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Contents:
1. Prologue
2. Laws, Treaties and Reports to Remember
3. Important Terms
4. Historical Background
5. Provisions of IPA 1970
6. WTO and TRIPS
7. IPA 1970 Vs TRIPS
8. Laws Enacted to comply with TRIPS
9. The Novartis Saga
10. Supreme Court Verdict 2013
11. Novartis: Timeline
12. Misc
1. Prologue
Asked in Mains 2013, the importance of this topic much broader since it covers some more topics
in GS syllabus. They are
a. Effect of policies and Politics of developed and developing countries on Indias Interest.
b. Issues related to IPRs
c. International institutions, Agencies their structure and Mandate.
2. Laws, Treaties and Reports to Remember:
1. Patents Laws of British Model enacted in 1852, 1857 and 1859
2. The Indian Patents and Designs Act, 1911
3. Tek Chand Report, 1950 and Ayyangar Report, 1959
4. Indian Patents Act, 1970 amended in 1999, 2002, 2005
5. National Drug Policy, 1970, Drug Price Control Order, 1970 Replaced in
1995 and 2013, National Pharmaceutical Pricing Policy 2012 for 348
Essential Drugs under DPCO 2013.
6. Drugs and Cosmetics Act, 1940
7. Monopolies and Restrictive Trade Practices Act, 1969 replaced by Indian
Competition Act, 2002 as amended in 2007
8. WTO, TRIPS, WIPO
3. Important Terms:
(Some Important Definitions we should know to avoid confusions in further read)
(i)
Radical Innovation: Involves a new product, process (or) system that results from a
technological breakthrough. In Pharmaceuticals it has limitations like side effects, extremely
costly, high risk etc.,
(ii)
(iii)
(iv)
(v)
(vi)
(vii)
(viii)
(ix)
4. Historical Background:
Has beginning in the Act VI of 1856 based on British modeled Patent law of 1852. This had
some exclusive privileges granted to inventors of new manufacturers for a period of 14 years.
The Act was repealed followed by Act IX of 1859 gave exclusive provisions in order to help
British patent holders gain control over the Indian Markets.
The Patents and Designs Act of 1911 first introduced Controller of Patents. The term was 16
years from the date of filing the application. Extended upto 7 years for certain cases additionally.
The Act of 1911 prevented domestic pharma industry from making reverse-Engineered drugs
for which foreign pharma companies held patent rights in India.
After Independence, Our country in need of revamping since the Pharma industry in bad shape
compare to other industries. Prices of Life saving Medicines were high and controlled by MNCs
in the Late 50s.
First set up Tek Chand Committee in 1950 to look into matters prevailing in the Act of 1911
and in its report gave information about the failure of the industry to serve the main purpose.
Second committee setup under Justice Rajagopala Ayyangar in 1957 and based on this report
new law was enacted as Indian Patent Act 1970 and Indian Patent Rules 1972.
Law was enacted to suit changed political condition and economic needs for providing impetus
technological development by promoting inventive activities in the country.
From then because of the provisions of IPA 1970 India go on to become The Pharmacy of the
Poor (or) The Pharmacy of the Developing Countries
TRIPS
Process and product patents in almost all
fields of technology
(iii)
(iv)
(v)
(vi)
(vii)
Made some flexibilities to help domestic drug makers and so the people through
sec 3(d) to counter Ever Greening.
Ever Greening- Patentees kept on applying for new patent rights for their old
products though it is expired by modifying their earlier products a little.
Ever Greening results in monopoly in the market and Expensive.
Under Sec 3(d) patents would not be granted on following grounds only
a. Mere discovery of known substances does not result in the enhancement of the
known efficacy of that substance.
b. Mere discovery of any new property (or) new use for known substances
c. Mere use of a known process, Machine (or) employs at least one new reactant.
So simply Known Substance=Same Substance unless differ in property regard
to efficacy.
So Sec 3(d) is upheld. Domestic Drug maker and interest groups rejoiced over the verdict.
Novartis said its going to cut the spending in R&D in India.
US and other western lobbying MNCs on the SC verdict said, the consequences would be felt in
the future.