the international treatment of biocultural property william fisher june 21, 2004

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 fashionQuinine in PeruTurmeric and Neem in IndiaRosy Periwinkle in Madagascar Plao-Noi and Pueraria in ThailandAfrican Soapberry in EthiopiaStevia rebaudiana Bertoni in

Paraguay

Neem tree

Traditional Uses in India cleaning teeth curing psoriasis control parasitic infections spermicide insecticide

W.R. Grace isolates and stabilizes azadirachtin1992: U.S. patent on stabilized solution1994: U.S. EPA approves “Neemix” as insecticide

Neem tree

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 ThailandTraditional 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 fashionQuinine in PeruTurmeric and Neem in IndiaRosy Periwinkle in Madagascar Plao-Noi and Pueraria in ThailandAfrican Soapberry in EthiopiaStevia rebaudiana Bertoni in

Paraguay

Potential Claimants in Case 1Individual owners of the plants or animals

from which the genetic material is takenThe nation from which the genetic material

is takenThe individual or company that purifies or

modifies the genetic material for therapeutic uses

The public

Potential Claimants in Case 2Individual owners of the plants or animals from

which the genetic material is takenThe nation from which the genetic material is

takenThe individual or company that purifies or

modifies the genetic material for therapeutic usesThe publicThe developers of biocultural knowledge

Rosy Periwinkle Potential Claimants


Madagascar


West Indies


Jamaica

Philippines


Eli LillyIndianapolis



Jamaica Philippines

West Indies

Madagascar

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 patentableThe plants themselves and knowledge of

how to use them are not “products of nature” doctrine nonobviousness novelty

Potential Claimants in Case 2Individual owners of the plants or animals from

which the genetic material is takenThe nation from which the genetic material is

takenThe individual or company that purifies or The individual or company that purifies or

modifies the genetic material for therapeutic modifies the genetic material for therapeutic usesuses

The publicThe developers of biocultural knowledge



Jamaica Philippines

West Indies

Madagascar

Possible Grounds for Allocating EntitlementsPossessionLabor-desert theoryUtilitarianismEnvironmentalismImperialismRespectNationalism

Possible Grounds for Allocating EntitlementsPossessionPossessionLabor-desert theoryUtilitarianismEnvironmentalismImperialismRespectNationalism

Cf. Allocating rightsto oil;Salmond on AdversePossession

Possible Grounds for Allocating EntitlementsPossessionLabor-desert theoryLabor-desert theoryUtilitarianismEnvironmentalismImperialismRespectNationalism

Divide rewards “equitably”between: (a) developers of thebiocultural knowledge;(b) drug companies

Possible Grounds for Allocating EntitlementsPossessionLabor-desert theoryUtilitarianismUtilitarianismEnvironmentalismImperialismRespectNationalism

Provide incentives for:--preservation of the knowledge;--willingness to disclose--collecting the knowledge--developing the drugs

Offset by:--social losses associatedwith monopoly pricing

Possible Grounds for Allocating EntitlementsPossessionLabor-desert theoryUtilitarianismEnvironmentalismEnvironmentalismImperialismRespectNationalism

(a) Preserve rainforests;(b) Reduce pesticide use;(c) Preserve biodiversity

Possible Grounds for Allocating EntitlementsPossessionLabor-desert theoryUtilitarianismEnvironmentalismImperialismImperialismRespectNationalism

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 EntitlementsPossessionLabor-desert theoryUtilitarianismEnvironmentalismImperialismRespectRespectNationalism

Much biocultural knowledgeis sacred;cf. “Moral Rights”

Possible Grounds for Allocating EntitlementsPossessionLabor-desert theoryUtilitarianismEnvironmentalismImperialismRespectNationalismNationalism

The government of eachnation has a right and dutyto 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 biodiversityParticipation

Training of local scientists in ICBG projects

Possible Reforms1) LDCs deny patent protection to drugs and plants developed from

local materials (novelty; naturally occurring substance)2) LDCs recognize prior user rights3) LDCs amend patent law to make plants or traditionally

medicinal uses thereof patentable locally4) DCs constrict rights associated with drug patents5) DCs treat holders of biocultural knowledge as coinventors6) Physical Exclusion of Bioprospectors7) National Natural Resources Laws8) Deals between individual countries and pharmaceutical firms

(e.g., Costa Rica; ICBG Projects)9) Cartel of Tropical Gene-Rich Countries10) 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 (Hatch-Waxman)

Possible Reforms1) LDCs deny patent protection to drugs and plants developed

from local materials (novelty; naturally occurring substance)2) LDCs recognize prior user rights3) LDCs amend patent law to make plants or traditionally


(e.g., Costa Rica; ICBG Projects)9) Cartel of Tropical Gene-Rich Countries10) TRIPS reform: violation of natural-resources laws =

affirmative defense (cf. inequitable conduct; patent misuse) or basis of a compulsory license

Possible Reforms1) LDCs deny patent protection to drugs and plants developed

from local materials (novelty; naturally occurring substance)2) LDCs recognize prior user rights3) LDCs amend patent law to make plants or traditionally


(e.g., Costa Rica; ICBG Projects)9) Cartel of Tropical Gene-Rich Countries10) TRIPS reform: violation of natural-resources laws =

affirmative defense (cf. inequitable conduct; patent misuse) or basis of a compulsory license

LD

CD

CL

DC

Int’

l

A Global Patent System?Unitary, global patents issued by branch offices of GPOSubject matter:

TRIPS standards [Living things; genes; software?]

First to file + provisional applications + prior-user rights1-year grace period for statutory barsEnglish Infringement

[Peripheral or central claiming?] [Equivalents doctrine?]

World Patent Court; judgments enforced by national courts

the international treatment of biocultural property william fisher june 21, 2004

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