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Whither Myriad?

My first question (of many) concerning the Fed.Cir.'s August 16th Ass'n for Molecular Pathology v. PTO ("the Myriad decision"1) is whether the Feds went as far as the Supremes wanted them to. The Supremes themselves will answer this question when and if the Supremes grant cert (assuming somebody files a petition of certiorari, which seems inevitable). I think that the Supremes will grant cert (although I wouldn't bet on it, it's just a hunch)—i.e., I'm guessing that the Supremes wanted to go further than the Feds did.

To Be, or not To Be,
Patentable Subject Matter

Myriad concerns what is, and is not, patentable subject matter, or, to put it in the Feds' terminology, what is patent eligible.2

The Supremes vacated the Feds' previous Myriad decision (in which the Feds decided all of the claims at issue were patent eligible) and remanded the case back to the Feds "for further consideration in light of Mayo Collaborative Services v. Prometheus Laboratories, Inc.," 132 S. Ct. 1289 (2012)—a case in which the Supremes used some very broad language to rule that the method claims at issue were not patent eligible.

The 3 different types of claims at issue in the Myriad patents are:

  1. composition claims to isolated DNA molecule(s) (specifically, the BRCA1/2 genes);
  2. method claims for screening cancer drugs using cells whose BRCA1/2 genes have been altered to produce cancer;
  3. method claims for testing human DNA samples to see if the BRCA1/2 genes have been altered.

A competent patent attorney could use the language of the Mayo decision to make reasonable arguments that all 3 types of claims in Myriad are patent ineligible (and some did). However, in the Myriad decision last week, the Feds ruled that only the third type of claim, involving the testing of human DNA samples, was patent ineligible, whereas the other two types remained patent eligible (i.e., for the first two types, the Feds ruled the same as before). In effect, the Feds limited Mayo as much as judicially possible (using Myriad).

The Key is The Screening Claim(s)
(or, Follow the Money)

Although much of the attention and hot air has been and will continue being generated concerning the first type of patent claim ("are humen genes patentable?"3), the key to the breadth of Mayo, as applied in Myriad, is the second type of claim, the screening claims. The Feds have ruled they are still patent eligible under Mayo. If the Supremes grant cert (again), there will be no need to wait for the arguments or for the decision, the screening claims are going down. The claims to the isolated DNA (the first type in Myriad) may be going down as well, but we'll have to wait for the decision to find out about that.

What I find interesting in this particular case, is that if the Supremes overrule the Feds (again), and declare the screening claims patent ineligible, the remaining claims, the claims to the isolated DNA, might become completely irrelevant. For, if Myriad's competitors can (1) create host cells with altered BRCA1/2 genes (altered such that they become cancerous) and then use those host cells to test potential drugs (i.e., the screening claims); and (2) test human samples for altered BRCA1/2 genes (i.e., the testing claims), what economically important conduct can Myriad prevent using the remaining isolated gene claims? In other words, who would be left for Myriad to sue, and for what? My guess is that the real money's in drug screening and diagnostics, and, if the screening claims are taken out (in addition to the already-ineligible testing claims), there may not be much economic value left in Myriad's patents, even with the isolated gene claims left intact.

At this juncture, although garnering the most media and academic attention, the patent claims directed to DNA sequences may be the least important to Myriad's business interests. If I were one of Myriad's attorneys, and the Supremes granted cert, I'd focus most of my attention on arguments why the screening claims are patent eligible, because, tho far less sexy than the DNA sequence arguments, they may be the last stand in terms of my client being able to make any money out of these patents.

tidgenotes

1 - "the Myriad decision" because Myriad owns the patents at issue.

2 - this somewhat awkward "eligibility" terminology is an attempt to separate the §101 (subject matter) issue from issues of "patentability," such as, inter alia, obviousness/anticipation (§§102/103) (see, e.g., Myriad slip op., pp. 37-8: the issue is "not whether the claims at issue are novel or nonobvious or too broad. ... The issue is patent eligibility, not patentability."). It still seems more natural to refer to it as a "patentability" issue, but I don't get to decide.

3 - as stated in Bryson's dissent: "From a common-sense point of view, most observers would answer, “Of course not. Patents are for inventions. A human gene is not an invention.”" (Myriad slip op.)

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