Bad Science Makes Bad Patent Law—No Science Makes It Worse (Part I)

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.

Of course, one can say that the Federal Circuit is bound by precedent and has no choice but to follow the Supreme Court. This is true but fails to grasp the problem: The Federal Circuit does not even recognize that the Supreme Court's definition is wrong. There have been no dissents by the Federal Circuit raising this issue. Instead, they apparently believe that the Supreme Court is correct, and thus only raise other concerns about the application of the Mayo test. Judge Lourie at least has attempted a formal statement of a law of nature, writing in his concurrence with the denial of en banc review in Ariosa, that "Laws of nature are exact statements of physical relationships, deduced from scientific observations of natural phenomena." This statement is correct, but it is not a complete statement of a law of nature. Merely having an exact statement of a physical relationship, derived from scientific observations does not make the relationship "lawful."

While there are a variety of different theories as to what constitutes a law of nature, here is list of criteria found in the literature:

1. Universality: The statement is true under any and all conditions and thus is independent of contingent facts. Consider the statement “All robin eggs are greenish-blue.” To be universal, there would have to be no examples of robin eggs that are not greenish-blue. Without this universality, the statement would not be a law of nature. It would merely be an “accidental generalization,” a statement that happens to be true for a large body of observations.
2. Necessity: The statement expresses something that must be true and not just true by definition (e.g., “all humans are mammals”) or by mathematics (e.g., “there is no largest prime number”). This requirement is called physical, natural or nomological necessity. Loosely speaking, is there something that makes it necessary that all robin eggs are blue? For some theories of laws of nature, necessity is what distinguishes a law-like statement from a (mere) universal truth.
3. Explanation: The statement is part of a theory that can explain the phenomena of interest and all of the instances. A law of nature regarding the particular color of robin eggs would be part of a theory that explains why and how this occurs.
4. Prediction: The statement makes predictions about future instances, which predictions can be confirmed (or disconfirmed). Will all robin eggs that are found in the future be greenish-blue?
5. Inference: the statement supports inferences from sets of facts to further sets of facts which can be confirmed. Given the color of robin eggs, can we infer any other useful facts? For example, as mentioned below, Newton's law allow us to derive Kepler's more specific laws, and thus confirm specific facts.
6. Counterfactuals: A statement like “It is a law that robin eggs are greenish-blue” must be true in counterfactual examples, hypothetical situations in which there are no robin eggs at all. In other words, if one imagines a hypothetical world where everything is the same except the specific facts that the law generalizes, would the law still be true?
7. Objectivity: Whether a statement is a law of nature does not depend on any human knowledge, belief, interest, need, or other subjective or pragmatic consideration. Thus, if it is a law that robin eggs are greenish-blue, it does not depend on any of our beliefs about robins, our perception of what is greenish-blue, or whether it is useful to humans that robin eggs have this color.
8. Scientific: A statement should be discoverable by scientists; it is what scientists would consider a law. Would the relevant scientific community recognize the evidence and explanation as sufficient to establish the truth of the law?

Perhaps the simplest definition of a law of nature is the following:

“What are the laws of nature? may be stated thus: What are the fewest and simplest assumptions, which being granted, the whole existing order of nature would result? Another mode of stating it would be thus: What are the fewest general propositions from which all the uniformities which exist in the universe might be deductively inferred?”

J. S. Mill, “A System of Logic" (1843)

Considering the above criteria or Mills' definition, none of various so-called "laws of nature" that have been found by the Supreme Court, the Federal Circuit, and the lower courts come even close qualifying as a true law. Here is a sample of "laws of nature" found in various court decisions:

• Detecting whether any antibody-antigen complexes are formed between the 125I-MuSK receptor and the antibodies present in said bodily fluid. Athena Diag., Inc. v. Mayo Collaborative Servs., LLC.
• The effect of nutrition on the expression of least one gene in the genomic map of an animal. Hemopet v. Hill's Pet Nutrition, Inc. (affirmed by Fed. Cir.)
• Whether a dog is susceptible to "exercise induced collapse" based on the presence of a mutation at position 767 of the DNM1 gene. Genetic Veterinary Sciences v. Canine EIC Genetics.
• The production of interferon-gamma by CD4 T-cells and CD6 T-cells in response to the presence in vitro to synthetic peptides found in tuberculosis bacterium. Oxford Immunotec Ltd. v. Qiagen, Inc.
• The presence of certain mutations in the kinase domain of a patient’s EGFR gene substantially increases the sensitivity of epidermal growth factor receptor to tyrosine kinase inhibitor therapy, in the treatment of epithelial cell cancer. Esoterix Genetic Labs. LLC v. Qiagen Inc.
• The relationship between an internal body temperature to ambient (skin) temperature. Exergen Corp. v. Brooklands Inc. (affirmed by Fed. Cir.)
• The bioavailability of controlled released oxymorphone being affected by renal function. Endo Pharms. Inc. v. Actavis Inc.
• The presence of two copies of the 577R allele being positively associated with "elite athletic performance." Genetic Techs. Ltd. v. Lab. Corp. of Am. Holdings.

None of these—and most obviously the last one—is a "law of nature." They are at best examples of accidental generalizations or in even more weakly, simply facts. In that sense they are no different that the vast number of patents relating to physical processes, such as the very first patent ever issued, for the process of making potash. Potash, a form of potassium carbonate and potassium salts, was an important ingredient during the industrial revolution. Potash is derived from the ashes of burned hardwood ("pot ash"). Samuel Hopkin's invention lay in the discovery that the raw ashes can be burned a second time in a furnace before they were dissolved in water, thereby reducing impurity. The second burning step more fully oxidized the ashes, resulting in much greater carbonate formation. Obviously, this fact is a result dictated by the "laws of chemistry". If Hopkins' patent was challenged today, a court would likely invalidate it. So much for progress.

The staple law of nature that the Supreme Court and other courts use is Einstein's E=mc². This equation, which states the mass-energy equivalence, is a physical law—it describes a universal constraint on all physical matter. This (real) law of nature is fundamentally different from the "laws of nature" that the courts have focused on and raised to the level of Einstein's law. The most obvious difference is this: the relationships set forth above, are biological relationships, and therefore they are the result of contingent evolutionary processes. By contrast, Einstein's law is a physical law—it describes the fundamental relationships of all matter. The difference between physical laws and generalizations in biology is not merely a matter of "narrow" versus "broad" laws of nature. Physical laws define the behavior of physical systems, based on underlying fundamental forces and properties. In that sense, all physical laws are reductionist: They take a broad array of specific details from many different instances and observations and distill out a simplified, discrete relationship. Consider Newton’s three laws of motion:

1. An object will remain at rest or in uniform motion in a straight line unless acted upon by an external force.
2. The force acting on an object is equal to the mass of that object times its acceleration.
3. To every action there is always opposed an equal reaction.

Also consider his law of universal gravitation:

A particle attracts every other particle in the universe using a force that is directly proportional to the product of their masses and inversely proportional to the square of the distance between them.

These statements are universal because they apply to any and all objects under all circumstances (excepting objects at quantum scales or relativist velocities). Newton’s laws explain not just the motion of apples and airplanes on Earth, or the motion of the Earth itself, but the motions of all of the planets and stars. Further, Newton’s laws are reductionist—they explain, for example Kepler’s specific laws of planetary motion in more general terms of mass and force. And the laws enable precise predictions of future events (as well as past conditions) that can be tested and reproduced. Similarly, Einstein's law is not specific to a particular type of matter—it is not limited to any particular chemical elements, let alone any particular physical substance. Einstein’s theory of relativity was further able to explain Newton’s laws in more general way, and thus was also reductionist. The relationships described by Newton’s, Einstein's and other physical laws are inherent in the structure of our physical reality.

But the biological generalizations of naturally occurring relationships are entirely different. In Part II I'll explain why. And it's no laughing matter. * Genetic Technologies has filed a petition for certiorari. In Part II I explain why the Court should grant the petition.

*The perspectives expressed in the Bilski Blog, as well as in various sources cited therein from time to time, are those of the respective authors and do not necessarily represent the views of Fenwick & West LLP or its clients.