Mayo – The Bell Tolled or, It’s the End of the World as We Know It (And I Feel Fine) May 3, 2012 AIPLA Biotechnology Committee Webinar James J. Kelley Senior Director – Assistant General Patent Counsel Eli Lilly and Company Indianapolis, Indiana The contents of this presentation represent the views of the author and do not represent the policies, viewpoints, or business of Lilly or its management.

A method of optimizing therapeutic efficacy for treatment of [condition X]…, comprising: – (a) administering a [particular] drug … to a subject; and – (b) determining the level of [biomarker] in said subject, – wherein the level of [biomarker] less than about 230 … indicates a need to increase the [dose] and – wherein the level of [biomarker] greater than about 400 … indicates a need to decrease the [dose]. Mayo v. Prometheus Conventional

Flook v. Diehr “The claim before us presents a case for patentability that is weaker than the (patent- eligible) claim in Diehr and no stronger than the (unpatentable) claim in Flook.” Mayo, slip op. at 13.

Flook 1. A method for updating the value of at least one alarm limit on at least one process variable involved in a process comprising the catalytic chemical conversion of hydrocarbons wherein said alarm limit has a current value of Bo+K wherein Bo is the current alarm base and K is a predetermined alarm offset which comprises: (1) Determining the present value of said process variable, said present value being defined as PVL; (2) Determining a new alarm base B1, using the following equation: B1=Bo(1-F)+PVL(F) where F is a predetermined number greater than zero and less than 1.0; (3) Determining an updated alarm limit which is defined as B1+GK; and thereafter (4) Adjusting said alarm limit to said updated alarm limit value. “… the formula is the only novel feature of respondent's method. The question is whether the discovery of this feature makes an otherwise conventional method eligible for patent protection.” Flook, 437 U.S. at 588. Conventional

Diehr 1. A method of operating a rubber-molding press for precision molded compounds with the aid of a digital computer, comprising: a)providing said computer with a data base for said press …, b)initiating an interval timer …, c)constantly determining the temperature (Z) of the mold at a location closely adjacent to the mold cavity in the press during molding, d)constantly providing the computer with the temperature (Z), e)repetitively calculating in the computer, at frequent intervals during each cure, the Arrhenius equation for reaction time during the cure, which is ln v = CZ+x, where v is the total required cure time, f)repetitively comparing in the computer at said frequent intervals during the cure each said calculation of the total required cure time calculated with the Arrhenius equation and said elapsed time, and g)opening the press automatically when a said comparison indicates equivalence. 450 U.S. 175, 181, footnote 5. Conventional “Contribution”

Flook v. Diehr v. Mayo Flook (1) (2) (3) Equation (4) Diehr a) b) c) d) e) Equation f) g) Mayo (1) (2) (3) Law of Nature Not Eligible Eligible

Claim Types Diagnostic correlations Biomarkers – Genes, alleles, polymorphisms, proteins – Metabolites – Single biomarkers – Multiple biomarkers General technology “platforms” – machines Kits Reagents – antibodies (for proteins) – probes (for genes) – chemicals Diagnostics in the guise of treatments? MayoMyriad?

E=mc 2 Linear Accelerator Control Room Linear Accelerator OK Al. Niels – My law relates mass and energy. I trust you to use it where relevant. If only I could get a patent claim that recites my law and says “apply the law.” That would be Diehr! No, that would be a Flook. I am now in a Funk. So are a Myriad of patent attorneys. With what does this Natural Phenomenon correlate? Mayo.