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The Times of India – February 13, 2014
MUMBAI: India is facing multiple threats on its trade and investment policies. After the USTR (US Trade Representative) targeted India earlier this week, another federal agency, International Trade Commission (ITC), is holding hearings on February 12-14 to decide the course of investigations, which could potentially lead to imposing trade sanctions against the country.
Though the complaints against India are non-specific about tariffs and customs procedures, and more specific about local content and technology transfer requirements, they could cover wide-ranging sectors including agriculture, biotechnology and pharma, and even manufacturing and services.
The implications for India are serious as these investigations will justify continuing action in the US Congress, including designating India as a 'Priority Foreign Country' (PFC), which could in turn lead to the imposition of trade sanctions, experts say.
The hearings are part of the US trade agency's investigations, launched in August last year, into the impact India's trade policies have on American companies and jobs, with the agency's final report expected in November. The investigation follows a flood of complaints from US companies and government representatives against India's trade policies, particularly the implementation of the amended Indian Patents Act (2005)."
Listing India as a PFC would trigger a formal investigation, under the broader Section 301 programme to determine unilateral sanctions," Sean Flynn, IP expert and associate director of Program on Information Justice and Intellectual Property, told TOI.
This is yet another sustained effort by the US to heighten pressure against India to reverse some of its public health safeguards. What is worrisome is that the attack is against India's judicial system, and its balancing of right to health, with intellectual property.
Though the sectors under attack by the US have not been discussed yet, it is clear that biotechnology and pharmaceuticals, and particularly, intellectual property, would form the core of the hearings, experts added.
"Heightened pressure from the US in the form of the present investigation by the USITC, and the push to designate India as a PFC in the 301 report are linked and are aimed at threatening India with trade sanctions over its patent law, patent examination and court decisions in the area of patentability of medicines. This involves patent cases before independent bodies like the IPAB, and Indian courts, mostly over life-saving cancer medicines priced by companies like Novartis, Bayer,Roche, Pfizer andBMSon an average at an eye-popping price of Rs 1 lakh per patient per month,"Leena Menghaneywith MSF, Campaign for Access to Essential Medicines, said.
Big Pharma is unhappy that their efforts at evergreening or predatory pricing in India have not worked and are now working through the US authorities to prevent India from working legal flexibilities in the TRIPS agreement, which include a strict patentability criteria to weed out evergreening patent claims, pre-grant patent opposition that increases the quality of patent examination resulting in patent rejections and revocations, and compulsory licensing if a patented drug is unaffordable and unavailable.
Strongly defending India's patent laws, US-based public interest groups, intellectual property experts and domestic pharma industry (Indian Pharmaceutical Alliance) will be presenting India's case at the hearings, while supporting its patent laws. In separate submissions before the ITC, these experts have said that India's recent enactment and implementation of its patent law (Section 3d) is fully in line with the World Trade Organization's agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS).
The investigations have been launched even as Big Pharma, being highly critical, has been wanting to take retaliatory action against India's move of issuing a compulsory licence on a patented drug Nexavar (Bayer), and against theSupreme Courtjudgment which rejected a patent on a critical cancer drug, Gleevec (Novartis).
Says Brook Baker, professor of law, Northeastern University, and senior policy analyst for Health Global Access Project, "The ITC investigation is intended to put pressure on India to reverse its pro-development industrial policies and to dismantle its carefully-crafted intellectual property regime that uses most of the flexibilities allowed under international law, most particularly theWTO TRIPSagreement.
The impact of a rollback of IP flexibilities and high standards of patentability would be disastrous both for India and for the millions of patients in low and middle-income countries who rely on India for affordable generic medicines that meet global quality standards."
On the key issues of theNovartiscase and compulsory licensing, the submission drives home the point that both instances are not TRIPS-violative, legal experts added.
Says Srividhya Ragavan, professor of law, University of Oklahoma, "The allegations are important and absolutely forces India to respond. The pressure from US will not only affect India adversely but other BRIC countries that are vying to and, in some cases, are required to institute similar policies given their local economic conditions. Specifically targeting the Novartis and theBayerjudgment is interference with another sovereign country's judiciary which is unacceptable."
Supporting India's move against evergreening, the experts have said "granting secondary patents, which promotes evergreening, is a controversial issue not just in India but also in the US", and "there is nothing wrong with India taking preemptive steps to avoid the mess that the US is currently in".
India faces US sanction threat - The Times of India
MUMBAI: India is facing multiple threats on its trade and investment policies. After the USTR (US Trade Representative) targeted India earlier this week, another federal agency, International Trade Commission (ITC), is holding hearings on February 12-14 to decide the course of investigations, which could potentially lead to imposing trade sanctions against the country.
Though the complaints against India are non-specific about tariffs and customs procedures, and more specific about local content and technology transfer requirements, they could cover wide-ranging sectors including agriculture, biotechnology and pharma, and even manufacturing and services.
The implications for India are serious as these investigations will justify continuing action in the US Congress, including designating India as a 'Priority Foreign Country' (PFC), which could in turn lead to the imposition of trade sanctions, experts say.
The hearings are part of the US trade agency's investigations, launched in August last year, into the impact India's trade policies have on American companies and jobs, with the agency's final report expected in November. The investigation follows a flood of complaints from US companies and government representatives against India's trade policies, particularly the implementation of the amended Indian Patents Act (2005)."
Listing India as a PFC would trigger a formal investigation, under the broader Section 301 programme to determine unilateral sanctions," Sean Flynn, IP expert and associate director of Program on Information Justice and Intellectual Property, told TOI.
This is yet another sustained effort by the US to heighten pressure against India to reverse some of its public health safeguards. What is worrisome is that the attack is against India's judicial system, and its balancing of right to health, with intellectual property.
Though the sectors under attack by the US have not been discussed yet, it is clear that biotechnology and pharmaceuticals, and particularly, intellectual property, would form the core of the hearings, experts added.
"Heightened pressure from the US in the form of the present investigation by the USITC, and the push to designate India as a PFC in the 301 report are linked and are aimed at threatening India with trade sanctions over its patent law, patent examination and court decisions in the area of patentability of medicines. This involves patent cases before independent bodies like the IPAB, and Indian courts, mostly over life-saving cancer medicines priced by companies like Novartis, Bayer,Roche, Pfizer andBMSon an average at an eye-popping price of Rs 1 lakh per patient per month,"Leena Menghaneywith MSF, Campaign for Access to Essential Medicines, said.
Big Pharma is unhappy that their efforts at evergreening or predatory pricing in India have not worked and are now working through the US authorities to prevent India from working legal flexibilities in the TRIPS agreement, which include a strict patentability criteria to weed out evergreening patent claims, pre-grant patent opposition that increases the quality of patent examination resulting in patent rejections and revocations, and compulsory licensing if a patented drug is unaffordable and unavailable.
Strongly defending India's patent laws, US-based public interest groups, intellectual property experts and domestic pharma industry (Indian Pharmaceutical Alliance) will be presenting India's case at the hearings, while supporting its patent laws. In separate submissions before the ITC, these experts have said that India's recent enactment and implementation of its patent law (Section 3d) is fully in line with the World Trade Organization's agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS).
The investigations have been launched even as Big Pharma, being highly critical, has been wanting to take retaliatory action against India's move of issuing a compulsory licence on a patented drug Nexavar (Bayer), and against theSupreme Courtjudgment which rejected a patent on a critical cancer drug, Gleevec (Novartis).
Says Brook Baker, professor of law, Northeastern University, and senior policy analyst for Health Global Access Project, "The ITC investigation is intended to put pressure on India to reverse its pro-development industrial policies and to dismantle its carefully-crafted intellectual property regime that uses most of the flexibilities allowed under international law, most particularly theWTO TRIPSagreement.
The impact of a rollback of IP flexibilities and high standards of patentability would be disastrous both for India and for the millions of patients in low and middle-income countries who rely on India for affordable generic medicines that meet global quality standards."
On the key issues of theNovartiscase and compulsory licensing, the submission drives home the point that both instances are not TRIPS-violative, legal experts added.
Says Srividhya Ragavan, professor of law, University of Oklahoma, "The allegations are important and absolutely forces India to respond. The pressure from US will not only affect India adversely but other BRIC countries that are vying to and, in some cases, are required to institute similar policies given their local economic conditions. Specifically targeting the Novartis and theBayerjudgment is interference with another sovereign country's judiciary which is unacceptable."
Supporting India's move against evergreening, the experts have said "granting secondary patents, which promotes evergreening, is a controversial issue not just in India but also in the US", and "there is nothing wrong with India taking preemptive steps to avoid the mess that the US is currently in".
India faces US sanction threat - The Times of India
