On October 22d, Myriad, represented by a Jones Day team, weighed in – literally – at the Federal Circuit with a 63 page brief supporting its appeal of Judge Sweet’s decision that claims directed to isolated DNA sequences are unpatentable products of nature and the cancer screening claims fail the machine or transformation test or are unpatentable as abstract ideas. Oddly, Myriad chose to spend 40 pages of their brief arguing that the claims to the isolated BRCA DNA molecules are patentable compositions of matter. They ably argued that “products of nature” should not be categorically unpatentable as “natural phenomena” and, as I have argued at length in previous posts, relied heavily on language from Bergy:  If pure strain microorganisms are patentable when isolated and cultured as useful  compositions of matter (to produce drugs), certainly DNA molecules of defined sequence and manifest utility are patentable compositions of matter. “Indeed, the claimed molecules here are not only purified ; they are chemically extracted (breaking their covalent bonds) and isolated from the native DNA as well, resulting in a new composition that is structurally and functionally different from native DNA” [Brief at page 36]. This is well-put, and in case you have not been following my posts on this saga, I don’t think Myriad can lose on this point.

Myriad also burned a legal “straw man” by arguing that “[t]he district court erroneously divined from Chakrabarty a legal standard requiring a claimed invention to be ‘markedly different’ from a naturally occurring product in order to be patent eligible.” Whether or not the Supreme Court intended to provide a test for when a natural product has been sufficiently changed from its natural state to qualify as a new “composition of matter”(which was not at issue in Chakrabarty), emphasis on this aspect of Judge Sweet’s opinion did not seem necessary in view of the preceding pages of argument relying on cases like Bergstrom, Bergy and Kratz that “these isolated molecules are new chemical compositions, which were unavailable to the public until [the Myriad inventors] discovered and isolated them.” [Brief at page 34].In my opinion, almost any emphasis on the old “purification” decisions is too much, and plays into the legal hands of plaintiffs, who are arguing that the DNA is not “markedly changed’ from its structure or function in its natural state.

The Myriad team even addressed Judge Dyk’s separate opinion in Intervet v. Meriel (2010), discussed in an earlier post, that an argument might be made that leaves might be patentable because they can be isolated in pure form from a tree. Myriad argued that the leaves “might fail under the logic of Funk Brothers, because the plucked leaf would have exactly the same properties as the unplucked leaf—unlike here, where isolated DNA molecules possess significantly different structural and functional characteristics from native DNA. In the words of Chakrabarty, the picked leaves would not be ‘a product of human ingenuity.’”[Brief at page 45].

Was surprised me the most was that the brief spends only 9 pages arguing that the claimed diagnostic methods are patentable subject matter. The Myriad team decided to try to finesse Judge Sweet’s abstract idea rationale by arguing that all of the screening claims meet the machine or transformation test. The heart of the argument is that “[t]he claims involving ‘analyzing’ and ‘comparing’ DNA sequences require extraction and processing of human tissue or blood samples” and are thus as transformative as the “determining” steps in Prometheus v. Mayo.:

“Under a proper claim construction, the claims require a transformation of a human sample, and the transformation of the specific BRCA molecules in that sample…the cells of the tissue sample must be broken open, and a sample of the DNA or RNA extracted. Sequencing is accomplished using a diagnostic probe or primer to hybridize to the target DNA or RNA to initiate a sequencing reaction. Second the DNA or RNA of the tissue sample is transformed when a primer or probe is used to bind to and ‘hybridize’ the DNA or RNA (etc.)”[Brief at page 57].

This is an argument that the recitations in the claimed diagnostic methods that the test subject’s DNA come “from a tissue sample” or is “in a tissue sample”, inherently require that the tissue sample and the DNA be transformed before the comparison with the standard sequence can occur. I have not studied the specification and prosecution histories in detail, to decide for myself if there is any basis to find these limitations in the claims, but claim 1 of the ‘857 patent follows:

“A method for identifying a mutant BRCA2 nucleotide sequence in a suspected mutant BRCA1 allele which comprises comparing the nucleotide sequence of the suspected mutant BRCA1 allele with the wild-type BRCA2 nucleotide sequence, wherein a difference between the suspected mutant and the wild-type sequences identifies a mutant BRCA2 nucleotide sequence.”

I don’t see any sample, sampling or sequencing in this claim. Likewise, claim 2 of the ‘857 patent recites comparing the germline sequence of the BRCA2 gene…in  a tissue sample from said subject” with the wild-type sequence. I think an argument based on clam interpretation is asking a few words to do a lot of heavy lifting of processing steps from the specification into the claims, particularly when what is recited is that the gene sequence simply exist in the tissue sample of the subject. I am not saying that this approach does not have merit. I think I am disappointed that the Myriad team chose to duck rebutting the  argument that such claims are patent-ineligible as “abstract ideas”. If the Federal Circuit chooses not to interpret the claims as involving a physical transformation of DNA, it has little upon which to base a holding that the diagnostic claims are sufficiently concrete to escape the “abstract idea” bar. Just one paragraph:

“While the method claims are transformative, and thus patent-eligible, it bears noting that Bilski removed any suggestion that the rigid “machine-or-transformation” test provides the exclusive test for patent eligibility, particularly as applied to ‘Information Age’ technologies like advanced diagnostic techniques claimed in the Myriad patents. Thus, even apart from the [M or T] test, these methods satisfy 101.: Under the plain statutory language, these methods are ‘new and useful process[es]” …and these extraordinarily useful (indeed lifesaving) methods are not mere ‘concepts,’ or ‘unpatentable abstract idea[s],’ as was the method of hedging ruled ineligible in Bilski, 130 S. Ct. at 3231. They are very real ways of diagnosing and treating cancers…Patents representative of this ‘Information Age’ id., should not be invalidated because they involve the use of information.”

Given that the Bilski claims were invalidated by the Supreme Court as abstract ideas (nearly copying Judge Rader’s dissent), and that Judge Sweet specifically rejected this claim interpretation-based “M or T “ argument and ruled that the diagnostic claims were attempts to patent abstract mental processes, the decision of the Myriad team to focus on the transformative aspects of the claims feels a little like watching your hockey team pull its goalie when the game is tied.

Myriad Brief of Appellant