Following the recent Supreme Court decision regarding Myriad, Dr. Hammer has sided with those who declare that "the sky has not fallen." He analyses the decision and points to the way forward. Dr. Hammer heads the "US Direct" patent prosecution practice at JMB Davis Ben-David, a US and Israel Intellectual Property Boutique located in the Har-Hotzvim high tech park in Jerusalem, Israel. In addition to filing and prosecuting patent and trademark applications worldwide for their Israeli clients, JMB Davis Ben-David files and prosecutes patent and trademark applications for clients the world over, both in the Israeli and US Patent and Trademark Offices.

1. The Myriad Case: Where Next for Gene
Patents in the United States?
Dr. Michael D. Hammer
JMB Davis Ben-David
From Molecules to Medical Devices
June 24, 2013

2. AMP vs. Myriad Genetics (2013)
• Naturally-occurring DNA is not patent eligible
• cDNA is patent eligible because it is not
naturally-occurring

3. Patent Eligibility vs. Patentability
Patent eligibility is the starting line
Patentability is completing the course

4. U.S. Patent Law – Constitutional Basis
To promote the progress of
science and useful arts, by
securing for limited times to
authors and inventors the
exclusive right to their
respective writings and
discoveries
Article I, Section 8

5. U.S. Patent Eligible Subject Matter
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.
35 U.S.C. 101

6. Patent Eligible Subject Matter Exclusions
Laws of Nature
Natural Phenomenon
(Products of Nature)
Abstract Ideas

7. Diamond v. Chakrabarty (1980)
A Biological Composition of Matter
• Pseudomonas transformed with oil-degrading plasmids
is patent eligible and not a “product of nature”
It is “a nonnaturally occurring
manufacture or composition
of matter -- a product of
human ingenuity having a
distinctive name, character
[and] use.”

8. Gene Patent Eligibility Before Myriad
USPTO Utility Examination Guidelines – 2001
• An inventor’s discovery of a gene can be the basis for a
patent on the genetic composition isolated from its
natural state and processed through purifying steps that
separate the gene from other molecules naturally
associated with it

9. AMP v. Myriad Genetics (2013)
• Mutations in the BRCA1 and BRCA2 genes are
present in a large % of women with breast and
ovarian cancer
• The inventors sequenced the BRCA1 and
BRCA2 genes and patented claims directed to
varied types of isolated DNA, diagnostic
methods, and methods for screening potential
treatments

10. Myriad – Atypical Patent Litigation
• Myriad aggressively and successfully enforced its
patents against institutions offering BRCA1/2
testing
• Myriad expressly refrained from enforcement
against researchers, but communicated this
poorly

11. 1. Isolated DNA
Myriad Genetics – Challenged Claims
Genomic DNA
cDNA
Fragments of genomic and cDNA ≥ 15 nt

12. 2. Methods of comparing or analyzing DNA sequences
Myriad Genetics – Challenged Claims II
3. Methods of screening potential cancer therapeutics
by assaying growth of BRCA1/2 transformed cells
Aprelikova O N et al. PNAS 1999;96:11866-11871
http://www.instituteforwomenshealth.ucl.ac.uk/academic_research/gynaecologicalcancer/trl/genomicsgroup

13. • District court - all challenged claims are ineligible
• CAFC*
– Isolated DNA claims, and screening methods –
patent eligible
– Methods of comparing and/or analyzing DNA
sequences - patent ineligible abstract ideas
• Supreme Court granted review of a single issue:
– Are human genes patentable? (Is isolated DNA
patent eligible?)
Myriad Genetics at the Court
*The CAFC heard the case twice (before and after Mayo v. Prometheus) and
reached the same decision both times

14. An isolated DNA coding for a BRCA1 polypeptide, said
polypeptide having the amino acid sequence set forth in
SEQ ID NO:2.
Myriad Genetics – Isolated DNA Claims
AND

15. The isolated DNA of claim 1, wherein said DNA has the
nucleotide sequence set forth in SEQ ID NO:1.
Myriad Genetics – Isolated DNA Claims II
An isolated DNA having at least 15 nucleotides of the DNA
of claim 1.
15 nt

16. Is isolated DNA patent eligible?
• Not if the sequence is at it exists in nature
15 nt
Genomic DNA cDNA (from a eukaryotic sequence)
DNA Fragments

17. Patent Eligibility of DNA Fragments
• Fragments of genomic DNA are ineligible
• Fragments of cDNA also found in genomic sequence are
ineligible
• Fragments of cDNA not found in genomic sequence are
eligible
Exon 1 Exon 2
Exon 1 Exon 2
Exon 1 Exon 2

18. “We merely hold that genes and the information
they encode are not patent eligible under §101
simply because they have been isolated from the
surrounding genetic material.”
Uncertainty after Myriad Genetics
• RNA?
• Proteins?
(Antibodies?)
• Stem cells?
• Other biomolecules?

19. Likely Patent Eligible
• Labeled/tagged biomolecules
• Isolated, processed biomolecules
• Anything that “shows the hand of the inventor”
Biotech after Myriad Genetics
Opinion Expressly Does Not Address
• Recombinant DNA
• Methods
• Applications of newly-identified gene sequences
Myriad does NOT state a new “product of nature” doctrine

20. Thank You!
For the record….
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