The Mayo-Alice Dogma and Paths to Eligibility for BioPharma Presentation for Massachusetts Association of Technology Transfer Offices April 25, 2018 Bruce D. Sunstein Sunstein Kann Murphy & Timbers LLP © 2018 Sunstein Kann Murphy & Timbers LLP

The Mayo-Alice Dogma: Mayo Collaborative Servs. v. Prometheus Labs The Mayo-Alice Dogma: Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66 (2012); Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 134 S.Ct. 2347 (2014) Patent protection should not extend to claims that monopolize the “building blocks of human ingenuity” “Therefore” claims directed to laws of nature, natural phenomena, and abstract ideas are not patent eligible [Critique: claims in issued patents are drawn to practical applications, not to these concepts]

The Two-Step Mayo-Alice Rule 1:“First, we determine whether the claims at issue are directed to” a patent-ineligible concept. 2: If so, in a search for an “inventive concept”, “we consider the elements of each claim both individually and ‘as an ordered combination’ to determine whether the additional elements ‘transform the nature of the claim’ into a patent-eligible application.” [Critique: this procedure is hopelessly subjective.]

A Federal Circuit Win at Step 1: Rapid Litigation Management Ltd. v A Federal Circuit Win at Step 1: Rapid Litigation Management Ltd. v. CellzDirect, Inc., 827 F.3d 1042 (2016) Method of providing hepatocytes having greater viability after freezing is patent eligible and not directed to a natural law Claims are not directed simply to the ability of hepatocytes to survive multiple freeze-thaw cycles. Rather, directed to “a new and useful technique for preserving hepatocytes.” Representative claim: 1. A method of producing a desired preparation of multi-cryopreserved hepatocytes, said hepatocytes being capable of being frozen and thawed at least two times, and in which greater than 70% of the hepatocytes of said preparation are viable after the final thaw, said method comprising: (A) subjecting hepatocytes that have been frozen and thawed to density gradient fractionation to separate viable hepatocytes from nonviable hepatocytes, (B) recovering the separated viable hepatocytes, and (C) cryopreserving the recovered viable hepatocytes to thereby form said desired preparation of hepatocytes without requiring a density gradient step after thawing the hepatocytes for the second time, wherein the hepatocytes are not plated between the first and second cryopreservations, and wherein greater than 70% of the hepatocytes of said preparation are viable after the final thaw.

CellzDirect analysis: “The inventors certainly discovered the cells' ability to survive multiple freeze-thaw cycles, but that is not where they stopped” “They employed their natural discovery to create a new and improved way of preserving hepatocyte cells for later use” Comment: their claims are directed to a method of producing a desired preparation of multi-cryopreserved hepatocytes

Mayo on Patent Claiming Those cases warn us against interpreting patent statutes in ways that make patent eligibility “depend simply on the draftsman's art” without reference to the “principles underlying the prohibition against patents for [natural laws].”

Post-Mayo, the Draftsman’s Art May Make a Difference in Step 1: Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371 (Fed. Cir. 2015) The invention: “we have demonstrated the feasibility of performing non-invasive foetal RhD genotyping from maternal plasma. … These observations indicate that maternal plasma/serum DNA may be a useful source of material for the non-invasive prenatal diagnosis of certain genetic disorders”

The claim deemed ineligible in Ariosa v. Sequenom 1. A method for detecting a paternally inherited nucleic acid of fetal origin performed on a maternal serum or plasma sample from a pregnant female, which method comprises amplifying a paternally inherited nucleic acid from the serum or plasma sample and detecting the presence of a paternally inherited nucleic acid of fetal origin in the sample.

What is claimed in Ariosa v. Sequenom As we noted above, the claimed method begins and ends with a naturally occurring phenomenon. Sequenom argues that “before the ′540 patent, no one was using the plasma or serum of pregnant mothers to amplify and detect paternally-inherited cffDNA.” … This argument implies that the inventive concept lies in the discovery of cffDNA in plasma or serum. Even if so, this is not the invention claimed by the ′540 patent.

What if this were claimed in Ariosa v. Sequenom? 1. A non-invasive method of performing prenatal diagnosis of a genetic trait in a fetus, the method comprising: obtaining a sample derived from blood of a female pregnant with the fetus; and using amplification to detect the presence of a paternally inherited nucleic acid of fetal origin in the sample.

What is the difference? Unlike the litigated claim, the suggested claim excludes from the preamble the novel aspect of the invention, and instead saves this material for the body of the claim

The draftsman’s art makes a difference: Vanda Pharmaceuticals Inc. v The draftsman’s art makes a difference: Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals Int’l Ltd., Fed. Cir. 4/13/18 Method of treatment held patent eligible in Mayo-Alice step 1, because claims require specific steps of determining the patient’s metabolizer CYP2D6 genotype and administering specific dosage ranges of the drug depending on the genotype Dissent (Prost, Chief Judge): because the language of the claim in Mayo did not make a difference to eligibility, it should not make a difference here

Fed. Cir. software cases may show how to win in step 2: Berkheimer v Fed. Cir. software cases may show how to win in step 2: Berkheimer v. HP Inc., 881 F.3d 1360 (2018) “At step two, we consider the elements of each claim both individually and as an ordered combination to determine whether the additional elements transform the nature of the claim into a patent eligible application… The second step of the Alice test is satisfied when the claim limitations involve more than performance of ‘well-understood, routine, [and] conventional activities previously known to the industry.’”

Berkheimer v. HP (cont’d) “[t]he question of whether a claim element or combination of elements is well-understood, routine and conventional to a skilled artisan in the relevant field is a question of fact. Any fact, such as this one, that is pertinent to the invalidity conclusion must be proven [at trial in an infringement case] by clear and convincing evidence.”

BioPharma Prosecution Strategy for Mayo Part 2 Include, in prosecution, a declaration establishing that the claimed subject matter is not routine, conventional or well understood. It is usually good to lay a foundation for this point when arguing for novelty and nonobviousness Can alternatively be in the application itself Under Berkheimer, this is evidence for the presence of “significantly more” than the ineligible subject matter. See also Aatrix Software, Inc. v. Green Shades Software, Inc., 882 F.3d 1121, 1128 (Fed. Cir. 2018).

Conclusion Go back to basics. Put the novel subject matter in the body of the claim to win in step 1. To win in step 2, include evidence that the claimed subject matter is not routine, conventional or well understood.

Bruce D. Sunstein bsunstein@sunsteinlaw.com Thank you. Bruce D. Sunstein bsunstein@sunsteinlaw.com