PATENT EVER GREENING : LAW AND ETHICS

(ICIL- 2016, University of Pretoria, South Africa,

22-23 Feb. 2016)

Dr. Lisa P. Lukose Asso. Professor, USLLS

GGS Indraprsatha University, Delhi, India

“The idea of a better ordered world is one in which

medical discoveries will be free of patents and there

will be no profiteering from life and death.”

( Indira Gandhi, World Health Assembly, 1982)

Dr. LP Lukose, 2016

Patents and Human Rights

Right to access to medicines and right to health is prejudicially affected by strong patents

8,000 people around the world die every day

owing to non- accessibility to treatment

Only about one in ten people in urgent need of

HIV antiretroviral treatment in low- and

middle-income countries has access to existing

medicines.

Dr. LP Lukose, 2016

Interplay between Right to Health and Patents

Right to health: Human right, Constitutional right and legal right. It includes

•Access to timely, acceptable, and affordable health care of appropriate quality

• Most importantly access to essential medicines.

Basic aim of patents

- To reward inventor &

- To allow the inventor to recoup the investment

Dr. LP Lukose, 2016

PATENTS • Patents – Private Right

• Exclusive right, akin to monopoly

• All fields of science and technology

• 20 years duration

• Patentee can control the market, Manufacture, license, price etc.

• Patentability criteria: Novelty, Inventive step, industrial utility.

• Un-patentable invention: TRIPS Flexibility (art. 27 (3) &(4).

Dr. LP Lukose, 2016

PHARMA PATENTS/DRUG PATENTS

• Both product and process

• Help to Recoup the R&D costs

• Encourages R & D, new Drugs

• help prevent manufacture of counterfeit

• Prevent sub-standard drugs from fake ingredients & incorrect composition which can affect the public health at large in developing and least developed countries.

Dr. LP Lukose, 2016

NEGATIVE IMPACT / UNETHICAL PRACTICES

• Intersection between patents and access to medicine

• Patents on medicines can make the difference between life and death for millions

• The relationship between patent incentives and drug development is stronger for global diseases

• Weaker for neglected disease • Lack of access to essential medicines in the

developing countries • Unethical practices, clinical trails without

consent, or on poor people

Dr. LP Lukose, 2016

PATENT VIS A VIS PUBLIC HEALTH

- High prices of drugs - Patented product : (90% more priced) - Generic drugs -prices drop by 90%. - Delay in generic entry helps in extending the gap between innovation and access - Burdensome for the public health budgets and for the consumer.

Dr. LP Lukose, 2016

EVER GREENING OF PATENTS: UNETHICAL PRACTICE

• A trifling change is made to an existing product and claimed as a new invention - Perpetual renewal of patents - preventing competition.

• Deriving new products from existing compounds through minor changes to existing products, such as changing a drug’s dosage or changing a drug from a tablet to a capsule.

• These changes are typically made to blockbuster drugs shortly before their patents expire

Dr. LP Lukose, 2016

- ‘New use’ patents directly or indirectly supports ever-greening in the developed nations. - Low standard benchmark set by the US for inventive steps and utility, allowing trivial drug patents

National Institute of Health Care Management on Pharmaceutical Innovation - over 75% of the patented drugs are new forms of known substances, eliminate competition, extend monopolies, make drugs unaffordable and adversely affect the right to health (2002 Report)

Dr. LP Lukose, 2016

Patenting Secondary Innovations

• Derivatives, isomeric forms, dosing regimen, combinations, screening methods

• It is clever addition of patents to the product by the innovator companies.

• It forces the generic manufacturer to wait indefinitely for all the patents to expire

Dr. LP Lukose, 2016

• Extends the period of market exclusivity

• Delays the introduction of generic competition

• Adversely impacts public health

• Plays a detrimental role in driving out the domestic generic medicine market which provide access to vital medicinal or life saving drugs at affordable prices to lower section of the society

Dr. LP Lukose, 2016

Novartis AG v. Union of India

AIR 2013 SC 1311

• Gleevec per tablet is Rs. 4,115/-

• Resonance and Indian Generic drug company sells it at Rs. 30/- per tablet.

• The annual cost of the Gleevec - Rs.15,00,000/- in India

• Generic versions costs Rs.10,000/-.

Dr. LP Lukose, 2016

Novartis

• Novartis ranked in a total turn over of US $ 1.69 billion from US alone in 2012 from the drug, Gleevec.

• Gilead’s patent on Tamilflu

• 2010 quarter - $21.9 million

Dr. LP Lukose, 2016

TRIPS • Obligation of non-discrimination - patent shall be available and patent rights enjoyable without discrimination as to the place of invention, the field of technology and whether products are imported or locally produced. (Article 27, ¶3; Article 65, ¶4; Article 70, ¶8;) • April 2005 to March 2010 - 3,488 drug patents - more than 3,000 were granted to foreign pharma companies. • April 2010 and March 2013 - 1,001 drug patents -771 given to foreign drug makers(77%) pfizer inc., .Eli Lilly, Novartis AG and F Hoffmann La Roche Ltd ,

Dr. LP Lukose, 2016

Quagmire in Compulsory Licensing

• Article 31 TRIPS

• Para 6 of Doha Declaration on the TRIPS agreement and public health

• National emergency, extreme urgency, public non commercial use

• Voluntary license on reasonable commercial terms – reasonable time

• If a legal process has determined that the patentee has engaged in “anti-competitive” practices.

Dr. LP Lukose, 2016

• Compulsory license must be used “predominantly” for supplying in the domestic market (art. 31(f))

• Beneficiary of a compulsory license is a member that can set up manufacturing capacities

• Developing countries don’t have the ability to produce their own generic drugs and would need to import from other countries.

• Countries having a generic drug industry are not permitted under TRIPS to issue a compulsory license authorizing someone to make a patent-protected drug primarily for export to other countries.

Dr. LP Lukose, 2016

Natco v. Bayer

• Lung kidney cancer drug sorafenib (Nexavar)

• IPO - its first compulsory license to NATCO pharmaceuticals

• generic version of the drug which was under the patent of Bayer Corporation.

• the reasonable requirement of the public with respect to Nexavar was not met - Bayer supplied the drug to only 2%

• unreasonably high price (Rs 2.8 lakhs per months).

Dr. LP Lukose, 2016

Doha Declaration on TRIPS and Public Health

‘We affirm that the (TRIPS) Agreement can and should be interpreted and implemented in a manner supportive of WTO members’ right to protect public health and, in particular, to promote access to medicines for all…’

Real objectives of patents?

How to materialize?

Eg. Sec 3 (d) of Indian patent Act – un-patentable inventions

Dr. LP Lukose, 2016

Suggestions • TRIPS flexibilities, exceptions and exemptions

intended to safeguard special needs of the least-developed countries

• A number of loopholes and infirmities in TRIPS - seriously limit these countries’ efforts to address public health

• Need to restructure the agreement in the light of adequacy, affordability and accessibility of healthcare facilities.

Dr. LP Lukose, 2016

• At present, compulsory licensing is highly restrictive - limits distribution of essential drugs to the territorial boundaries of affected countries - runs counter to the spirit of the Preamble.

• To ensure right to access of essential medicines, the said restriction need to be relaxed to save patients in countries with inadequate production capacity.

Dr. LP Lukose, 2016

• Countries must penalise ever-greening practices by making necessary amendments in their patent laws

• Eg. Australian patent law ; Republic of Korea-United States Free Trade Agreement (KORUSFTA)

• Patents should no way result in non-availability and non-affordability of medicines.

Dr. LP Lukose, 2016