Transcript The International Treatment of Biocultural Property

The International Treatment of
Biocultural Property
William Fisher
June 21, 2004
Ways in which Plant-Derived
Drugs are Developed
(1) Random Screening
(2) Investigations by ethnobotanists, followed
by purification and testing
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
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
Neem tree
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
Rosy Periwinkle
Etching by Anne Stromquist
-- http://artangel.com/Stromquist/flower.html
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
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
Pueraria
Pueraria
 Located in Thailand
 Traditional Thai use:


estrogen booster
enlarges women’s breasts
 Two Japanese pharmaceutical companies
seeking patents on purified forms of its
active ingredient
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
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
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
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
Rosy Periwinkle Potential Claimants
Rosy Periwinkle Potential Claimants
Madagascar
Rosy Periwinkle Potential Claimants
West Indies
Rosy Periwinkle Potential Claimants
Jamaica
Philippines
Rosy Periwinkle Potential Claimants
Eli Lilly
Indianapolis
Rosy Periwinkle Potential Claimants
Eli Lilly
Indianapolis
West Indies
Jamaica
Madagascar Philippines
Related Problem
 Agricultural Companies derive superior
strains of crops from varieties cultivated by
traditional communities, then market them
world-wide
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
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
Rosy Periwinkle Potential Claimants
Eli Lilly
Indianapolis
West Indies
Jamaica
Madagascar Philippines
Possible Grounds for Allocating
Entitlements







Possession
Labor-desert theory
Utilitarianism
Environmentalism
Imperialism
Respect
Nationalism
Possible Grounds for Allocating
Entitlements







Possession
Labor-desert theory
Utilitarianism
Environmentalism
Imperialism
Respect
Nationalism
Cf. Allocating rights
to oil;
Salmond on Adverse
Possession
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
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
Possible Grounds for Allocating
Entitlements







Possession
Labor-desert theory
Utilitarianism
Environmentalism
Imperialism
Respect
Nationalism
(a) Preserve rainforests;
(b) Reduce pesticide use;
(c) Preserve biodiversity
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.”
Possible Grounds for Allocating
Entitlements







Possession
Labor-desert theory
Utilitarianism
Environmentalism
Imperialism
Respect
Nationalism
Much biocultural knowledge
is sacred;
cf. “Moral Rights”
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
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
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
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 (HatchWaxman)
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
Possible Reforms
Int’l
LDC
DC
LDC
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
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