The Federal Circuit’s recent decision in McRO has been interpreted by many in the patent community as a further signal that the so-called “pendulum” is swinging back to a more favorable position for patentees.  There is some superficial evidence of this possibility.  Let’s look at the numbers. September 2016 was the first time since Alice that the number of federal court decisions finding eligible subject matter (16) exceeded those finding ineligible subject matter (13).  Those sixteen decisions also mark the highest number of eligibility decisions in a single month.  The most significant contribution to the switchover is that only two motions to dismiss under § 101 were granted in September, compared to nine that were denied, the largest gap since March 2016 (6 granted, 10 denied).
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In Part I, I explained some general criteria for laws of nature, considering the prototypes of Newton’s laws and Einstein’s E=mc2. Now I’ll turn to whether there are laws of nature in biology. Biological generalizations, such as those identified by the courts (and similarly found in many rejected patent applications), do not meet the various criteria used to identify laws of nature. Most significantly, they are not universal—they apply only to specific characteristics of human biology. And while in some cases they allow for predictions, they are not reductionist: They do not explain more specific phenomena in more general terms. In many cases, the generalizations are not objective and independent of human concerns but entirely dependent on them—for example the alleged law relating specific genes to elite athletic performance. Mother Nature does not concern herself with Usain Bolt’s sprinting prowess. The reason that biological generalizations are not universal is that they are the result of evolution—they are contingent outcomes, they could have been otherwise. Indeed it is possible that they could not have arisen at all. This thesis is known as the Evolutionary Contingency Thesis.
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I believe that the opinions of the Federal Circuit do not reflect a deep understanding of science and technology. In this blog I’ll focus specifically on the issue of laws of nature. It appears that the Federal Circuit has uncritically accepted the Supreme Court’s statement in Mayo that a law of nature is any natural relationship that exists “in principle apart from any human action.” In Genetic Technologies v. Merial*, the panel (Dyk, Prost, Taranto) held that the “linkage disequilibrium between the non-coding and coding regions,” the condition in which certain alleles at two linked loci are non-randomly associated with each other, “is indisputably a universal, inherent feature of human DNA” and thus a law of nature. The panel in Ariosa (Reyna, Linn, Wallach) held that Sequenom’s claims to identifying parental cell-free DNA “begins and ends with a natural phenomenon. Thus, the claims are directed to matter that is naturally occurring.” Judge Dyk in his concurrence with the denial of en banc review in Ariosa clearly accepted the Supreme Court’s definition, saying, “Mayo contributed only routine application to a law of nature that was already well known.” In Rapid Litigation Management v. CellzDirect, the panel (Prost, Moore, Stoll) skipped the question of whether the ability of liver cells to survive multiple freeze-thaw cycles was a law of nature: “The district court identified in these claims what it called a “natural law”—the cells’ capability of surviving multiple freeze-thaw cycles. We need not decide in this case whether the court’s labeling is correct.” Instead, the court engaged in the convoluted exercise of whether the claims were “directed to” this ability. While the result of this decision was correct—the claims were patent eligible—a more direct path to that outcome would have been a finding that there was no law of nature being claimed at all.
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It's been one year since the Supreme Court's decision in Alice Corp. v. CLS Bank. On its face the opinion was relatively conservative, cautioning courts to "tread carefully" before invalidating patents, and emphasizing that the primary concern was to avoid preemption of "fundamental building blocks" of human ingenuity.  The Court specifically avoided any suggestion that software or business methods were presumptively invalid.  But those concerns seem to have gone unheeded.  The Court's attempt to sidestep the tricky problem of defining the boundary of an exception to patent eligibility—"we need not labor to delimit the precise contours of the "abstract ideas category in this case""—has turned into the very mechanism that is quickly "swallow[ing] all of patent law.” The federal courts, the Patent Trial and Appeal Board, and the USPTO are using the very lack of a definition to liberally expand the contours of abstract ideas to cover everything from computer animation to database architecture to digital photograph management and even to safety systems for automobiles.

Let's look at the numbers to present an accurate picture of the implications of the Supreme Court’s decision. My analysis is a data-driven attempt to assess the implications of Alice one year out. It is with an understanding of how the Supreme Court’s decision is actually playing out in the theater of innovation that we can better project and position ourselves for what the future holds.

Alice at Court

Table 0 Fed Courts

As of June 19, 2015 there have been 106 Federal Circuit and district court decisions on § 101 grounds, with 76 decisions invalidating the patents at issue in whole or in part.  In terms of patents and claims, 65% of challenged patents have been found invalid, along with 76.2% of the challenged claims. 


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In Ameritox v. Millenium Health (W.D. Wis., J. Conley) the court rejected the defendant's motion to reconsider its earlier ruling that Ameritox's patents were not ineligible.  (The earlier decision cited my Law360 article, noting that only 26% of patents have survived post-Alice motions.)  Here, Millenium argued that the court should not have considered that "the prior art steered a skilled artisan away" from the claimed invention, and that one of the claimed steps was not conventional, since this allegedly conflated eligibility with novelty and non-obviousness.  The court ripped Millenium on this point, saying "this argument ignores that Millenium itself squarely argues the relevant relevance of this factor in assessing the eligibility of the ’680 patent under § 101, by citing the Federal Circuit's decisions in In re BRCA1- and BRCA2- Based Hereditary Cancer Test Patent Litigation, where the court specifically held that "what practitioners already knew" and what were "well-understood, routine, and conventional techniques that a scientist would have thought of" were relevant to eligibility.

This is, in my view, the right approach.   Several recent district court decisions have said that evidence of novelty is not relevant to eligibility, and cited Diehr's statement that "the "novelty" of any element or steps in a process, or even of the  process itself, is of no relevance in determining whether the subject matter of a claim falls within the § 101 categories of possibly patentable subject matter."  This interpretation utterly misreads Diehr: the Court was discussing claim dissection, emphasizing that "it is inappropriate to dissect the claims into old and new elements and then to ignore the presence of the old elements in the analysis."  The Court was criticizing the approach of disregarding "old elements" that lack novelty from the the claim for the purposes of eligibility–not saying that actual novelty was irrelevant.  


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By: Robert R. Sachs

On January 31, 2014, Fenwick & West and the Center for the Protection of Intellectual Property (CPIP) at George Mason University School of Law held a roundtable on Patentable Subject Matter at Fenwick’s Silicon Valley office. 

Our approach to this roundtable was different from the typical conference or roundtable on patent

By: Robert R. Sachs, Daniel R. Brownstone

Last week, we filed two amicus briefs with the Supreme Court in Alice Corp. v. CLS Bank, one on behalf of Advanced Biological Laboratories (ABL), and one for Ronald M. Benrey (Benrey). It goes without saying that this is the bellwether case for the patent eligibility of software. The question

By: Robert R. Sachs

The Supreme Court’s actions to invalidate the patents at issue in Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. ___ (2012) and Association for Molecular Pathology, et al. v. Myriad Genetics, Inc., et al., 569 U.S. ___ (2013), unequivocally demonstrate that the USPTO has failed to properly prevent patents on laws of nature from issuing. Similarly, the Food and Drug Administration does not appear to understand the significance of its role as potential steward of biological laws of nature in approving new therapeutics, many based on what we now know to be patented laws of nature. In view of this melancholy state of affairs, I have a very modest proposal.


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By: Robert R. Sachs, Jennifer R. Bush

In our previous post, we explored the philosophical aspects of what is a law of nature. We can now apply that analysis and consider whether Prometheus’ claim recites a law of nature under the variously described criteria. Here is the claim 1 of the ‘623 patent:

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 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 administered to said subject. 


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