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Volume XII, Number 273

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Tillis Bill Tries to Fix Section 101

This recently introduced bill would replace section 101 with a lot of text. The commentators are all commentating, but I have yet to read whether or not the “outlaw” status of claims to diagnostic methods—led by varying interpretations of Mayo v. Prometheus—has been clearly lifted by this bill. Here are the relevant parts, at least setting up the discussion on this point.

Section 101. Patent Eligibility

(a) IN GENERAL—Whoever [post- Thaler v. Vidal, we know that this must be a human being] invents or discovers any useful process, machine, manufacture, or composition of matter, or any useful improvement thereof, may obtain a patent therefore, 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:

***

(B) A process that—

          ***

(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.—

 ***

(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—

***

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

***

Well now, does this bill abrogate Mayo v. Prometheus and permit patents on diagnostic assays as simple as “If A, then B” (If assay indicates high homocysteine then diagnostic conclusion is low cobalamin)? Let’s start with a simple “If A, then B” claim, like the one in Athena (If autoantibodies to MuSK are detected, subject may be afflicted with MG). The presence of antibodies that bind to MuSK occurs in nature wholly independently and prior to any human activity. See, section I (B) (iii). So to be patentable, a process comprising the detection of the antibodies or of a MuSK-antibody complex in order to diagnose MG must fall within one of the “conditions” of the statute as set forth in 2(B).

The problem, and I hope it is not a big one, is that 2(B) does not mention “processes” employing “natural materials.” Applicants are left to argue that the anti-MuSK antibodies per se are altered by human activity, e.g., by binding to MuSK, and so are “modified.” They can also argue that the antibodies are employed in a useful discovery since they are the biomarker for MG. But, of course, the applicants wanted to claim a process, not just the biomarker detected by the assay.

Regarding diagnostics, is the key phrase “otherwise employed in a useful invention or discovery”? Of course, the argument is that the useful invention or discovery is the diagnostic process, from initial sampling to drawing a diagnostic conclusion. For years I have proposed that s. 101 bills on diagnostic clams need a sentence like, “A process includes recognition of the utility of a naturally occurring correlation.” In other words, you are not trying to patent the correlation itself, like “blood containing antibodies that bind to MuSK”. The necessary steps include both isolation and detection of the antibodies and recognition that their presence indicates something about the patient. (Note that Mayo did not invent the correlation between the level of the metabolites of the administered drug and the need to adjust the dose of the drug. Mayo took a known correlation and refined the optimal range of metabolite concentration that arose after administration of the “parent drug”. One could call this the recognition that an improved correlation could be reached, but nothing in the Tillis bill says that, apart from novelty, the invention needs to be improved over any earlier version or alternative. This draft of the bill needs some work but it is a valuable start to ending the s. 101 nightmare.

© 2022 Schwegman, Lundberg & Woessner, P.A. All Rights Reserved.National Law Review, Volume XII, Number 220
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About this Author

Warren Woessner, Registered Patent Attorney, Schwegman Lundberg Law firm
Shareholder

Warren Woessner is a registered patent attorney and a founding shareholder of Schwegman, Lundberg & Woessner. His practice focuses on chemical patent law, including biotechnology, pharmaceuticals, vaccines, medical treatments, diagnostics, and biofuels and agricultural chemistry, including related opinion and licensing matters.

Warren received his B.A. in chemistry (1966) from Cornell University, his Ph.D. (organic chemistry, 1971) and his law degree (J.D., cum laude, 1981) from the University of Wisconsin...

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