!!!! The United States Constitution and the patent laws of the United States are intended to encourage inventions that are of “overriding importance.” The goal is to encourage innovation, not to take it out behind the wood shed and shoot it in the head, then stomp on it, then light it on fire and shoot it again before burying it in a shallow grave.
Newsflash!!!!!!!!!!!!!!!! Innovation is encouraged by providing incentive, not by providing disincentive. And, by the way, we tolerate incremental innovation and advance because we know that if there is not tinkering and attempts to advance the likelihood of a achieving a pioneering invention that is fundamental and foundational is pretty well zero. And, by the way, what we want are those pioneering inventions; as many as possible in fact. Those pioneering inventions we want, like cures for cancer, new antibiotics that kill antibiotic resistant bacteria, life saving medical devices and so many other enormously desirable inventions are by definition of “overriding importance.”
For crying out loud, WAKE UP people!!!! Where and when will this assault on the patent system stop? Do we have to drive our economy straight into a ditch and declare war on what little industry we have left and every high tech, research based, intellectual property driven industry as well? Try and pay attention enough to not destroy the patent system. At least try and not shred the Constitution, OK? And can we please stop trying to execute our economic future as if it were a homicidal, maniacal killer on a multi-state shooting spree having finished and gotten caught in Texas?
Our founding fathers seemed to have done quite well with this “American experiment” and one thing is certain, they knew a thing or two about incentivizing people in the face of long odds. They also felt it necessary to mention intellectual property, specifically patents, in the Constitution, which is an almost unbelievably short document that does little more than announce fundamental principles. For those who have trouble keeping up, this means the US patent system was considered of FUNDAMENTAL IMPORTANCE by the likes of Jefferson, Madison, Washington and all the others in the starting a thriving and sustaining democracy Hall of Fame!
Gene… Gene… snap… snap…
Picture begins to wiggle out of focus and fades to black in three… two… one… Hakuna matada, that’s the motto. It isn’t just a passing craze. Hakuna matada, its just a matter of time before the United States Court of Appeals for the Federal Circuit reverses Judge Sweet, because word on the street is Myriad WILL appeal (surprise surprise). Hakuna matada. You may now return to your regularly scheduled lives, and while your at it, keep an eye on Myriad Genetics stock, those who foolishly dumped on this news have created a very nice entry point for you! Hakuna matada everyone!- - - - - - - - - -
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Posted in: Biotechnology, Gene Patents, Gene Quinn, IP News, IPWatchdog.com Articles, Patent Litigation, Patents
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.