Intellectual Property and the Global Public Interest

The Role of Building IP Capacity in Developing Countries

Intellectual Property, Social Justice and the Global Public Interest

When properly managed, IP can advance social justice by facilitating equitable access to essential innovations in pharmaceuticals, vaccines and agricultural biotechnologies. This will promote the global public interest by improving basic health and nutrition, especially among the poor of developing countries, disproportionately represented by women and children.

Capacity it Key

Capacity in IP management and technology transfer is key for sustainable development. Capacity is the presence of trained and educated personnel, integrated with investments in physical and institutional resources.

• Narrow perspective … operational level• Examples of (patented) technologies applicable• Integration into a broader, development, perspective

IP Capacity Building: The “Narrow” Perspective

In developing countries, building and strengthening of human and institutional capacity in IP management will:

• Promote industrialized country entities to partner with developing countries in international development initiatives,

• Encourage developing countries to advance legal infrastructure congruent with their economic, urban and population growth,

• Rationalize valuation of native traditional knowledge and biodiversity resources,

• Foster domestic invention and innovation, and• Stabilize food and health security in many regions of the

world.

Examples of Biotechnological Innovations Serving the Global Public Interest

1. Golden Rice

2. Parasitic Roundworm Vaccine

3. Phytoremediation of Dioxin

4. Red Detect Landmine Detection System

Golden Rice

• Vitamin A deficiency is a global crisis. • 140 million preschool-age children and over 7

million pregnant women are afflicted. • Anemia, growth retardation, increased

infectious morbidity and death. • Greatest burden in among those from the

developing world

Global Level of VAD

Effects of VAD:Permanent eyeDamage and BlindnessBurden on thePoor in developingcountries

Golden Rice cont.

• “Golden Rice” is genetically engineered to accumulate beta-carotene (pro-vitamin A) in the grain and thereby provide a cost-effective means for production and delivery of vitamin A to those suffering from deficiency. However, this is a very complex biotechnological invention, embodying numerous patented technologies. This complicates transfer and restricts access.

The Complexity of Golden Rice

Gt1p psy (phytoene synthase) nos (ter)

35S (ter) aphIV (Hygromycin R) 35S (pro)

LB RB

35S (pro) tp crtI (phytoene desaturase) nos(ter)

pGt1psyH

psy (phytoene synthase)

pCPsyHDaffodil cDNA

Gt1p

pKS1Rice glutelin

promoter

pCIB900

pYPIET4

35S (pro) tp crtI (phytoene desaturase)nos(ter)

pSNIF83Pea RuBisCo transit peptide

pCRT-1Erwinia uredovorapBI121

pBin19hpc

nos(ter)

The Complexity of Golden Rice, cont.

23 USSchreier 1985Pea RuBisCo transit peptide - tp

No. of AssigneesNo. of PatentsReferenceComponent

21 JP

1 PCT

Okita et al 1989Rice glutelin promoter - Gt1p

None foundNone foundNopaline synthase terminator - nos(ter)

None foundNone foundCaMV35S Terminator -

35S(ter)

23 US

1 PCT

CaMV35S Promoter -

35S(pro)

11 USWaldron et al, 1985

Wunn et al, 1996

Hygromycin phosphotransferase -aphIV

63 US, 1 EP

1 JP, 3 PCT

Schledz et al, 1996Phytoene synthase -

Psy

21 US

2 PCT

Fraser et al, 1992Phytoene desturase -

crtI

Parasitic Roundworms (Ascaris)

• Ascaris is a parasitic roundworm that lives in the small intestine of humans.

• Worms can become quite large, up to one foot (30 centimeters) in length

• Ascaris is spread via fecal contamination; in the intestines, and in children can be quite serious, i.e., increased morbidity and mortality.

• Ascaris infections, known as ascariasis, are common throughout tropical regions of the world.

• Ascariasis is endemic in many developing countries: the number of infections is estimated at over one billion, with the greatest burden of suffering falling on the poorest people.

• Vaccines have been developed that immunize against nematode parasitic infections (e.g., Ascaris).

Parasitic Roundworm Ascaris

Ascaris bolus

Phytoremediation of Dioxin

• From 1961 until 1971 the U.S. military conducted a series of defoliation sprayings in Vietnam, and to a lesser extent in Cambodia and Laos. Codenamed “Operation Ranch Hand”.

• 13 million gallons were sprayed over 6500 square miles. The dominant herbicide used was Agent Orange, which is contaminated with highly toxic dioxin.

• In Vietnam, residual dioxin contamination in the soil has been linked to elevated risks of cancer and birth defects.

• Phytoremediation is the use of plants to remove pollutants (e.g., heavy metals, pesticides, explosives, toxic organics) from the soil, rather like a biological vacuum cleaner.

• Genetically engineered plants may will likely be able to not only extract but also detoxify dioxin from contaminated soils.

Agent Orange Application in Vietnam

Red Detect

• Landmine contamination, a persistently lethal problem, is another legacy or war.

• In 2004 there were 6000 worldwide casualties from landmine encounters, with the overwhelmingly majority occurring in developing countries.

• Among the most landmine-polluted countries is Cambodia; decades of war and social upheaval have left wounds still felt to this day.

• In 2004, Cambodia suffered 900 casualties from landmine encounters, a disproportionate number of whom are women and children.

• Common wounds include traumatic amputations and blindness. • A Danish company, in collaboration with the Danish army, has invented

the “Red Detect” landmine bio-detection system. In Red Detect, plants are genetically engineered to turn from green to red when grown in the vicinity of high explosives (TNT) leaching out of landmines.

Young Landmine Victim

The Red Detect Landmine System

Red Detect in Action

Carsten MeierInventor, Red Detect Mine Detection System

Yes but …..Once somebody “has” access to the patent

application, or document, then they can use the invention …. Correct?

Asparagus Bed (top view)

Asparagus Bed (Cross view)

Sprouts = patent

Crowns and roots,Hidden beneath the Surface =Essential know-how,Show-how,Trade secrets

Hybrid Licensing

• Technology transfer• Building partnerships in research and development• Trust, cooperation, collaboration• Capacity in IP is essential• Capacity building is two-way, that is, reciprocal• Not only about “getting” IP• Part of the larger development perspective

IP Capacity: The Broader Perspective, Comprehensive, Coordinated and Integrated

International DevelopmentInternational Development

Access to Essential

Technologies

Building Institutional Infrastructure

Institutional and Human IP Capacity

Idealistic and Naive?

Old Concepts, if Good, Come Back

Alliance for Progress of the early 1960s. Now long forgotten, the Alliance was a dynamic fusion of the practical wisdom of President Eisenhower and the empathetic vision of President Kennedy. Initially conceptualized by Eisenhower, the Alliance was implemented by Kennedy, who acutely knew that sustainable international development could only be realized via the difficult work of building institutional infrastructure in developing country partners. The Alliance died with Kennedy, and has been largely supplanted with alternate strategies of international development, e.g., the current U.S. efforts in the Middle East.

The Alliance for Progress

Partnerships in Development: IP Capacity is Fundamental

Product development partnerships are taking an increasingly dynamic role in addressing global concerns in public health and nutrition.

However, for sustainable development, the common cornerstone of every effort is the requirement for systematic establishment and strengthening of technology transfer and IP management capacity in developing countries.

Role of Pierce Law?

Formation of International Technology Development Institute

1.Contribute to published literature,2.Assist existing initiatives on relevant

projects,3.Work with developing countries to establish

technology transfer/IP management offices.

Existing Initiatives (we have worked with)

the Public-sector Intellectual Property Resource for Agriculture (PIPRA), www.pipra.org, an organization that seeks to facilitate access to intellectual property in order to foster the development and distribution of improved crops, for use in developing countries.

The Public Interest Intellectual Property Advisors (PIIPA), www.piipa.org, which seeks to make intellectual property counsel available, free or pro bono, for developing countries and public interest organizations, in order to promote agriculture, biodiversity, traditional knowledge and health care, and

The Centre for the Management of Intellectual Property in Health Research and

Development (MIHR), www.mihr.org, which seeks to promote access to health technologies in order to improve the well-being of poor people across the globe, via improved management of innovation and intellectual property in research and development.

Scholarship

Handbook of Best Practices in IP Management:• Funded by the Rockefeller Foundation• 2000 pages, over 150 chapters• Both paper and web versions• Subsidized distribution to developing countries.

Freedom to Operate Analysis

• Assist PIPRA in analysis of patent landscapes relevant to agbiotech to be deployed in developing countries

• Insect resistant sweet potatoes for equatorial Africa.

• Implemented as an advanced IP Tools course, with Professor Jon Cavicchi

• So far, three course and 10 students.

Pandemic Influenza Meeting

WIPO, Geneva Switzerland

Organized by MIHR

April 2006

Managing Patents that Impact Global Access to Influenza Vaccines

Technology transfer/IP management offices

• Educationally support the establishment and survival of technology transfer offices in developing countries

• Practical implementation of WIPO’s policy statements, which have stressed the importance of establishing IP institutions in developing countries.

• Successful institutional relationships leading to the establishment of technology transfer offices will increase the potential for technology transfer, development, innovation and utilization, at the national, and ideally, regional levels.

• Practical way for developing countries to management biodiversity and traditional knowledge resources.

Final Thoughts

This Handbook arises from the premise that developing the products of science and technology is of profound public benefit, a benefit that requires both scientific and industrial participation. This is a many-faceted concept, yet today we exist in an era of such pervasive scientific and technological advance that the development of these benefits, and their movement into commerce and among nations, warrant our most concerned efforts.

Judge Pauline Newman, CAFC

Public-Private Partnerships are needed to share research and development costs for “pro-poor” biotechnology.

Professor Norman Borlaug1970 Nobel Peace Prize, Presidential Medal of Freedom,

Congressional Gold Medal Recipient

Who are our clients?

PIPRA?

MIHR?

Developing country technology transfer/IP managers?