new barriers to patent enforcement affect personalized medicine
DESCRIPTION
The Supreme Court and the Federal Circuit have imposed new challenges for companies in diagnostics and personalized medicine. This presentation suggests the kinds of claims that may survive these new rulings.TRANSCRIPT
Personalized Medicine and Diagnostics:
New Barriers to Patent Enforcement
August 25, 2014
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Agenda
Background: Patents and Patent Eligibility
Special Hurdles in the Enforcement of Method Claims
Practical Applications
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The Battleground: Patents
Background What does a patent do? How does it do that? How important are patents in the life sciences?
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What’s Not Patent-Eligible?
“Laws of Nature”Prometheus v. Mayo (2012)
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What’s Not Patent-Eligible?
“Laws of Nature”Prometheus v. Mayo (2012)
“Products of Nature”AMP v. Myriad (2013)
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What’s Not Patent-Eligible?
“Laws of nature”Prometheus v. Mayo (2012)
“Products of nature”AMP v. Myriad (2013)
“Abstract ideas”Alice v. CLS Bank (2014)
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What’s Not Patent-Eligible?
Thousands of issued claims are invalid under one of these three cases
Including many protecting innovations in personalized medicine and diagnostics
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Agenda
Background: Patents and Patent Eligibility
Special Hurdles in the Enforcement of Method Claims
Practical Applications
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Method Claims
In personalized medicine, “method” claims are important. Methods of diagnosing Methods of treatment
Who performs method (and directly infringes)? Physician Patient Laboratory
So claim is made Against the “generic”-type test-producer For inducing infringement under 35 U.S.C. §271(b) by
the direct infringer.Section 271(b): “Whoever actively induces infringement of a patent shall be liable as an infringer.”
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Special Hurdles in the Enforcement of Method Claims
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Special Hurdles in the Enforcement of Method Claims
Divided infringementLimelight v. Akamai (2014)
Knowledge standard for inducing infringement: inducer must “know” that the “induced acts constitute patent infringement”Global Tech v. SEB (2011)Commil v. Cisco (2013): A “good-faith belief of invalidity may negate the requisite intent for induced infringement.”
Divided infringementLimelight v. Akamai (2014)
Knowledge standard for inducing infringement: inducer must “know” that the “induced acts constitute patent infringement”Global Tech v. SEB (2011)Commil v. Cisco (2013): A “good-faith belief of invalidity may negate the requisite intent for induced infringement.”
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What Must the Plaintiff Show
Composition Claims Method Claims
Direct infringement Direct infringement (can’t be divided!)
Active inducement of the direct infringer
Defendant’s knowledge that induced acts infringe the patentNote: a good faith belief that the induced acts do not infringe is a defense
Facts sufficient to rebut the defendant’s defense that it had a good-faith belief that the patent was invalid
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Agenda
Background: Patents and Patent Eligibility
Special Hurdles in the Enforcement of Method Claims
Practical Applications
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Claim 1: Method of Identifying Optimal Treatment
A method for identifying an optimal cancer treatment comprising:Performing assay 1 to determine expression levels of genes BANG and SMASH;
Performing sequencing analysis on genes THUMP and STOMP; and
Accessing a bioinformatic algorithm relating to the relationship between BANG, SMASH, THUMP, and STOMP and different tumor types; and
Producing a computer generated report identifying an optimal treatment based on the results of the bioinformatic analysis.
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Claim 1: Method of Identifying Optimal Treatment
Problems: Prometheus: Isn’t this just the application of a “law of nature”? Myriad: Those genes aren’t patentable, remember! Alice: Bringing a computer into the picture doesn’t make the method
patent-eligible, and algorithms are abstract ideas. Limelight: Is a single actor performing all the steps of this method? Global Tech: Is anybody inducing another to perform this method?
Does the inducer know about the patent? Does it know that its acts are inducing infringement? Does it lack a good faith belief that the patent is invalid?
A method for identifying an optimal cancer treatment comprising: Performing assay 1 to determine expression levels of genes BANG and
SMASH; Performing sequencing analysis on genes THUMP and STOMP; and Accessing a bioinformatic algorithm relating to the relationship
between BANG, SMASH, THUMP, and STOMP and different tumor types; and
Producing a computer generated report identifying an optimal treatment based on the results of the bioinformatic analysis.
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Claim 2: Method for Diagnosing Cancer
A method for diagnosing cancer X in a human, comprising: Analyzing a DNA sample obtained from the human to determine if allele Q of biomarker Z is present; and
Performing CT scanning on the human to detect the presence of a tumor if allele Q of biomarker Z is present in the DNA sample.
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Claim 2: Method for Diagnosing Cancer
A method for diagnosing cancer X in a human, comprising: Analyzing a DNA sample obtained from the human to determine if allele Q of biomarker Z is present; and
Performing CT scanning on the human to detect the presence of a tumor if allele Q of biomarker Z is present in the DNA sample.
Problems: Prometheus: Isn’t this just a trivial, known step (CT
scanning) added on to the application of a “law of nature”? Limelight: Is a single actor performing the DNA analysis
and the CT scan? Global Tech: Is anybody inducing another to perform this
method? Does the inducer know about the patent? Does it know that its acts are inducing infringement? Does it lack a good faith belief that the patent is invalid?
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Claim 3: Method for Assessing a Patient’s Response to a Drug
A method for assessing the response of a patient’s tumor cells to a drug, comprising: Before administering the drug, obtaining a first
sample of tumor cells; Within a selected interval after administering the
drug, obtaining a second sample of tumor cells; Assessing the activation state of one or more
analytes in the first sample; Assessing the activation state of one or more
analytes in the second sample; and Determining whether the patient’s tumor is
responding to the drug by comparing the activation state of the one or more analytes in the second sample to the activation state of the one or more analytes in the first sample.
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Claim 3: Method for Assessing a Patient’s Response to a Drug
A method for assessing the response of a patient’s tumor cells to a drug, comprising: Before administering the drug, obtaining a first sample of tumor cells; Within a selected interval after administering the drug, obtaining a second
sample of tumor cells; Assessing the activation state of one or more analytes in the first sample; Assessing the activation state of one or more analytes in the second sample;
and Determining whether the patient’s tumor is responding to the drug by
comparing the activation state of the one or more analytes in the second sample to the activation state of the one or more analytes in the first sample.
Problems: Prometheus: Isn’t “determining” just the application of a “law
of nature”? Limelight: Is the same actor obtaining the samples, assessing
activation states, and making the critical determination? Global Tech: Is anybody inducing another to perform this
method? Does the inducer know about the patent? Does it know that its acts are inducing infringement? Does it lack a good faith belief that the patent is invalid?
© 2008 Foley Hoag LLP. All Rights Reserved. Presentation Title | 2020
Claim 1 Reconceived
Treating a patient is generally considered an active step that may confer patent eligibility and overcome the Prometheus problem.
To overcome the Limelight problem, claim must be written to target a single actor, typically a treating physician.
It will still be difficult to prove inducement of infringement under Global Tech unless a company is producing a test kit that includes both diagnostic steps plus access to the algorithm, with instructions to perform all the steps of the method
A method for identifying an optimal cancer treatment comprising: Performing assay 1 to determine expression levels of genes BANG and
SMASH; Performing sequencing analysis on genes THUMP and STOMP; and Accessing a bioinformatic algorithm relating to the relationship
between BANG, SMASH, THUMP, and STOMP and different tumor types; and
Producing a computer generated report identifying an optimal treatment based on the results of the bioinformatic analysis.
© 2008 Foley Hoag LLP. All Rights Reserved. Presentation Title | 2121
Claim 1 Reconceived
A method of selecting a cancer treatment for a patient diagnosed with cancer X, comprising: Requisitioning the performance of assay 1 to determine expression levels
of genes BANG and SMASH; Requisitioning a sequencing analysis of genes THUMP and STOMP; Requisitioning the execution of a bioinformatic algorithm relating
expression levels of BANG and SMASH and mutations of THUMP and STOMP to different tumor types of cancer X and optimal treatments therefor; and
Prescribing a treatment from among those identified by the algorithm as optimal.
A method for identifying an optimal cancer treatment comprising: Performing assay 1 to determine expression levels of genes BANG and
SMASH; Performing sequencing analysis on genes THUMP and STOMP; and Accessing a bioinformatic algorithm relating to the relationship
between BANG, SMASH, THUMP, and STOMP and different tumor types; and
Producing a computer generated report identifying an optimal treatment based on the results of the bioinformatic analysis.
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Patent-Eligibility Fallout
From patents to trade secrets - National Research Council Report (2005):
Risk of halting innovation originating from venture-backed pre-market companies.
Time for the pendulum to swing back.
Personalized Medicine and Diagnostics:
New Barriers to Patent Enforcement
August 25, 2014