March 26, 2013
Is Lack of Preemption the Key for the Supreme Court to Decide in Myriad's Favor?
By Kevin E. Noonan --
The U.S. Supreme Court will hear arguments in Association for Molecular Pathology v. Myriad Genetics, Inc. on April15th, and the parties and their different cadres of amicihave submitted briefs of varying degrees of helpfulness and coherence to the Court. In reviewing these briefs, and the Mayo Collaborative Services v. Prometheus Laboratories, Inc. decision that forms the basis for re-review by the Federal Circuit (albeit with little having been changed from that reconsideration), the question arises whether what is at issue in this case is the extent to which Myriad's claims unduly preempt what should be "free to all men and reserved exclusively to none." Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U.S. 127,130 (1948).
The context for the Court's decision is its own recognition that patent eligibility should be given an expansive scope, as mandated by Congress under 35 U.S.C. § 101. The Court recognized Congress's intent expressly in Diamond v. Chakrabarty, 447 U.S. 303, 309 (1980), quoting the famous aphorism from the legislative history that statutory subject matter should "include anything under the sun that is made by man," a sentiment sounding in Thomas Jefferson's vision that "ingenuity should receive a liberal encouragement." 5 Writings of Thomas Jefferson 75-76 (Washington ed. 1871). The Court has been parsimonious in setting forth what was not patent-eligible: "laws of nature, physical phenomena, and abstract ideas" have fallen outside the statutory scope, and the Court has provided explicit examples of what should reside inside those excluded categories ("a new mineral discovered in the earth or a new plant found in the wild is not patentable subject matter" and "[l]ikewise, Einstein could not patent his celebrated law that E=mc2; nor could Newton have patented the law of gravity." Chakrabarty, 447 U.S. at 309).
These concerns were of primary importance in the Court's Mayo v Prometheusdecision, in which the claims (according to the Court) were directed to a natural law relating to the proper therapeutic dosage of a drug for treating Crohn's disease. In finding the claim ineligible for patenting, the Court said that:
The claims purport to apply natural laws describing the relationships between the concentration in the blood of certain thiopurine metabolites and the likelihood that the drug dosage will be ineffective or induce harmful side-effects. We must determine whether the claimed processes have transformed these unpatentable natural laws into patent eligible applications of those laws. We conclude that they have not done so and that therefore the processes are not patentable.
The deficiency in the claim was thus that it did no more than "inform a relevant audience about certain laws of nature," and "any additional steps [recited in the claim] consist of well understood, routine, conventional activity already engaged in by the scientific community." Accordingly, "those steps, when viewed as a whole, add nothing significant beyond the sum of their parts taken separately" and thus the claimed method was unpatentable.
These concerns frequently arise when the claims produce nothing more than information ("inform a relevant audience about certain laws of nature"); this deficiency can be seen to be in common with Mayo and earlier cases involving the limits of statutory subject matter. These include O'Reilly v. Morse, claiming a method of transmitting information using electromagnetism (56 U.S. 62 (1853)); Benson v. Gottschalk, claiming methods for converting binary-coded decimal (BCD) numerals into pure binary numerals on a general purpose digital computer using a particular algorithm (409 U.S. 63 (1972)); Parker v. Flook, claiming methods for determining an alarm limit (437 U.S. 584 (1978)); and Bilski v. Kappos, claiming methods for hedging commodity trading outcomes (130 S. Ct. 3218 (2010)). These decisions of the Court stand in contrast with its decision in Diamond v. Diehr, where a method for curing rubber using an application of the Arrhenius equation was deemed patent-eligible (450 U.S. 175 (1981)). The production of a tangible outcome, cured rubber, distinguishes the patent-eligible claims in Diehr from the information produced in those methods deemed patent-ineligible by the Court in Mayo,Morse, Benson, Flook, and Bilski.
The distinction can also be drawn that in Diehr the claimed methods were particularly drawn to a specific, tangible result (the cured rubber) and that the claim did not preempt all uses of the Arrhenius equation. The Supreme Court has been wary of claims that preempt all uses of a law of nature, as it deemed them to be in Mayo, Benson, Flook, and Bilski; in Mayo, the Court warned that "upholding the patents would risk disproportionately tying up the use of the underlying natural laws, inhibiting their use in the making of further discoveries" and would "threaten to inhibit the development of more refined treatment recommendations (like that embodied in Mayo's test), that combine Prometheus' correlations with later discovered features of metabolites, human physiology or individual patient characteristics." These statements illustrate this Court's continuing concern voiced in Funk Brothers that laws of nature should not be burdened with patent exclusivity.
Unlike the method claims in Mayo, Benson,Flook, and Bilski, Myriad's composition of matter claims at issue in the Myriad case are not broadly preemptive in the same way. They are both specific and particular and as such do not implicate the policy concerns enunciated by the Court in those earlier cases where preemption rendered claims patient-ineligible. Myriad's claims, when considered as a whole are narrowly focused on isolated human DNA molecules that encode a protein having a particular amino acid sequence. The consequences of this specificity narrow the scope of these claims substantially. Taking claim 1 of Myriad's U.S. Patent No. 5,837,492 as an example:
An isolated DNA molecule coding for a BRCA2 polypeptide, said DNA molecule comprising a nucleic acid sequence encoding the amino acid sequence set forth in SEQ ID NO:2.
The scope of this claim should be understood by these affirmatively recited limitations:
• an isolated DNA molecule that
• encodes a specifically-recited amino acid sequence.
Much of the discussion surrounding these claims in the Federal Circuit's opinion and in Plaintiffs' and their amici's briefs to the Court focus on the requirement that the DNA molecule is isolated. Neglected in this discussion, and particularly relevant to the question of preemption and the scope of Myriad's composition of matter claims, is the narrowness of the scope of this claim and the consequences of this narrow scope on the preemption issue. First, the only isolated (human) DNA molecules falling within the scope of this claim are those that encode this (and only this) particular amino acid sequence encoding BRCA2, which in this case encompasses 3,418 amino acids arrayed in a particular and specific order. An isolated human DNA comprising any change in this encoded amino acid sequence is not exclusive to the patentee and can be performed freely without literal infringement liability by anyone. (The availability of the doctrine of equivalents for isolated human DNA claims is severely limited by U.S. Patent and Trademark Office practice in interpreting the application of 35 U.S.C. § 112(a) to such claims, and by ensuing prosecution history estoppel.)
The significance of this limitation in scope of Myriad's claims can be understood by the following example. If the single change in the amino acid sequence of the BRCA2 protein encoded by the claimed isolated human DNA is from a valine (Val) residue to an isoleucine (Ile) residue, the number of atoms in the protein would be increased by a mere 3 atoms (the difference in structure between these two amino acids is a methylene group,-CH2-) out a total of more than60,000 atoms in the protein. Yet, even such a molecule changed to such a small degree would not literally infringe claim 1 of Myriad's '492 patent. Similarly, insertions or deletions of the sequence, mutations and sequence variants (naturally occurring or man-made) do not fall within the scope of Myriad's claims to a specific, particular isolated human DNA, due to this restricted scope. Properly construed, claims to isolated human DNA are the antithesis of the type of broadly preemptive claims that have concerned the Supreme Court in its earlier precedent, because by their nature such claims do not "impede the flow of information that might permit, indeed spur, invention" and thus do not call within the Court's proscriptions based on these concerns.
Moreover, such changes, insertions or deletions in the sequence, mutations and sequence variants (naturally occurring or man-made) are independently patentable to future researchers who describe such variants and satisfy the statutory requirements embodied in 35 U.S.C § 112. (The Federal Circuit has interpreted the disclosure requirements of 35 US.C. § 112 to require that claims to isolated human DNA must disclose the specific sequence claimed (or provide a biological deposit thereof). Regents of the University of California v. Eli Lilly & Co.; Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co. (en banc). The U.S. Patent and Trademark Office has implemented this interpretation of the statutory requirements (see USPTO Written Description Examination Guidelines, 66 Fed. Reg. 1092 (2001)). In fact, disclosure of the predicted amino acid sequence encoded by the human BRCA2 gene in Myriad's '492 patent, required as it is by 35 U.S.C. § 112(a) to provide "a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and  the best mode contemplated by the inventor or joint inventor of carrying out the invention" provides the best starting point for work by future inventors to identify or produce such changes, insertions or deletions of the sequence, mutations and sequence variants (naturally occurring or man-made) and patent them, independent of any restrictions that can be imposed by Myriad (or any other patentee). Disclosure as required by the Patent Act is "the quid pro quoof the right to exclude." Kewanee Oil Co. v. Bicron Corp., 416 U.S. 470, 484 (1974), and Myriad's disclosure of the BRCA1 and BRCA2 gene sequence provides future researchers with the ability to continue to research and make improvements, as envisioned in Article I of the U.S. Constitution.
In view of these distinctions, it should be evident that Myriad's claims to isolated human DNA are different in both kind and effect than the claims the Court has proscribed due to their capacity to unduly preempt future invention. Viewed in this light, and stripped of the emotional and political implications generated by presenting the question of whether human genes should be patent-eligible (a legal question) (as opposed to whether isolated human DNA should be patented, a policy decision best left to Congress), the real question before the Court is whether there are grounds consistent with the issues and concerns motivating prior decisions that support those who would have the Court apply a categorical rule that isolated human DNA should be proscribed. The Court can certainly decide that such policymaking falls within its purview, but only by expanding the grounds is has previously applied for finding otherwise statutory subject matter not to be eligible for patenting.
Overview of what will be discussed in this case