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Alternative Reasoning for Supreme Court's Life Sciences Subject Matter Eligibility Jurisprudence

By Kevin E. Noonan --

Last week, IP Law360 published an erudite and provocative article by Joseph Matal and his colleagues regarding the Supreme Court's recent subject matter jurisprudence in the context of earlier decisions in the 19th and early 20th Centuries (see "How Mayo V. Prometheus Strays From Patent Precedent").  These decisions included Le Roy v. Tatham, 55 U.S. 156 (1852) (manufacture of lead pipes); Burr v. Duryee, 68 U.S. 531 (1863) (hat-making machinery); Mitchell v. Tilghman, 86 U.S. 287 (1874) (methods for making fat-acid and glycerin from natural fats); and Eibel Process Co. v. Minnesota & Ontario Paper Co., 261 U.S. 45 (1923) (related to paper-making machines) as examples.  While not every one of these cases held that the patent at issue recited eligible subject matter, the article maintains that together they set forth consistent, well-established principles of subject matter eligibility.  In particular, these authors argued that the principle that discovery of a "law of nature" did not preclude patentability of an application thereof was so well-established that Mr. Matal and his colleagues quote the Rivise and Caesar treatise to the effect that "'where the inventor was . . . also the discoverer of the law or force utilized,' the claimed invention was patentable even if 'it appeared that the application or utilization of the law became self-evident as soon as the principle was formulated.'"  Charles W. Rivise & A.D. Caesar, Patentability and Validity §33-34 (1936).

The article identifies the Court's decision in Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U.S. 127 (1948), as the case where the Court's eligibility jurisprudence turned (wrongly), leading to later cases culminating in the Court's decision in Mayo Collaborative Services v. Prometheus Laboratories Inc., 566 U.S. 66 (2012), which decision Mr. Matal asserts "is at war with the rest of the Supreme Court's eligibility jurisprudence and with core premises of the patent system."  This is a sentiment with which many patent practitioners would agree.  The remainder of the article is a respectful explication of why the Court's recent subject matter eligibility decisions are inconsistent with the earlier precedents discussed therein.

But there is perhaps another perspective.  Perhaps stare decisis (or doctrinal consistency), particularly when considered in a historical context measured in centuries, is not the proper role of the Court (while recognizing the necessity for such consistency over shorter timeframes to avoid serious societal disruption; see, e.g., Dobbs v. Jackson Women's Health Organization, 597 U.S. ___ (2022)).  Strict compliance with earlier precedent would have prevented the Court from deciding Brown v. Board of Education the way it did in view of Plessy v. Ferguson, after all.  It may be better to think about the role of the Court in the "checks and balances" constitutional scheme is to remain a constant check on how or whether the other branches have exceeded their constitutional authority, and regarding subject matter eligibility that is certainly a strong basis for the current state of the law.

Mr. Matal and his colleagues are correct, of course, in identifying Funk Bros. v. Kalo Inoculants as a break point in the Court's considerations of the proper scope of subject matter eligibility, and that the Court's decision in Mayo (and Myriad) were consistent with this decision (albeit being inconsistent with the earlier precedent cited by Mr. Matal).  This leads straightforwardly to a consideration of why the Court has taken this tack, and a comparison of the earlier cases cited by Mr. Matal regarding their eligible subject matter with the ineligible subject matter under Funk Bros., Mayo, and Myriad provides a suggested common thread.

And that thread is subject matter, and its underlying natural laws, related to biological inventions.  It is entirely possible that without subscribing completely to District Court Judge Sweet's rationale for why a gene should not be patent-eligible (being the "physical embodiment of biological information") the Court is concerned with permitting patenting of biological inventions based on natural laws regarding biology.  Professor Andrew Torrance has advanced this argument in his paper "Nothing under the Sun That Is Made of Man" (Torrance, Andrew W., 2021, "Nothing Under the Sun that is Made of Man," 2020 Mich. St. L. Rev.).  (This thinking can be extended to include a basis for the Court's distaste for inventions implicating human thought, no matter how attenuated it may be in practice.)  In addition, it is evident that Justice Breyer in particular has such concerns in his dissent in LabCorp v. Metabolite and Mayo (see Noonan, K.E., 2022, "Justice Breyer: No Friend to IP Law,  21 UIC Rev. Intell. Prop. L. 58).  Thus, one method for determining whether there is such a prejudice against biological invention would be to make a hypothetical comparison or two between those cases that the Court would have been likely to have found to be eligible in the era discussed by Mr. Matal and colleagues and what the Court has decided since Funk Bros.

Hypothetical claim 1

A method for predicting a nuclear power plant reactor failure, comprising the steps of assaying pressure in a reactor coolant tank and correlating pressure fluctuations with the likelihood of failure, wherein a pressure fluctuation of +/- 7% indicates a greater than 90% likelihood that the reactor will fail.

It is unlikely that such a claim would be considered ineligible for many of the reasons enunciated in the earlier Supreme Court cases cited in Mr. Matal's article.  The claim involves an application of a law of nature -- the effects of high pressure created by the heat generated by nuclear fission in a reactor -- under circumstances entirely created by man (i.e., man-made nuclear fission in a man-made reactor).  The claim takes advantage of an application of this law of nature under circumstances that do not arise naturally, thus providing no basis for the application of the Court's recent subject matter eligibility proscriptions.

Hypothetical claim 2

A method for predicting escalation of a hurricane to Category 5 status, comprising the steps of assaying ocean temperature along a predicted storm track, wherein the hurricane is predicted to achieve Category 5 status if the ocean temperature changes by more than 5 degrees Celsius over less than 100 miles of the storm track.

This claim presents a closer case, because it involves a natural phenomenon -- a hurricane -- and the relationship between ocean temperature and future severity of the storm.  However, it is also a clear application of that law of nature for a human purpose -- predicting future hurricane severity and obtaining the benefits thereof -- specifically applied to this particular phenomenon.

Myriad – Claim 2 of U.S. Patent No. 6,033,857, invalid under Mayo

A method for diagnosing a predisposition for breast cancer in a human subject which comprises comparing the germline sequence of the BRCA2 gene or the sequence of its mRNA in a tissue sample from said subject with the germline sequence of the wild-type BRCA2 gene or the sequence of its mRNA, wherein an alteration in the germline sequence of the BRCA2 gene or the sequence of its mRNA of the subject indicates a predisposition to said cancer.

This claim, invalidated by the Federal Circuit in applying the rubrics from Mayo, shares many of the characteristics of the hypothetical claims, specifically by making a prediction of a future eventuality -- breast cancer incidence -- based on the relationship between the presence of certain mutations in the BRCA2 gene with such incidence (a discovery of a natural law).  As with the relationship between heat and pressure in Hypothetical 1 and between ocean temperature and hurricane intensity in Hypothetical 2, the relationship between BRCA gene mutations and disease is a natural phenomenon that can be (and has been) exploited for human benefit.  Note that this application of the consequences of genetic analysis does not involve nor require any rights to the underlying gene to be expropriated, which was at least the apparent basis for the challenge to "gene patents" that resulted in the Myriad decision (see, e.g., Contreras, 2021, The Genome Defense).

What this assessment indicates is that the Court at this time has decided that claims that so intimately implicate fundamental biological laws (particularly but not exclusively involving human biology) should be restricted in scope.  There is precedent for this legal distinction already in U.S. patent law, specifically in the differential treatment of medical (especially surgical) methods under 35 U.S.C. § 287(c).  There are certainly arguments to be made why this is unnecessary for any fundamental legal or moral principle and, indeed, may be contrary to such principles, insofar as the recent Supreme Court decisions have impeded development of genetically based diagnostic tests.  But relying on the inconsistencies of these decisions with earlier Supreme Court precedent seems to miss the more fundamental fact that the Court does not appreciate there to be any such inconsistency and indeed believes these decisions to be entirely consistent with its role in cabining Congress's subject matter eligibility within proper constitutional grounds in order to promote progress.

These considerations explain to some degree the Court's refusals to grant certiorari in the many Federal Circuit decisions applying the Court's subject matter eligibility framework to diagnostic method claims.  They also suggest that the Court's next foray into questions involving scope of biologically related patent claims, the upcoming Amgen v. Sanofi case, is unlikely to result in any expansion of claim scope and that the Court will look favorably on the Federal Circuit's recent decisions requiring the scope of a validly granted claim to be restricted to what has been expressly disclosed.  Such a decision, if it comes to pass, will require patent practitioners' noted cleverness in crafting claims that are sufficient to protect commercial embodiments of inventions having extraordinarily high costs to bring to market.  It also may, in its own way, impede innovation in some inventions as much as the Court's recent subject matter eligibility jurisprudence has.

Conference & CLE Calendar

November 22, 2022 - "What Constitutes A 'Willing Licensee'?" (OxFirst) - 15:00 (GMT)

December 1-2, 2022 - International Summit on Biosimilars and Originator Biologics (American Conference Institute) - Munich Germany,

Webinar on What Constitutes A Willing Licensee

OxFirst Limited will be offering a webinar entitled "What Constitutes A 'Willing Licensee'?" on November 22, 2022 at 15:00 (GMT).  Peter Pereira and Ashley Grant of Kirkland will explore the latest developments in case law in assessing whether a potential licensee is 'willing' in the United Kingdom, Germany, the Netherlands, and the U.S.

While there is no cost to participate in the program, those interested in attending the webinar should register here.

Regeneron Files Amicus Brief in Support of CVC and Reversal in Interference No. 106,115*

By Kevin E. Noonan --

Biotechnology company Regeneron Pharmaceuticals, Inc. filed an amicus curiae brief at the Federal Circuit in support of the appeal by Junior Party the University of California/Berkeley, the University of Vienna, and Emmanuelle Charpentier (collectively, "CVC") of the Patent Trial and Appeal Board's decision to award priority to Broad Institute, Harvard University, and MIT (collectively, "Broad") as Senior Party for claims reciting eukaryotic embodiments of CRISPR-Cas9 (see "PTAB Grants Priority for Eukaryotic CRISPR to Broad in Interference No. 106,115").

Regeneron's argument was based on its assertion that the PTAB had misapplied the law regarding conception; the error, Regeneron asserts, is that the PTAB confused conception with reduction to practice.  The distinction is one well-established in the law, according to the brief, going back to Thomas Jefferson and the beginning of the U.S. patent system, on the principle that "'Invention' thus 'is not the work of the hands, but of the brain,'" citing Edison v. Foote, 1871 C.D. 80, 81 (Comm'r Pat. 1871), and in more recent precedent, Pfaff v. Wells Elecs., Inc., 525 U.S. 55, 60 (1998).  And in the interference context, the brief cites Price v. Symsek, 988 F.2d 1187, 1190 (Fed. Cir. 1993) (citing Lutzker v. Plet, 843 F.2d 1364, 1366 (Fed. Cir. 1988), for the rubric that invention belongs to the first to conceive the invention "even if the inventor was last to reduce the invention to practice."

The PTAB did not follow this precedent, according to the brief, because it "conflated conception—a mental act that the patent system promotes and protects—with actual reduction to practice—a physical step" (emphasis in brief).  And this conflation was based on two "fundamental errors" in Regeneron's view:

• First, the Board improperly required CVC to know that its invention would work for its intended purpose, a burden Regeneron asserts has been rejected by the Federal Circuit in Burroughs Wellcome Co. v. Barr Lab'ys, Inc., 40 F.3d 1223, 1228 (Fed. Cir. 1994) (citing MacMillan v. Moffett, 432 F.2d 1237, 1239 (C.C.P.A. 1970), Applegate v. Scherer, 332 F.2d 571, 573 (C.C.P.A. 1964), and Oka v. Youssefyeh, 849 F.2d 581, 584 n. 1 (Fed. Cir. 1988), relegating any such belief that the invention will work to an inventor's reduction to practice.

• Second, and similarly, the Board erred by ascribing any difficulties encountered by CVC and colleagues in reducing the invention to practice as inapposite to conception, stating that "post‑conception experimental failures cannot undo an earlier conception," citing In re Jolley, 308 F.3d 1317, 1325 (Fed. Cir. 2002).

After setting forth the precedential distinctions between conception and reduction to practice, Regeneron argues that the Board erred in applying even black-letter law, specifically that the "inventor need not know that the invention will work for conception to be complete," Burroughs Wellcome, and then misapplies it ("it did not practice what it preached").  This is by stating as a basis of denying CVC priority to eukaryotic CRISPR that "[t]o have conceived of an embodiment of Count 1," the CVC inventors must "have had a definite and permanent idea of . . . a system they knew would produce the effects on genes in a eukaryotic cell recited in Count 1," which, the brief states bluntly, "is not the law" (even outside the interference context, citing Dana-Farber Cancer Inst., Inc. v. Ono Pharm. Co., 964 F.3d 1365, 1372 (Fed. Cir. 2020), and  Univ. of Pittsburgh v. Hedrick, 573 F.3d 1290, 1298 (Fed. Cir. 2009)).  Indeed, the brief argues that far from knowing that a invention would work for its intended purpose, conception and thus entitlement to priority does not require that an inventor have a reasonable expectation that the invention will work for its intended purpose (emphasis in brief).  Simply put, the brief argues that "the Board got the law of conception wrong."

And the principle that an inventor cannot retroactively conceive an invention under Cooper v. Goldfarb, 154 F.3d 1321, 1331 (Fed. Cir. 1998), is "irrelevant" in this case, Regeneron argues, because the Board improperly required CVC to have knowledge that its eukaryotic CRISPR invention would work.  In doing so, "[a]ll the Board did was mangle an actual rule precluding nunc pro tunc conception into a non‑existent rule requiring knowledge that the invention will work" the brief asserts.  The principle that conception requires "conceiving a way to make an idea operative" under Dawson v. Dawson, 710 F.3d 1347, 1356 (Fed. Cir. 2013), "merely distinguishes 'a specific, settled idea' for 'a particular solution to the problem at hand' (a conception) from 'just a general goal or research plan' that the inventor 'hopes to pursue' (not a conception)."  Here, Regeneron argues, CVC's inventors "easily satisfied" the proper test, based on identifying a particular problem (adapting CRISPR for eukaryotic cells) and forming a specific solution (sgRNA).

The Board came to its erroneous conclusion despite accepting CVC's evidence of conception (laboratory notebooks, invention disclosure forms) and that "'only routine materials and techniques, as described by the CVC inventors, were required for' their invention to become operative."  Nevertheless, the Board's conclusion that CVC's inventors were uncertain about the operability of their conception "trumped that evidence and fatally undermined their conception" was the Board's error, Regeneron argued, based on precedent and in particular In re Jolley (where "tentative and uncertain" notebooks were not enough to negate conception).

The Board's second mistake in Regeneron's view was to let evidence of experimental failures negate conception, which conflates the requirements of both concepts.  Post-conception testing is the essence of reduction to practice, insofar as it is how an inventor establishes that the conceived invention works as intended.  While this can be established merely by constructing simple inventions (Scott v. Finney, 34 F.3d 1058, 1061 (Fed. Cir. 1994)), "[t]esting sufficient to show a reduction to practice has often been at issue in interference proceedings," citing Newkirk v. Lulejian, 825 F.2d 1581, 1582 (Fed. Cir. 1987)).  But these considerations are separate from conception, according to the brief, citing Burroughs Wellcome, and "[j]ust because 'subsequent experimentation shows that an invention that was only conceived does not work, that fact does not vitiate the earlier conception.  A conception not later reduced to practice may have little significance, but it is important that we not confuse concepts.  The conception was still a conception.'" Relying on John Gladstone Mills III et al., Patent Law Fundamentals § 2:4 (2d ed.), Regeneron argues that:

[T]he test for conception requires only that the inventor's idea for solving a particular problem encompassed the claimed invention.  That the inventor had trouble reducing the invention to practice says nothing about what idea the inventor had in mind before attempting to reduce it to practice.

These principles are supported by numerous examples and precedent cited in the brief, all of which Regeneron asserts the Board ignored (or was persuaded to discount).  The language from Burroughs Wellcome that the Board did rely upon:

A conception is not complete if the subsequent course of experimentation, especially experimental failures, reveals uncertainty that so undermines the specificity of the inventor's idea that it is not yet a definite and permanent reflection of the complete invention as it will be used in practice

was "cherrypicked" according to the brief and was applicable only to "the so-called doctrine of simultaneous conception and reduction to practice" which was not applied by the Board (although Broad had referenced the concept earlier in the proceedings; see "Broad Files Priority Motion in CRISPR Interference"*).  The significance of this distinction is that in simultaneous-conception-and-reduction-to-practice situations "reduction to practice in effect provides the only evidence to corroborate conception of the invention," citing Amgen, Inc. v. Chugai Pharm. Co., 927 F.2d 1200, 1206 (Fed. Cir. 1991), and here the Board properly did not invoke the doctrine (albeit applying the principle in finding against CVC's priority of invention).  And although courts (including the Burroughs Wellcome court) have held that reduction to practice can corroborate conception, the brief argues that this application is not universal, citing Judge Lourie's concurring-in-part and dissenting-in-part opinion in Burroughs Wellcome for the concept that corroboration of conception need occur at the alleged conception date.  The Board for its part in this case had "made reduction to practice a necessary element of conception" which was its "fundamental error" that Regeneron urges the Federal Circuit to correct.

*On November 2nd, the Federal Circuit granted Broad's motion to extend the time for filing its principal brief as cross appellant and responsive brief as appellee to February 7, 2023.

Oral Arguments Scheduled in CRISPR Interferences

By Kevin E. Noonan --

On October 24th, the Patent Trial and Appeal Board scheduled back-to-back oral hearings for interferences between Sigma-Aldrich (Senior Party) and Junior Party The Regents of the University of California, University of Vienna, and Emmanuelle Charpentier (collectively, "CVC"; Interference No. 106,132; Order) and Junior Party The Broad Institute, Massachusetts Institute of Technology, and The President and Fellows of Harvard College (collectively, "Broad"; Interference No. 106,133; Order).  In the '132 Interference, the hearing will commence at 1:00 pm EDT on November 17th, and for the '133 interference, the hearing will start at 3:00 pm EDT that day.  The hearings will be conducted by telephone.

Interested members of the public may be granted access by request sent to PTABHearings@uspto.gov prior to the hearing date.

The issues to be discussed can be found on the PTAB website and in several prior Patent Docs posts.

Conference & CLE Calendar

November 15, 2022 - "The End of U.S. Government Guidance on FRAND?" (Intellectual Property Owners Association) - 11:00 am to 12:00 pm (ET)

November 15, 2022 - "Examiner Interviews -- Dos and Don'ts" (National Association of Patent Practitioners) - 12:00 pm to 1:00 pm (ET)

November 15-16, 2022 - Summit on Life Sciences IP Due Diligence (American Conference Institute) - Boston, MA

November 16, 2022 - "PTAB Pendulum Swings the Other Way: Practice Updates, A Year in Review" (McDonnell Boehnen Hulbert & Berghoff LLP) - 10:00 am to 11:15 am (CT)

November 17, 2022 - "Opting out of the Jurisdiction of the Unified Patent Court - Why, When and How?" (J A Kemp) - 16:00 pm to 17:00 pm (GMT)

November 17, 2022 - "Future-Proofing IP Workflows in the Face of Economic Headwinds" (IPWatchdog and IP.com) - 12:00 pm (ET)

November 18, 2022 - Innovator Diversity Pilots Conference (U.S. Patent and Trademark Office and High Tech Law Institute (HTLI) of the Santa Clara University School of Law) - 9:00 am to 5:00 pm (PT), Santa Clara University School of Law, Santa Clara, CA

December 1-2, 2022 - International Summit on Biosimilars and Originator Biologics (American Conference Institute) - Munich Germany,