WTO- TRIPS Flashcards
IP
Intellectual property is the work of intellect or mind to create products that have the potential to have commercial use products like drugs, painting, literature etc.
IP Types
Patents: New, useful and non-obvious inventions, Exclusionary right
Copyrights: Creative and artistic works
Trademarks: Distinctive sign that is used to distinguish the products or services of different companies.
Industrial design right: Protects the form of appearance, style or design of an industrial object
Geographical Indicators
These are world famous goods that owe their origin to the region in which they originate and are nurtured. The climate, soil and native efforts of the region account for their fames, utility and qualities.
Gl is granted to a community or a group or an institution that represents the interest of the product. Generally not given to an individual.
Geographical indications of goods (Registration and Protection) Act, 1999:
-Provides for the registration and protection of geographical indicators related to goods in india.
Agreements on TRIPS
Agreement on TRIPS lays down legal standards for the member countries to protect intellectual property rights
TRIPS regulates dispute resolution procedures and enforcement procedures
Patent
A patent is an exclusionary right.
It grants the right to exclude others from making use of the patented invention for the given period of 20 years.
In return, the inventor offers to put the knowledge in public domain for use.
Rationale behind Patent:
Incentive for research and innovation.
Product Patent:
Absolute protection for the patent exhausting all processes that may lead to the product.
Process Patent:
Provide patent only for a particular method or process for preparation
It does not prevent someone to use other method or use reverse engineering to make the product.
Generic medicines are allowed
Special Case for CFD: TRIPS allow both product and process patent, Although only product patent can be given for - Chemical - Food - Drugs/Pharmaceutical
Developing countries:
TRIPS is an integrated package. Developing countries agreed to it because:
- Concessional terms
- Benefit in other fields like services
Safeguards on TRIPS
Parallel Imports:
-Importation of drugs from another country where they are sold at a lower price to meet a public health emergency.
- When patent holder company is unwilling to reduce the price for public health concern
Compulsory Licensing:
-Allows government to temporarily override a patent.
-Government issue a compulsory license to a company to produce generics when faced with a public health crisis.
- Three conditions for compulsory licensing:
i) German firm was able to supply its drugs to only 2% of the country’s patient population. Does not met the required ‘reasonable public access’ criteria
ii) Not reasonably affordable
iii) Imported and not manufactured.
Sui-generis System
TRIPS agreement provides Sui-generis option regarding patent laws.
Sui-generis means generating by itself or of itself
It is a choice given to members in place of patents
That is they can protect inventions either in the basis of TRIPS pattern or any other indigenous system
India and IPR
India has enacted several laws to protect IPR
Copyright Act
Trademark Act
Designs Act
Patent Act, 1970
Geographical Indications Act
India and TRIPS
India has met its entire TRIPS obligations in various stages starting from providing Mailbox applications in 1999 with retrospective effect
Amendment to the Patent Act in 2003
-This amendment brought the Indian Patent Act more or less on a par with the developed countries by providing a 20 year patent term
- Safeguarded national interest by remodeling compulsory license provisions by introducing Bolar and import Provisions
3rd Amendment to Patents act in 2005: Provided product patenting in pharmaceuticals, food, and chemicals, rationalizing and reducing timelines for processing of patent applications and doing away with Exclusive Marketing Rights
Patents Amendment Act, 2005
Product patent protection to food, pharma and chemicals.
Availability of pre grant and post grant challenge.
- Pre grand: Perhaps given before license is actually given e.g. Cipla filed against Gilead for Tamiflu
Discovery of new form of a known substance does not qualify for a patent nor mere discovery of any new property or new use of a known substance.
Introduction of provision for grants of compulsory licensing and parallel imports to meet public health crisis.
1970 Acts provided for process patents for drugs=> Allowed for Generic drugs by Cipla, Ranbaxy
Why India accepted TRIPS
Indian pharmaceutical industry is going global
More investment and FDI
Prices will not rise. DPCO will ensure essential drugs are under NELM
Compulsory licensing and parallel imports
97% of drugs manufactured in India are off-patents and will remain unaffected.
India accepted TRIPS: Criticisms
African countries depend upon Indian medicines,
2/3 of world’s population depends upon Indian Medicines
Patents being given for 20 years will stunt technological growth in India.
Cases
Tamiflu:
- Generic drug by Cipla
- CIPLA filed pre-grant opposition suit claiming Tamiflu does not have inventiveness or non-obviousness
- IPO denied the patent to Tamiflu
Gilvec by Novartis:
- Pharmaceutical efficacy
- No evergreening
Nexavar:
Compulsory licensing to Natco pharma
GATS
Full form: General Agreement on Trade in Services
Set of regulations that govern trade in services among the WTO countries
Broad range of economic activities: Health care, education, telecom, banking, insurance, BPO, tourism
India is interested.
With GATS, multilateral trading system extends to services for the first time.
GATT did not cover the services
GATS: Four modes of supply
Mode 1: Cross Border supply
Mode 2: Consumption Abroad
Mode 3: Commercial presence
Mode 4: Natural presence