Intellectual Property

Rights

By

Arun

Viswanathan

M.Sc. BMB

14368005

Lets define

“The application of science and technology to living

organisms, as well as parts, products and models there of,

to alter living or non-living materials for the production of

knowledge, goods and services”

Biotechnology!

(Source: “A framework for biotechnology statistics”, OECD, Paris, 2005)

According to European Commission, biotechnology can be divided into

3 major streams.

Green Biotechnology

The use of genetically altered plants or animals to

produce more environmentally-friendly farming solutions as an

alternative to traditional agriculture, horticulture,

and animal breeding processes.

Red Biotechnology

Refers to the use of organisms in genetic

engineering processes in order to design and

manufacture pharmaceutical products

like antibiotics and vaccines.

White Biotechnology

Encompasses the application of

biotechnology-based tools to traditional industrial

processes to make intermediate and end-

products more efficiently with less

environmental impacts by making use of renewable

resources.

What is Intellectual Property?

• Examples of intellectual property– Include an author's copyright on a book– A distinctive logo design representing a soft drink company and its products, – Unique design elements of a web site– A patent on the process to manufacture chewing gum.

Intellectual property is an intangible creation of the human mind, usually expressed or translated into a tangible form that is assigned certain rights of property.

What is IPR?A general term covering Patents,

Copyright, Trademark, Industrialdesigns, Geographical indications,Protection of layout design ofintegrated circuits and Protectionof undisclosed information (tradesecrets).

It refer to the legal ownership by aperson or business of aninvention/discovery attached toparticular product or processeswhich protects the owner againstunauthorized copying or imitation.

(Source: Business Guide to Uruguay Round, WTO, 1995)

Types of IPR

• Patents

• Trademarks

• Registered Design

Industrial design rights, Supplementary protection certificates for pharma’ products , Database rights, Copyright, Domain names

• Trade secrets

• Circuit design rights

• Plant breeders' rights or Plant variety rights

Patents

• A patent is an exclusive right granted by law to applicants / assignees to make use of and exploit their inventions for a limited period of time (generally 20 years from filing).

• The patent holder has the legal right to exclude others from commercially exploiting his invention

• In return for exclusive rights, the applicant is obliged to disclose the invention to the public in a manner that enables others, skilled in the art, to replicate the invention.

• The patent system is designed to balance the interests of applicants and the interests of society

Conditions to be patentable

Novelty• The patenting invention should be novel or a satisfy -able improvement in old

patents.

• Information related to patents should be disclosed to public and should be available in prior

Inventiveness• A patent should be inventive

• It should be decided on the material contained in unpublished patents. The complexity or the simplicity of an inventive step not have any bearing on the grant of a patent.

Usefulness• An invention must possess utility for the grant of patent

• No valid patent can be granted for an invention devoid of utility

An invention must satisfy the following three conditions of:

Where to Apply?

• A patent application can be filed online or offline at respective patent offices which has specific territorial jurisdiction

• Territorial jurisdiction is decided by place of residence of applicant or place of invention or address of a office given by foreign applicant

Where to apply?

Patent office Territorial Jurisdiction

Mumbai Gujarat, Maharashtra, MP, Goa, UT’s daman & Diu, Dadra & Nagar Haveli

Delhi Haryana, HP, J&K, Punjab, Rajasthan, UP, NC Delhi,

Chennai AP, Kerala, Telangana, TN, PY, Lakdives

Kolkata (Head office) Rest of India

Where to Apply?

Hierarchy of patent office in India

Controller General of Patents, Designs, Trademarks & GI

Assistant Controller of patents & Designs

Deputy Controller of Patents & Designs

Joint Controller of Patents & Designs

Senior Joint Controller of patents & Designs

Examiners of Patents and

Designs

Patenting in India

Patenting in India

Som

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Som

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Compulsory patenting

• CL are made to prevent the abuse of patents as

monopoly & to make way for commercial

exploitation of the invention

• Any person can make an application for grant of CL. It

is given for a term of 3 yrs

• Cl is given for requirements of public, if product not

available for reasonable price, if patented work is not

in territorial jurisdiction of India

CL maybe granted under certain specific circumstances such as:

• Where a dependent patent is blocked;

• Where a patent is not being worked;

• Where the invention is of public interest such as foods or medicines and other essential commodities.

• An export market is not being supplied; or

• The working of any other patented invention which makes a substantial contribution is prevented; or

• The establishment of commercial or industrial activities in the country is unfairly prejudiced

Govt.’s Supreme Power

• Any patent issued by India can be used by gov. for its purpose with a order

• If gov. uses an invention before patenting it in India no royalty need to be paid to patentee. Otherwise an agreement on royalty is made by Gov. and party in HC

• Gov. can also undertake any patents if its contrary to public interest of gov or policies

Competition Policy of India

• Competition Act, 2002- a succesor of The Monopolies and Restrictive Trade Practices Act, 1969 (MRTP)

• the prohibition of the anti-competitive practices and agreements by way of exerting dominance and abusing this right relates directly to the Agri-biotechnology community in India

• Prohibition of terminator or the generic use restriction technologies (GURT) by Section 4 of CP Act 2002, DBT issued a circular for banning GURT based on this act

• Bt gene developed & patented by Monsanto was sold in India at Rs.900 for 450gms of seeds

• MRTP Commission was approached to investigate on 2006 and found that ‘commodity is overpriced’

• followed by various state governments imposing price controls under the Seed Control Order under Essential Commodities Act

• SC of India has not considered it fit to interfere with the orders of the MRTP Commission.

Competition Policy of India

Monsanto: the Microsoft of Agriculture

• Provide for the establishment of an effective system for protection of plant varieties, the rights of farmers and plant breeders and to encourage the development of new varieties of plants

• Ensures high quality seeds for farmers

• Respects activities of natural breeding and selection by farmers and ensure the rights of farmers

• Protect plant breeders right and thus boost development of new variety of palnts

Plant Variety & Farmer’s Rights Act, 2001

Duration of protection

• For trees and vines – 18 yrs.

• For other crops - 15 yrs.

• For extant varieties - 15 yrs

Exemptions

• Farmers’ Exemption:

Farmer shall be entitled to produce, save, use, sow, re-sow, exchange, share or sell his farm produce including seed of a variety protected under this Act.

• Researcher’s Exemption:

(i) the use of registered variety for conducting experiment.

(ii) the use of variety as an initial source of variety for the purpose of creating other varieties

Plant Variety & Farmer’s Rights Act, 2001

PPV & FR AUTHORITY, INDIA• The authority regulates plant registration in India• A plant variety (not wild) can be registered as a new variety

or as transgenic variety or extant variety• Registration can be done by farmer, breeder, research

institutes, University• Registration can be done by sending Seeds, Leafs, Live plants

or propagating material to regional or head office of authority

• The seed samples received by the Authority will be properly tested for its purity and germination.

• A part of the seed sample will be sent to the test centre for conduct of tests

• A part of it will be kept by the Authority in the National Gene Bank to maintain the seed samples of the registered varieties for their entire period of protection

• Authority issues specific guidelines to test each variety of plant

• Comprises Chairman, commissioner, registrar, assistant registrar

TRIPS Agreement• The Agreement on Trade-Related Aspects of Intellectual

Property Rights (TRIPS) is an international agreement by WTO that sets down minimum standards for many forms of IP regulation as applied to nationals of other WTO Members. It was negotiated at the end of the Uruguay Round of the General Agreement on Tariffs and Trade (GATT) in 1994.

• Specifically, TRIPS requires WTO members to provide – copyright rights, covering content producers including performers

producers of sound recordings & broadcasting organizations– GI, including appellations of origin– industrial designs; IC layout-designs– Patents, new plant varieties– TM and Trade secrets

• TRIPS also specifies enforcement procedures,remedies, and dispute resolution procedures.

• In 2001, developing countries, concerned that developed countries were insisting on an overly narrow reading of TRIPS, initiated a round of talks that resulted in the Doha Declaration.

The Doha declaration is a WTO statement that clarifies the scope of TRIPS, stating for example that TRIPS can and should be interpreted in light of the goal "to promote access to medicines for all.“

• DD also ensured that developing nations can issue CL on inventions related to HIV/AIDS and other epidemics

DohaDeclaration

•It also challenges TRIPS and allowed developing countries to make its own regime for IPR

•It enabled countries to acquire patent under emergency situations it faces

•The a of amendment of trips is currently extended since only 45 member nations are accepting the amendment

•Since then all developed countries including India stood along with Doha declaration

The Copyright Act1957

1958The Copyright Rules

1970The Patents Act

1999 International Copyright OrderThe TM ActThe GI of Goods Act

2003 The Patents RulesThe TM RulesThe PPV and FR Rules

2000 The Semiconductors IC Layout-Design ActThe Designs Act

2001The Designs RulesThe Semiconductors IC & LD RulesThe PPV and FR Act

2002 The GI of RulesThe Biological Diversity ActThe TM Rules

2004 The Biological Diversity Rules

2010 IPAB Rules and procedures

Rules & Laws : IPR in India

IPR & Corporate monopoly

''Granting exclusive patent rights amounts to stealing economic options of daily

survival from the developing world”

-Dr. Vandana Shiva-

India’s new IPR policy

• After series of Modi-Obama visits America promised of $ 4 billion investment

• The attack on India’s intellectual property rights became intense after 2012, when the Indian patent controller allowed local production of an expensive cancer drug which reduced its price by 97 percent (Novartis, Imatinib). The controller refused to grant patent to American pharmaceutical company, Gilead, for an extremely expensive drug for hepatitis C. The drug costs $ 1000 a pill in the US, while it can be produced locally at $ 1 a pill.

• India is on a “priority watch list” in America’s special 301 report, that identifies countries which do not provide "adequate and effective" protection of IPR or "fair and equitable market access to US persons that rely upon IPR.”

India’s new IPR policy

• It’s a globally acknowledged fact that India’s existing IPR policy regime, although against US & EU, has been a lifesaver for not just Indians, but also people from other developing countries

• Cancer drug Glivec, sold by Swiss Pharma company Novartis for more than Rs one lakh, is now available in the generic from for about Rs 8,800 and its price is likely to fall further

• Affordable Care Act (ACA), US by Obama

How India’s New IPR Policy can cause a genocide in S.AfricaIndia’s new IPR policyWith Indian generic companies entering in

voluntary licensing agreements with Gilead Sciences, the price of the drug was brought down from $1,000 per pill to $900 for a 12-week course for Indian patients.

Cipla is known for offering generic anti-retroviralsat $304 a year, or less than a dollar a day, when Pfizer was charging nearly $12,000 dollars per patient, per annum.

How India’s New IPR Policy can cause a genocide in S.Africa

Minister Aaron Motsoaledisays,

“Yes, I called it genocide because I was showing the number of people in sub-Saharan Africa who depend on generic anti-retrovirals, specially generics from India. I was showing them how many people will die if the policies change.” For instance, out of the 8 million people who are on anti-retrovirals in the world, 6 million are in Sub-Saharan Africa, most of them alive because of generics from India. If these six million do not have access to affordable generic anti-retrovirals, all of them will be gone. I mean, that’s genocide

Electrified the global health community a by producing cocktails of AIDS medicines for $1 per day.

Dr. Yusuf K. Hamiedthe modern world Robin Hood

Now it is 20 cents per day, & more than 6 million people in developing world now receive treatment.

In the past Indian companies would have launched generic versions in the developing world at lower rates, but in 2005 India adopted WTO-TRIPS obligations, making it difficult for Indian companies to make generics of patented drugs. But the country held on to crucial rights, including the right to grant a compulsory licence to local manufacturers in case of health emergencies

The seeds of Vandana Shiva

She started The Navdanya is a movement for Earth Democracy based on the philosophy of 'Vasudhaiv Kutumbakam' .

To protect the India's biodiversity based food heritage through Bija Swaraj, Ann Swaraj, Bhu Swaraj and Gyan swaraj

Through 'Bija Swaraj' they have created 122 Community Seed Banks in 18 states of India and Bhutan.

They also distributed the seeds of hope to the farmers after disasters like Odisha Super Cyclone, Tsunami, Floods in Uttarakhand, Phailin in Odisha, Earth quack of Nepal disaster without any money in return.

The seeds of

Vandana Shiva• Since 1991 they have been campaigning against GM crops and food in

India. Working with citizens' movements, grassroot organisations, NGOs and governments, they have made significant contributions to the Convention on Biological Diversity (CBD) and the BiosafetyProtocol.

• During the WTO Hong Kong Ministerial, Navdanya joined 740 other organisations in presenting their opposition to the WTO's stance on GMOs.

• Biopiracy: Navdanya started the campaign against biopiracy with the Neem Campaign in 1994 and mobilised 1,00,000 signatures against neem patents and filed a legal opposition against the USDA and WR Grace patent on the fungicidal properties of neem (no. 436257 B1) in the European Patent Office (EPO) at Munich, Germany.

• The patent on Neem was revoked in May 2000 and it was reconfirmed on 8 March 2005 when the EPO revoked in entirety the controversial patent, and adjudged that there was “no inventive step” involved in the fungicide patent, thus confirming the ‘prior art’ of the use of Neem.

The seeds of

Vandana Shiva• The next victory against "biopiracy" for Navdanya came in October 2004 when

the European Patent Office in Munich revoked Monsanto’s patent on the Indian variety of wheat “Nap Hal”.

• This was the third consecutive victory on the IPR front after Neem and Basmati(Taxmati by Ricetec). Monsanto was assigned a patent (EP 0445929 B1) on wheat on 21 May 2003 by the European Patent Office in Munich under the simple title “plants”.

• On January 27, 2004 Research Foundation for Science Technology and Ecology (RFSTE) along with Greenpeace and Bharat Krishak Samaj (BKS) filed a petition at the European Patent Office (EPO), Munich, challenging the patent rights given to Monsanto on Indian Landrace of wheat, Nap Hal. The patent was revoked in October 2004.

• Now leading a no GMO banana campaign against GM banana with enriched iron

That s all folks

Thank youCirrhosis.pptx by Arun Viswanthan is licensed under a Creative Commons Attribution 4.0 International License.