New Barriers to Patent Enforcement Affect Personalized Medicine

Personalized Medicine and Diagnostics:

New Barriers to Patent Enforcement

August 25, 2014

© 2008 Foley Hoag LLP. All Rights Reserved. Presentation Title | 22

Agenda

Background: Patents and Patent Eligibility

Special Hurdles in the Enforcement of Method Claims

Practical Applications


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”Prometheus v. Mayo (2012)

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



“Laws of nature”Prometheus v. Mayo (2012)

“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





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.”





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.”


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


Agenda





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

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



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

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

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.

Personalized Medicine and Diagnostics:

New Barriers to Patent Enforcement

August 25, 2014