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Human Growth Hormone

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Human Growth Hormone Whitney Laemmli IGSP Center for Genome Ethics, Law & Policy Summer 2005 Early hGH Development 1956-1958: Discovery of naturally-occurring human ... – PowerPoint PPT presentation

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Title: Human Growth Hormone


1
Human Growth Hormone
  • Whitney Laemmli
  • IGSP Center for Genome Ethics, Law Policy
  • Summer 2005

2
Early hGH Development
  • 1956-1958 Discovery of naturally-occurring human
    growth hormone and demonstration of its clinical
    efficacy
  • hGH deficiences associated with hypopituitarism,
    Turners syndrome, kidney disorders, short
    stature
  • 1974 Cho Hao Li patent on synthetic hGH
  • 1974 Cohen-Boyer patent application filed
  • 1975 Work on recombinant hGH begins at
    University of California San Francisco

3
University of California San Francisco
  • Peter Seeburg arrives at UCSF in 1975
  • Work in the Boyer, Goodman labs
  • Collaboration with John Baxter
  • Expression of rat growth hormone in 1977
  • Sequencing of the gene for human growth hormone
    in 1978

4
Intellectual Property at UCSF
  • Allocation of credit
  • New connections between academic science and the
    commercial realm
  • Conflicts intensified as a result of new
    commercial interests? A turning point?

5
Exodus to Genentech
  • 1976 Genentech formed by Robert Swanson and Herb
    Boyer
  • 1977 Genentech makes a proposal to AB Kabi on
    recombinant human growth hormone project
  • Mid-1978 exodus of UCSF scientists Seeburg and
    Shine join Genentech
  • Transfer of materials and The Midnight Raid

6
Genentechs Success
  • Plan is to construct a semi-synthetic gene
  • May 1979 Genentech successfully expresses hGH
  • July 1979 Genentech files a patent application
    and announces news publicly
  • 1985 FDA approves Protropin for use in children
    with hypopituitarianism

7
UCSF v. Genentech (19901999)
  • UCSF seeks 1.2 billion in damages from Genentech
    for patent infringement
  • Doctrine of Equivalence
  • Enablement
  • Willfulness

8
Issues raised at trial
  • Commercial pressure on Genentech from AB Kabi
  • Scientific ethics and the 1979 Nature article
  • Seeburgs royalties from the UCSF patent
  • Patenting and inventorship at Genentech
  • Transfer of materials between academia and
    biotech

9
UCSF v. Genentech Decision
  • Jury voted 8 -1 for patent infringement
  • Enablement charge found not valid
  • Genentech settled out of court for 200 million
  • 50 million toward new research building
  • 30 million to the UC general fund
  • 85 million split between the patent
    collaborators
  • 35 million to UCSF

10
Current Status of hGH
  • Marketed in some form by 8 companies
  • Wide illicit use in sports, anti-aging, beauty,
    etc.
  • 2003 FDA approved the use of hGH for otherwise
    healthy children of abnormally short stature
  • Current academic research on treatment of HIV,
    heart disease, aging related conditions

11
Citation Trends
12
Publication Trends
The availability of unlimited supplies of
recombinant human GH has led, not surprisingly,
to an extensive re-evaluation of clinical
indications, both in the traditional endocrine
setting and in the non-classical areas
Michael Sheppard Source Monson, John P., ed.
Challenges in Growth Hormone Therapy. Malden, MA
Blackwell Science, 1999.
13
Patenting Trends
14
Remaining Questions
  • Impact of the intellectual property history of
    hGH on its current status and future uses
  • Comparison of litigation history and licensing
    behavior in academia and industry
  • Analysis of the distribution of profits gleaned
    from hGH
  • Comparison of UCSF v. Genentech with other court
    cases involving growth hormone (ex. consolidated
    Eli Lilly cases)

15
Questions?
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