Senator Tillis' Patent Eligibility Reform Proposal: A Biopharma Perspective

By Kevin E. Noonan --

Senator Thom Tillis (R-NC) introduced S. 4734, entitled "A Bill to amend Title 35, U.S. Code, to address matters relating to patent subject matter eligibility, and for other purposes" last night, as was discussed in an earlier Patent Docs post (see "Senator Tillis Proposes Patent Eligibility Reform (Again)").  Even a cursory read of the bill reveals that portions of it have been specifically crafted to address issues that have arisen in the inferior courts' applications of the Supreme Court's recent subject matter eligibility jurisprudence (particularly, and chronologically, Mayo Collaborative Services v. Prometheus Laboratories, Inc., Association for Molecular Pathology v. Myriad Genetics, Inc., and Alice Corp. v. CLS Bank Int'l), that have made patenting diagnostic methods and natural products difficult or impossible (see, e.g., "Athena Diagnostics v. Mayo Collaborative Services -- The Dissents").  This post addresses the Senator's attempt to remedy the current situation by legislation.

The Bill contains the following provisions, amending and adding certain definitions to Section 100 and entirely revamping Section 101:

§ 100. Definitions

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(b) The term "process" means process, art or method, and includes a new use of a known process, includes a use, application, or method of manufacture of a known or naturally-occurring process, machine, manufacture, composition of matter, or material.

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(k) The term 'useful' means, with respect to an invention or discovery, that the invention or discovery has a specific and practical utility from the perspective of a person of ordinary skill in the art to which the invention or discovery pertains.

§ 101. Patent eligibility

(a) IN GENERAL.—Whoever invents or discovers any useful process, machine, manufacture, or composition of matter, or any useful improvement thereof, may obtain a patent therefor, subject only to the exclusions in section (b) and to the further conditions and requirements of this title.

(b) ELIGIBILITY EXCLUSIONS.—

(1) IN GENERAL.—Subject to paragraph (2), a person may not obtain a patent for any of the following, if claimed as such:

(A) A mathematical formula, apart from a useful invention or discovery.

(B) A process that—

(i) is a non-technological economic, financial, business, social, cultural, or artistic process;

(ii) is a mental process performed solely in the human mind; or

(iii) occurs in nature wholly independent of, and prior to, any human activity.

(C) An unmodified human gene, as that gene exists in the human body.

(D) An unmodified natural material, as that material exists in nature.

(2) CONDITIONS.—

(A) CERTAIN PROCESSES.—Notwithstanding paragraph (1)(B)(i), a person may obtain a patent for a claimed invention that is a process described in such provision if that process is embodied in a machine or manufacture, unless that machine or manufacture is recited in a patent claim without integrating, beyond merely storing and executing, the steps of the process that the machine or manufacture perform.

(B) HUMAN GENES AND NATURAL MATERIALS.—For the purposes of subparagraphs (C) and (D) of paragraph (1), a human gene or natural material that is isolated, purified, enriched, or otherwise altered by human activity, or that is otherwise employed in a useful invention or discovery, shall not be considered to be unmodified.

(c) ELIGIBILITY.—

(1) IN GENERAL.—In determining whether, under this section, a claimed invention is eligible for a patent, eligibility shall be determined—

(A) by considering the claimed invention as a whole and without discounting or disregarding any claim element; and

(B) without regard to—

(i) the manner in which the claimed invention was made;

(ii) whether a claim element is known, conventional, routine, or naturally occurring;

(iii) the state of the applicable art, as of the date on which the claimed invention is invented; or

(iv) any other consideration in section 102, 103, or 112.

(2) INFRINGEMENT ACTION.—

(A) IN GENERAL.—In an action brought for infringement under this title, the court, at any time, may determine whether an invention or discovery that is a subject of the action is eligible for a patent under this section, including on motion of a party when there are no genuine issues of material fact.

(B) LIMITED DISCOVERY.—With respect to a determination described in subparagraph (A), the court may consider limited discovery relevant only to the eligibility described in that subparagraph before ruling on a motion described in that subparagraph.

(where the italicized language in the bill is directed to concerns raised by the biopharma patenting community).

The effect of the amendments to Section 100 would be to expressly include use of a naturally occurring process (for example, a biological process of cause and effect) within the definition of a "process" that can be patent eligible, wherein the mere fact that the process is naturally occurring would not by itself make the process per se ineligible.  New subsection (k) defines "usefulness" by cabining it to utilities that are "specific" and "practical" as understood by the person of ordinary skill in the art.  The advantage of these definitions is akin to restricting obviousness in Section 103 to what was known in the prior art by the ordinarily skilled artisan, and in so doing remove the subjectiveness that can (and has) crept into such determinations when made by judges rather those in the art that understand the technology at issue.

There are several subsections in proposed revised Section 101 that specifically and frankly address not only the concerns of the biopharma patent community but also its critics and discontents.  The frankest example is Subsection (b)(1)(C), which codifies the Court's decision in Myriad that human genes in nature are not patent eligible per se.  Subsection (b)(1)(D) further codifies the extension of this principle that has arisen in practice, that any naturally occurring product is ineligible as it occurs in nature.  The genesis of this distinction, and one that the proposal attempts to constrain, is that "mere" isolation of a natural product may not be (although in practice often has been found not to be) patent eligible.  These concessions are realistic, insofar as the American Civil Liberties Union was a vocal critic of Senator Tillis' attempts to remedy patent eligibility issues in 2019 (the ACLU appears to be gearing up its opposition again; see "ACLU Opposes Legislation to Enable Patents on Human Genes," which is equally frank (and wrong) in its position that "mere" isolation is not enough to confer patent eligibility).

But the Bill also contains several provisions that are directly aimed at limiting the harm that the current eligibility regime has effected on the biopharma industry.  Regarding natural products, Subsection (b)(2)(B) limits the scope of Subsections (b)(1)(C) and (D) by defining as patent eligible human genes or natural material "that is isolated, purified, enriched, or otherwise altered by human activity."  This language is consistent with the provisions of the Supreme Court's Myriad decision that rendered cDNA patent eligible because it did not occur in nature and was the product of "the hand of man," distinctions also consistent with Diamond v. Chakrabarty, a decision the Court expressly did not overturn in Myriad.  The bill expands this distinction in favor of patent eligibility to include all natural products, not just cDNA, and in addition to being consistent with Myriad is consistent with traditional patent eligibility standards that have had changes effected in kind by isolation (e.g., wherein active compounds present in small amounts naturally have been changed to be effective drugs, additives, sweeteners, etc. by the process of their isolation).  Under the current eligibility regime, excluding isolated compositions of such compounds based solely on their isolation negates the inventive contribution that produced them.  For example, while it may be true that taxol, a product of the yew tree, inherently has anticancer activity against inter alia breast cancer, deciding that therapeutically effective amounts of isolated taxol are not patent eligible on that basis requires that the fact that trees don't get cancer be disregarded (and the human inventive activity identifying this anticancer activity also be disregarded).  Under Senator Tillis' proposed legislation there is ample opportunity in the other sections of the Patent Act (Section 102, 103, and 112) to preclude patentability outside the black-and-white strictures of patent eligibility under Section 101 as it now exists.

With regard to diagnostic method claims reconsideration under proposed Section 101 is less directly addressed; indeed, changes in the definition of "process" carries much of the water supporting such claims.  But the provisions of Subsection (c)(1)(A) and (B)(ii) are important because they would proscribe the habit, used by district courts and affirmed by the Federal Circuit (see, e.g., "Ariosa Diagnostics, Inc. v. Sequenom, Inc. (Fed. Cir. 2015)"; "Is It Time for Federal Circuit to Rethink Its Subject Matter Eligibility Jurisprudence?") of parsing claims into their component parts and then cherry-picking claim elements to arrive at a Mayo/Alice-sanctioned ineligibility conclusion.  Subsection (c)(1)(A) requires that the claims be considered "as a whole," consistent with Diamond v. Diehr (1981) (another Supreme Court decision not overturned, here in Mayo) and Subsection (c)(1)(B)(ii) which disengages from the eligibility calculus the "known, conventional, [and] routine" and adds "or naturally occurring" considerations that have been used to find claims ineligible without considering the claims as a whole.  This is particularly important in cases where courts have looked at the existence inter alia of a detection method in the prior art without assessing whether it was "known, conventional, [and] routine" to apply that method to detect the biomarker or other biological product (such as cell free DNA in Ariosa v Sequenom) recited in the claim (it was not, because the marker or correlation with specific disease was not appreciated in the prior art).  Statutory prohibitions against such analytical sloth are necessary to prevent subject matter eligibility to swallow all of patent law, which the Supreme Court has itself counseled against.

Prospects for passage of Senator Tillis' bill are uncertain; it will be noted that, not surprisingly, Senator Leahy is not a co-sponsor, while he was a co-sponsor of another bill proposed by Senator Tillis (S. 4704, A bill to require the Comptroller General of the United States to submit a report regarding ways to improve the patent examination process at the United States Patent and Trademark Office, and for other purposes).  This is not unexpected, in view of Senator Leahy's predilection to align himself with those who espouse the rhetorical idea that "bad patents" are exacting a rent or drain on American innovation (without any actual evidence for the proposition; see, Mossoff, "Unreliable Data Have Infected the Policy debates over Drug Patents," Policy Memo, Hudson Institute, January 2022).  Politics is the art of the possible, and the political headwinds are certainly blowing against any legislation that would bolster patent protection for pharmaceuticals.  But as with semiconductors and artificial intelligence, there may be a window for convincing other Members that the current eligibility regime is inimical to innovation in the biopharmaceutical arts and that foreign competitors will be all too willing to step into the breach to charge American consumers whatever the traffic will bear for diagnostic methods and therapeutic drugs produced abroad.  Whether that is enough remains to be seen, but Senator Tillis has provided a beachhead for attempting to stem the tide against patent protection for these important technologies.

Comments

[Bart van Wezenbeek]

Some kind of codification of the patent eligibility of biotechnological inventions is required to overcome the arbitrariness of the courts in deciding on these matters, where it seems that other aspects (novelty; inventive step) play a role in the eligibility decision.
If jurisdictions with legislation (e.g. the EPC) and without (e.g. USA, Canada) are compared, it appears that there are far fewer controversies of court decisions in countries in which the patent eligibility of biotechnological inventions is embedded into the Patent Act.

[skeptical]

Changing the definition in 100 of process to this type of "must make" (i.e. manufacture) SHOULD BE rejected.

More Trojan Horse stuff here...