In the Kenny Rogers song, “The Gambler,” Rogers sings “You got to know when to hold ‘em, know when to fold ‘em.” There is still time for Myriad to “fold ‘em” and drop its appeal of the district court decision ruling that the main claims of a group of “BRCA2 patents” are not patent-eligible under s. 101. Remember, this is not AMP’s appeal any more. The Supreme Court vacated the Fed. Cir. decision that held while the claims to isolated DNA sequences and to the use of transgenic BRCA2 cells for drug screening were patentable subject matter, the “diagnostic method claims” to comparing a patient’s BRCA2 sequence to a reference sequence or to analyzing the sequences for differences were simply abstract ideas, and not patent-eligible a la Bilski. The Court remanded the suit to the Fed. Cir. for reconsideration in view of Mayo v. Prometheus, which has nothing to do with composition of matter claims or with Chakrabarty-type “use” claims.
However, Myriad’s legal team seems to want a “win” at any cost, and oral argument is set for Friday. Other commentators including Prof. Hal Wegner, have argued that the “cost” to the ability to advance “personalized medicine” may be high indeed. In ruling all of the “diagnostic claims” patent-ineligible, the Fed. Cir. only spent about five pages of the more than a 100 page opinion discussing these claims. Most of Myriad’s arguments were an attempt to convince the court that, because one of the DNA sequences was necessarily obtained by sampling patient tissue and sequencing its DNA, that the claims met the M or T test. Judge Lourie dismissed this argument summarily and focused on the claims that only recited “analyzing” or “comparing” the sequences for differences. He mentioned that practical application of the analyzing or comparing steps might describe patentable subject matter, he lost the thread, and did not explain why at least some of the method claims did not meet this standard.
But claim 2 of Patent No. 6,035,857 directed to a method of diagnosing cancer by comparing the patient’s sequence with a reference sequence and recites that sequence alterations are predictive of cancer. This is close to the claim to diagnosing cobalamin deficiency disparaged by Justice Breyer in the Metabolite dissent, and stated to be patentable in dicta by the Fed. Cir. in at least one of its Prometheus opinions. While the district court found all the “diagnosis claims” to be patent-ineligible, failing the M or T test, this “rule” is no longer controlling, and the Fed. Cir. should revisit at least the claim that specifically recites a diagnosing step.
However, this is not the case where this will happen. The parties and amici have not argued that the “cancer diagnosis claim” is not an abstract idea, but instead have put all their briefing energy into arguing that the isolated DNA claims and the screening claim are patent-eligible. Of course they are, but who really cares? The district court was clearly wrong when it labeled the DNA claims as directed to natural products and that the screening claim is a natural phenomenon, and the Fed. Cir. will get this. But claims to intact, isolated DNA sequences are of little value in today’s genomic research, (see, C. Holman, IP Theory, 2, 1 (2011)), and the screening claim cannot be of significant value to anyone. If Myriad “wins” this appeal without a chance of a reversal of the earlier holding invalidating the diagnostic claim(s), the IP/biotech community will be stuck with a precedential ruling, essentially affirming the Metabolite dissent, that can only be overruled en banc. If Myriad drops this unnecessary appeal, the battle can be fought another day, and the PTO will also not be forced to finalize examiner guidelines saying that correlating biomarkers—like PSA– to pathologies or to predispositions to disease are no longer patentable subject matter. Myriad, please fold ‘em and walk away!
See my other Myriad posts: