Myriad Revisited – The Consequences of Prometheus Unbound

In my last post on Prometheus, I concluded: It is hard to think of a diagnostic assay claim that does not either detect the +/- presence of a marker (like anti-HIV antibodies) or involve the comparison of the level of a marker of some sort (like homocystine or PSA) with a benchmark level (which could be normal or pathological)…all of these assays seem to have been converted into no more that the discovery of laws of nature” with unpatentable pre-solution and post-“processing” steps. I wrote that the key phrase in the decision may be that the steps were “specified at a [too] high level of generality.”

But how much generality is too much generality? Justice Breyer teases patent attorneys like Gypsy Rose Lee at her best – offering a glimpse of a rule, then whisking it away from an ever more agitated audience. For example, at page 18 of the slip op. he writes:

“We need not, and do not, now decide whether were the steps at issue here less conventional, these features [the administration, assay and indication steps] of the claims would prove sufficient to invalidate them. For here, as we have said, the steps add nothing of significance to the natural laws themselves.”

The reader of this opinion keeps waiting for Justice Breyer to give us some  hint of the degree of unconventionality or amount of significance that would suffice in the context of a diagnostic test “to transform an unpatentable law of nature into a patent-eligible application of such a law”, but none is forthcoming. Instead, there is a lengthy discussion of a UK decision – Neilson v. Haford – that involved an improved method of blowing air into a furnace by using a pre-heated receptacle chamber for the air. Breyer writes: ‘thus, the claimed process included not only a law of nature but also several unconventional steps (such as inserting the receptacle, applying heat to the receptacle externally, and blowing the air into the furnace that confined the claims to a particular, useful application of the principle.” Slip. op. at 14-15.

But what are sufficient unconventional steps in a claim to a diagnostic method? I looked at some of the claims in the Myriad patents that were not in suit for clues, but they are hard to find. This is because steps carried out in locating genetic mutations involve techniques that are well-known to molecular biologists. The method claims lost in Myriad included claim 1 of US Pat. Nos. 5753441, 6033857 and 5710001.  They all involved screening a subject’s BRCA gene sequence against a wild-type BRCA sequence to identify “differences”. The sequences were obtained from tissue or tumor samples in the ‘441 and ‘001 patents but this did not save them from being held attempts to claim “abstract ideas”.

One unchallenged claim reciting forming a heteroduplex between the two BRCA1 gene fragments and analyzing the heteroduplex to see if the patient’s DNA has a mismatch, and then sequencing the patient’s DNA sample if there is a mismatch. (Claim 11 of ‘441). Unchallenged claim 4 of the ‘857 patent listing twelve known assay techniques to detect the alteration in the germline BRCA2 gene sequence. All very concrete and transformative steps, but hardly unconventional. Remember, Justice Breyer specifically criticized the manipulative and indicating/thinking steps in the claim as adding “noting specific to the laws of nature other than what is well-understood, routine, conventional activity, previously engaged in by those in the field.” Slip op. at 13.

Claim 30 of the ‘441 patent recites detecting alterations “consisting  of a deletion of 11 nucleotides corresponding to base numbers 189-199 in SEQ ID NO: 1.” This might allay Justice Breyer’s fear of an overreaching diagnostic claim but don’t bet on it. “And, as we have previously pointed out, even a narrow law of nature (such as the one before us) can inhibit future research,” writes the Justice at page 20.

The thinnest ray of sunshine illuminates this black hole of IP despair. At page 18, Justice Breyer writes, “Unlike, say, a typical patent on a new drug or a new way to use an existing drug, the patent claims [here] do not confine their reach to particular applications of those [natural] laws.” So composition and new uses of “old compounds” are still patent eligible, right? But what happened to methods of medical treatment generally?  They come in for implicit, if not explicit criticism at page 23 where Justice Breyer quotes from amicus brief that argues that “claims to exclusive rights over the body’s natural responses to illness and medical treatment” will inhibit “sound medical care” and from another brief that observes that “methods of medical treatment are not patentable in most of Western Europe” [note: This is simply not the whole truth when you can obtain “first” and “second medical use” claims”.

I can think of a few classes of diagnostic method claims that would survive this degree of auto de fe, but will save them for a future post. And I can’t wait to read the PTO’s commentary and instructions to Examiners on this decision. Talk about a need for a “drafting effort”!

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