| The major concern that the social and economic costs | | | | • Exceptions from patentability; and |
| of introducing pharmaceutical patents are likely to | | | | • Limits on data protection |
| outweigh the benefits in the case of most developing | | | | India as a member of WTO, tried to make its patent |
| countries suggests a cautious approach to intellectual | | | | legislation TRIPS compliant by bringing into force the |
| property protection in the area of pharmaceuticals. On | | | | Patents (Amendment) Act 2005 w.e.f. 1st January, |
| the other side, there is also evidence that the patent | | | | 2005 which provided for product patents - a long |
| system has a detrimental impact on pharmaceutical | | | | debated issue globally and nationally. |
| prices, particularly if the product itself is protectable. | | | | Making the patent legislation in compliance with the |
| The WTO's Agreement on Trade-Related Aspects of | | | | TRIPS would put India in the row of nations having |
| Intellectual Property Rights (TRIPS) introduced | | | | strong patent legislation. Salient features of the Patents |
| intellectual property rules into the multilateral trading | | | | (Amendment) Act 2005 related to product patents:a) |
| system for the first time. The World Trade | | | | Extension of product patent protection to products in |
| Organization (WTO) is the only most powerful | | | | sectors of drugs, foods and chemical.b) Term for |
| legislative and judicial body which makes an economic | | | | protection of product patent shall be for 20 years.c) |
| relationship between trade and nations with its "free | | | | Introduction of a provision for enabling grant of |
| trade" agenda. | | | | compulsory license for export of medicines to |
| The Agreement on Trade Related Aspects of | | | | countries which have insufficient or no manufacturing |
| Intellectual Property Rights (TRIPS) is a treaty | | | | capacity; provided such importing country has either |
| administered by the World Trade Organization (WTO) | | | | granted a compulsory license for import or by |
| which sets down minimum standards for forms of | | | | notification or otherwise allowed importation of the |
| intellectual property (IP) regulation that was negotiated | | | | patented pharmaceutical products from India (in |
| at the end of the Uruguay Round of the General | | | | accordance with the Doha Declaration on TRIPS and |
| Agreement on Tariffs and Trade (GATT) treaty in | | | | Public Health)d) A new provision has been introduced |
| 1994. The new WTO regime effectively outlawed the | | | | that provides that the mere discovery of a new form |
| generic production of new medicines | | | | of a known substance which does not result in the |
| It was made mandatory by the WTO for its | | | | enhancement of the known efficacy of that |
| developing nations to fully abide by their IP laws and | | | | substance or the mere discovery of any new |
| enforcement practices with the agreement on TRIPS | | | | property or new use for a known substance or of the |
| by no later than 1st January 2005. It lays down | | | | mere use of a known process, machine or apparatus |
| minimum standards for protection and enforcement of | | | | unless such known process results in a new product |
| intellectual property rights in member countries which | | | | or employs at least one new reactant, shall not be |
| are required to promote effective and adequate | | | | patentable. |
| protection of intellectual property rights with a view to | | | | These amendments have been made with the |
| reducing distortions and impediments to international | | | | intention to make India drug and pharma industries |
| trade. For the least-developed countries (LDCs) the | | | | competitive at par with multinational companies. The |
| transition period will remain in force for pharmaceutical | | | | generic drugs would have a limitation and the MNCs |
| patents and data protection at least until 2016 under | | | | would enjoy monopolistic rights, however there is a |
| Article 66.1 of TRIPS under paragraph 7 of the Doha | | | | silver lining in this concept that it would attract contract |
| Declaration. | | | | R&D and therefore MNCs would prefer to open |
| Further, Article 27 of the TRIPS Agreement | | | | their R&D centers in India. |
| harmonizes the subject matter of patent in a broad | | | | The major concern arising out of these amendments |
| manner which clearly states that the patents shall be | | | | is increased prices of drugs thus creating problems for |
| available for any inventions, whether products or | | | | the poor. Resolving such a problem would not be easy |
| processes, in all fields of technology, provided that they | | | | but other regulatory mechanisms could be put in place |
| are new, involve an inventive step and are capable of | | | | to control the drug prices. Indian government can make |
| industrial application and patent rights enjoyable without | | | | use of price controls, its bargaining power as a large |
| discrimination as to the place of invention, the field of | | | | purchaser, and compulsory licenses in the meantime to |
| technology and whether products are imported or | | | | ensure that the process does not proceed more |
| locally produced. | | | | quickly than is desirable. |
| Under article 28 (1) (a) of TRIPS, there are exclusive | | | | Indian pharmaceutical firms may also suffer with the |
| rights for product patents to prevent third parties not | | | | lack of Indian jobs. This fear is by no means |
| having the owner's consent from the acts of: making, | | | | far-fetched, but there are lots of reasons to have a |
| using, offering for sale, selling, or importing for these | | | | faith that Indian industry would be able to compete with |
| purposes that product. | | | | global players. Such as an educated, well-trained |
| Overall, the TRIPS Agreement will have a substantial | | | | scientific workforce that is a backbone of current |
| impact on intellectual property regimes in developing | | | | successful Indian Pharmaceutical industry. Moreover, |
| countries. Although, under the TRIPS Agreement | | | | by passing such reforms that would encourage the |
| member countries are bound to provide such | | | | development of venture capital, India's government can |
| protection, yet certain compensatory measures and | | | | make certain that funding will be available for the |
| schemes are taken in the hands to avoid the negative | | | | country's nascent biotechnology industry, an industry |
| impact of monopolization of product patents especially | | | | that holds the promise of making significant |
| in health and pharmaceutical sectors. Such measures | | | | contributions to India's economic growth and public |
| as per the TRIPS are as follows: | | | | health needs. |
| • Transition periods | | | | Taking into account social benefits only is |
| • Compulsory Licensing | | | | compromising with economic stand. For making the |
| • Public, non-commercial use of patents | | | | nation strong, the approach should be for |
| • Parallel imports | | | | socio-economic development. |
| • Exceptions to patent rights | | | | |