Seemingly every new court decision addressing subject matter eligibility under 35 U.S.C. § 101 progressively weakens the patent system, especially in the life sciences. And each case seems to present a new low in terms of the depth and quality of analysis. Courts have misapplied § 101 in a variety of contexts against a wide range of technologies.
But I perceive a common thread running through these decisions, typified in the Federal Circuit’s recent decision in Ariosa v. Sequenom, supporting the growing feeling amongst the innovation community that § 101 decisions have taken on an arbitrary, outcome-driven quality warned against by Judge Moore in the AMP v. Myriad case:
Holding isolated DNA not patentable would destroy long settled industry expectations for no reason other than a gut feeling that DNA is too close to nature to be patentable, an arbitrary decision based on a judge-made exception.
A close analysis of recent court decisions shows how early in the process the ultimate outcome is set. Courts are striking down patents simply because the challenger has convinced the judge(s), on Judge Moore’s “gut” level, that the patents are bad, e.g., for patients, for large electronics companies supposedly pestered by trolls, etc. The first, and practically speaking last, step in the process of reaching a policy-driven decision to arbitrarily strike down an unpopular patent is to broadly and imprecisely define what is claimed in terms of its “essence.”
Essence of the Claim
The first and most critical task in most eligibility analysis is carefully and precisely defining the subject matter of the claims as well as the natural phenomenon that is potentially being claimed. The superficial definitions in current court decisions are usually found in the part of a decision where the court explains what the patentee “essentially” or “generally” claimed. I understand that judges are not technology experts, but the current shortcut of boiling claims down to their “essence” is particularly problematic in a § 101 case. Everything is a “natural phenomenon” if this term is treated expansively. Easier to define (and thus more appropriate as a ground for objective rather than arbitrary eligibility analysis) are “products of nature” and “natural laws.” Unfortunately, patent examiners and courts have jumped to “natural phenomena” as their go-to basis for § 101 rejections precisely because it is amorphous and may be used to readily reject or invalidate a claim they don’t like.
Hence the majority’s statement of the case:
Thus, the claims at issue, as informed by the specification, are generally directed to detecting the presence of a naturally occurring thing or a natural phenomenon, cffDNA in maternal plasma or serum. As we noted above, the claimed method begins and ends with a naturally occurring phenomenon.
Others have appropriately criticized the lack of depth of analysis typified by this ill-defined “begins and ends” test. Here I focus more on the problems with choosing such a generalized and imprecise starting point, and how such a starting point all but guarantees an outcome of invalidity.
The natural product in Ariosa was DNA, not “cffDNA.” I think Sequenom was seriously harmed in this case by what I call the jargon jinx. People love jargon and snappy acronyms, especially if that jargon is coined incident to a relatively new, significant scientific advance. Pursuant to this general human tendency, “cffDNA” in this case gained a special status and somehow came to be regarded as some special new type of DNA. It is not; it is DNA. The “natural product” at issue in this case was DNA. If we must get a little more specific, then we can say the judicial exception in this case was fetal DNA. The fact that fetal DNA is found in various locations may be a “natural phenomenon” in the broadest sense of that term, but that is not a judicial exception (natural product or natural law) that is even capable of claiming. This is particularly tragic when you consider the claims themselves never use the term “cffDNA.” They instead say “a paternally inherited nucleic acid of fetal origin [in] a maternal serum or plasma sample.”
To illustrate the importance of the difference between claims to DNA and Sequenom’s claims to a laboratory method of processing samples for DNA testing, let’s suppose the claim read “A fetal DNA molecule located in maternal serum or plasma” or even “A fetal DNA molecule isolated from maternal serum or plasma.” Such a claim would be ineligible because it claims fetal DNA (which is a natural product), not because it claims the “natural phenomenon” of fetal DNA being located in maternal serum. The patent challenger successfully caught the court up in the drum beat of “Sequenom is claiming cffDNA” when Sequenom did nothing of the sort.
The record suggests the presence of certain fetal biomolecules (e.g., proteins) in maternal serum was well-known at the time of filing. The same is true for the presence of “cell-free” DNA of other origin (e.g., from tumors). Most importantly, however, Sequenom’s patent itself teaches it was known in the art that fetal cells can pass into the mother’s blood. Diagnostic techniques had been devised to isolate these cells and analyze the fetal DNA extracted from them, but these techniques were expensive and time consuming. When viewed from this background, the claimed invention is clearly a technical improvement in the processing of samples for prenatal diagnosis.
Correctly Envisioning the Invention
The summary of the invention in the patent begins as follows: “This invention provides a detection method performed on a maternal serum or plasma sample from a pregnant female, which method comprises detecting the presence of a nucleic acid of foetal origin in the sample.” Thus, the invention in Ariosa lies in devising a new sample input for a laboratory process, thus greatly improving that process. Sequenom did not invent or claim fetal DNA. Nor did Sequenom claim all methods of testing fetal DNA or even all methods of testing fetal DNA in maternal blood. Sequenom instead claimed a modification to routine laboratory testing methods by altering how the samples were processed so that fetal DNA testing could be improved.
The following diagram helps illustrate this critical point:
Thus the claim is not to any DNA per se or even the fact of fetal DNA floating around free of cells in maternal plasma (the dangerous jargon of “cffDNA”). It is to an inventive modification in an existing technological process that significantly improves the technical performance of that process. Sequenom failed to get the courts to view the invention from this technological process perspective. Instead the court got hung up on the presence of DNA in the claim and Ariosa’s framing of the case in terms of the location of fetal DNA.
Not that we can fault Sequenom for this failure. Patentees so far have a very poor record in getting judges to see past the rhetoric and understand sometimes complex technical issues (see, e.g., Justice Scalia’s concurrence in AMP v. Myriad). And patent challengers, empowered by convincing PR spin and misdirection about harm to patients, have found all too sympathetic judicial audiences. Courts these days are making policy-based decisions, untethered from any rule of law, aimed at killing patents they don’t like and I am skeptical that any amount of skill could have changed that in Ariosa (or in AMP, In re Roslin, UURF v. Ambry, etc.).
In what other field would devising a new starting material for a process that significantly improves the process’s yield not be considered patentable? It is only when one starts by defining the potentially claimed judicial exception imprecisely and overly broadly (“the natural phenomenon of cffDNA”) that one jumps onto the slippery slope leading to an abyss where nothing in the life sciences is patent eligible. This initial definition of what is claimed and what is the judicial exception against which it must be compared is the fundamental error in most eligibility analyses and the battleground where eligibility will most often be decided. As long as challengers enjoy judges more than willing to adopt their boiled-down, incomplete depiction of claims, I fear the tide will continue to roll against incentives for innovation in the life sciences.