Resist the U.S. Administration Pressure and Reject the Misleading Allegations of U.S. Business Associations
We the undersigned organizations and individuals are writing this letter to urge you to reject the pressure tactics of the United States (US) administration against India and to resist and challenge such US unilateral threats at multilateral forum.
The unilateral pressure by US administration on India, at the behest of US Business Associations lobby through U.S. International Trade Commission (USITC) investigations and request to USTR to enlist India under Priority Foreign Country under Special 301 review lacks legitimacy under WTO framework. They are also in conflict with WTO legal obligations and these unilateral pressure and threat of sanctions are in violation of legal obligations under WTO framework. Further these unilateral measures adopted by US to pressure India undermine the existence of WTO’s dispute settlement mechanism.
The key reason for these multiple attacks and increased lobby against India by US administration is the rejection of patent for Gleevec and for granting the first ever compulsory license for cancer drug Nexavar in India. In particular US Chamber of Commerce’s Global Intellectual Property Center (GIPC), Pharmaceutical Research and Manufacturers of America (PhRMA), the Biotechnology Industry Organization (BIO) and Intellectual Property Owners Association (IPO) have made submissions to USITC alleging India’s intellectual property environment has declined and India’s policies are harming US companies. Their submissions are based on their perception of India’s intellectual property rights regime and disregard the facts in each of the case.
The decision of the Supreme Court to reject patent to Gleevec and the issuance of compulsory license for Nexavar by India are lawful, valid and permissible measures and they do not violate Trade Related Aspects of Intellectual Property Rights (TRIPS) Agreement as alleged by the US business industries. India has rightfully utilized the TRIPS flexibilities to advance the public health requirements of our country.
It is also important to reiterate that TRIPS agreement does not prescribe patentability standards and it is up to member countries to determine the standards of patentability including novelty, inventive step and industrial applicability which will help to achieve their developmental interest.
India therefore adopted domestic patentability standards according to its needs and amended Section 3(d) to prevent grant of patents to incremental innovation and ensured to adopt a patentable standard which would enable only genuine inventions are granted patent monopoly.
The intent of the parliament and the objective of the Section 3(d) was confirmed and cemented by the decision of the Supreme Court which reiterated only genuine inventions should enjoy patent monopoly and noted patents on incremental innovations will hinder further innovation and also delay early entry of generic medicines thereby affecting access to affordable medicines.
However the ongoing allegations by US industries against India’s intellectual property regime and threats of unilateral sanctions by US has failed to consider the available flexibilities for every Member State under the TRIPS agreement and the 2001 Doha declaration on public health which reinforced every Member State has the right to make full use of TRIPS flexibilities to address public health concerns including access to affordable medicines.
It is pertinent to note that India’s total health spending is abysmal and most health expenditure is private out of pocket payments. The major expenditure is on drugs priced exorbitantly when bought by patients from pharmacies of private doctors and hospitals. One of the possible ways for government to ensure medicines are made available at affordable prices is to use TRIPS flexibilities to its fullest to enable availability of highly priced patented medicines at affordable price.
Apart from patients in India, millions of patients from both developed and developing countries depend on affordable generic medicines produced in India. Hence any law and policy change in India to minimize the use of flexibilities would not only have an impact on the health of people in India but also in many other countries which are dependent on Indian generic medicines.
The multinational pharmaceutical lobby and US government are targeting India in order to collaterally prevent many other developing countries in using flexibilities to check the abuse of patent monopoly. As you know at present developing countries such as South Africa and Brazil are in the process of amending their patent laws to incorporate provisions similar to India’s patent laws to check patent abuse and enable access to affordable medicines. Building up and strengthening of an alliance of like-minded developing countries at various international fora is of utmost importance to forge a united front to push back the threat of these illegitimate sanctions from the US Government.
Against this background we urge you
In Solidarity,
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