KEI
4. March 2010 - 17:10
The ties between Universities and businesses are often complex and blurred. Private companies or trade associations fund research and seminars, and have consulting relationships with faculty members, trying to shape public policy and judicial decisions on a wide range of issues. A particularly interesting industry/university connection concerns something called the "India Project," that is associated with the George Washington University (GWU) Law School.
The GWU India Project was started in 2003 and its stated objective is to "create interactions between leading US, European, Asian and Indian academics, industry leaders, lawyers, judges and policy-makers in the field of IP." With backing by a number of major corporations with extensive patent and copyright interests, the India Project targets high level Indian government officials and judges, who are invited to participate in a number of seminar and trips, to receive training and advice in how to increase the level of patent and copyright protection in India, featuring one-sided presentations from a selective group of "experts."
Recently, a number of Indian journalists and NGOs have been to press their own government and GWU for more transparency of this University/Industry advocacy effort.
On February 26, 2010, several NGOs sent a letter to Mr. Shri Anand Sharma, Indian Minister of Commerce and Industry (letter reproduced below) demanding transparency and more information on these meetings and for the Indian government to put a stop to such industry sponsored lobbying with Indian judges and policymakers.
The following are excerpts from two recent reports by Indian journalists, and the Indian civil society letter:
Latha Jishnu for the Business Standard: Insidious India project. MNC-backed IP summits try to influence sitting judges on patent law enforcement issues pending in Indian courts. Reports:
"Grandly titled, `The India Project,' GWU has brought several delegations of American IP heavyweights from leading law firms, judges of the Federal Circuit (the central US court of appeal) and a clutch of academics primarily to teach Indians "the importance of IP." That’s what Raj Dave, manager of the India Project, an alumnus of IIT-Khargapur who is now partner in a Washington law firm, has been saying repeatedly."
"These symposiums are all sponsored by big business, many of whom have a vested interest in how the judiciary is tackling the numerous patent cases now being fought in the high courts and the Supreme Court. The 2009 symposium, for instance, was sponsored by Novartis, The Pharmaceutical Research and Manufacturers of America, which is the association of the big boys of the US pharma industry; Intellectual Ventures, a firm specializing in buying up IP rights of other companies; software giant Microsoft and chip designer Qualcomm. The grand sponsor has been the US-India Business Council (USIBC), a lobby that which has been leading a powerful campaign against certain provisions in the Indian Patent Law."
"This year’s event (February 14-18) had USIBC and Gilead Sciences as the sponsors and among those attending the February conclave was the Controller General of Patents PH Kurian along with senior lawyer Amarjit Singh Chandiok who has appeared for the government in a case where Bayer has challenged a key section of India’s patent law. Sponsors, who pay hefty sums to send delegates to the events, are also allowed to make presentations, an opening that some companies have used to push their own case. In what has come as a shock to participants at the 7th IP Summit held last month in Delhi and Mumbai is that Gilead was allowed to make a presentation on its AIDS drug Tenofovir, the patent for which has been rejected by the Indian Patent Office. Gilead’s appeal against the rejection is pending with the Intellectual Property Appellate Board (IPAB). The presentation made by the company had this closing warning: "The licensing model — Gilead licenses its patents to generic firms — is at risk and the decision by the IPAB will send a powerful signal about prospects for tech transfer partnerships with Indian companies."
Ramesh Shankar for Pharmabiz: Experts, NGOs oppose CII-GWU summit on IP for strong patent regime in India.
Reports:
"Even as the Confederation of Indian Industry (CII)'s two-day 'Summit on IP' in association with the George Washington University (GWU) has got underway in Mumbai, several public interest groups and experts have raised eyebrows expressing apprehensions that the one-sided focus of IP Summit is detrimental to Indian interests.
This is highly disturbing, as the merits of a strong IP law regime is being contested globally, and there are no empirical proofs of the benefit of a stronger IP law regime. The World Intellectual Property Organization's (WIPO) Development Agenda has clearly shown that strong IP law regimes are not an unquestionable good. It emphasises a balanced IP law regimes instead of a strong one, which must be a regime that takes into consideration the developmental level of each country. Even WIPO agrees that intellectual property is not an end in itself, and that a strong IP law regime but a tool that has to be used carefully, the NGOs and experts said.
The NGOs, who will soon send a missive to the CII and other concerned organisations, said the US patent system is widely recognized as having broken down completely and is currently being reconsidered at multiple levels -- at the legislative level by the Congress and the Senate in the form of the Patent Reform Acts, at a judicial level by the Supreme Court of the USA, and at the administrative level by the USPTO.
Given that, it is questionable what effects the US to India knowledge transfer, which is touted as the prime objective of these summits, will have.
Vehemently opposing the summit, experts said that the US law on patents, for instance, does not have many of the public interest provisions that the Indian law does. The US government and industry lobby groups like PhRMA and IIPA, which contribute to the US Trade Representative's annual Special 301 report, have consistently opposed many public interest provisions various laws, such as the provisions for post-grant oppositions. They have also consistently pushed for a "TRIPS-Plus-Plus" regime, repeatedly pressuring the Indian government to enact legislation to cover optical discs; to implement the WIPO Internet Treaties, which India has so far refused to sign; to strengthen criminal enforcement of IPR beyond the requirements of Art. 61 of the TRIPS agreement; to introduce data exclusivity, which a governmental committee has in the past rejected as against Indian pharmaceutical companies' interests."
The following is the letter sent by Indian NGOs to the Minister of Commerce and Industry:
Friday, February 26, 2010
To: Shri Anand Sharma,
Honorable Minister of Commerce and Industry
Room No. 45, Udyog Bhavan
Rafi Marg New Delhi – 110 001
Tel: 2306 1492 / 1008 Fax: +91-11-23062947
Re: Summits on Intellectual Property by George Washington University India Project and CII, and
Re: Ethics of interaction with Indian Judges, law and policy makers at these summits
Honorable Minister,
We, the undersigned public interest organizations and individuals from different fields, note with great concern meetings and "interactions" being organised annually with Indian judges and policy makers on intellectual property as part of so-called summits on intellectual property (IP Summits).
These IP summits in major cities of India are organised annually by the India Project of the George Washington University of the United States, and the Confederation of Indian Industry (CII) with funding from multinational pharmaceutical companies, industry associations and corporate law firms. Even though George Washington University claims to organise and co-sponsor with the Confederation of Indian Industry, industry sponsorship is prominently displayed at the IP summit (See annexure 1).
India’s patent laws and access to essential medicines
Sir, as you are aware, when India’s patent law was amended in 2005 (mandated by the WTO TRIPS Agreement), the Indian Parliament included key public health safeguards to ensure the continued manufacture and supply of safe, effective and affordable Indian generic medicines.
The availability and affordability of generic medicines is crucial not only for Indian patients but also for those in the rest of the developing world. Currently 92% of people living with HIV on treatment in low- and middle-income countries use generic drugs mostly from India.
Attempts to change India’s pro-public interest IP laws
Since 2005, there are continuing attempts through cases against the government of India (Novartis vs. Union of India, Bayer vs. Union of India) by the multinational pharmaceutical industry and through free trade agreement negotiations with developed countries to force India to adopt greater standards of intellectual property protection which are far beyond the mandatory levels required by the WTO-TRIPS Agreement. This is aimed at preventing the domestic production, registration and export of essential medicines by Indian generic manufacturers.
The Indian courts too are constantly faced with the difficult prospect of multiple litigations where they are balancing private patent rights with the fundamental rights of life and health enshrined in the Indian Constitution.
US Industry funded IP Summits
In this regard, we are extremely concerned about the "IP Summits" organised by the US based George Washington University India Project in collaboration with CII.
Sponsors of the George Washington University’s IP Summits which include the US-India Business Coalition (USIBC), pharmaceutical companies and the law firms that represent them in patent disputes before the Indian courts have the privilege to nominate speakers and be included in all programmes including in meetings and discussions that involve Indian judges and senior government policy makers.
Over the years, prominent sponsors and organisers of these summits have included multinational pharmaceutical companies like Novartis, Gilead Sciences, Intellectual Property Owners Association, The Pharmaceutical Research and Manufacturers of America (PhRMA) and the US-India Business Council (USIBC). (Annexure 2). The manner in which these Summits have been used by these sponsors in relation to pharmaceutical patents is discussed in greater detail below.
The sponsors of the IP summit also include Intellectual Ventures, Microsoft, and Qualcomm. These companies have a vested interest in software patents as they have already amassed a large number of such patents in the few countries that allow for patenting of software.
As things stand, computer programmes per se are not patentable in India by virtue of being excluded from patentability by section 3(k) of the Indian Patent Act. Indeed, Parliament in 2005 rejected an attempt to create exceptions for that provision. Still, these companies wish to change the Indian Patent Office's application of the law to go against the dictate of the Indian Parliament, and are doing so by time and again questioning the Indian law.
Many academics, civil society organizations, and people from the indigenous software industry as well as the free/open source software community have pointed out the hazards of changing the law on software patents to the Indian software industry. Yet these voices are not allowed to be present at meetings such as these organized by CII.
Interactions with the judiciary as part of these IP summits
This year’s programme – the 7th IP Summit was held from 14-18 February 2010 in Delhi and Mumbai. On 14 February, an ‘Interaction with Judiciary and Moot Court on IPR’ organised by GW University and CII as part of the programme at the National Law University in Dwarka, Delhi.
According to sources, the moot court problem placed before the judges related to enforcement of intellectual property rights. This is an area of growing controversy as developed countries like the US and EU and their multinational pharmaceutical companies are pushing for greater enforcement – these issues are before the courts in many cases (sub-judice) and it is of great concern that judges of the Supreme Court and Delhi High Court were presented with similar problems at a summit funded by multinational pharmaceutical companies. It is evident that the Supreme Court, the Delhi High Court, the Ministry of Law and Justice and the Ministry of Commerce and Industry were not fully informed of who was funding/co-organising this summit.
Moving away from what is usually an academic exercise with students, at this moot court, practising lawyers argued the problem before sitting judges. Given the funding of these summits and the statements of George Washington University staff and organisers, we are hard pressed to believe that such interactions are merely academic exercises. This is confirmed by the following quote of one of the prominent staff members of the George Washington University:
"…one of the goals of the India Project -the objective of which was to create interactions between leading US, European, Asian and Indian academics, industry leaders, lawyers, judges and policymakers in the field of intellectual property - was to work closely and cooperatively with Indian judges to ensure not just enaction but enforcement of patent laws. Because it's all fine to have good laws but the important thing is to enforce them." [Emphasis added. See: Intellectual Property experts to help India revamp laws, RediffNEWS, February 01, 2006, Annexure 3]
2010 IP Summit – Attacking Section 3(d) – India’s safeguard against evergreening of patents
As the Honorable Minister is aware, the USIBC, a prominent sponsor of this year’s IP summit, has published a report criticising India’s patent law; specifically the report has attacked Section 3(d) of the Patents Act, 1970. This provision in fact stipulates that companies should not be able to obtain patents in India for medicines that are not actual inventions, such as drug combinations or slightly improved formulations of existing medicines and actually ensures patents should only be granted on medicines that are truly new and innovative. While the USIBC attempted to invite the Hon’ble Minister to the release of this report during his visit to the US last year, the Hon’ble Minister made it clear during his visit that India takes its role in supplying safe, effective and affordable medicines seriously.
Patient groups such as the Cancer Patient Aid Association and PLHIV networks have argued for strict patentability criteria and have filed pre-grant oppositions against patent applications claiming patents on new forms, combinations of known medicines – to protect domestic production of essential cancer, Hepatitis C and AIDS medicines.
As the Honorable Minister is also aware, having lost the case to strike down Section 3(d) of the Patents Act two years ago, Novartis has now launched fresh legal proceedings in the Supreme Court of India to weaken this critical public health safeguard. This case will have important implications on the patentability criteria of medicines and hence has implications for Indian patients.
The law firm representing Novartis in the Supreme Court case challenging the scope of Section 3(d) also presented at this meeting how Section 3(d) did not comply with TRIPS and the interpretation of Section 3(d) it wants the Indian Patent Office to adopt (Annexure 4). Incidentally, Novartis has been a prominent sponsor of the IP Summits. Apart from their lawyers, Novartis also featured prominently on the rest of the agenda of this year’s summit both in Delhi and in Mumbai.
2010 IP Summit - Pharma companies lobby against patent rejections
Apart from the interactions with the judiciary, policy makers and key government officials also feature prominently in these meetings. That these meetings are being used as forums by companies to promote their intellectual property and to lobby for either law amendments or even to plead their cases currently pending before, for instance, the Indian Patent Office is clear from the agenda and the programme.
This year, for instance, Gilead Sciences, a sponsor of the IP summit 2010 used its presentation to discuss why it deserves a patent on the drug tenofovir – a key AIDS drug at a time when its appeal against the rejection of its patent applications is pending before the Indian Patent Office. The audience during such "presentations" as noted above features policy makers and government officials including from the Patent Office. For your reference, the presentation made by Gilead Sciences is attached (Annexure 5).
We believe that it is highly unethical and inappropriate that a meeting organised and/or funded by such companies includes in it interactions with the Indian judiciary and patent office officials before whom are pending appeals filed by pharmaceutical companies against patent rejections decisions.
CII fails protect national interest and domestic industry
In this regard we will be writing separately to the Minister on the role of the CII which we believe no longer promotes the interests of India or of domestic companies. CII’s IP agenda is consistently against the interests of domestic industry and undermines India’s negotiating positions in international forums and free trade negotiations. Specifically meetings organised by CII are lobbying against some of the strong positions on IP taken by India to protect its national interests in the international arena. In this context, we request the government of India to disassociate with CII on any of its IP agendas and programmes.
Imposition of US based positions on IP
While George Washington University claims that its India project is to help enhance India's intellectual property law capacity, it fails to appreciate that India’s lawmakers and judiciary have a history of not only understanding intellectual property (like the Ayyangar Report) and its implications and in fact have devised the most progressive patent laws in particular in the area of food and medicines. As far back as the 1970s, the Indian government recognised the impact of patents on medicines when former Prime Minister, Mrs. Indira Gandhi said, "The idea of a better-ordered world is one in which medical discoveries will be free of patents and there will be no profiteering from life and death."
Critiques of India’s patent law by the GW University’s faculty and majority of speakers at the IP summit are not balanced with presentations supporting the Indian legislation or highlighting its importance from a right to health and medicines perspective. Groups or others with a different point of view that IP laws need to be appropriate to development needs - have little space at these meetings other than token invitations. Attempts to comment or raise questions are often ignored, cut short or even shouted down by delegates brought in by George Washington University who have a strong IP enforcement bias.
It is evident that these meetings are NOT an independent academic exercise of a US University but actually feature mostly the views of multinational pharmaceutical companies and multinational IT companies, a majority of whom feature prominently as sponsors and in the agenda.
IP summit 2010 and role of DIPP
Given this background, we are extremely concerned that these one-sided meetings have received support from the Department of Industrial Policy and Planning (DIPP). This year’s programme featured the logo of the DIPP. The messages promoted at these meetings go against India’s legal standards on patentability and several of the positions on IP being taken by India at the international level and the Ministry’s support for such meetings sends out a confused message on India’s position on these matters.
We are also surprised to learn from interviews with George Washington University staff that several of these issues have featured in trainings for Indian patent office officials. We quote below the relevant paragraph from the interview:
"We have contributed to education by heightening the dialogue and understanding between India and the U.S. on IP law. We have done so in a collaborative way, as we have much to learn from our Indian counterparts. For example, the new Indian patent law, enacted in 2005, involves a range of issues that require clarification, and the project has resulted in a two-way discussion of real importance to the future of IP protection in India and across the world. Is the new law in compliance with Indian constitutional standards? How does it compare with U.S. law in addressing issues that arise during the processing of a patent application? (With regard to this question we recently held educational sessions with patent examiners at various Indian patent offices). Is it consistent with international standards? These are just some of the issues that attract the attention of people associated with GW's India Project." [Emphasis added. Text of full interview attached to this letter as Annexure 6]
Request to cease unethical and non-transparent lobbying with judges and policy makers
Industry led initiatives with the Indian judiciary are considered unethical and unacceptable. However, CII and GW University have through their annual IP summits in India interacted closely with the Indian judiciary. GW University openly claims this as the positive outcome of the project without clarifying as to how they have organised close interactions with the Indian judges while at the same time worked on this project with the involvement of industry associations and financial support from industry sponsorship that they accept for this programme. Pushing a one-sided agenda that favours the handful of sponsors in a meeting involving higher level judiciary and very senior policymakers and representing this as an academic exercise is highly objectionable.
In light of the above, we urge, the Government of India to undertake the following:
- We re-iterate that "interactions" with the Indian judiciary and law and policy makers as part of such summits is highly unethical and improper at a time when several of the issues being discussed at such meetings are before the courts or the patent offices for adjudication. We request the government of India to take immediate steps to put a stop to such industry sponsored lobbying with judges and policymakers.
- We urge that before lending support and credibility to such exercises, the government of India acquaint itself of all the sources of funding for such meetings and the backgrounds and conflict of interests of key organisers and sponsors. We also urge the Ministry to proceed with caution in supporting such summits that push for stronger IP law regimes without taking into context the interests of Indian industry, especially small and medium enterprises, and the Indian public.
- We request the government of India to disassociate with CII on any of its IP agendas and programmes.
- We also request, that as a recipient of significant government funding and as a stakeholder identified by the government on policy matters, an official enquiry be conducted by the government of India into CII’s IP programmes and sponsors over the past five years.
- We request that the George Washington University India Project no longer be given access to the Indian patent Office, Indian Patent examiners, Indian government officials and most importantly the Indian judiciary. Given their funding, and the manner in which they have carried out their programmes and their admitted interest in the "enforcement of patent laws", they should be recognised as an industry lobby and not an independent academic institution.
- Given that George Washington University has gained access to Indian patent examiners and the Indian judiciary, we request the government of India to ask for a detailed record of all the funding of the George Washington University India Project since its inception, of the contacts and conflicts of interest of key persons associated with the Project and a detailed list, agenda, copies of presentations and notes of all formal and informal meetings held by the University in India with the judiciary, patent offices and government officials. This information should be made public as soon as possible.
Yours sincerely,
- National Working Group on Patent Law
- All India Drug Action Network (AIDAN)
- Centre for Trade and Development (Centad)
- Delhi Science Forum (DSF)
- Creating Resources for Empowerment in Action (CREA)
- Delhi Network of Positive People (DNP+)
- Drug Action Forum – Karnataka (DAF-K)
- International Treatment Preparedness Coalition – India (ITPC – India)
- Knowledge Commons
- Maharashtra Network of People living with HIV (MNP+)
- Torchbearers - Advocacy for Disabling Brain Illnesses
- Talking About Reproductive and Sexual Health Issues (TARSHI)
- Naz Foundation (India) Trust
- Centre for Internet and Society (CIS)
- Alternative Law Forum
- IT for Change
- G. Nagarjuna
- Initiative for Health Equity & Society (IHES)
- Diverse Women for Diversity
- Research Foundation for Science Technology & Ecology
- All India Peoples Science Network (AIPSN)
Cc.
1. Mr. M. Veerappa Moily
Hon’ble Minister of Law
402-A, 4th Floor, Shastri Bhawan
New Delhi – 110 001
Tel: 23387557, 23384777, 23384617
Fax : 011-23384241, 011-23387259, 011-23382733
2. Shri Ghulam Nabi Azad
Hon’ble Minister of Health and Family Welfare
Room No. 344, 3rd Floor
Nirman Bhavan
New Delhi – 110 001
Tel: 011-23061647, 23061751,
Fax: 23017798, 23792341
3. Shri Rajinder Pal Singh
Secretary
Department of Industrial Policy & Promotion
Ministry of Commerce and Industry
Room 157, Udyog Bhavan, Rafi Marg
New Delhi – 110 011
Tel: 23061815, 23061667
Fax: 011-23061598
4. Mr. D. R. Meena
Secretary - Legal Affairs
Ministry of Law and Justice
409-A, 4th Floor, Shastri Bhawan
New Delhi – 110 001
Tel: 011-23384777,
23382902, 23387259
5. Shri Rahul Khullar
Secretary
Department of Commerce
Ministry of Commerce and Industry
Room No. 143, 1st Floor
Udyog Bhawan, Rafi Marg,
New Delhi – 110 001
Tel: 23063664, 23063617
Fax: 23061796
6. Ms. K. Sujatha Rao
Secretary
Dept. of Health and Family Welfare
Ministry of Health and Family Welfare
Government of India
149-A, Nirman Bhawan, New Delhi – 110 011
Tel: 23061863 / 23063221
Fax: 23061252
7. Mr. P.H. Kurian
Controller General of Patents, Designs & Trade Marks
Boudhik Sampada Bhavan
Near Antop Hill Head Post Office
S.M. Road, Antop Hill
Mumbai – 400 037
Tel/Fax: 022-2413275
8. Prof. G. Mohan Gopal
Director
National Judicial Academy
Bhadbhada Road, P.O. Suraj Nagar,
Bhopal-462044, M.P. India
Tel: 0755-2696766 Fax: 0755-2696904
