Historical Background
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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.
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The Act was repealed followed by Act IX of 1859 gave exclusive provisions in order to help British patent holders gain control over the Indian Markets.
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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.
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The Act of 1911 prevented domestic pharma industry from making reverse-Engineered drugs for which foreign pharma companies held patent rights in India.
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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 50’s.
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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.
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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.
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Law was enacted to suit changed political condition and economic needs for providing impetus technological development by promoting inventive activities in the country.
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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’
Provisions of IPA 1970
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The Act revoked product patent on Food, Medicines, Drugs, Chemicals either produced or prepared. It paved way for domestic generic drug makers use extensive technology of research fellows and manufactured huge sum of drugs, Thus making India ‘Pharmacy of the Poor’.
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Allowed making process patents for making pharmaceutical compounds.
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@present India is biggest producer of generic drugs by volumes & leading exporter of medicines to developing countries, Leading supplier of AIDS medicines. Before 1970 MNCs share was 68% in the market.
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Act imposed very broad ‘Compulsory Licensing’ for pharma process patents. Within 3 yrs of the grant, the patents were deemed ‘Right to license’. Means, anyone could use the process if they paid royalty to the patentee. It encouraged lot of competitors and household drug industry.
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It also given in cases of, Reasonable requirements of public not satisfied, Patented Invention is not available to public @affordable Cost and Patented Invention if not worked in the Territory of India.
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Simply put, Pharmaceutical products had no patents & Process patents were protected for only 3 years if a royalty given and 5 years if royalty not given.
WTO and TRIPS
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The End of Uruguay round in 1994 led establishment of WTO and so TRIPS(Trade Related Intellectual Property Rights). Countries signed WTO must adopt TRIPS Compliances.
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US led talks to make developing countries to come under its purview and to enact law to protect patent holder, piracy, dumping of products in International Market.
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TRIPS gave 10 yrs Waiver as transition period till 2005 to become fully compliance with its Laws to developing countries in place of ‘Green Box’ and ‘Exclusive Marketing Rights(EMR)’ provisions.
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‘Green Box’ proviso is applying for patents, for anything process(or) product, those who applied earlier given patent rights once the transition period completes and TRIPS compliances were fulfilled (Sort of ‘First Come First Serve’).
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EMR provisions were given to applicants in ‘Green Box’ and they all facilitated with supports from government to be big player in the Market.
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At the end of ‘Doha Development Round’ in 2001, the TRIPS under WTO allowed member countries to formulate laws within its framework & they are free to adopt national policies & ‘Right to Health’. Art 27 to 34 of TRIPS=Particularly to Patents.
IPA, 1970 Vs TRIPS
IPA, 1970
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TRIPS
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Only process not product patents in food, medicines and chemicals.
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Process and product patents in almost all fields of technology
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Term of patents 14 years; 5-7 years in chemicals, drugs.
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Term of patents 20 years
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Compulsory licensing- In a compulsory license, a government can force the holder of a patent right to grant use to the state or others.
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Limited compulsory licensing- under specific circumstances only compulsory license can be granted.
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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)
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Almost all fields of technology patentable. Only area conclusively excluded from patentability is plant varieties; debate regarding some areas in agriculture and biotechnology
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Government allowed to use patented invention to prevent scarcity
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Very limited scope for governments to use patented inventions
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Laws Enacted to Comply with TRIPS
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The First Amendment of IPA, 1970:
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The Indian Patent (Amendment) Act 1999 was enacted after much deliberation and delay. Since India agreed to ‘Mail Box’ and ‘EMR’ provisions of TRIPS in 1995, it did not make them as a law. So US dragged India to WTO dispute settlement mechanism in 1997 and India ensured them in the amendment of 1999.
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The Second Amendment of IPA, 1970:
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The Indian Patents(Amendment) Act 2002 was further included the TRIPS compliance of patent term for 20 yearsThis Act also cemented India’s accession to the Paris Convention & Patent Co-operation Treaty (1970).These two treaties are part of WIPO (World Intellectual Property Organization) and India a signatory since 1998.Paris Convention’s national treatment principle- Prohibits discriminating treatment of foreign applicants as well as its rights of priority.The Amendment also includes new definition for ‘invention’ and ‘Inventive Step’.Also included patentability of micro-organisms and gave broader definitions to ‘Compulsory Licensing’.
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The Last Amendment:
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Much important Indian Patents (Amendment) Act, 2005 was the last step to fulfill TRIPS compliances.For the first time since 1970, India allowed patents protection to substances & being used in Food, Medicines, Agro Chemicals etc.,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 onlyMere discovery of known substances does not result in the enhancement of the known efficacy of that substance.Mere discovery of any new property (or) new use for known substancesMere 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.
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