An opinion piece from August 22, 2016, titled “Patent Judges Should Be Scientists, Too” in the Wall Street Journal proclaims that patent judges should be scientists and that the “courts aren’t equipped to weigh technical claims in fields like biotech, raising uncertainty for innovators.” However, such a proposal would not likely fix the identified problems as the complexity of the technology is not the issue. It’s confusion in the law itself.
The authors, Alex Berezow, a senior fellow at the American Council on Science and Health, and Neal Mody, the managing director of a Seattle venture-capital firm, highlight three biotech cases that were in front of the Federal Circuit and the Supreme Court such as Sequenom (prenatal testing), In Vitro v. Cellzdirect (refreezing liver cells for research), and Myriad Genetics (breast cancer gene screening).
The authors propose (emphasis added):
Why such confusion surrounding biotech patents? For one thing, courts have little to no technical expertise. Judges, who seldom have laboratory experience, are having to determine what constitutes a novel, and therefore patent-eligible, innovation. An idea that appears obvious to a legal expert might be revolutionary in the scientific community. The opposite can also be true.
The authors conclude that “Congress ought to create a court that focuses specifically on patents that involve extremely complicated technology” that is staffed with “judges and experts who have backgrounds in software, artificial intelligence, nanotechnology, biotechnology and other scientific fields.” There are several issues with this idea.
Primarily, each of the cited cases involved multi-million dollar biotechnology but was decided as a matter of law—i.e., whether the subject matter was “patent eligible” under 35 U.S.C. § 101 and the 2014 SCOTUS case, Alice. Courts invalidating patents via deeming “patent ineligible subject matter” has not been limited to the biotech field (“naturally occurring phenomena” not patent eligible), as software and business method patents have felt the same heat (“abstract ideas” such as algorithms, math, or fundamental economic principles are not eligible). While the new proposed court would presumably have experts in each technology, patents across many disciplines invalidated under the new legal interpretation indicates that the legal precedent is to blame. Congress and/or the courts need to clear up the confusion on the legal issues soon.
Secondly, the authors conflate “patent eligibility” with “patentability.” There is an important distinction in the patent world as patent-eligible subject matter was the deciding factor in the referenced cases. Specifically, patent eligibility is determined under 35 USC § 101 while the key statutes for patentability are in 35 USC § 102 (novelty) and § 103 (non-obviousness). A novel invention may not be patent eligible and a patent-eligible innovation may not be novel or non-obvious.
While this may seem unimportant, procedurally, it is vital. Typically, whether a judge kills a patent under § 101 is a matter of law (e.g., dismissal or summary judgment) while invalidation of a patent under sections 102 or 103 may have issues of fact involved. For those reasons, a judge and jury will hear testimony from expert witnesses on such matters as interpretation of the patent and the state of the art. This is similar to many trials with complex subject matter where each party presents an expert to report and opine on the issues of fact —e.g., product liability, construction, medical malpractice, finance, and forensic and scientific dependent torts and crimes. Invalidations under § 101 have occurred earlier and earlier in trials as a mechanism of judicial economy.
Judges and USPTO patent examiners have been known to conflate the issues of eligibility and patentability as well, but most in the industry would attribute that to an interpretation of the law in flux rather than ineptitude with the technical aspects. Invalidation of a patent as “well-understood, conventional and routine” would seem like an issue under sections 102 or 103, but is actually a determination under part II of the Alice test for section 101. Whether she is a scientist, a legal scholar, or both, a consistent analysis is not easy.
Thirdly, the Federal Circuit was created specifically for patent matters and the judges, respectfully, need to be held accountable for this quagmire. Specifically, while other appeals courts have the task of error correction, the CAFC has the mission of creating uniformity in patent law. It is unclear that creating good, clear precedent is still a goal.
One of the main qualifications is the ability to handle patent cases, as each judge is nominated by the President and must be confirmed by the Senate. For instance, Judge Newman and Judge Laurie each have a Ph.D. in chemistry. Judge Chen, Judge Stoll, and Judge Moore, each has a background is in electrical engineering. Of course adding more technical judges to the federal bench is never a bad thing, but creating an entirely new court solely for complex tech could both render the Federal Circuit superfluous and further muddy important legal interpretations.
Accordingly, while most inventors and patent practitioners would not disagree that there is a problem in biotech and other technology when an invention “appears obvious to a legal expert might be revolutionary in the scientific community,” this is a problem with the law. To the extent that a judge has to “determine what constitutes a novel…innovation,” that is a determination based on presented evidence and expert testimony (see, e.g., the experts at TechPats).
So if your concern is uncertainty for innovators in a multi-billion dollar biotech industry, then your letters to congress should plead for statutory clarification on subject matter eligibility and not creation of a new kangaroo court.