January 17, 2017International Judicial Academy

1
Patent Eligible Subject Matterin the United
StatesJorge A. Goldstein, Ph.D.,
Esq.Washington, DC, USA
2
Outline

• Patents in multiple dimensions
• Patent eligibility vs. ability.
• The US statutory scheme
• Eligibility from Chakrabarty to Bilski
• Cutting edge issues Diagnostic genetics

3
Patents In Six Dimensions

• Historical Venetian Code Statute of Monopolies
  French Assembly Thomas Jefferson
• Constitutional - legal U.S. Constitution Art I,
  Section 8 to promote the progress of science
  and the useful arts
• Human Creative ideas belong to creator
• Technological Exclusivity promotes disclosure
• Commercial Exclusivity promotes investment in
  risky enterprises
• Political - economic The developing world

4
Examples from the Extremes

• Ideal A synthetic drug patented worldwide by
  Merck (or, after US Bayh Dole Act, by the Harvard
  Chemistry Department and licensed to Merck), and
  used in France.
• Cutting edge An online business method patented
  worldwide by the Harvard Business School, and
  used in Gambia.

5
Patent Eligibility

• What subject matter is eligible?
• Easy
• Machines, synthetic drugs, methods of industrial
  manufacture
• Harder
• Purified natural products (antibiotics, genes?)
  Live products? (microbes, plants, animals?)
• Software? Algorithms?
• New methods of doing business?
• Natural phenomena in disguise? (genetic
  correlations?)

6
Patentability

• What are the universal requirements for
  obtaining patent protection on an eligible
  invention?
• Usefulness / industrial applicability
• Novelty
• Non obviousness / inventive step
• A proper filing with full disclosure
• Full description
• Reproducibility
• (In the US Best mode)

7
U.S. Statute on Eligibility

• 35 U.S.C. 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.

8
Legal Precedents in the U.S. Eligible Products
of Nature

• Such patents claim isolated molecules not their
  natural form
• 1912 Adrenalin practically free from gland
  tissue
• 1970 Prostaglandin in sufficiently pure form
• 1979 Strawberry flavoring comprising...
  substantially pure 2-methyl-2-pentanoic acid

9
Legal Precedents in the US Eligible Live
Inventions

• 1977 Biologically pure culture of
  Streptomyces vellosus
• 1980 Diamond v. Chakrabarty (Supreme Ct)
• Human-made micro-organisms eligible.
• Broad dicta anything under the sun made by
  man
• 1985 Ex Parte Hibberd (USPTO Board)
• Plants eligible (in addition to plant patents and
  the UPOV-based PVPA.)
• 1987 Ex Parte Allen (USPTO Commissioner)
• Higher animals eligible
• 1988 First animal patent issued to Harvard
  University for a cancer-susceptible transgenic
  mouse (the onco-mouse)

10
Patents for Human Therapeutic GenesHuman
Erythropoietin

• Amgens US Patent 4,703,008
• Issued Oct 1987.
• Claim 1
• 1. A purified and isolated DNA sequence encoding
  erythropoietin, said DNA sequence selected from
  the group consisting of (a) the DNA sequences
  set out in FIGS. 5 and 6 or their complementary
  strands the human erythropoietin gene

11
First Detour
Q A
Who owns your genes?
Depends if they are (1) in your body (you do)
or (2) having been extracted, and now in a test
tube (the hospital or lab)
See Moore v. Regents of U. of California (1990)
12
Detour (II)
Q A
If you arrange with the lab for you to preserve
ownership of your genes after isolation, who owns
them?
You do.
13
Detour (III)
If I have a patent on your isolated genes, can
you commercialize them?
Q A
No. You own the tangible, personal property, but
I own the intangible, intellectual property.
14
Detour (IV)
Q A
Can I use my patent on the isolated genes I now
own to stop you from metabolizing?
Of course not! Patents cover isolated genes not
the genes in the natural context.
15
Patents for Methods of Human Genetic Diagnoses

• Genetic diagnoses use correlations between
  isolated human gene sequence variants (e.g.
  mutants or SNPs) and disease.
• Examples Huntingtons (MGH) or Cystic Fibrosis
  (U Michigan and HSC Toronto) BRCA1 and BRCA2
  breast cancer (U Utah)

16
Second Detour In re Bilski (2008) Eligibility
of Abstract Methods

• A method for managing the consumption risk costs
  of a commodity sold by a commodity provider at a
  fixed price comprising the steps of
• initiating a series of transactions between said
  commodity provider and consumers of said
  commodity wherein said consumers purchase said
  commodity at a fixed rate based upon historical
  averages, said fixed rate corresponding to a risk
  position of said consumer
• identifying market participants for said
  commodity having a counter-risk position to said
  consumers and
• initiating a series of transactions between said
  commodity provider and said market participants
  at a second fixed rate such that said series of
  market participant transactions balances the risk
  position of said series of consumer transactions.
• This is a method of hedging risk, i.e., a
  business method

17
BilskiCourt of Appeals Analysis

• Bilskis claim is clearly to a process
• Although claim meets the dictionary definition of
  a process, that definition has been limited by
  the U.S. Supreme Court, e.g.,
• Eligible processes cannot include laws of nature,
  natural phenomena, or abstract ideas.
• Eligibility requires a two step test That the
  process be tied to (A) a machine or (B) to
  transformation of an article

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Analysis of the Machine or Transformation Test

• (A) Machine Is the Bilski claim to a financial
  process tied to a particular machine?
• No, Bilski admitted their claim is not limited to
  a particular machine or apparatus
• (B) Transformation What type of things
  constitute articles of matter?
• Physical objects or substances? YES, articles
• Electronic signals and data? MAYBE
• If data represents a physical object, e.g.,
  transformation of data representing body tissues
  into a visual depiction on a display? YES,
  article.
• Gathering data and making a determination based
  on that data? NO, not article.

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Application Of Transformation Sub-Test to
Bilski facts

• So, does the Bilski claim transform an article of
  matter?
• The data in Bilskis claims represents legal
  relationships and business risks, which are
  not physical objects or substances
• The data itself is not representative of
  physical objects or substances
• Thus the claims neither involve the
  transformation of any physical object or
  substance, nor an electronic signal
  representative of any physical object or
  substance.
• Conclusion Hedge process not eligible under
  either machine or transformation

20
In October 2009 Bilski was arguedbefore the
Supreme Court

• The USPTO argued for affirmance.
• Mr. Bilski argued for reversal.
• Case is under advisement.
• 20 amicus curiae briefs were filed.
• One from the American Medical Association and the
  American College of Medical Geneticswhy?
• Patents in the fields of diagnostic genetics and
  personalized medicine

21
1989 Pure Diagnostic Algorithms not Eligible -
In re Grams

• 1. A method of diagnosing an abnormal condition
  in an individualwith data resulting from a
  plurality of chemical and biological
  constituents comprising
• a performing a plurality of clinical
  laboratory tests on the individual
• b producinga first quantity representative of
  the condition of the individual
• c comparing the first quantity to a first
  predetermined value
• d upon determiningthat the individual's
  condition is abnormal, successively testing and
  
• e identifyinga subset of parameters
  corresponding to the abnormal condition

22
2009 Pharmacodiagnostics ClaimEligible -
Prometheus v Mayo

• A method of optimizing therapeutic efficacy for
  treatment of an immune mediated gastrointestinal
  disorder, comprising
• (a) administering a drug providing 6-thioguanine
  to a subject and
• (b) determining the level of 6-thioguanine in
  said subject,
• wherein the level of 6-thioguanine less than
  about 230 pmol per 8x108 red blood cells
  indicates a need to increase the amount of said
  drug subsequently administered to said subject
  and
• wherein the level of 6-thioguanine greater than
  about 400 pmol per 8x108 red blood cells
  indicates a need to decrease the amount of said
  drug subsequently administered

23
Prometheus v Mayo (2009) (contd)

• Court of Appeals held that both the steps
• (a) administering a drug and
• (b) determining the level are transformative.
• The steps are neither just natural correlations
  nor data gathering steps
• In contrast, the ineligible claims in Grams were
  data-gathering steps followed by an algorithm
• Conclusion Eligible

24
2009 Bio-Reference Labs v Ipsogen

• U.S.Patent No.7,429,456, Claim 1
• An in vitro method to determine the presence of
  the G1849T mutation in the JAK2 gene in a human
  patient comprising
• a) obtaining and analyzing a nucleic acid sample
  from the human patient
• b) detecting a T in the JAK2 gene at position
  2343 of SEQ ID NO 2 in the sample and
• c) recording the presence of a T in the JAK2
  gene at position 2343 of SEQ ID NO 2 in the
  sample.
• Is this claim patent eligible under Bilski and
  Grams?
• Stay tuned

25
2009 Association for Molecular Pathology et al
v US PTO

• BRCA1/2 gene patent case brought by the ACLU in
  the U.S. District Ct in New York
• November 1, 2009 Case survived a motion to
  dismiss
• Judge Sweet said
• The patents might grant Myriad ownership
  rights over products of nature, laws of nature,
  natural phenomena, abstract ideas and basic
  human knowledge and thought in violation of the
  First Amendment s protection over freedom of
  thought. Myriads ownership of correlations
  between certain BRCA1/2 mutations and an
  increased risk of breast and/or ovarian cancer
  might have inhibited further research on
  BRCA1/2 as well as genes that interact with
  BRCA1/2.

26
Conclusions

• Thirty years of expansion of patent eligibility
  animals, plants, genes, genetic diagnostics,
  software, business methods.
• Courts are now being asked to draw sharper lines
• So far the legislature (Congress) has stayed out
  of it

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Contact Information

• Jorge A. Goldstein, Ph.D., Esq.
• Sterne Kessler Goldstein Fox PLLC
• 1100 New York Ave
• Washington DC 20005
• Tel [phone] (direct)
• Fax [phone]
• E Mail jgold_at_skgf.com