A “Myriad” Of Questions To Resolve? Back To The Basics Of 101

Thinking about Judge Sweet’s recent decision in Ass’n of Molecular Pathologists v. USPTO et al. (The “Myriad Decision”), I am again struck by the wide path the good judge slashed through the field (or is it the jungle now) of patentable subject matter – that is, the type of “invention” that an inventor can apply to patent. Too many of my colleagues, I fear, are simply saying something like “Of course DNA is patentable,” and let’s move on. But I think that the numerous amici planning on weighing in on this decision had better be ready to split some legal hairs. Oh, and we do need a Bilski decision that does away with the M or T test, and here is why.

A claim to an isolated DNA coding for a BRCA1 peptide of SEQ ID NO: X is patentable subject matter as a new and useful composition of matter, and that’s that (note that the statute says “new” – probably to prevent filings on natural products “plucked from nature”—it is not a reference to 102 novelty). We can debate what is and is not a natural product, but the isolated DNA sequences claimed by Myriad are as every bit as much new and useful compositions of matter as the biologically pure cultures of microorganisms claimed In re Bergy, 596 F.2d. 592 (CCPA 1979). In Bergy, the PTO tried to duck the examiner’s “product of nature” rejection but the CCPA specifically ruled on it as a question of law. Of course the CCPA found that the microorganisms were patentable subject matter. (The Court also decided that the transformed microorganisms claimed by Chakrabarty were patentable subject matter. When the decisions were appealed to the Supreme Court, Bergy was noted as moot, leaving Chakrabarty as the only appeal to be heard, and we all know how that came out.)

In re Bergy is remarkably well-written and researched, which is probably why it only got a footnote or so in the Myriad decision. The CCPA assumes that isolated chemical compounds are patentable subject matter and analogizes at length between such lifeless compositions and living chemical factories like microorganisms:

“What we deal with here in each appeal is an industrial product used in an industrial process in a useful or technological art….The nature and commercial uses of biologically pure cultures of microorganisms like the one defined in Bergy’s claim 5 and the modified microorganisms claimed by Chakrabarty are analogous in practical use to inanimate chemical compositions such as reactants, reagents, and catalysts used in the chemical industry [read “isolated DNA molecules”]. …the law has long and unhesitatingly granted patent protection to new, useful and unobvious chemical compounds and compositions [read “isolated DNA molecules”], in which category are to be found such important products of microbiological process[sic] as vitamin B-12 and adrenalin and countless other pharmaceuticals.”…[clarifying In re Mancy]: We were thinking of something preexisting and merely plucked from the earth and claimed as such, a far cry from a biologically pure culture produced by great labor in a laboratory and so claimed.”

So Myriad can’t lose on the isolated DNA claims, but there are two other “claim sets” to consider. An easy one is the drug-screening claim:

“Claim 20 of the ‘282 patent claims a method for determining the effectiveness of a potential cancer therapeutic comprising growing cells carrying an altered BRAC1 gene known to cause cancer in the presence and absence of a potential cancer therapeutic, comparing the growth rates of the cells, and concluding that a slower growth rate in the presence of the potential therapeutic indicates that it is indeed a cancer therapeutic.”

This is a claim to a use or process employing transformed cells that can change their behavior when exposed to a “cancer therapeutic.” If a claim to a bacterium transformed by the hand of man is patentable subject matter, as both the CCPA and the Supreme Court have ruled that it is, then a method of using it is both per se patentable subject matter and per se patentable. Do we really need to revisit In re Ochiai and In re Plueddemann? In my desk they are in a file labeled “The Death of Durden.”

A different question arises, however, regarding the various “cancer screening” claims. Some of the claims require “analyzing a sequence of a BRAC1 gene…from a human sample” to look for “alterations” (sounds like the claim requires both sampling and sequencing – probably meets M or T test). But other claims are more disembodied:

 “A method for screening a tumor sample from a human subject for a somatic alteration in a BRAC1 gene in said tumor which comprises comparing a first gene sequence selected from the group consisting of a BRCA1 gene from said tumor sample…etc, with a second sequence selected from the group consisting of BRCA1 gene from a nontumor sample of said subject….etc., wherein a difference in the sequence[s] indicates a somatic alteration in the BRAC1 in the tumor sample.”

Will this “comparing and concluding” claim pass the Bilski machine-or-transformation test, should the test survive Supreme Court review? If the Bilski test is upheld, what will be the fate of claims to uses for biomarkers discovered by “data mining”? I will let you reach your own conclusions, but I think I would rather be handling the appeal/rehearing for Prometheus, no matter how Bilski is decided.

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