Download MEYER Myriad 2013 Japan Comm Meeting

AIPLA
1
Myriad
The Future of DNA
Claims
Mercedes Meyer, Ph.D., JD
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Myriad is Back at the Supreme Court
The Question:
1.
1.
Are human genes patentable?
2. Issues ignored
1.
Standing
2.
Method claim
3. What does it mean?
35 USC 101
 § 101:
 Whoever invents or discovers any new and useful process,
machine, manufacture, or composition of matter, or any new
and useful improvement thereof, may obtain a patent therefor,
subject to the conditions and requirements of this title.
 The Exceptions to Eligibility:
 Law of nature
 Algorithm
 Abstract idea
 AIA § 33. Notwithstanding any other provision or law, no patent
may issue on a claim directed to or encompassing a human
organism.
Myriad Claims
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 Claim 1 of the USPN 5,747,282:

1. An isolated DNA coding for a BRCA1 polypeptide, said
polypeptide having the amino acid sequence set forth in SEQ
ID NO: 2.

This “isolated DNA” does not constitute a gene
Myriad DNA Claims
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
4184-4187 in SEQ. ID. NO:1.
 6. An isolated DNA molecule coding for a mutated form of
the BRCA2 polypeptide set forth in SEQ ID NO:2, wherein
said mutated form of the BRCA2 polypeptide is associated
with susceptibility to cancer.
 7. The isolated DNA molecule of claim 6, wherein the DNA
molecule comprises a mutated nucleotide sequence set
forth in SEQ ID NO:1.
Myriad DNA Claims
USPN 5,747,282
 1. An isolated DNA coding for a BRCA1 polypeptide, said polypeptide having




the amino acid sequence set forth in SEQ ID NO:2.
2. The isolated DNA of claim 1, wherein said DNA has the nucleotide sequence
set forth in SEQ ID NO:1.
5. An isolated DNA having at least 15 nucleotides of the DNA of claim 1.
6. An isolated DNA having at least 15 nucleotides of the DNA of claim 2.
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.
The Science - 1
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Eukaryotic Genes
The Science - 2
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Protein
 The RNA is spliced to form mRNA
 For BRCA1 and BRCA 2 there are multiple splice forms
 BRCA1 is 110 kb and BRCA2 is 70 kb
 BRCA2 has 22 exons / BRCA1 has 27
Only 5,500 and 10,200 bases approximately are claimed
The Politics
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 Sec. 27 of the AIA
 Health Care


Laboratory developed tests (LDTs)
Breast Cancer Survivors
 Potential Relevance to Companion Diagnostics

Erbitux, Herceptin, Tarceva – Cancer
 Insurance reimbursement, anti-kickback and healthcare
fraud statutes, contractual limitations, institutional
policies, malpractice and other tort concerns, practice
patterns, professional talent distribution, financial and time
restraints, and more.
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 DNA patent.
Thank You
MERCEDES MEYER, PH.D.
DRINKER BIDDLE & REATH LLP
WASHINGTON, DC
[email protected]
202-842-8821