The Fat Lady Sings

J.D. Salinger said “It’s not over until the fat lady sings.” He was referring to long dramatic operas which conclude with an aria sung by an [often zoftig] female soprano. Association for Molecular Pathology v Myriad Genetics has been a long dramatic opera.

The Supreme Court of the United States (SCOTUS) issued its long awaited decision in that case last week and now it is over.

The Court explicitly stated that it paid no deference to USPTO policy and then demonstrated that fact. In the popular press some headline read "Supreme court upholds gene patents" and others said “Supreme court says no to gene patents.

The gist of it is that the ACLU has pretty much succeeded in obliterating gene patents based on a DNA sequence.

The SCOTUS decision shows that the lady of Justice is truly blind.  She has upset the apple-cart of biotechnology patents. The apple remaining in the cart (cDNA claims) is bruised by remarks made in the opinion: “In that situation, [where no introns are present] a short strand of cDNA may be indistinguishable from natural DNA.[and therefore ineligible under §101]”

In a chilling footnote, the Court indicated: “We express no opinion whether cDNA satisfies the other statutory requirements of patentability. See, e.g., 35 U.S.C. §§102, 103 and 112; Brief for United States as Amicus Curiae 19, n. 5.”  The increasingly widespread availability of "whole genome sequencing" is likely to make those sections of the law relevant to any discussion of future patent claims that recite oligo-nucleotide sequences as a feature.

This decision ends the prolonged opera which began in Federal district court in New York, went to the Court of Appeals of the Federal Circuit (CAFC), was appealed to SCOTUS, remanded to the CAFC for further consideration and returned to SCOTUS.

In retrospect, it seems that the climactic aria was actually sung in the earlier CAFC decision on remand:
"We also reverse the district court’s decision that Myriad’s method claim to screening potential cancer therapeutics via changes in cell growth rates of transformed cells is directed to a patent-ineligible scientific principle. We affirm the court’s decision, however, that Myriad’s method claims directed to “comparing” or “analyzing” DNA sequences are patent ineligible; such claims include no transformative steps and cover only patent-ineligible abstract, mental steps. "

These two types of method claims were not re-addressed by SCOTUS, although the outcome would likely have been the same since the CAFC clearly followed the Mayo v Prometheus decision which caused SCOTUS to remand the case to them.

The CAFC decision on remand, practically dictated by SCOTUS, effectively rendered patent claims to medical diagnostic methods which rely upon comparison of two sequences to analyze mutations invalid as being directed to non-statutory subject matter under §101.   

Until last week’s SCOTUS decision, practice of those medical diagnostic methods which rely upon comparison of two sequences might have infringed patent claims directed towards “An isolated nucleotide sequence comprising…” . The fat lady’s closing aria makes it clear that even this possibility has vanished.

It is of interest to note that the USPTO was originally opposed to biotechnology patents. In the landmark  Diamond V Chakrabarty case, it was the Commissioner of Patents and Trademarks that appealed all the way to SCOTUS. The Chakrabarty case centered around US 4,259,444 (granted March 31, 1981) and involved genetically modified bacteria capable of digesting hydrocarbons (e.g. petroleum products) but did not claim any “isolated nucleic acid/oligonuclueotide sequence” per se.  A quick search of the USPTO database suggests that “an isolated nucleic acid sequence” was first claimed in US 4713332 (granted December 15, 1987). 

In terms of the judicial history of this type of phrasing in US patent claims, the first case seems to be Amgen, Inc v. Chugai Pharm. Co. Ltd., 13 U.S.P.Q. 2d 1737 (D. Mass. 1989), aff'd in part, rev'd in part, vacated in part, 927 F.2d 1200 (Fed. Cir. 1990).

Interestingly, SCOTUS denied certiorari  in this case  (502 U.S. 856 (1991)) which gave rise to the long opera culminating in last week’s final aria over 20 years later. It is the fact that we were putting apples in the cart for 20 years that makes us so upset that it has been overturned.