Box 1: Country Profile - India

Box 1: Country Profile - India

India has fostered a vibrant generic industry since 1970when it lawfully amended its existing patent act todisallow patent protection for pharmaceutical products. Since that time, India has transformed from a countryimporting most of its medications at some of the highestprices in the world to the leading producer of affordablemedications for most developing countries. As mandated by the TRIPS agreement in 1994,however, India was required to start collecting drugpatent applications filed between 1995 and 2005 and toamend its patent law to formally recognise productpatents by January 1, 2005. Despite the newrequirements, the agreement permitted the continuedproduction of pre-1995 drugs and several ‘transitional’years to become TRIPS-compliant. It also containedallowances to enable continued public health protection,which were upheld in the ‘Doha Declaration’ of 2001and expanded further in 2003.In order to comply with the January 1, 2005 deadlineto render its intellectual property regime TRIPScompliant,the Indian government issued a temporaryordinance in late December 2004. The ordinance madeseveral amendments to the country’s patent regime,including:

1. Extended full TRIPS coverage to food, drugs andmedicines;
2. Required patents to be granted to products, while India’s previous patent regime only required processpatents;
3. Modified the procedures through which patents can bechallenged before they are granted;
4. Stated that ‘mere new use’ of existing drugs is notpatentable;
5. Required countries interested in importing genericmedicines produced exclusively for export under acompulsory licence issued by the Indian governmentto issue a separate compulsory licence for import.

Critics of the ordinance, described as ‘TRIPS-plus’,contended that many of the provisions were morerestrictive than TRIPS required and thus potentiallydeleterious to generic production and drug prices. Forexample, many argued that the compulsory licencescheme set forth by the ordinance failed to takeadvantage of WTO provisions to allow countries withlittle or no pharmaceutical capacity to import cheapgeneric versions of drugs still under patent protection.However, commerce and industry leaders defended thenew patent rules, promulgating an appropriate balancebetween the protection of intellectual property rights,public health and national security.

Following an intense period of lobbying and socialmobilisation worldwide, the final patient law, enacted inMarch 2005, adopted some mitigating amendments tothe ordinance. Despite these revisions, many argue thatthe new patent laws restrict India’s ability tomanufacture the newest generations of low-cost essentialmedicines. Moreover, there is concern regardingadditional intellectual property protections in the formof new data exclusivity rules. Currently, India isconsidering whether to grant five years of dataexclusivity for proprietary clinical data, even though it isnot required by TRIPS.