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Genetic Technologies Affirms Ariosa/Myriad With Introduction By Sequenom Petition for Cert.

On April 1st, Lilly filed an amicus brief in favor of Sequenom’s petition for cert. seeking to reverse Ariosa, that caused a lot of buzz in the IP community. (A copy is available at the end of this post.) To summarize, it argued that the courts’ attempts to interpret and define the judicial exceptions to s. 101 patent-eligibility was leading them to an unwarranted expansion of these policy-driven exceptions that threaten concrete technological advances that would otherwise be eligible for patent protection under the patent statute. In other words, the brief argued that the proper application the strictures of ss. 102 (requirement for physicality), 103 (inventiveness), 112(a)(WDR) and (f)(means plus function claiming) are sufficiently developed so that the court should abrogate the judicial exceptions that presently exclude what I will refer to as PAIN (phenomena of nature, abstract ideas and natural laws). (I checked that definition of “abrogate” and it does mean “do away with or to abolish by formal of official means.”)

I have written numerous posts in the last six years about the rise in importance of the written description requirement, as well as the evolution of s. 103 and I am willing to accept Lilly’s arguments. For example, the s. 102 requirement for novelty is sufficient to guard against issuance of patents on natural phenomena like fire, since fire is in the prior art. Pure concepts like blocking the NF-kB signaling  pathway to treat a condition ameliorated by blocking the NF-kB pathway would fail the written description requirement. Mental steps are permissible in a claim, but the claim cannot be entirely mental steps or disembodied functional language (See 112(f)). (This brief is worth reading just for its discussion of the mental steps doctrine at pages 18-21.)

Will the Supreme Court, “led” by Justice Breyer, or the Fed. Cir., “led” by Judge Dyk buy into this “modest proposal” when s. 101 adherence as a question of law can be used to invalidate a claim at the pleadings stage, without even a Markman hearing in most cases? As Church Lady used to say in SNL skits, “How convenient!”

Well I have spent more time than I intended on the Lilly amicus brief, and its attractive logic was eclipsed on April 8th when a Fed. Cir. panel (Dyk, Taranto and Proust, Dyk writing)(Appeal no. 1215-1202, -1203) affirmed the invalidity of certain of the claims of US Pat. No. 5,612,170 in Genetic Technol. Ltd. v. Meriel, LLC. (A copy is available at the end of this post.) Only claim 1 was discussed in detail:

1.  A method for detection of at least one coding region allele of a multi-allelic genetic locus comprising;

a) amplifying genomic DNA with a primer pair that spans a non-coding region sequence [an intron], said primer pair defining a DNA sequence which is in genetic linkage with said genetic locus and contains sufficient number of non-coding region sequence nucleotides to produce an amplified DNA sequence characteristic of said allele; and

b) analyzing the amplified DNA sequence to detect the allele.

As defined in the opinion, “the patent claims focuses on a newly discovered fact about human biology (the linkage of coding and non-coding region of DNA), involves no creation or alteration of DNA sequences and does not purport to identify novel detection methods.” Slip. op. at 11. (Claim 9, also invalidated though not argued, [why not?] added the phrase to step (b), “to determine the presence of a genetic variation in said amplified DNA sequence to detect the allele. Claim 15 –also invalid – reads “The method of claim 9 wherein said allele is associated with a monogenic disease [like cystic fibrosis].  So here is the utility of  the invention –  an improved method to detect gene mutations to diagnose genetic “diseases.”

I wrote earlier that in Ariosa, claim 21, and in Myriad, at least one of the BRCA1 comparison claims that recited a diagnostic conclusion were not mentioned when the other claims on appeal were analyzed and invalidated by the Fed. Cir.  Judge Dyk (“the panel”) attempts to tie these decisions to the Mayo/Alice rule with duct tape and bailing wire. Remember if the claims are “directed to [PAIN, see above]”  the court must conduct a search for an inventive concept…that is sufficient to ensure that the patent in practice amounts to significantly more than a patent upon the ineligible concept itself.” Slip op. at 8, quoting Alice.

To begin with, the Alice S. Ct. opinion uses the term “directed to” PAIN when more a more appropriate term would be “recites” or even “contains” PAIN. If the claim is facially directed to PAIN it is patent-ineligible under s. 101 period, e.g., “1. Non-coding sequences representative of the linked coding sequences” or “2. Maternal serum containing cffDNA” or “3. The BRCA1 gene.”

Nonetheless, the panel has no trouble with step 1 of the Mayo/Alice test; Claim 1 “is directed to…a law of nature. Claim 1 broadly covers essentially all applications, via standard experimental techniques, of the law of linkage disequilibrium to the problem of detecting coding sequences of DNA.” [But, again, query: why weren’t the claims that recited mutations associated with specific “diseases” argued separately?]

Plaintiff argued that the recitation in claim 1 that the users should ‘’analyz[e] the amplified DNA sequence to detect the [coding region] allele” and that the discovery that this could be done “provides sufficient inventive concept to pass step two of the Mayo/Alice test.” No luck, as the panel characterized the term “to detect an allele in the coding region” as a mental process step, one that provides claim 1 with a purpose but does not create the requisite inventive concept, because it merely sets forth a routine comparison that can be performed by the human mind.”

The panel relies on Cybersource as supporting the unpatentability of methods which can be performed entirely in the human mind. But this is not such a method. The panel also characterizes  Mayo as containing diagnostic and therapeutic method claims as containing a “simple” mental process step with other conventional steps like administering the drug or measuring its metabolites. The panel then dismisses the phrase “to detect the allele” as simply informing the “relevant audience…to apply a law of nature for a purpose.” But this  is the foundation of all diagnostic and therapeutic method steps, isn’t it?

The panel again discusses Ariosa with approval, although claim 21, that recited as the final step “performing a prenatal diagnosis,” was never analyzed in that opinion. Remarkably, the panel characterizes “performing a prenatal diagnosis” as a mental process step tacked on to the routine and conventional steps of amplifying and detecting cffDNA in maternal serum. To add insult to injury, the panel then goes on to characterize claim 8 –reciting the comparison of BRCA1 sequences – without a diagnostic conclusion step—as an abstract idea as well. Perhaps simply comparing two DNA sequences to see if there are mutations is an abstract idea – Judges Lourie and Moore said so—but is arriving at a diagnostic conclusion based upon the differences that are identified entitled to no weight as an inventive concept?

I have been arguing for since March 2014 (PTO 101 Guidance Day) that, while an in vivo correlation should not be per se patent-eligible (e.g., blood containing a “high” homocysteine concentration and a “low” cobalamin deficiency), the discovery that a diagnostic conclusion can be drawn from the correlation (e.g., A method of detecting cobalamin deficiency by measuring blood homocysteine levels, wherein an elevated homocysteine level indicates a cobalamin deficiency) should be sufficient to render the practical application of the correlation a patent-eligible diagnostic method. I think it is very important to realize that at least justice Breyer as well as Judge Dyk and as many as five of his colleagues disagree. At page 12 of the opinion, the panel tries to define the “inventive concept” of step two of the Mayo/Alice test:

“The inventive concept necessary at step two…cannot be furnished by the unpatentable law of nature (or natural phenomenon or abstract idea) itself. That is, under the Mayo/Alice framework, a claim directed to a newly discovered [PAIN]  cannot rely on the novelty of that discovery for the inventive concept necessary for patent eligibility; instead the application must provide something inventive, beyond mere “well understood, routine conventional activity. [citing Mayo, Myriad and Ariosa].”Slip op. at 12.

So there you/we have it. It this is indeed the law, any claim reciting a PAIN will have to contain two inventive features – the discovery of the applicability of the natural correlation to a diagnostic conclusion or therapeutic outcome plus something else “inventive”. The sky has fallen, and the appropriate question to present to the Fed. Cir. for en banc consideration, or to the Supreme Court is written out for us at page 12 of the opinion. I admit, at first I saw the Lilly amicus brief as an cleverly written work-around to the Mayo/Alice test – now I hope it outlines the future of s. 101 jurisprudence in the United States.



© 2021 Schwegman, Lundberg & Woessner, P.A. All Rights Reserved.National Law Review, Volume VI, Number 102

About this Author

Warren Woessner, Registered Patent Attorney, Schwegman Lundberg Law firm

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...