By Kevin E. Noonan --
Castigating the Supreme Court, at least in patent circles, has become as prevalent as the Court's forays into patent law have been to overrule the Federal Circuit. While even those who give the Court the benefit of the doubt and appreciate the parsimony with which many of its decisions are written, the cultural and institutional differences between the way the Court addresses issues, and the higher certainty that those who rely on intellectual property protection need to justify the investment that turns innovation into commercialization, frustrate both.
These differences are illustrated in the standards the Court enunciated in its Mayo v. Prometheus regarding diagnostic method claims. In particular, the Court's reliance on what is "routine, conventional and well-understood" in deciding that the claims at issue were not patent eligible provide a focus for this analysis. In the Mayo case, the Supreme Court reversed the Federal Circuit's determination that the following claim recited patent-eligible subject matter:
1. 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 8x108 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 8x108 red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject.
(U.S. Patent No. 6,355,623). In Justice Breyer's opinion for a unanimous Court, the "administering" step "simply refer[s] to the relevant [preexisting] audience, namely doctors who treat patients" with thiopurine drugs. The "determining" step provided non-limiting disclosure, encompassing all methods for determining drug or metabolite levels, and according to the Court the step embodied "well-understood, routine, conventional activity previously engaged in by scientists who work in the field." All that was left for these claims was the "wherein" clauses, which merely recite a law of nature regarding how a drug is metabolized (with it being unknown, of course, whether a new drug would lead to a different conclusion.)
Having set forth the general principles contained in its Mayo opinion, the Court as is its wont left it to lower courts to explicate the scope of the instances where a claim is not patent eligible. And this is where the mischief begins; while there are few instances where what is claimed includes administration of a new drug, in several instances district courts (and perhaps the Federal Circuit) have interpreted what is "routine, conventional and well-understood" far beyond the circumstances that gave rise to the Court's invalidation of the claims in Mayo.
The first instance is the Federal Circuit's decision in Perkin Elmer Inc. v. Intema Ltd. (Fed. Cir. 2012). The claims of the patent-at-issue, U.S. Patent No. 6,573,103 were directed to prenatal diagnostic testing for Down's syndrome, intended to avoid the need for invasive testing like chorionic villus sampling that incurs the risk of miscarriage:
1. A method of determining whether a pregnant woman is at an increased risk of having a fetus with Down's syndrome, the method comprising the steps of:
measuring the level of at least one screening marker from a first trimester of pregnancy by:
(i) assaying a sample . . . ; and/or
(ii) measuring at least one first ultrasound screening marker from an ultrasound scan . . . ;
measuring the level of at least one second screening marker from a second trimester of pregnancy, the at least one second screening marker from the second trimester of pregnancy being different from the at least one first screening marker from the first trimester of pregnancy, by:
(i) assaying a sample . . . ; and/or
(ii) measuring at least one second ultrasound screening marker from an ultrasound scan . . . ;
and determining the risk of Down's syndrome by comparing the measured levels of both the at least one first screening marker from the first trimester of pregnancy and the at least one second screening marker from the second trimester of pregnancy with observed relative frequency distributions of marker levels in Down's syndrome pregnancies and in unaffected pregnancies.
In reversing the District Court, the Federal Circuit opined that In its view, the claimed methods do not contain an "inventive concept" (defined as in Mayo as "other elements or a combination of elements  sufficient to ensure that the patent in practice amounts to significantly more than a patent upon the natural law itself") because these claims "contain nothing more than 'well-understood, routine, conventional activity previously engaged in by researchers in the field.'" The opinion states that the "measuring" steps are insufficient to supply the ineffable "something more" required by the Supreme Court, because (as in Mayo) the method steps encompass any and all methods for measuring the markers. The panel stated that "'[t]he individual measurements are obtained through known methods. . . ." and thus the panel characterized the measuring steps as encompassing "well-understood, routine, conventional activity previously engaged in by scientists who work in the field."
A similar result (albeit using a more logically strained and expansive analysis) was obtained in Ariosa v. Sequenom (N.D. Cal. 2013) over claims for identifying and characterizing paternal DNA in blood from a pregnant woman (and making diagnoses therefrom); claim 1 of U.S. Patent No. 6,258,540 is illustrative:
A method for detecting a paternally inherited nucleic acid of fetal origin performed on a maternal serum or plasma sample from a pregnant female, which method comprises
amplifying a paternally inherited nucleic acid from the serum or plasma sample and
detecting the presence of a paternally inherited nucleic acid of fetal origin in the sample.
Here, the District Court's opinion frankly relied on the proposition that amplifying and detecting DNA from plasma or serum was well known at the time the invention was made and thus these were "routine, well-understood and conventional" methods that disqualified them from positively affecting the patent eligibility analysis under Mayo. The court further stated that:
Because the claimed processes at issue -- apart from the natural phenomenon of paternally inherited cffDNA -- involve no more than well-understood, routine, conventional activity, previously engaged in by those in the field, they are not drawn to patent eligible subject matter and are invalid under § 101.
(Of course, "the claimed process at issue" here differed in a major way from the processes in the claims at issue in Mayo: the process recited by the claim as a whole was not "routine, conventional and well-understood"; unlike in Mayo, the prior art did not teach detecting paternal DNA in maternal blood for any purpose.)
The Ariosa District Court also extended the requirements for what would not be "routine, well-understood and conventional" steps to be only those for which there were commercially available alternatives for practicing the invention at the time it was made:
In support of [the] argument [that the claims do not impermissibly preempt all methods for detecting paternal DNA (cffDNA) in maternal blood], Sequenom has presented the Court with scientific articles describing methods for detecting cffDNA. Ariosa argues that even if these articles disclose alternative methods of detecting cffDNA, Sequenom has failed to present any evidence showing that any of these alternative methods are practical and commercially viable. In response, Sequenom argues that it is only relevant that the alternative methods can be practiced, not that they are commercially viable alternatives. The Court disagrees. If the alternative methods are not commercially viable, then the effect of the patent in practice would be to preempt all uses of the natural phenomenon. It is important to note that the '540 patent does not merely claim uses or applications of cffDNA, it claims methods for detecting the natural phenomenon. Because generally one must be able to find a natural phenomenon to use it and apply it, claims covering the only commercially viable way of detecting that phenomenon do carry a substantial risk of preempting all practical uses of it. It is also important to note the age of the patent. The '540 patent was issued in July 2001. That twelve years have passed since the issuance of the patent but Sequenom does not present the Court with any evidence of a commercially viable alternative method of detecting cffDNA reflects the broad scope of the '540 patent's claims and the great risk that the patent could preempt the use of cffDNA. Indeed, Sequenom itself has acknowledged the preemptive effect of its patent. (albeit supported by some improvident statements by Sequenom in the record).
Thus, in addition to not being "routine, well-understood and conventional" the only method claims patent eligible in the District Court's opinion would be those that could be practiced without infringement on the day the patent application was filed.
Finally, in Genetic Technologies Ltd. v. LabCorp. (D. Del. 2014), the District Court adopted a magistrate judge's recommendation that the claims in U.S. Patent No. 7,615,342 were patent ineligible; claim 1 is representative:
1. A method to predict potential sprinting, strength, or power performance in a human comprising:
a) analyzing a sample obtained from the human for the presence of one or more genetic variations in α-actinin-3 (ACTN3) gene;
b) detecting the presence of two 577R alleles at the loci encoding amino acid number 577 of the α-actinin-3 (ACTN3) protein; and
c) predicting the potential sprinting, strength, or power performance of the human, wherein the presence of two copies of the 577R allele is positively associated with potential sprinting, strength, or power performance.
The magistrate judge's reasoning was consistent with (and relied upon) the California District Court's Ariosa decision; what was unique in this case is that it was decided on the pleadings under Fed. R. Civ. Pro. 12(b)(6), denying the patentee of any opportunity to present the Court with evidence contrary to its prejudices and defendant's arguments.
Finally, similar sentiments were voiced by the panel at oral argument in Myriad Genetics v. Ambry Genetics (heard on October 6, 2014; discussed more fully in a later post).
There are several reasons that these decisions are a cause for deep concern. Despite occasional appearances to the contrary, it is unlikely that the Supreme Court has intended to do serious violence to well-established principles of patent law in Mayo, AMP v. Myriad Genetics, or any of the other cases decided in recent years. However, by making the decisions it has made, using "less than pellucid" language and by failing to recite examples of what the Court does not intend to do, the Court has permitted lower courts to do such violence (perhaps because these lower courts are no more versed in the minutiae of patent law than the Court itself). One example is the ease with which courts have ignored or eluded the principle that claims must be interpreted as a whole. (It is clear that the Supreme Court understands, or has come to understand this principle: the Court, albeit in a footnote, made this clear in its Alice v. CLS Bank opinion.) Perhaps lower courts will take this cue to address claims as a whole in performing their patent eligibility assessment.
Another reason that the current methods for determining patent ineligibility are disquieting is that it has always been the case that a new use for an old (or otherwise unpatentable) compound can be patentable (and thus patent eligible). In re Hack, 245 F.2d 246 (CCPA 1957). This is a qualified statement, because the mere recognition of a property or principle of an old compound, see, In re May, 574 F.2d 1082 (CCPA 1978), or the realization that the practice of a method has a particular effect, see, In re Tomlinson, 363 F.2d 928 (CCPA 1966), can defeat patentability (and eligibility) on principles of inherency. As the Federal Circuit stated in In Re William J. King, 801 F.2d 1324 (Fed. Cir 1986):
[T]he law is, and long has been, that "if a previously patented device, in its normal and usual operation, will perform the function which an appellant claims in a subsequent application for process patent, then such application for process patent will be considered to have been anticipated by the former patented device." In re Ackenbach, 45 F.2d 437, 439, 7 USPQ 268, 270 (CCPA 1930) (citing with approval Claude Neon Lights v. E. Machlett & Son, 27 F.2d 702, 707-08 (2d Cir.1928)). Accord In re Watson, 44 F.2d 868, 870, 7 USPQ 113, 115 (CCPA 1930); In re Ernst, 150 F.2d 133, 135, 66 USPQ 71, 73 (CCPA 1945) (citing with approval In re Ackenbach, supra). See generally Carnegie Steel Co. v. Cambria Iron Co., 185 U.S. 403, 22 S.Ct. 698, 46 L.Ed. 968 (1902) (prior art device anticipates later process if device carries out process in normal operation). Cf. In re Tarczy-Hornoch, 397 F.2d 856, 158 USPQ 141 (CCPA 1968) (a process claim, otherwise patentable, should not be rejected merely because the application of which it is part discloses apparatus which will inherently carry out the recited steps).
But that is not the situation in any of the cases discussed here. In each case, the claim as a whole was (undisputedly) novel, and the putative "routine, well-understood and conventional" methods were used in new, inventive ways. Only by taking a categorical approach for the individual steps recited in these claims are "routine, well-understood and conventional" have courts been able to come to the conclusion that the claims are not patent eligible.
It is the categorical approach, sanctioned generally by the Supreme Court in its preference for the "well settled" law of Section 101 of the Patent Statute (rather than the more objective and specific portions of the law such as Sections 102, 103 and 112), that encourages if not mandates the conclusions of the courts discussed above. Permitted to apply merely their subjective views of whether a claim recited "something more" than a judicial exception to patent eligibility (laws of nature, natural phenomena and abstract ideas) and detached from art or other reality-based considerations available in the §§ 102/103 analysis, it should not be surprising that courts have exercised their authority to strike down claims that they have been convinced should not be patent eligible. This subjectivity is of course the basis for the Court's apparent belief that its views on patent law should be superior to the Federal Circuit's, a view the Court did not espouse when the appellate court's opinions were penned by Judges Rich or Markey. And such subjectivity is perhaps required for a Court that believes that courts in general need to play Goldilocks for the patent system, making sure the amount of patents is "just right" to avoid the purported evils of too much or too little patenting. But as the cases discussed herein illustrate, what these subjective measures are certain to do is make the patent grant less reliable and patent protection less predictable, and this outcome will harm the economy, innovation, and American's quality of life, as investors leave the less predictable arts like medicine, pharma, and biotechnology to invest in the latest "iSomething." It is hard to believe that this is the outcome desired by the Court, but if its members are paying attention perhaps they will take the likelihood of these outcomes into consideration when next they deign to opine on patent law.