The Myriad Case: Where Next for Gene
Patents in the United States?
Dr. Michael D. Hammer
JMB Davis Ben-David
From Molecule...
AMP vs. Myriad Genetics (2013)
• Naturally-occurring DNA is not patent eligible
• cDNA is patent eligible because it is no...
Patent Eligibility vs. Patentability
Patent eligibility is the starting line
Patentability is completing the course
U.S. Patent Law – Constitutional Basis
To promote the progress of
science and useful arts, by
securing for limited times t...
U.S. Patent Eligible Subject Matter
Whoever invents or discovers any new and
useful process, machine, manufacture, or
comp...
Patent Eligible Subject Matter Exclusions
Laws of Nature
Natural Phenomenon
(Products of Nature)
Abstract Ideas
Diamond v. Chakrabarty (1980)
A Biological Composition of Matter
• Pseudomonas transformed with oil-degrading plasmids
is ...
Gene Patent Eligibility Before Myriad
USPTO Utility Examination Guidelines – 2001
• An inventor’s discovery of a gene can ...
AMP v. Myriad Genetics (2013)
• Mutations in the BRCA1 and BRCA2 genes are
present in a large % of women with breast and
o...
Myriad – Atypical Patent Litigation
• Myriad aggressively and successfully enforced its
patents against institutions offer...
1. Isolated DNA
Myriad Genetics – Challenged Claims
Genomic DNA
cDNA
Fragments of genomic and cDNA ≥ 15 nt
2. Methods of comparing or analyzing DNA sequences
Myriad Genetics – Challenged Claims II
3. Methods of screening potentia...
• District court - all challenged claims are ineligible
• CAFC*
– Isolated DNA claims, and screening methods –
patent elig...
An isolated DNA coding for a BRCA1 polypeptide, said
polypeptide having the amino acid sequence set forth in
SEQ ID NO:2.
...
The isolated DNA of claim 1, wherein said DNA has the
nucleotide sequence set forth in SEQ ID NO:1.
Myriad Genetics – Isol...
Is isolated DNA patent eligible?
• Not if the sequence is at it exists in nature
15 nt
Genomic DNA cDNA (from a eukaryotic...
Patent Eligibility of DNA Fragments
• Fragments of genomic DNA are ineligible
• Fragments of cDNA also found in genomic se...
“We merely hold that genes and the information
they encode are not patent eligible under §101
simply because they have bee...
Likely Patent Eligible
• Labeled/tagged biomolecules
• Isolated, processed biomolecules
• Anything that “shows the hand of...
Thank You!
For the record….
This is not legal advice or advice in any shape or form. We can only advise when we
have all t...
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After Myriad: Where next for gene patents in the US? by Patent Attorney Dr Mike Hammer, June 2013

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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.

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  • First, it is important to review what we are talking about – and to make the distinction between PE and P clear – because this is something that the court is not being as careful about as it should.
  • The US patent law defines PE subject mater in extremely broad terms…
  • The reasoning behind these exclusions is the belief that allowing a patent on such things would inhibit invention by others, and go against the constitutional mandate of “promoting progress in science and the useful arts” In the cases that we will discuss today, the challengers to the patents attempted (and as we will see, succeeded) to have the Court expand these exclusions to sweep in the challenged patent claims.
  • Several types of Myriads claims in several different patents where challenged in court….
  • In the initial law suit, the DC…..The case was reviewed by the CAFC twice – once after the DC decision and again on remand from the SC to take another look in view of Prometheus. Both times…The decision of the SC to review only the single issue is significant….
  • After Myriad: Where next for gene patents in the US? by Patent Attorney Dr Mike Hammer, June 2013

    1. 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. 2. AMP vs. Myriad Genetics (2013) • Naturally-occurring DNA is not patent eligible • cDNA is patent eligible because it is not naturally-occurring
    3. 3. Patent Eligibility vs. Patentability Patent eligibility is the starting line Patentability is completing the course
    4. 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. 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. 6. Patent Eligible Subject Matter Exclusions Laws of Nature Natural Phenomenon (Products of Nature) Abstract Ideas
    7. 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. 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. 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. 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. 11. 1. Isolated DNA Myriad Genetics – Challenged Claims Genomic DNA cDNA Fragments of genomic and cDNA ≥ 15 nt
    12. 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. 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. 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. 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. 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. 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. 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. 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. 20. Thank You! For the record…. This is not legal advice or advice in any shape or form. We can only advise when we have all the facts in front of us and are asked to do so and If we are qualified. Discussing something in this forum isn't legal advice. Nor is anything contained in any printed materials distributed in the framework of this forum.

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