Myriad Genetics: Laws of Nature and the Philosophy of Science

In Association for Molecular Pathology vs. Myriad Genetics, the Federal Circuit on August 16, 2012 issued its opinion regarding the patentability of Myriad’s method and composition of matter claims after the case was remanded by the Supreme Court in light of Mayo Collaborative Services v. Prometheus, Inc., 566 U.S. ___, 132 S. Ct. 1289 (2012).  The Federal Circuit upheld the patentability of Myriad’s composition of matter claims to isolated DNA encoding a mutation that is associated with an increased risk of breast cancer in women.  The Federal Circuit also upheld the patentability of Myriad’s therapeutic screening method but affirmed its earlier position that Myriad’s diagnostic methods are invalid under 35 U.S.C. § 101. This article discusses the composition of matter claims only.

 Recall that in this case, the issue (in regard to the composition of matter claims) was whether the cDNAs were or were not patentable as naturally-occurring compositions of matter (products of nature) under the Chakrabarty and Funk Brothers Supreme Court cases. The composition of matter claims were not precisely at issue under the “law of nature” doctrine. Still, a judgment had to be made as to what is “naturally occurring.” And this depends on one’s view of the “laws” of nature involved in gene sequencing and isolation.

 For many philosophers of science, laws of nature are descriptive not prescriptive. If we push a ball bearing off a table, it will fall to the floor. But we don’t imagine that, at the exact instant that the ball bearing ceases to be on the table, it says to itself “Oh my gosh, I’d better hurry up and fall to the floor, or I will be violating a law of nature!” No. What we call a “law” of nature here is that over thousands of years, people have observed that ball bearings or other objects fall to the floor when they are pushed off tables. We describe the result rather than prescribing it. Certainly, we can generalize the “law” well beyond ball bearings and tables. We can say that any macro object in a gravitational field will behave similarly. But our ability to generalize depends upon the lack of observation, in similar circumstances, of any exception to the “law.”

Until relatively modern times, we did not have the testing tools available that would let us modify the “law.” But now we know that in a zero-G environment such as an aircraft following a parabolic arc or in a spacecraft circling the earth, a ball bearing will not always fall to the floor when pushed off a table. Again, though, we don’t imagine the ball bearing saying to itself, “Thank God I don’t have to fall to the floor in this environment.” We can describe what will happen in that particular environment, but we don’t prescribe it.

 Because “laws” of nature are descriptive rather than prescriptive, natural laws can change over time. But we don’t imagine that before a zero-G environment was available for testing, ball bearings would have behaved any differently than they do now that we have the means to vary the testing environment. We just describe the effects of gravity differently, because now we are able to observe instances in which ball bearings don’t fall to the floor.

 The same is true in the wacky worlds of quantum mechanics and particle physics. “Laws” that work at the macro level simply don’t work at the quantum level. Some philosophers believe that fundamental physics is the only science in which it is possible to discover “exceptionless regularities” that can be called “laws.” All other sciences (including genomics) can only specify regularities that are true in a particular context. An interesting discussion of this idea and the idea of laws of nature generally can be found in Carroll, John W., “Laws of Nature”, The Stanford Encyclopedia of Philosophy (Spring 2012 Edition), Edward N. Zalta (ed.), URL = <http://plato.stanford.edu/archives/spr2012/entries/laws-of-nature/&gt;.

 This is why it is difficult to apply Section 101 of the U.S. patent law consistently. The case law around Section 101 states certain inventions are a priori unpatentable, namely, inventions that pre-empt a law of nature or a product of nature. There is a sense that the laws and products of nature should be freely available to anyone. The problem comes in figuring out 1) what law or product of nature is at stake and 2) does the particular invention pre-empt that law. Furthermore, because “laws” of nature are descriptive of the state of scientific knowledge at a given point in time, and scientific knowledge changes as discoveries are made, “laws” of nature (as described by human beings) for many philosophers of science cannot be prescriptive, that is, covering all known instances and unknown future instances. Thus, the really difficult question in cases such as Myriad is whether the issue is one of law or one of philosophy.

 In the August 16 decision, Judge Lourie re-affirmed his earlier holding that the claimed cDNAs were not “naturally occurring” because they do not exist in nature in their exact molecular form. In nature, the cDNAs only exist as a part of genomic DNA. The cDNAs were created by severing covalent chemical bonds, removing the DNA from its natural state where it is bound to histones, and then removing the introns from the genomic DNA. To put his holding into the concepts we are discussing, Judge Lourie was saying, in effect, “genomic scientists have not found any instance of a free standing cDNA with the sequence of nucleotides claimed.”  Thus, the “law” of nature is that living cells do not have such free standing cDNAs (a description). It is conceivably possible that a cell might be found in nature with such cDNAs, so the “law” is not prescribing that such cDNAs cannot be found in nature. It is enough that they are not. Furthermore, Judge Lourie is saying that what makes a cDNA patentable subject matter is not its nucleotide sequence (which is the same in the genomic DNA), but rather the absence of covalent chemical bonds between the cDNA and other entities. Yet this is a challengeable position, and Judge Bryson does challenge it, as we will see below.

 Judge Moore agreed with Judge Lourie that there are chemical differences between the chemical structure of the cDNAs and naturally occurring DNA.  However, for Judge Moore, it is not the absence of chemical bonds alone in the claimed cDNAs that make them patent eligible under Section 101. Rather, it is the different function that cDNAs perform (such as use in primers and probes) that makes them patentable.

 Judge Bryson’s view is that breaking chemical bonds is not patentably different from taking a cutting from a wild plant. For Judge Bryson, “there is no magic in a chemical bond that requires us to recognize a new product when a chemical bond is created or broken, but not when other atomic or molecular forces are altered.” Judge Bryson seems to be saying that different “laws” of nature are not involved in breaking a chemical bond vs. cutting tissue with a scissors.  He is not clear, however, on why breaking a chemical bond does not involve a different “law” than physical cutting. As discussed above, for some philosophers of science, the closer we get to fundamental physics, the more likely the possibility of finding “exceptionless regularities.” Clearly, breaking a chemical bond is much closer to fundamental physics than cutting tissue with a scissors. His other theory is that the inventors in Myriad Genetics were simply isolating the cDNAs “according to nature’s predefined boundaries, i.e., at points that preserve the ability of the gene to express the protein for which it is coded.” This sounds like a prescriptive law, not a descriptive law. Are there “predefined boundaries” in nature?  For example, Judge Bryson says:

 “…the function of the claimed molecule is dictated by the nucleotide sequence of the gene – a sequence that is determined by nature and that appears in nature exactly as it appears in the claimed isolated DNA.”

The continuing discoveries of genomic scientists on the precise inter-working of codons with non-coding portions of DNA makes such a pronouncement risky.

 Judge Lourie stated:

 “The remand of this case for reconsideration in light of Mayo might suggest, as Plaintiffs and certain amici state, that the composition claims are mere reflections of a law of nature. Respectfully, they are not, any more than any product of man reflects and is consistent with a law of nature. Everything and everyone comes from nature, following its laws. But the compositions here are not natural products. They are the products of man, albeit following, as all materials do, laws of nature.” (italics added)

But for many philosophers compositions of matter (whether they be ball bearings or cDNAs) do not “follow” laws of nature (in the sense of obeying them). At any point in time, we only perceive that there are no instances of a particular type of entity not behaving in accordance with observable natural “laws.” Laws of nature describe the way objects in the natural universe behave; they do not prescribe such behavior.

As Judge Lourie further stated:

 Under the statutory rubric of § 101, isolated DNA is a tangible, man-made composition of matter defined and distinguished by its objectively discernible chemical structure. Whether its unusual status as a chemical entity that conveys genetic information warrants singular treatment under the patent laws as the district court did is a policy question that we are not entitled to address. Cf. Nat’l Fed’n of Indep. Bus. v. Sebelius, 132 S. Ct. 2566, slip op. at 6 (2012) (“[W]e possess neither the expertise nor the prerogative to make policy judgments. Those decisions are entrusted to our Nation’s elected leaders, who can be thrown out of office if the people disagree with them.”).

 Ultimately, whether or not isolated cDNAs should be unpatentable because they have the same nucleotide sequence as “naturally occurring” DNA is a philosophical, scientific, and policy question, not purely a legal question.

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Posted on October 12, 2012, in Patent and tagged , . Bookmark the permalink. Comments Off on Myriad Genetics: Laws of Nature and the Philosophy of Science.

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