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Biotechnology Patents Issues, Concerns, and Unintended Consequences

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Biotechnology Patents Issues, Concerns, and Unintended Consequences Do Biotechnology Patents Stifle Innovation? The Tragedy of the Anticommons Tragedy of the ... – PowerPoint PPT presentation

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Title: Biotechnology Patents Issues, Concerns, and Unintended Consequences


1
Biotechnology PatentsIssues, Concerns, and
Unintended Consequences
2
Do Biotechnology PatentsStifle Innovation?
3
The Tragedy of the Anticommons
  • Tragedy of the commons
  • Overuse of commonly owned resources results when
    there are no restrictions on use or incentives to
    conserve
  • Hardin, G. (1968) Science 1621243
  • Tragedy of the anticommons
  • Multiple owners of a given resource can result in
    underuse of that resource
  • So-called patent thicket threatens innovation
  • High transaction costs
  • Significant delays due to multiple negotiations
  • Failure to obtain only one of many licenses can
    derail project
  • Biomedical research particularly vulnerable
  • DNA, research tools, reagents
  • Heller, M.A and Eisenberg, R.S. (1998) Science
    280698

4
The Tragedy of the Anticommons
  • Common example- Golden Rice
  • Rice expressing pro-Vitamin A-three foreign genes
    two from daffodil one from a bacterium to combat
    vitamin A deficiency, a serious third world
    problem
  • Technology encompasses 40 patents and contractual
    obligations (MTAs) affecting commercial
    development
  • Madey v. Duke impact on academic freedom
  • Research exemption does not apply by virtue of
    non-profit status
  • Universities have commercial interests
  • Obtaining government and private grants
  • Sports marketing
  • Technology Transfer
  • Patent Trolls- Exert rights in large patent
    bundles
  • Time lost in litigation
  • Money lost rather than fighting

5
The Myth of the Anticommons
  • If tragedy of the anticommons exists, should
    see
  • Decrease in research development expenditure
  • Fewer innovative therapies tested
  • In fact, since 1998 see
  • Research development expenditures increased 60
  • Venture capital funding increased 200
  • Employment increased 21
  • Clinical trials increased 37
  • T. Buckley (2007) Biotechnology Industry
    Organization (BIO) White Paper

6
The Myth of the Anticommons
  • Madey v. Duke shows little impact on academic
    research
  • Only 8 of researchers report being aware of
    third party IP
  • Of the 8, 12 report changing their approach and
    16 report a delay of more than one month
  • However, this simply means academic researchers
    are routinely infringing patents.
  • Generally, companies are not exerting their
    patent rights against academic researchers- not
    biting the hand that feeds?
  • Will university technology transfer/licensing
    change this benevolence?
  • Academic DNA patent licensing practices are
    diverse and flexible
  • Non-exclusive licensing
  • Retained academic and humanitarian rights
  • Field restrictions
  • Patent pools

Source Walsh et al. (2005) Science 3092002-2003
Source Pressman et al. (2006) Nat. Biotechnol.
2431-39
7
Gene Patenting
8
Gene Patenting
  • Gene patenting has been possible since the
    Diamond v. Chakrabarty case
  • Claims drawn to isolated nucleotide sequence to
    avoid product of nature rejections
  • Both composition and method of use claims are
    possible
  • Compositions
  • Isolated nucleotide sequence
  • Expression vectors
  • Probes
  • Methods of use
  • Production of therapeutic proteins
  • Gene therapy
  • Diagnostics
  • Transgenic plants and animals

9
Gene PatentingThe Numbers
  • 4,270 patents claiming human DNA sequences
  • 63 patents owned by private firms
  • e.g., Incyte, Human Genome Sciences, Isis, Amgen,
    Glaxo, Millennium, Roche/Genentech, Celera
    (Applera), Myriad
  • Represents 4,382 genes or 20 of the human
    genome
  • 3,000 genes have only a single intellectual
    property rights holder

Source Jensen and Murray (2005) Science
310239-240.
10
Gene Patenting Controversy Public Awareness
  • Public awareness of gene patenting resulted from
    several events
  • High profile of the Human Genome Project
  • Publication of Next, introduction of Genomic
    Research and Accessibility Act and New York
    Times Op-Ed piece by Michael Chrichton
  • Legal Activities of Myriad Genetics
  • From awareness grew controversy

11
Gene Patenting Run Amok
  • Dramatic increase in the number of DNA sequence
    patents filed during Human Genome Project
  • Intellectual property land grab
  • Rush to file resulted in substandard patent
    applications claiming
  • DNA fragments
  • SNPs
  • Domains
  • Genes with no known function
  • Poor quality applications and public pressure
    forced a re-evaluation of patentability
    guidelines by USPTO
  • New guidelines issued in 2001 to ensure only
    tangible inventions receive protection

12
Gene Patenting Controversy The Myriad Firestorm
  • In 2001 Myriad Genetics begins to exert its
    patent rights relating to breast and ovarian
    cancer susceptibility genes, BRCA1 and BRCA2
  • Testing must occur solely through Myriad or its
    licensees
  • Test 3000
  • Opponents contend Myriad position restricts
    patient access
  • High cost
  • Not all insurance providers reimburse
  • Lack of second opinion opportunity
  • Opponents cite this as an example of private
    profit at public expense
  • Development costs significantly lower than
    biologics
  • Less regulatory hurdles for approval

13
Gene Patenting ControversySummary
  • Product of nature
  • Wheres the invention?
  • Genes must be isolated, altered to be patented
  • Ownership
  • How can a company own my genes?
  • Patents do not convey ownership
  • Limits to Access
  • Profits versus the public good

14
Stem Cell Patenting
15
Stem Cell Patenting
  • Stem cell patenting is in a position to be as
    controversial as gene patenting
  • Perfect storm conditions
  • Ethical, moral, religious issues
  • Federal research restrictions
  • Miracle cure aura
  • Intense media coverage
  • Ten year market potential of 4 billion
  • Arguments for and against stem cell patenting are
    similar to those of gene patenting

16
Stem Cell Patenting
  • Through 2005- Patents covering uses methods or
    compositions involving human or animal stem
    cells
  • 1,724 granted and 3,711 pending- USPTO
  • 421 granted and 560 pending- EPO
  • 4,265 published- PCT

Ownership of Granted Stem Cell Patents
Source Bergman Graff (2007) Nat. Biotechnol.
25419-424
17
Stem Cell Patenting
  • Currently, most of the controversial focus on
    stem cell patents is on three patents in
    particular
  • Primate Embryonic Stem Cells
  • US 5,843,780- Primate embryonic cells
  • US 6,200,806- Human embryonic stem cells (hES)
  • US 7,029,913- Cultures of hES cells
  • James A. Thomson, inventor
  • Wisconsin Alumni Research Foundation (WARF),
    assignee

18
Follow-On Biologics
19
Generic Drugs
  • Prior to 1984, FDA approval of generic drugs
    required the same clinical trials as brand-name
    drug
  • Duration and costs of trials had a dramatic
    negative impact on introduction of generics
  • Only 35 of brand-name drugs had generics
  • Drug Price Competition and Patent Term
    Restoration Act-1984 (Hatch-Waxman Act)
  • Sought to balance patent protection and generic
    drug availability

20
Generic Drugs
  • Long clinical trial times required by FDA before
    approval eats into patent life
  • Hatch-Waxman provides for patent extension- 100
    approval time and 50 of trial time maximum of 5
    years
  • Hatch-Waxman Abbreviated New Drug Application
    (NDA)- prove bioequivalence, not efficacy
  • Small molecules easy to demonstrate molecular
    equivalence
  • /- 20 bioavailability of brand-name
  • No generics approved within 5 years of brand-name
    approval, so-called data exclusivity
  • NDA data considered trade secret
  • Safe Harbor provision
  • Exempt from infringement if generating data for
    FDA
  • Established process for patent challenge

21
Summary Patent Issues in Biotechnology
  • Patents offer inventors a limited monopoly to
    their inventions in exchange for sharing the
    inner workings of those inventions with the
    public
  • Provides incentives to inventors
  • Stimulates innovation
  • Changes in case law that allowed the patenting of
    biological processes, components and organisms
    led to the advent of the biotechnology industry
  • Diamond v. Chakrabarty
  • The Bayh-Dole Act helped bring university
    research from the lab to the marketplace
  • A large percentage of university licensing is in
    the life sciences
  • Long development times and high costs of bringing
    biotech products to market make patents vital to
    the biotechnology industry
  • Biotechnology patents raise many ethical issues
    for the public
  • Patenting of life
  • The public good vs. private profits
  • Biotechnology companies and public policy makers
    must work together to ensure that patents
    continue to stimulate innovation and bring new
    diagnostic, preventative and therapeutic products
    to market
  • Avoid the anticommons
  • Preserve academic freedom
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