Between February and May of this year, IPO, AIPLA and the ABA IP Section have released proposals for amendments to 35 U.S.C. s. 101 to void the Mayo/Alice Rule and to clarify the definition of an “abstract idea” as it relates to patent-eligibility. This is a topic I have followed closely since the March 2004 “Guidance” from the USPTO, particularly with respect to how Mayo, Myriad and Ariosa have made it nearly impossible to get claims allowed to diagnostic methods and to putative “natural products.” While the USPTO has noted that methods of medical treatment are outside of the Mayo/Alice Rule, the major question of how to patent a simple “If A, then B” diagnostic test has remained clouded, particularly since at least some of the Federal Circuit judges and Supreme Court justices believe that discovery of the utility or “correlation” by the inventor of a naturally-occurring relationship cannot provide the additional inventive step beyond the natural law required by Mayo. The “marked difference” requirement promulgated by the PTO to limit patenting natural products is so poorly shaped that drugs in an aqueous carrier are being rejected on the basis that water is a natural product.
The proposals for legislative reform are lengthy, but they contain appendices explaining the motivation for the proposed amendments to s. 101. Assuming that you are familiar with the facts of Mayo, Myriad, Alice and Ariosa, you will obtain the best incites for your effort by focusing on these Appendices.
IPO PROPOSED AMENDMENTS
IPO’s Section 101 Legislative Task Force released its proposed amendment in February. The proposal removed “new” from section 101(a) but kept “useful” to discourage courts from beginning a novelty analysis based on s. 102. The last phrase reads, “shall be entitled to a patent for a claimed invention….” “Claimed invention” is added to attempt to get the courts to focus on the invention considered as a whole, as opposed to a focusing on the recitation of a natural law and/or mental step in the claim. (Consider the quote in Ariosa that the claim begins and ends with the natural phenomenon.)
The proposal adds 101(b) entitled “Sole Exception to Subject Matter Patentability” which states that “a claimed invention is ineligible under subsection (a) if and only if the claimed invention as a whole, as understood by a person having ordinary skill in the art to which the claimed invention pertains, exists in nature independently of and prior to any human activity, or exists solely in the human mind.”
Regarding the “exists in nature independently” clause, the Appendix states that it reflects the notion of inventions that are the result of some act by a human upon the state of nature, “that is, anything …(’made by human skill; produced by humans (opposed to natural.’).” Disturbingly, this explanation stated to be consistent with Myriad, in which the S. Ct. denied patent eligibility to an isolated “gene”, while permitting the patenting of cDNA. Since Myriad ignored the human effort required to isolate a gene, or even to design a primer pair, I would have written this section to state that it is intended to moot the Myriad decision, not to be consistent with it.
The comments on patent ineligibility for inventions that exist solely in the human mind is pretty much on point, stating that purely mental phenomena should not be patentable. However, it misses the point that a mental step does not per se render a claim patent ineligible, e.g. a detection method that requires recognition by a technician of the significance of a natural phenomenon. In other words, there in nothing fatal in a claim limitation that requires someone to think—unless that is the only claim element.
Instead, the Appendix states, “this ineligibility criterion is directed to abstract ideas and thus makes eligible any claim limitation that requires some external involvement with the physical world…” This statement is unclear. The ineligibility of a given claim limitation is not at issue, since claims are to be considered as a whole.
AIPLA PROPOSED AMENDMENTS
The AIPLA Legislative Proposal takes a similar approach to the IPO proposal. It “cleans up” s. 101(a), although it keeps “new” as a modifier for the primary classes of invention but deletes it from “new and useful improvement thereof.” Section 101(b) is added stating that “a claimed invention is ineligible under subsection (a) only if the claimed invention as a whole exists in nature independent of and prior to any human activity, or can be performed solely in the human mind.” The Appendix states that the use of “only if” is intended to block the current judicial exceptions to patentability. The Appendix states that “as a whole” is intended to focus courts on “what the claim language states” and directing the courts to not ignore claim limitations in characterizing a claim.
The AIPLA Proposal is stronger than the IPO proposal in stating that “[t]he Legislative Proposal diverges from current eligibility law in that it permits any human contribution to meet the eligibility requirement [regarding ‘natural products’].” This interpretation of the “exists in nature” clause overrules Myriad, and renders all subunits of naturally occurring chromosomal DNA, RNA etc. patent eligible if they meet the utility requirement in 101(a).
The proposed language “or can be performed solely in the human mind” is explained more clearly and forcefully than in the IPO Appendix. The AIPLA Appendix states “[t]his exception does not apply, for example, when any part of a claims requires the use of a physical device such as computer hardware or involves a physical test such as a diagnostic assay. It thus excludes only claims describing purely mental calculations or associations.” Note that a dependent claim reciting an algorithm would be patent-eligible if claim 1 requires physical process steps.
ABA PROPOSED AMENDMENTS
The ABA IP Section’s Supplemental Comments issued on March 28, 2017 takes a somewhat different tack and focuses on preemption. The proposed s.101 adds s.101(b). It states that the subject matter of s. 101(a) “may be denied eligibility…on the ground that the scope of the exclusive rights under such a claim would preempt the use by others of all practical applications of a law of nature, natural phenomenon, or abstract idea. Patent eligibility under this section shall not be negated when a practical application of a law of nature, natural phenomenon, or abstract idea is the subject matter of the claims upon consideration of those claims as a whole, whereby each and every limitation of the claims shall be fully considered and none ignored.”
While I like the use of the “practical application” standard, since it would at least allow patents on simple diagnostic methods and on DNA isolated or designed for a particular purpose, I seem to recall that Myriad had trouble escaping preemption for claims to “naked” BRCA genes. However, many commenters have argued that the utility and written description requirements, coupled with a robust experimental use exception from infringement, would screen out overly preemptive claims without the need to define (and redefine) the permissible scope of preemption. After all, our patent system is inherently preemptive – that is how inventors are rewarded for disclosing their inventions.
I will close with a quotation from Hans Sauer, as reproduced at the IAM blog posting:
“No subject of substantive patent law is raised and discussed more frequently by BIO member companies. Current jurisprudence in the area of patent-eligible subject matter is unstable, it creates unnecessary business uncertainty, and it is an astonishing anomaly in international patent law. There are biotechnologies for which it is now easier to get a patent in Europe and China than it is in the United States.”
It’s time. There oughta be a law!