Transcript Prometheus & Myriad

Prometheus
&
Myriad
The Future of
Diagnostic & Gene Claims
Mercedes Meyer, Ph.D.
Kevin Noonan, Ph.D.
Discussion Points
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A rear view of Classen and Labcorp.
AIA 35 USC § 101 change.
USPTO Memo Guidance March 21, 2012
The tension – McKesson & Akamai
35 U.S.C. § 287(c)
Smartgene – March 30, 2012
2 | The Future of Diagnostic Claims
More Discussion Points
 The politics
– The public
– The stakeholders
– The politician – Congresswoman Wasserman-Schultz
• AIA S. 27
• The Hearings Feb. 16 & Mar. 9
– The White House, DOJ, USPTO, NIH
– LDTs, CLIA, and the FDA
• Stakeholders: Pharma, Consumers/Patients, Companion
diagnostic manufacturers, Payers, Physicians, Regulatory,
and Testing Labs
3 | The Future of Diagnostic Claims
Some myths on gene patents
 Patents and Costs
– No evidence was found demonstrating that patents accelerated
or inhibited test development for certain conditions (e.g. hearing
loss).
– Price for genetic tests did not appear to correlate with patent
status. Some for-profit providers had the same cost as not-forprofit testing providers.
– Patents have been found not impede consumer utilization of the
tests.
– The marketplace is the driver of gene testing.
– Incorrect data – the myth that 20% of the human genes are
patented is false.
• Whole Genome Sequencing – does not infringe a gene patent.
4 | The Future of Diagnostic Claims
Some more myths on gene patents
 Patents and Innovation
– No evidence for a “tragedy of the anticommons” regarding basic
research
• >9,000 scientific journal articles on BRCA genes post-patenting
– “Isolated DNA” claims not infringed by genetic diagnostic testing
• Claims require isolation of full-length genes capable of producing
encoded protein
• Isolation not required for genetic diagnostic tests
– Oligomer claims of questionable validity
– Gene patents do not inhibit information about genes
• Genetic information is not patented and gene patent claims not
infringed by in silico analyses
5 | The Future of Diagnostic Claims
A Slippery Slope & The Future
 Some (Judge Moore) voice a concern that if
DNA patents are attacked there will be a slippery
slope effect to capture other compounds.
– Antisense, siRNA.
– Proteins and peptides.
• Antibodies and their fragments.
 Method of treatment claims
are recognized for Orange
Book listings.
 Companion Diagnostics.
6 | The Future of Diagnostic Claims
A Slippery Slope & The Future
 Consider these examples:
– Isolated chemical compound from crude oil
useful as a lubricant
– Isolated chemical compound from a plant
useful as a drug
– Isolated protein from an animal useful to
cure/ameliorate human disease
– From a human?
7 | The Future of Diagnostic Claims
Myriad DNA Claims - Eligible?
USPN 5,693,473
 1. An isolated DNA comprising an altered
BRCA1 DNA having at least one of the
alterations set forth in Tables 12A, 14, 18
or 19 with the proviso that the alteration is
not a deletion of four nucleotides
corresponding to base numbers 41844187 in SEQ. ID. NO:1.
8 | The Future of Diagnostic Claims
Myriad DNA Claims - Eligible?
USPN 5,747,282
 7. An isolated DNA selected from the group consisting
of:
– (a) a DNA having the nucleotide sequence set forth in
SEQ ID NO:1 having T at nucleotide position 4056;
– (b) a DNA having the nucleotide sequence set forth in
SEQ ID NO:1 having an extra C at nucleotide position
5385;
– (c) a DNA having the nucleotide sequence set forth in
SEQ ID NO: 1 having G at nucleotide position 5443;
and, (d) a DNA having the nucleotide sequence set
forth in SEQ ID NO:1 having 11 base pairs at
nucleotide positions 189-199 deleted.
9 | The Future of Diagnostic Claims
Is Licensing “THE” Issue?
 Single Providers
– Myriad / BRCA1 & 2
– Canavan Disease –
Miami Children’s
Hospital
 Multiple Providers
– Long QT Syndrome has two
providers with separate blocking
patents
– Hearing loss – multiple providers for
patents and unpatented genes
– Hereditary hemochromatosis –
multiple LDTs; no IP impact
– Alzheimer’s Disease
– Lynch Syndrome (HNPCC)
– Familial adenomatous polyposis
(FAP)
– Spinocerebellar ataxia
10 | The Future of Diagnostic Claims
Myriad
Internationally
Gene Patent
Attacks Globally
International Stance
 Canada – Myriad attacked the government.
Today, Myriad’s patents are primarily ignored.
 Europe – Opposed by Institut Curie.
– UK – provides BRCA testing without payment to
Myriad.
 Australia – the government investigated and
came close to banning gene patents.
 Japan – exclusively licensed the rights to Falco.
12 | The Future of Diagnostic Claims
Questions?
Mercedes K. Meyer, Ph.D.
Drinker Biddle & Reath LLP
Washington, DC 20005
Kevin E. Noonan, Ph.D.
McDonnell Boehnen Hulbert
& Berghoff LLP
Chicago, IL 60606