New Barriers to Patent Enforcement Affect Personalized Medicine

Personalized Medicine and
Diagnostics:
New Barriers to Patent
Enforcement
August 25, 2014

Agenda
Background: Patents and Patent
Eligibility
Special Hurdles in the Enforcement of
Method Claims
Practical Applications
© 2008 Foley Hoag LLP. All Rights Reserved. Presentation Title | 22

The Battleground: Patents
 Background
 What does a patent do?
 How does it do that?
 How important are patents in the life sciences?

What’s Not Patent-Eligible?
“Laws of Nature”
Prometheus v. Mayo (2012)

“Laws of Nature”
“Products of Nature”
AMP v. Myriad (2013)

“Laws of nature”
“Products of nature”
AMP v. Myriad (2013)
“Abstract ideas”
Alice v. CLS Bank (2014)

Thousands of
issued claims are
invalid under one
of these three
cases
Including many
protecting
innovations in
personalized
medicine and
diagnostics

Agenda
Eligibility
Method Claims

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.”

Special Hurdles in the
Enforcement of Method Claims

Special Hurdles in the
Enforcement of Method Claims
Divided infringement
Limelight 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.”

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 patent
Note: 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

Agenda
Eligibility
Method Claims

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.

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.
 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?

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.

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?

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.

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?

Claim 1 Reconceived
comprising:
SMASH;
 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

Claim 1 Reconceived
comprising:
SMASH;
 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.

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.

New Barriers to Patent Enforcement Affect Personalized Medicine

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