Talks But No Breakthroughs Yet On IP Issues For Ministers At WTO [International]

Intellectual property issues have been a topic of debate at the World Trade Organization ministerial negotiations since Friday and while there have been no changes in positions there has been some talk of looking for compromises, according to sources attending the event. Ministers from some IP-proponent countries raised the issues as critical to the heads of delegation meeting on Monday, the first day of the mini-ministerial in Geneva, while opponents held a meeting of like-minded countries reinforcing their position against the inclusion of IP issues in the talks, sources said.

WTO Director General Pascal Lamy began on Friday to talk with officials about IP issues in an attempt to find a way to navigate the standstill on them, sources said. Lamy held meetings on Friday, Saturday and Sunday, they said. However, on Monday evening, the issue was not a primary topic of the Green Room meeting, the smaller, closed gathering held in Lamy’s office. The ministerial is scheduled to run from 21-27 July.

The focus in the next few days is expected to be squarely on the issues of agriculture and non-agricultural market access (NAMA) before IP issues become critical, if at all, according to several sources. But the outcome of the mini-ministerial (about 40 of the WTO’s 153 members) will be tied to addressing demands from the European Union, Switzerland, India, Brazil and others on issues related to intellectual property and trade.

The IP issues are: the creation of a mandated register on geographical indications - product names associated with a place and characteristics - for wines and spirits; extension to other products of the higher-level GI protections currently enjoyed by wines and spirits; and an amendment to the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) to require the disclosure of origin of traditional knowledge and genetic material in patent applications, intended to bring TRIPS in line with the UN Convention on Biological Diversity (CBD).

A draft modalities text has been prepared by proponents, claiming support from a majority - over 100 - of WTO members (IPW, WTO/TRIPS, 18 July 2008). The text, TN/C/W/52, is now posted as a document to the WTO website. The opponents’ longstanding position favouring a voluntary register and database for consultation, referred to as the joint proposal, has been submitted again and posted as document TN/IP/W/10/rev.1.

A possible split in the IP issues may have been suggested by Lamy, according to sources. It generally has been the view that the GI register and the CBD amendment might have more middle ground for negotiating, while the GI extension might be more two-dimensional, sources said.

But such a split would not be acceptable to IP proponents, an official from a proponent country said. And the opponents’ meeting on Monday, which included countries such as Australia, Chile, Costa Rica, Mexico, New Zealand and the United States, reconfirmed the view that none of these issues should be discussed this week, according to a participant.

USTR pushes for drug data exclusivity [India]

The thorny issue of providing data exclusivity to pharma MNCs has come under limelight. The United States Trade Representative (USTR) seems to be lobbying hard with the health ministry for data exclusivity, which if allowed, will adversely affect domestic pharma companies that are making generic versions of patented drugs. Data exclusivity, if implemented, will stop or delay marketing approval of many generic drugs as the domestic pharma companies will not be able to rely on the clinical data which has been submitted by MNCs to the drug regulator, when they seek approval.

The Indian health ministry has not been in favour of granting data exclusivity to pharma MNCs, which effectively offers monopoly to the developer of a new drug even without a patent, restricting cheaper generic versions for several years. While one round of negotiations have been held earlier this year between USTR representatives and health ministry officials, the issue is expected to come up again soon, sources said. "The focus (of USTR) has shifted to the health ministry which is being urged to take a decision on the issue," sources said. For USTR, a change in the ministry's view is important before WHO-established Intergovernmental Working Group on Public Health, Innovation and Intellectual Property (IGWG) meets in Geneva this month, to negotiate an action plan for R&D that prioritizes the health needs of developing countries. Data exclusivity can be introduced through an amendment in the Drugs and Cosmetics Act, which is under the purview of the health ministry. The health ministry had then suggested data protection and not data exclusivity, which is compliant with TRIPs. Data protection prevents disclosure of clinical test data to competitors, but allows the drug regulator to use it for granting approval to generic companies. On the other hand, if data exclusivity proposal is accepted, the regulator cannot use the clinical test data submitted by an innovator company, to give marketing approval, which are developing cheaper generic versions.

Says Indian Pharmaceutical Alliance secretary general DG Shah: "India is not obliged to grant data exclusivity under TRIPS. Protecting the originators data against 'unfair commercial use' is agreed by all sections of the industry. So why are attempts being made to get it (data exclusivity) back?" Developing countries along with the WHO, feel that the draft action plan being negotiated in Geneva should focus on a global strategy on health and innovation, and intellectual property should be managed in a pro-public health manner. Intellectual property rights should not become an obstacle to access low cost generic medicines public health groups say.

Indian Government notifies Intellectual Property Enforcement Rules [India]

Vide Circular 41/2007 –Customs, The Government of India has notified and published the Intellectual Property Rights (Imported Goods) Enforcement Rules, 2007 and the instructions for its implementation.

The Government of India in compliance with its TRIPS obligations to implement border control issues [Articles 51 – 60] and curb infringement of intellectual property rights has issues the aforesaid circular that prohibits import of goods that infringe national IPR laws as well as IPR laws prevailing in the EU and other countries.

The Rules, among other aspects, also provide for modalities pertaining to registration by the Customs, issuance of notice by the IPR holder, provisions for protection to the rightful importer etc.

Full details of the Circular may be accessed from here.

Mounting support [and pressure] for the TRIPs Amendment to protect Biodiversity [Developing Countries]

Longstanding differences on whether WTO rules should be altered to require patent applicants to disclose the use of any biological resources or associated traditional knowledge - on pain of patent revocation - featured prominently at a 13 March meeting of the WTO Council for Trade-Related Aspects of Intellectual Property Rights (TRIPS).

Brazil, India, Cuba, Peru, Ecuador, Pakistan, Thailand, and Venezuela said there was significant and growing support among the WTO Membership for an amendment of the sort they had proposed in order to protect biodiversity (IP/C/W/474, available at http://docsonline.wto.org). Uganda expressed a similar view, on behalf of the group of least-developed countries.

Their proposed amendment would include a mandatory requirement to disclose the origin of biological resources and/or associated traditional knowledge in patent applications. It would also require evidence of compliance with prior informed consent and fair and equitable benefit sharing arising from the commercial or other utilisation of such resources and knowledge. They argue that such an amendment - with the threat of revocation if disclosure requirements are not adequately met - is necessary to prevent 'biopiracy'.

The Dominican Republic and the group of African, Caribbean, and Pacific (ACP) countries recently announced their backing for the proposal, prompting their co-sponsors to note that nearly 80 of the WTO's 151 members now support a TRIPS amendment.

Following the typical pattern established for discussions on the issue, the US, Japan, Australia, New Zealand, Canada and Korea said that while they were opposed to bio-piracy, they did not consider a disclosure requirement to be the most efficient way of addressing such concerns.

They added that they were still not convinced about the existence of a conflict between the TRIPS Agreement and the Convention on Biological Diversity (CBD), and thus there was no need for amending the WTO rules. They argued for considering alternative methods for preventing misappropriation of traditional knowledge and genetic material, such as the database system proposed by Japan (IP/C/W/504 and IP/C/W/472). More facts-based discussions on concrete cases of misappropriation are needed, they said.

The EU reiterated that it was prepared to negotiate a disclosure of origin requirement, but it would not support requirements for either prior informed consent or proof of equitable benefit sharing. However, it contended that the World Intellectual Property Organisation (WIPO), rather than the WTO, was the appropriate forum for discussions on disclosure. The EU also argued that failing to accurately provide information on the origin of biodiversity or traditional knowledge used in an invention should not result in patent revocation, in order to avoid endangering the viability of the patent system. Sanctions, it claimed, should instead be sought outside patent law.

The US, for its part, argued that a disclosure requirement would not address resources exported from countries through normal commercial channels that eventually may be used as starting materials for research and or innovation. It added that due to the tenuous relationship between origin and inventorship, it is not likely that the disclosure proposal would prove effective at achieving its stated purpose.

The TRIPS Agreement itself provides for a review of Article 27.3(b), which deals with the patentability of plants and "essentially biological" processes for producing them. The Doha mandate asked WTO Members to broaden this review to look at the relationship between the TRIPS Agreement, the Convention on Biological Diversity, and the protection of traditional knowledge and folklore.

Patents and Human Rights [comments by Dr. Ekbal]

There is growing recognition that the regulation of patents and other Intellectual Property Rights (IPRs) cannot be reasonably made with a unique, universal standard. Different socio-economic conditions and levels of development require different intellectual property systems, the former Vice-Chancellor of the University of Kerala and neuro-surgeon B. Ekbal said.
He was presenting a paper ‘Intellectual Property Rights: Challenges to Academic Research’ at a national seminar on ‘Quality Access and Social Justice in Higher Education,’ organised by the Kerala State Higher Education Council.

The patent system may entail considerable short-term costs for developing countries, mainly due to administrative costs and problems with higher prices for medicines and key technological inputs while long-term benefits seem uncertain and costly to achieve in many nations, particularly poor countries. Moreover, higher standards of patent protection are unlikely to have a positive effect on local innovation except in countries and sectors that have reached a certain level of technological development and have the capacity to finance substantial research and development, Dr. Ekbal said.

IPRs should not be implemented so as to violate and infringe upon human rights; they should be subsumed to human rights, national interests and the preservation of genetic resources. “In fact, intellectual products are basically social products. While granting certain rights to innovators, this should not be forgotten. Therefore intellectual property rights cannot be considered as ‘rights’ as in the case of immutable human rights,” he argued in his paper.

Dr. Ekbal pointed out that the whole argument regarding IPR is built on a contradiction that in order to promote the development of ideas it is necessary to reduce the freedom with which people can use them. Central to the projected utility of IPRs is the notion that creation is facilitated by the provision of a temporary monopoly that ensures that the author of a work will be the sole beneficiary of any profits. With the institutionalisation of IPRs, individual creators ceased to be beneficiaries and were replaced by large corporate interests. Most individual creators do not gain much from IPRs and are frequently ignored or exploited.

Drug makers concerned over compulsory licensing [India]

Local units of multinational drug makers — who make billions of dollars of revenues from drugs protected by patents — say they are increasingly worried over a vigorous push by Indian peers to revoke such protection through what are called compulsory licences, and questioned such efforts in the absence of a national emergency.

Local drug makers, who make most of their revenues from sales of non-patented or generic drugs, are exploring the use of a controversial public health provision in global trade laws called compulsory licence that allows the World Trade Organization’s member-nations to override patents and permit cheaper versions of patented drugs. This provision can be invoked if a drug maker is willing to make and supply copies of patented drugs in a medical emergency or to export to least developed countries, which are yet to be covered by the TRIPS, or the Trade-Related aspects of Intellectual Property Rights, regime and entitles the patent holder to an “adequate remuneration”.

It was reported on 29 January that Hyderabad-based Natco Pharma Ltd’s request for compulsory licences on two patented cancer drugs could emerge as a larger trend. Natco Pharma is seeking licences for Sutent, a renal cancer drug of Pfizer Inc. and Swiss F. Hoffmann-La Roche Ltd’s lung cancer medication, Tarceva, which costs Rs1.5 lakh for a month’s treatment—nearly four times the Indian per capita annual income. Sutent, awaiting a patent grant in India, is likely to be priced at $4,000 (Rs1.57 lakh) for a six-week treatment.

Expressing concern that patent provisions could be misused to make products available illegally in the Indian market, Pfizer Ltd’s managing director Kewal Handa said in an email response, “This would be a clear disregard of Indian patent laws.” He added that if continued, this would take the country back “to the pre-product patent era.” He expects the judiciary and the Indian government to “uphold the spirit of innovation.”

The top executive at Novartis India Ltd said the move was unjustified in the absence of a national emergency for which compulsory licensing is designed. “Generic drug makers talk of evergreening of patents but this is (cutting short) patents. What signals are we giving to the global drug makers?” asked Ranjit Shahani, managing director of the Novartis unit. Makers of patented drugs are often accused of trying to extend the life of patents beyond 20 years, a tactic commonly called patent evergreening.

Roche Scientific Co. (India) Pvt. Ltd’s managing director Girish Telang declined comment.
Cipla Ltd, one of country’s largest drug makers, is fighting Roche over the latter’s patent in India for Tarceva in the Delhi high court, though the Indian firm is not asking for a compulsory licence on it.

Foreign drug makers also point out that they run patient access programmes to deliver their patented drugs to those who can’t afford it, though patient groups argue the reach of such initiatives is limited. Pfizer, for instance, has recently put together a Sutent Patient Access Programme that will partly or fully subsidize treatment options for patients in India and expects to extend it to Nepal.

Novartis’ Glivec International Patient Assistance Programme helps some 7,000 patients of myeloid leukaemia, the company says on its website. Novartis is fighting in court and at an appeals tribunal the rejection of a patent for the cancer drug by Indian authorities.

Disparities Seen In Developing Countries’ TRIPS Implementation

There are considerable differences in developing countries’ implementation of the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) and their use of flexibilities in it, according to speakers at a recent South Centre event.

Although developing countries have strong concerns about the TRIPS agreement, a significant number of them have implemented even higher IP standards than those required by TRIPS, according to research on 107 countries presented by Carolyn Deere, director of the Global Trade Governance Project at the University of Oxford.

The 5 December panel entitled “The Implementation Game: Developing Countries; the TRIPS Agreement and the Global Politics of Intellectual Property” was part of a seminar series at the South Centre.

Deere classified the countries studied into three groups: the TRIPS-plus countries (countries that went beyond their TRIPS obligations); countries which made mixed use of TRIPS flexibilities; and countries that are still in the process of reforms to meet TRIPS commitments.

Based on analysis of TRIPS-based legislative reforms, the TRIPS-plus countries range from Mali and Cambodia to the Dominican Republic, Mexico and Peru. There were 14 least-developed countries in the list. Deere’s survey showed that there is no clear correlation between the strength of IP standards and the Gross Domestic Product per capita. Some of the poorest countries in the world, like Niger, are among the TRIPS-plus countries, Deere said.

The explanation for the variation between developing countries seems to lie in the interplay of domestic politics and international pressure, Deere said. Developing countries are influenced by the degree of pressure applied by international donors, investors and trading partners, she said, but added that this does not explain the range of variation. Some countries, such as Brazil, which have been subject to pressures from the United States are not in the TRIPS-plus cluster, but rather make mixed use of flexibilities, she said.

The Implementation Game: A Battle for Influence

Two sides have been debating on TRIPS implementation: one in favour of swift compliance and limited use of flexibilities, and the other advocating a more flexible approach tailored to specific national development priorities. The first group uses coercive pressures such as trade deals and threats, WTO disputes and diplomatic demands, she said. To foster a “pro-IP climate”, this group also used the “power of ideas”, turning to the media, public outreach, research, monitoring and capacity building. The second group lacks the means to exert coercive pressure, Deere said, but nonetheless harnesses “ideational” power, including for example by running campaigns for an end to “TRIPS-plus” pressures that impact health and access to knowledge. To win over developing country decision-makers, the two groups engaged in a “research war” and a “competition” in the area of capacity building, she said.

According to Deere, politics at the national level contribute to the variation, either amplifying or filtering the influence of external pressures. In most developing countries, a lack of expertise and consultation within government, and the small number of active local interest groups limit national debate about TRIPS implementation. Instead, most governments defer to national IP offices for direction, she said, which in turn are strongly influenced by the largest donors, such as the World Intellectual Property Organization (WIPO). There also is lack of coordination between the national capitals and international government representatives, she said.

Deere’s research is expected to be published in a book in 2008.

TRIPS Flexibilities Difficult to Implement

Boumediene Mahi from the permanent mission of Algeria to the UN and coordinator of the African Group to WIPO, invited to comment on Deere’s presentation, added that most African countries had inherited colonial IP systems and had joined the TRIPS Agreement without having participated in negotiations. Moreover, he said, “there was big pressure on the developing countries during the TRIPS negotiations and it is still the case.”

Ignorance of the flexibilities and the way to use them has prevented countries from benefiting from them. Sometimes, “sub-regional offices such as the African Intellectual Property Organization made a decision that was applied in individual countries without them having the possibility to discuss the decision at national level,” said Mahi.

He also noted that the technical assistance to use flexibilities was essential. “It is only over the last two years that WIPO has started to deliver technical assistance” that refers to the flexibilities but there is still a number of least developed countries that do not know how to use them. Mahi said that the new WIPO Development Agenda promotes the idea of balanced protection: encourage innovation while protecting the public interest, which he said is an encouraging first step toward more fairness.

For Christoph Spennemann, legal expert of the intellectual property team at UN Conference on Trade and Development, there is a strong link between the degree of expertise and the use of flexibilities in developing countries. The countries which participated in the Uruguay Round of WTO negotiations that led to TRIPS make use of flexibilities and are aware of their implications while in developing countries that played little role in the negotiations there is a higher protection level.

The TRIPS-plus countries are sometimes more familiar with the potential benefits of IP than the challenges it can present, Spennemann said. He cited the example of local producers in West African countries who are keen on pharmaceutical patents, but lack awareness of the impact of IP on the public domain. Spennemann noted these producers believe that stronger IP protection can attract foreign investment but ignore the importance of flexibilities as a potential attraction for investors in generic industries. As a result, the pre-TRIPS colonial laws remain untouched or are modified into TRIPS-plus, Spennemann said. Those countries also have to face a “race of technical assistance providers to win the game,” he said. To attain better results in the use of flexibilities, he stressed the importance of IP capacity building that takes into account both development objectives and flexibilities.