The International Treatment of Biocultural Property

1
The International Treatment of Biocultural
Property

• William Fisher
• June 21, 2004

2
Ways in which Plant-Derived Drugs are Developed

• (1) Random Screening
• (2) Investigations by ethnobotanists, followed by
  purification and testing

3
Ways in which Plant-Derived Drugs are Developed

• (1) Random Screening
• (2) Investigations by ethnobotanists, followed by
  purification and testing
• Disagreement concerning the relative efficacy of
  these two approaches
• --ICBG-Peru Project estimates (2) is 4 times
  more efficient

4
Examples of Plants developed in the second fashion

• Quinine in Peru
• Turmeric and Neem in India
• Rosy Periwinkle in Madagascar
• Plao-Noi and Pueraria in Thailand
• African Soapberry in Ethiopia
• Stevia rebaudiana Bertoni in Paraguay

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Neem tree
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Neem tree

• Traditional Uses in India
• cleaning teeth
• curing psoriasis
• control parasitic infections
• spermicide
• insecticide
• W.R. Grace isolates and stabilizes azadirachtin
• 1992 U.S. patent on stabilized solution
• 1994 U.S. EPA approves Neemix as insecticide

7
Rosy Periwinkle
Etching by Anne Stromquist -- http//artangel.com
/Stromquist/flower.html
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Rosy Periwinkle

• Species probably originates in the West Indies,
  spreads to many tropical countries, including
  Madagascar
• Traditional Uses
• treatment of diabetes (reported in Jamaica and
  Philippines)
• treatment of sore throat, pleurisy, dysentery

9
Rosy Periwinkle

• Eli Lilly tests samples from Madagascar
• ineffective for diabetes
• effective for childhood leukemia
• Eli Lilly secures patents on two derivatives --
  vincristine and vinblastine
• increase remission rate from 20 to 80
• annual revenue exceeds 200,000,000

10
Pueraria
11
Pueraria

• Located in Thailand
• Traditional Thai use
• estrogen booster
• enlarges womens breasts
• Two Japanese pharmaceutical companies seeking
  patents on purified forms of its active ingredient

12
Examples of Plants developed in the second fashion

• Quinine in Peru
• Turmeric and Neem in India
• Rosy Periwinkle in Madagascar
• Plao-Noi and Pueraria in Thailand
• African Soapberry in Ethiopia
• Stevia rebaudiana Bertoni in Paraguay

13
Examples of Plants developed in the second fashion

• Quinine in Peru
• Turmeric and Neem in India
• Rosy Periwinkle in Madagascar
• Plao-Noi and Pueraria in Thailand
• African Soapberry in Ethiopia
• Stevia rebaudiana Bertoni in Paraguay

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Potential Claimants in Case 1

• Individual owners of the plants or animals from
  which the genetic material is taken
• The nation from which the genetic material is
  taken
• The individual or company that purifies or
  modifies the genetic material for therapeutic
  uses
• The public

15
Potential Claimants in Case 2

• Individual owners of the plants or animals from
  which the genetic material is taken
• The nation from which the genetic material is
  taken
• The individual or company that purifies or
  modifies the genetic material for therapeutic
  uses
• The public
• The developers of biocultural knowledge

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Rosy Periwinkle Potential Claimants
17
Rosy Periwinkle Potential Claimants
Madagascar
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Rosy Periwinkle Potential Claimants
West Indies
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Rosy Periwinkle Potential Claimants
Jamaica
Philippines
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Rosy Periwinkle Potential Claimants
Eli Lilly Indianapolis
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Rosy Periwinkle Potential Claimants
Eli Lilly Indianapolis
West Indies
Jamaica
Philippines
Madagascar
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Related Problem

• Agricultural Companies derive superior strains of
  crops from varieties cultivated by traditional
  communities, then market them world-wide

23
Current Patent Law

• Purified forms of the drugs are patentable
• The plants themselves and knowledge of how to use
  them are not
• products of nature doctrine
• nonobviousness
• novelty

24
Potential Claimants in Case 2

• Individual owners of the plants or animals from
  which the genetic material is taken
• The nation from which the genetic material is
  taken
• The individual or company that purifies or
  modifies the genetic material for therapeutic
  uses
• The public
• The developers of biocultural knowledge

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Rosy Periwinkle Potential Claimants
Eli Lilly Indianapolis
West Indies
Jamaica
Philippines
Madagascar
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Possible Grounds for Allocating Entitlements

• Possession
• Labor-desert theory
• Utilitarianism
• Environmentalism
• Imperialism
• Respect
• Nationalism

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Possible Grounds for Allocating Entitlements
Cf. Allocating rights to oil Salmond on
Adverse Possession

• Possession
• Labor-desert theory
• Utilitarianism
• Environmentalism
• Imperialism
• Respect
• Nationalism

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Possible Grounds for Allocating Entitlements

• Possession
• Labor-desert theory
• Utilitarianism
• Environmentalism
• Imperialism
• Respect
• Nationalism

Divide rewards equitably between (a)
developers of the biocultural knowledge (b) drug
companies
29
Possible Grounds for Allocating Entitlements

• Possession
• Labor-desert theory
• Utilitarianism
• Environmentalism
• Imperialism
• Respect
• Nationalism

Provide incentives for --preservation of the
knowledge --willingness to disclose --collecting
the knowledge --developing the drugs Offset
by --social losses associated with monopoly
pricing
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Possible Grounds for Allocating Entitlements

• Possession
• Labor-desert theory
• Utilitarianism
• Environmentalism
• Imperialism
• Respect
• Nationalism

(a) Preserve rainforests (b) Reduce pesticide
use (c) Preserve biodiversity
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Possible Grounds for Allocating Entitlements

• Possession
• Labor-desert theory
• Utilitarianism
• Environmentalism
• Imperialism
• Respect
• Nationalism

President Mwinyi Most of us in developing
countries find it difficult to accept the notion
that biodiversity should flow freely to
industrial countries while the flow of
biological products from the industrial
countries is patented, expensive and considered
the private property of the firms that produce
them. This asymmetry reflects the inequality of
opportunity and is unjust.
32
Possible Grounds for Allocating Entitlements

• Possession
• Labor-desert theory
• Utilitarianism
• Environmentalism
• Imperialism
• Respect
• Nationalism

Much biocultural knowledge is sacred cf. Moral
Rights
33
Possible Grounds for Allocating Entitlements

• Possession
• Labor-desert theory
• Utilitarianism
• Environmentalism
• Imperialism
• Respect
• Nationalism

The government of each nation has a right and
duty to protect its own citizens
34
What do the providers of Knowledge/Genetic
Material Want?

• Credit
• Co-inventor status
• Other forms of acknowledgment
• Payment
• Up-front fees for access
• Payments in stages as drugs are developed
• Share of profits if drug is successful
• Indemnification for the costs of preserving
  biodiversity
• Participation
• Training of local scientists in ICBG projects

35
Possible Reforms

1. LDCs deny patent protection to drugs and plants
   developed from local materials (novelty
   naturally occurring substance)
2. LDCs recognize prior user rights
3. LDCs amend patent law to make plants or
   traditionally medicinal uses thereof patentable
   locally
4. DCs constrict rights associated with drug patents
5. DCs treat holders of biocultural knowledge as
   coinventors
6. Physical Exclusion of Bioprospectors
7. National Natural Resources Laws
8. Deals between individual countries and
   pharmaceutical firms (e.g., Costa Rica ICBG
   Projects)
9. Cartel of Tropical Gene-Rich Countries
10. TRIPS reform violation of natural-resources
    laws affirmative defense (cf. inequitable
    conduct patent misuse) or basis of a compulsory
    license

36
Possible constrictions of the rights associated
with drug patents

• Expanded definitions of prior art (e.g.,
  elimination of publication requirement for
  inventions in use in other countries)
• Narrowing of the purified substance doctrine
• Elimination of extended term (Hatch-Waxman)

37
Possible Reforms

1. LDCs deny patent protection to drugs and plants
   developed from local materials (novelty
   naturally occurring substance)
2. LDCs recognize prior user rights
3. LDCs amend patent law to make plants or
   traditionally medicinal uses thereof patentable
   locally
4. DCs constrict rights associated with drug patents
5. DCs treat holders of biocultural knowledge as
   coinventors
6. Physical Exclusion of Bioprospectors
7. National Natural Resources Laws
8. Deals between individual countries and
   pharmaceutical firms (e.g., Costa Rica ICBG
   Projects)
9. Cartel of Tropical Gene-Rich Countries
10. TRIPS reform violation of natural-resources
    laws affirmative defense (cf. inequitable
    conduct patent misuse) or basis of a compulsory
    license

38
Possible Reforms

1. LDCs deny patent protection to drugs and plants
   developed from local materials (novelty
   naturally occurring substance)
2. LDCs recognize prior user rights
3. LDCs amend patent law to make plants or
   traditionally medicinal uses thereof patentable
   locally
4. DCs constrict rights associated with drug patents
5. DCs treat holders of biocultural knowledge as
   coinventors
6. Physical Exclusion of Bioprospectors
7. National Natural Resources Laws
8. Deals between individual countries and
   pharmaceutical firms (e.g., Costa Rica ICBG
   Projects)
9. Cartel of Tropical Gene-Rich Countries
10. TRIPS reform violation of natural-resources
    laws affirmative defense (cf. inequitable
    conduct patent misuse) or basis of a compulsory
    license

LDC
DC
LDC
Intl
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(No Transcript)
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A Global Patent System?

• Unitary, global patents issued by branch offices
  of GPO
• Subject matter
• TRIPS standards
• Living things genes software?
• First to file provisional applications
  prior-user rights
• 1-year grace period for statutory bars
• English
• Infringement
• Peripheral or central claiming?
• Equivalents doctrine?
• World Patent Court judgments enforced by
  national courts