Myriad

1
AIPLA

• Myriad Prometheus
• The Aftermath Future Concerns
• Mercedes Meyer, Ph.D.

2
I am NOT Your Lawyer

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  been prepared solely for educational and
  entertainment purposes to contribute to the
  understanding of U.S. intellectual property law
  and practice. These materials reflect only the
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• And nothing represents the views Drinker Biddle
  Reath, its members, or any sentient life form on
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  alive or dead, fictitious, or real!

3
Myriad Decided

• The Court asked Are human genes patentable?
• ANSWER NO
• cDNAs or complementary DNAs are patentable
• No decision on method claims in Round 2.
• What do these answers mean? CONFUSION
• Why?
• They got the science wrong
• Nucleotides that do not code for amino acids are
  introns. Slip. Op. 2
• They confused the law

4
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.
• Genes

5
Myriad Claims

• 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.
• The Supreme Court found that this claim would
  include a gene
• No claim construction performed
• Term isolated DNA did not make it patent
  eligible
• This was the USPTO authorized way of claiming all
  the DNAs that could encode the same protein
• A practitioner would not have considered this to
  include a gene
• Claim is PATENT INELIGIBLE

6
Myriad DNA ClaimsUSPN 5,747,282

• 1. An isolated DNA coding for a BRCA1
  polypeptide, said polypeptide having the amino
  acid sequence set forth in SEQ ID NO2.
• Ineligible
• 2. The isolated DNA of claim 1, wherein said DNA
  has the nucleotide sequence set forth in SEQ ID
  NO1.
• Patent eligible
• 5. An isolated DNA having at least 15 nucleotides
  of the DNA of claim 1.
• Ineligible
• 6. An isolated DNA having at least 15 nucleotides
  of the DNA of claim 2.
• Valid? Yes, according to Myriad!
• 7. An isolated DNA selected from the group
  consisting of
• (a) a DNA having the nucleotide sequence set
  forth in SEQ ID NO1 having T at nucleotide
  position 4056
• (b) a DNA having the nucleotide sequence set
  forth in SEQ ID NO1 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 NO1
  having 11 base pairs at nucleotide positions
  189-199 deleted.
• Apparently valid

7
The Science - 1
Eukaryotic Genes
8
The Science - 2
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

9
Good News / Bad News

• Gave credence to Funk Brothers
• Funk Bros. relates to obviousness legal
  confusion
• Claim 5 of 282 patent ineligible
• This style of claim was a problem for freedom to
  operate opinions at least in the US, the
  problem is saved
• Still a problem elsewhere globally
• How to claim single nucleotide mutations?
• The location and order of the nucleotides
  existed in nature before Myriad found them. Nor
  did Myriad create or alter the genetic structure
  of DNA. Op. at 12.
• Composition may not be patentable unless using
  consisting of language or synthetic language
• Use in a method of diagnosis should be patentable

10
Impact on Genes?

• First isolated genes / proteins patents now
  expired
• Human genome project done in early 2000
• Most of those patent applications stand abandoned
• In silico data only
• Many of the patents are expired for failure to
  pay maintenance fees
• No real DNA drugs approved yet
• Polypeptide drugs are still eligible
• Most biologic drugs are modified or non-natural
  (e.g., antibodies)
• BUT.

11
Future Problem in Other Areas??

• DNA from bacteria
• Does not contain introns is it patentable
  just by saying cDNA?
• Purified compounds
• Allegedly examiners are rejecting naturally
  occurring polypeptides
• What about purified silica? Purified gold?
• What about product-by-process claims for natural
  compositions?
• Stem cells? Plant extracts? Taxol?
• Enzymes from newly identified organisms that have
  unusual properties?

12
Claiming Solutions - DNA

• Isolated / purified will not work!
• How to claim DNA?
• cDNA
• An isolated cDNA coding for a BRCA1 polypeptide,
  said polypeptide having the amino acid sequence
  set forth in SEQ ID NO 2. Eligible
• Synthetic DNA
• DNA lacking genomic sequences (intronic
  sequences)
• Using consisting of v. comprising to exclude
  genomic sequences
• Other DNAs fusion DNA, siRNAs, antisense DNA,
  DNAs / RNAs modified with a chemical - eligible
• DNAs obtained by directed evolution?

13
MORE Claiming Solutions

• Proteins
• Synthetic polypeptide not produced in its
  native cell?
• Chemical modifications - Unglycosylated or
  lacking another native modification (fatty acid,
  unphosphorylated, etc.)
• Modified protein non-naturally occurring
  variants, non-naturally encoded amino acids,
  pegylation, fusion proteins, etc.
• Product By Process
• Do we have to demonstrate that the product does
  not exist in nature? How do we claim purified
  compositions?
• Will product characterization require evidence
  that it is not naturally-occurring?

14
Myriad The Fight Continues

• Myriad has sued Ambry and Gene-by-Gene for
  infringement based on their other BRCA1/2
  patents
• Ambry argues that Myriad prohibits enforcing
  synthesized DNA that mirrors genomic DNA,
  including probes
• Quest Diagnostics has sued Myriad in California
  on 14 patents, 4 are not part of the other suit

15
Prometheus What is the PTO Saying?

• Inquiry 1 Part I
• Does the claim include additional
• elements/steps that integrate the natural
• principle into the process?
• It is not necessary that every step show
  integration.
• If the additional elements/steps do not
  integrate the
• natural principle, there is no practical
  application.
• If not, the claim fails the analysis and should
  be
• rejected.
• See http//www.cabic.com/bcp/090512/BIO_9_2012_101
  _Train_Update(HANDOUT)_TC1600.pdf

16
Prometheus and the PTO

• Inquiry 2 Part II
• Does the claim include additional
• elements/steps that amount to significantly
• more than the natural principle itself?
• Is the claim as a whole more than a natural
• principle plus the general instructions to
• simply apply it?
• If not, the claim fails the analysis and should
  be
• rejected.

17
Aria Diagnostics, Inc. v. Sequenom, Inc.(Fed.
Cir. 2013)

• A method for detecting a paternally inherited
  nucleic acid of fetal origin performed on
  maternal serum detecting the presence of a
  paternally inherited nucleic acid of fetal origin
  of the sample.
• Reversed and remanded. Claim construction
  assessed.
• See also Digitech Image Technologies v. Konica
  Minolta Holdings, Inc. 2013 WL 3947158 (C.D. Cal.
  July 31, 2013)
• Claim construction is going on in these 101
  applications!

18
Method Claiming Solutions?

• Claim the product or method at least in a picture
  claim
• You will avoid written description and enablement
  issues in the US and globally
• Claim the method where the steps are taken by one
  actor
• McKesson/Akamai issue
• Claim the compound to distinguish it over natural
  compositions
• Claim narrowly
• Novozymes A/S v. DuPont Nutrition Biosciences APS
  (Fed. Cir. 2013)

19
Thank You

• Mercedes Meyer, Ph.D.
• Drinker Biddle Reath LLP
• Washington, DC
• Mercedes.Meyer_at_dbr.com
• 202-842-8821

20
USPTO Example

• 1. A method of determining the increased
  likelihood of having or developing rheumatoid
  arthritis in a patient, comprising the steps of
• obtaining a serum sample from a patient
• contacting the serum sample with an anti-IgM
  antibody
• and
• determining that the patient has rheumatoid
  arthritis or an increased likelihood of
  developing rheumatoid arthritis based upon the
  increased binding of the anti- IgM antibody to
  IgM rheumatoid factor in the serum sample.

21
Example Claim Not Patent Eligible

• Inquiry 1 The claim is a process claim.
• Inquiry 2 The claim includes the limitation of
  the correlation between rheumatoid arthritis and
  the rheumatoid factor IgM, which is a natural
  principle/law of nature.
• Inquiry 3 All of the additional steps integrate
  or relate to the correlation.
• The additional steps of obtaining and
  contacting are well understood steps that are
  routinely conducted to analyze a serum sample.
• The steps are claimed at a high level of
  generality.
• Considered as a whole, the steps taken together
  amount to no more than recognizing the law of
  nature itself.

22
USPTO Example

• 2. The method of claim 1 further comprising
• providing a positive control sample and
• contacting the positive control sample with an
  anti-IgM antibody,
• wherein the step of determining that the patient
  has rheumatoid arthritis or increased likelihood
  of developing rheumatoid arthritis comprises a
  step of comparing the anti-IgM antibody in the
  serum sample to the positive control sample. NOT
  ELIGIBLE
• 3. The method of claim 1 or 2, wherein the
  anti-IgM antibody is antibody XYZ. ELIGIBLE

23
PTO Guidelines

• Inquiry 1 The claim is a process claim.
• Inquiry 2 The claim includes the limitation of
  the correlation between rheumatoid arthritis and
  the rheumatoid factor IgM, which is a natural
  principle/law of nature.
• Inquiry 3 The additional step of using a
  particular anti-IgM antibody
• (especially one that is not known in the field)
  integrates the law of nature as it is used to
  express the principle and is also sufficient to
  limit the application of the law of nature.
• The claim does not cover substantially all
  practical applications of the correlation between
  IgM and arthritis, because the claim is limited
  to those applications that use the antibody XYZ.
• Considered as a whole, the steps taken together
  amount to a practical application of the law of
  nature.