“Public Health and Intellectual Property”

Presented by : Dr.Dawal SalveActivity Guide : Dr . V.K. Sonkar

Index• Role of innovation in health and its impact in

developing and underdeveloped countries.• Understanding 3D cycle of innovation• Role of patent system in health• Understanding WTO and TRIPS• Disadvantage of TRIPS• India and TRIPS implementation• Indian history of patent system• Trade in health services• Recent updates in India in implementing TRIPS.

Health, wealth and poverty• By 2003 about 5.3 billion people in developing

countries (80% of the total worlds population)• Poverty affects purchasing power and in turn

demand.World bank categorizes as per capita incomeLow income countries - US $ 825 or lessLower middle income countries-US $ 3325 (India

1489)Upper middle income countries – US $ 10065

TABLE 1.4 WORLD PHARMACEUTICAL MARKET BY REGION (US$ BILLION,EX-MANUFACTURER PRICES)

• REGION 2004 2005 GLOBAL SHARE OF SALES 2005 (%)

• North America 249.0 268.8 44.4• Europe 169.2 180.4 29.8• Japan 66.1 69.3 11.4• Oceania 7.1 7.7 1.3• CISa 4.2 5.0 0.8 • South-east Asia 25.3 28.8 4.6• Latin America 24.4 26.6 4.4• Indian subcontinent 6.6 7.2 1.2• Africa 6.3 6.7 1.1• Middle East 4.7 4.9 0.8• Total world market 562.9 605.4 100.0

Changing disease trends

• Emergence of HIV/AIDS since 1980 with resurgence of TB and Malaria in developing countries.

• Diseases of poverty• Double scourge of communicable and non

communicable diseases.• Non communicable diseases will cause twice

death than the communicable diseases by 2015.

Ways towards better health

• Prevention of various kind which involves choice among biomedical intervention

• Behavioral change or eradication of vector• Cure with existing treatment• Search for an important method of prevention

diagnosis or treatment

Health development and MDG

• Health and development are complementary• Reduction of child mortality by two thirds between 1990

and 2015 (goal 4, target 5)• Reduction of maternal mortality by three quarters (goal

5, target 6), • Halting by 2015 and beginning to reverse the spread of

HIV/AIDS (goal 6, target 7), halting by 2015 • Beginning to reverse the incidence of malaria and other

major diseases (goal 6, target 8)• Cooperation with pharmaceutical companies, providing

access to affordable essential drugs in developing countries (goal 8, target 17)

Health development and MDG

• Halving the proportion of people living in extreme poverty or hunger (goal 1, targets 1 and 2)

• Universal primary education (goal 2)• Eliminating gender disparities in education

(goal 3, target 4)

Progression towards MDG • HIV/AIDS reversal is short fall• Malaria face the resistance problem• Progress to child mortality is mixed• Maternal mortality progress is poor• Progress in halting and reversing TB is hardly

better.

Desired characteristic of public health intervention

• Available in sufficient quantities• Accessibility• Effective and good quality• Lowest possible cost to facilitate the access

Defining the problem

• Type I disease : Incident in both rich and poor• Type II disease : Incident in both but

substantial proportion in poor • Type III disease: Overwhelmingly and

exclusively incident in developing countries.

Economics of innovation and access

• Demand

• Supply: i) Discover phase ii) Development phase iii) Delivery phase

Development

DeliveryDiscovaryi

3D innovation cycle

Role of patent

• Incentive function• Transactional function• Disclosure function• Signaling function

GATT and the World Trade Organization(WTO)

• The General Agreement on Tariffs and Trade (GATT) was a multilateral agreement regulating international trade signed in 1947 and lasted until 1994.

• Replaced by the World Trade Organization (WTO)in 1995.

• There are a total of 157 member countries in the WTO, with Russia and Vanuatu being new members as of 2012.

World Trade Office(WTO)

• Location: Geneva, SwitzerlandEstablished:1 January 1995Created by: Uruguay Round negotiations (1986-94) Membership: 157 countries on 24 August 2012Budget: 196 million Swiss francs for 2011Secretariat staff: 640Head: Pascal Lamy (Director-General)

• Functions:• Administering WTO trade agreements• Forum for trade negotiations• Handling trade disputes• Monitoring national trade policies• Technical assistance and training for developing countries• Cooperation with other international organizations

Trade and health

Thirteen

multilateral

agreements on

trade in

goods

General Agreeme

nt on

Trade in Services

Agreement on

Trade-

Related Aspects of

Intellectual Propert

y(TRIPS)

World Trade Organization

What are intellectual property rights?

• Intellectual property rights are the rights given to persons over the creations of their minds.

• They usually given the creator an exclusive right over the use of his/her creation for a certain period of time.

What are intellectual property rights?(i) Copyright and rights related to copyright.• The rights of authors of literary and artistic works• The main social purpose of protection of copyright

and related rights is to encourage and reward creative work.

(ii) Industrial property. a) Protection of distinctive signs, trademark and

geographical indications. b) In this category fall inventions (protected by

patents), industrial designs and trade secrets.

Intellectual Property Rights

• Set of exclusive rights granted to the owner of intellectual property

• Patents• Trademark• Copyrights• Industrial designs• Plant varieties protection• Trade secrets and geographical indications

Trade-Related Aspects of Intellectual Property(TRIPS).

• Minimum standards for governing the scope availability and use of intellectual property, including

medical technologies and pharmaceuticals• Trade-Related Aspects of Intellectual Property

Agreement extends patent protection, including both product and process patenting, to a minimum of 20 years from the filing date

International trade regime

• Trade related intellectual property established by the WTO reduces space of countries with regard to access of medicine and health service.

• Transition period for developing and least developed countries.

Nature of TRIPS obligation

• Compulsory product patents for pharmaceuticals and agro-chemicals,20 year duration of protection.

• Transitional period provided to developing countries to comply .

Developing countries transition periods

• Developing countries and economies in transition from central planning did not have to apply most provisions of the TRIPS Agreement until 1 January 2000. Least-developed countries were given until 1 January 2006.

DOHA DECLARATION ON THE TRIPS AGREEMENT AND PUBLIC HEALTH (2001)

• Recognize the gravity of the public health problems

• The need for the WTO agreement on trade-related aspects of intellectual property rights (trips agreement) to be part of the wider national and international action.

• Recognize that intellectual property protection is important for the development of new medicines.

DOHA DECLARATION ON THE TRIPS AGREEMENT AND PUBLIC HEALTH(2001)

• Agree that the TRIPS agreement does not and should not prevent members from taking measures to protect public health

Disadvantage of TRIPS • For the developing and underdeveloped

countries it takes away the freedom to decide the level of IP protection in members country.

• Patent protection -Denial of access to medicine by developing and

least developed countries. -Monopoly for limited number of years.

India and TRIPS Implementation• India as a member of WTO has an obligation under TRIPS

to comply with its patent provision.• First dead line 1995 to introduce mail box protection

and exclusive marketing rights (emr).• Second was in 2000 to comply with trips provisions on

duration of patent protection, compulsory license, extension of patent protection to microorganism etc.

• Third deadline was to introduce product patent protection for pharmaceuticals and agrochemicals by 1 January 2005.

India and TRIPS Implementation• Restricted approach to the scope of patentability by

India . Not eligible for patent protection -known substance -substance obtained from by a mere admixture• Indian Patents Act provides strong provisions against

abuse of patented invention• The Act contains compulsory license and government

use provisions.• Patent Act also allows parallel importation, which allows

third parties to import the patented article.

Indian patent act and TRIPSIndian Patent Act of 1970 TRIPs

Only process not product patents in food, medicines, chemicals

Process and product patents in almost all fields of technology

Term of patents 14 years; 5-7 in chemicals, drugs

Term of patents 20 years

Compulsory licensing and license of right Limited compulsory licensing, no license of right

Several areas excluded from patents (method of agriculture, any process for medicinal surgical or other treatment of humans, or similar treatment of animals and plants to render them free of disease or increase economic value of products)

Almost all fields of technology patentable. Only area conclusively excluded from patentability is plant varieties; debate regarding some areas in agriculture and biotechnology

Government allowed to use patented invention to prevent scarcity

Very limited scope for governments to use patented inventions

Compulsory licensing• Government allows someone else to produce the

patented product or process without the consent of the patent owner.

• The person or company applying for a license must have first attempted, unsuccessfully, to obtain a voluntary license from the right holder on reasonable commercial terms .

• If a compulsory license is issued, adequate remuneration must still be paid to the patent holder.

• National emergency, extreme emergency, public non commercial use etc.

IMPORTING UNDER COMPULSORY LICENSING

• TRIPS Agreement says products made under compulsory licensing must be “predominantly for the supply of the domestic market”

• Impact on the countries which can not manufacture the drug.

• This was sorted out in 2003 when WTO members agree to legal changes for importing medicines.

History of Indian Patent System

• 1856:THE ACT VI OF 1856 ON PROTECTION OF INVENTIONS. -To encourage the inventions -To induce inventor to disclose their secretes of inventions.

• 1859:THE ACT MODIFIED AS ACT XV; - Grant of exclusive privileges to useful inventions only . - Extension of priority period from 6 months to 12 months. - This Act excluded importers from the definition of inventor.

• 1872:THE PATENTS & DESIGNS PROTECTION ACT. - To provide protection relating to designs.

History of Indian Patent System

• 1883:THE PROTECTION OF INVENTIONS ACT.

• 1888:CONSOLIDATED AS THE INVENTIONS & DESIGNS ACT.

• 1911:THE INDIAN PATENTS & DESIGNS ACT. - This Act brought patent administration under the management of

Controller of Patents for the first time - Amended in 1930 increase term of the patent from 14 years to 16

years

• 1972:THE PATENTS ACT (ACT 39 OF 1970) CAME INTO FORCE ON 20TH APRIL 1972.

History of Indian Patent System

• 1999:ON MARCH 26, 1999 PATENTS (AMENDMENT) ACT, (1999) CAME INTO FORCE FROM 01-01-1999.

• 2002:THE PATENTS (AMENDMENT) ACT 2002 CAME INTO FORCE FROM 2OTH MAY 2003

• 2005:THE PATENTS (AMENDMENT) ACT 2005 EFFECTIVE FROM IST JANUARY 2005.

WHAT IS A PATENT?

Is an exclusive right awarded to an inventor to prevent others from making, selling,

distributing, importing or using their invention, without license or authorisation from the

patent holder for a fixed period of time (TRIPS Agreement stipulates at least 20 years of

protection).

What does “generic” mean?

• Dictionaries tend to define a “generic” as a product — particularly a drug — that does not have a trademark.

• Sometimes “generic” is also used to mean copies of patented drugs or drugs whose patents have expired .

• Generic copies are legal from the patent point of view when they are made after the patent has expired or under voluntary or compulsory licsence — but pirated and counterfeit products are by definition illegal.

REQUIREMENTS FOR PATENTABILITY OF AN

INVENTION

1. Novelty- New characteristics which are not “prior art”.

2. An Inventive Step – Not obvious to one skilled in the field.

3. Industrial Applicability.

WHAT IS THE IMPLICATION OF PATENTS ON HEALTH?

1. Patent Rights on Medicines lead to Monopoly Pricing, Affordable only to the Rich.

E.G, a 20 year Patent for an Essential Medicine will mean that only the Patent holder can produce it for that period, before Competitors can be permitted to

produce it.

And during the 20 years, the Patent holder can most likely produce less than the required quantities and sell at

high prices.

IMPLICATION OF PATENT ON HEALTH CONTINUED

2. A Patent gives the holder the Right to exclude Competition.

3. Right to set prices at what the Market will bear. E.G, “Research Based” Pharmaceutical Companies (Basically Multinational Cos) use the protection & enforcement of Patents & Test Data to gain monopoly rights which then allows them to charge very high prices & obtain profitability.

Trade in health service• The growing potential for trade in health services:• Decline in public sector expenditure on health services

and the rise of private sector participation in healthcare;

• Liberalization of related sectors like insurance and telecommunications services;

• Increasing mobility of consumers and health service providers;

• Technological developments enabling cross-border delivery of health services .

Trade in health service

WHO has identified three policy objectives• Equitable access to health services, • Quality of health services and • Efficient allocation of resources for health Services.

Mode of delivery of the Service Kind of service delivered

Cross-border service (mode 1) Shipment of samples, diagnosis, clinical consultation via traditional mail channels.Electronic delivery of health services like telemedicine, telesurgery, telediagnosticservices; medical back office services, medical transcription services and onlinemedical education services.

Consumption abroad (mode 2) Medical tourism for super specialty medical services and alternative systems of healthcare.

Commercial presence (mode 3) Establishment of super specialty hospitals and clinics, diagnostic and treatmentcentres in collaboration between domestic and foreign health services providers,health insurance services and hospital management services.

Movement of natural persons (mode 4) Services of doctors, surgeons, nurses and midwives in foreign countries.

Trade in health service

Recent updates….• Health ministry govt. of India pushes for end to

sale of branded drugs.(Times of India Oct.2012)• Govt. order to state not to issue license to the

trade name and promote the generic medicines.

Natco’s compulsory licence for selling generic copies of Bayer’s cancer drug Nexavar upheld by Ipab4 MAR, 2013, 07.56PM IST, SANJAY VIJAYAKUMAR,ET BUREAU

• The Intellectual Property Appellate Board has upheld the compulsory licence issued to Hyderabad-based Natco Pharma for selling generic copies of Bayer's cancer drug Nexavar, citing "affordability" and "product access" as the reasons for the decision.

References

• Text book of public health and community Medicine. Department of Community Medicine, AFMC Pune.

• Oxford Textbook of Public Health,4th edition.• http://www.wto.org/english/tratop_e/trips_e/publi

c_health_faq_e.htm accessed on 21/1/13.

• http://www.wto.org/english/thewto_e/whatis_e/who_we_are_e.htm accessed on 21/1/13.