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Anna B. Laakmann, M.D., J.D.
Salishan Patent Law Conference
September 26, 2014
Do Patents Still Make Sense? The Shifting IP Landscape For Medical Diagnostics
“As numerous amicus briefs argue, the machine-or-transformation test would create uncertainty as to the patentability of software, advanced diagnostic medicine techniques, and inventions based on linear programming, data compression, and the manipulation of digital signals…”
Bilski v. Kappos, 130 S. Ct. 3218 (2010)
Revival of § 101 Excep1ons
Held: Method for hedging risk in commodities trading is a patent-‐ineligible abstract idea
Abstract Ideas
Method for monetizing and distributing copyrighted products is patent-‐eligible, because the steps require application to the Internet and likely require intricate and complex computer programming.
Cybersource Corp. v. Retail Decisions, Inc., 654 F.3d 1366 (Fed. Cir. 2011)
Method for detecting fraud in online credit card transactions is patent-‐ineligible, because the claim “is drawn to an unpatentable mental process – a subcategory of unpatentable abstract ideas.”
Ultramercial, Inc. v. Hulu, Inc., 722 F.3d 1335 (Fed. Cir. 2013)
Ø Vacated and remanded in light of Alice v. CLS Bank
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Abstract Ideas
Held: Computer-‐implemented scheme for mitigating settlement risk in Einancial transactions is patent-‐ineligible
Alice Corp. v. CLS Bank International, 134 S. Ct. 2347 (2014)
“The claimed methods do not, for example, purport to improve the functioning of the computer itself…Nor do they effect an improvement in any other technology or technical field.”
Mayo Collaborative Services v. Prometheus Laboratories, Inc., 132 S.Ct. 1239 (2012)
“Prometheus' patents set forth laws of nature—namely, relationships between concentrations of certain metabolites in the blood and the likelihood that a dosage of a thiopurine drug will prove ineffective or cause harm…The relation is a consequence of the ways in which thiopurine compounds are metabolized by the body - entirely natural processes.”
Natural Laws
Abstract Ideas Or Natural Laws?
Ass’n for Molecular Pathology v. USPTO, 689 F.3d 1303 (Fed. Cir. 2012)
“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.” 689 F.3d at 1309.
“The Court [in Mayo] made clear that such diagnostic methods in that case essentially claim natural laws that are not eligible for patent.” 689 F.3d at 1333.
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Recent Cases Involving Diagnos1c Methods
Held: Non-‐invasive method of determining fetal risk of Down’s syndrome, based on measuring a biomarker and/or an ultrasound screening marker at two different times, is patent-‐ineligible
PerkinElmer, Inc. v. Intema Ltd., 496 Fed.Appx 65 (Fed. Cir. 2012) (unpublished)
“The claims thus recite the mental process of comparing data to determine a risk level…Intema also claims a law of nature: the relationship between screening marker levels and the risk of fetal Down’s syndrome.”
Recent Cases Involving Diagnos1c Methods
Ariosa Diagnostics, Inc. v. Sequenom, Inc., 2013 WL 5863022 (N.D. Ca. 2013)
Held: Non-‐invasive prenatal test, using cell-‐free fetal DNA circulating in blood of pregnant women, is patent-‐ineligible
“[T]he claimed processes at issue – apart from the natural phenomenon of paternally inherited cffDNA – involve no more than well-understood, routine, conventional activity.”
Recent Cases Involving Diagnos1c Methods
Smartgene, Inc. v. Advanced Biological Laboratories, 555 Fed.Appx 950 (Fed. Cir. 2014) (unpublished)
Held: Compter-‐implemented method for guiding selection of a medical treatment regime is patent-‐ineligible
“As Cybersource explains, [earlier] precedents rest on Supreme Court decisions that section 101 covers neither ‘mental processes’ – associated with or as part of a category of ‘abstract ideas’ – nor processes that merely invoke a computer and its basic functionality for implementing such mental processes.”
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Recent Cases Involving Diagnos1c Methods
Held: Motion to dismiss denied in patent infringement case involving methods for amplifying and analyzing DNA to detect links between variations in non-‐coding and coding DNA
“Given the alleged availability of alternative methods of genomic analysis, clear and convincing evidence is lacking that the # 179 patent impermissibly ties up the relevant field.”
Genetic Technologies Ltd. v. Agilent Technologies, Inc., 2014 WL 941354 (N.D. Ca. 2014)
The PTO’s Myriad-‐Mayo Guidance
• Does not cover the examina1on of claims reci1ng an abstract idea
• Examiners are to ask the following ques1ons: 1. Is the claimed inven1on directed to one of the four
statutory patent-‐eligible subject maQer categories? 2. Does the claim recite or involve a law of nature,
natural phenomenon, and/or natural product? 3. Does the claim as a whole recite something
significantly different than the judicial excep1on(s)?
The PTO’s Myriad-‐Mayo Guidance
Example F: Claim 1: A method for determining whether a human patient has degenerative disease X, comprising:
obtaining a blood sample from a human patient; determining whether misfolded protein ABC is present in
the blood sample, wherein said determining is performed by contacting the blood sample with antibody XYZ and detecting whether binding occurs between misfolded protein ABC and antibody XYZ using Elow cytometry, wherein antibody XYZ binds to an epitope that is present on misfolded protein ABC but not on normal protein ABC; and diagnosing the patient as having degenerative disease X if misfolded protein ABC was determined to be present in the blood sample.
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The PTO’s Myriad-‐Mayo Guidance
Example H:
Claim 1: A method for identifying a mutant BRCA2 nucleotide sequence in a suspected mutant BRCA2 allele which comprises comparing the nucleotide sequence of the suspected mutant BRCA2 allele with the wild-‐type BRCA2 nucleotide sequence, wherein a difference between the suspected mutant and the wild-‐type sequences identiEies a mutant BRCA2 nucleotide sequence.
A Turn Toward Secrecy?
Heightened Regulatory Scru1ny
On July 31, 2014, the FDA notiEied Congress that it will propose a “risk-‐based, phased-‐in framework for oversight of LDTs in a manner that is consistent with FDA’s current regulation of in vitro diagnostic devices.”
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Future Direc1ons
