Transcript Diagnostics: Patent Eligibility and the Industry Perspective

Diagnostics: Patent
Eligibility and the Industry
Perspective
Presentation to MATTO
Kimya Harris, Ph.D.
Melissa Hunter-Ensor, Ph.D., Esq.
Moderator: John Cosmopoulos
© Copyright 2015 Saul Ewing LLP
What is Patent Eligible Subject
Matter?
35 U.S.C. §101 - Any new and useful:
♦
♦
Process
♦
Machine
♦
Manufacture or composition of matter or improvement
thereof
♦
“Anything under the sun made by man”
Unpatentable subject matter (judicial exceptions)
♦
Laws of nature
♦
Products of nature
♦
Mathematical algorithms
© Copyright 2015 Saul Ewing LLP
AMP v. MYRIAD GENETICS, Sup Ct June 2013
Subject Matter Eligibility of Products
• BRCA1 and BRCA2 are genes that account for most inherited forms
of breast and ovarian cancer.
• Myriad’s genetic test identified women at increased risk of suffering
from breast or ovarian cancer.
• Two types of claims were at issue:
(i) composition claims directed to isolated DNA molecules;
(ii) composition claims directed to cDNA
• Court found that isolating DNA molecules was not sufficient to
confer patent eligibility, because “Myriad did not create or alter any
of the genetic information encoded in the BRCA1 and BRCA2
genes.”
• cDNA is not a “product of nature” and is patent eligible under § 101.
© Copyright 2015 Saul Ewing LLP
Mayo v. Prometheus, Sup. Ct. March 2012
Subject Matter Eligibility of Processes
• The court found that medical tests that rely on
correlations between drug dosages and treatment are not
eligible for patent protection.
• The court reasoned that natural laws themselves may not
be patented, and natural laws cannot be patented in
connection with processes that involve “well-understood,
routine, conventional activity.”
© Copyright 2015 Saul Ewing LLP
How do Myriad and Prometheus affect
patent eligibility for diagnostics?
• The Court’s analysis of patent eligibility in Myriad focused on
whether products occurred in nature.
 Include claims to compositions that are not naturally occurring.
• Capture molecules (Abs/Nucleic acids) fused to a substrate.
• Polynucleotides comprising a detectable moiety.
• Humanized or chimeric antibodies.
• The Court’s analysis of patent eligibility in Prometheus focused on
laws of nature, mental steps, and routine conventional activity.
 Include claims to diagnostic methods featuring patentable compositions
(e.g., antibodies, microarrays, detectable polynucleotide probes that
hybridize to SNPs).
 Claims to companion diagnostics (e.g., a method of treating a patient by
administering drug X, wherein the patient is selected as having disease
Y).
© Copyright 2015 Saul Ewing LLP
Highlights from the USPTO Interim Guidance
on Subject Matter Eligibility (Dec. 2014)
 Includes all claims (product and process) “directed to” a judicial
exception
 Step 2A analysis: compare product in the claim to its naturally
occurring counterpart to identify markedly different characteristics
— Includes structure, function, and/or other characteristics
 Step 2B analysis: determine if additional elements add significantly
more to the exception
 Streamlined eligibility analysis: claim clearly does not seek to preempt all uses of the exception
 Clear statement that mere possibility that something exists in nature
does not bar eligibility
Kimya Harris 3.4.2015
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Comparison of Patent Eligibility for Diagnostics Worldwide
Europe
Canada
Japan
Australia
Methods
- Patentable
- Must have in
vitro step
- Patentable
- “Diagnostic
method” or
“diagnostically
effective amount”
- Not patentable
- “Method of using
X as an indicator
for Y”
Patentable
Compositions &
Kits
Patentable
Patentable
- Patentable
- Composition
limited by use
Patentable
Relevant Court
Decisions
- Myriad patents
opposed
- Patents upheld
on appeal
- Patent eligible
subject matter
affirmed
- No Myriad
challenges
- CHEO challenged
gene patent
No Myriad
challenges
- Myriad upheld by
Federal Court of
Australia
- “Isolated genes are
not naturally
occurring”
- Standard for
“invention” is an
artificially created
state of affairs
Kimya Harris 3.4.2015
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Case Studies
• Correlation between a SNP in a certain gene (or SNPs in multiple genes)
and diagnosis of a specific disease.
• Higher levels of phosphorylation at a specific serine position of a certain
protein represents a biomarker of patients with bipolar disease who will
respond to lithium treatment (patient stratification tool/companion Dx type
situation).
• The inverse correlation between low levels of a specific protein in the tumor
microenvironment and the aggressiveness of the tumor.
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Case Studies (continued)
• Identification of a (or more than one) circulating biomarker that is correlated
to a disease.
• Panel of mutations in one or more genes that provide responses to
specific clinical questions (e.g. Is the cancer invasive? How to stratify
patients or classify the cancer?)
• Correlation of certain altered methylation patterns with increased
probability of carcinogenesis in specific tumor types.
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