ICTSD reporting.

Chile, Brazil, Nicaragua, and Uruguay put forward a work plan calling for global norms establishing a “minimum mandatory [level of] exceptions and limitations particularly with regard to educational activities, people with disabilities, libraries and archives, and exceptions that foster technological innovation.”

Clearly-defined exceptions and limitations on copyright protection are important for improved access to knowledge, backers say, particularly for libraries and schools. They are also crucial for groups such as blind people: in the US and many other countries, it is legal to produce alternate versions of - audio tape or braille, say - of copyrighted works for use by the visually impaired, without permission from the copyright holders. Such exceptions do not exist everywhere.

Several developing countries expressed support for the work plan, which Chile presented on behalf of the four sponsors to the 10-13 March session of WIPO’s Standing Committee on Copyright and Related Rights (SCCR). The plan built on an earlier Chilean proposal dating back to 2005.

The work plan would consist of four phases. First, the SCCR, with assistance from the WIPO secretariat and interested stakeholders, would examine the availability, scope and nature of exceptions and limitations to copyright protection at the international level.

Second, a similar research and information exchange exercise would also be carried out on the availability, scope and nature of exceptions and limitations in national copyright systems, and for their interaction with contractual practices and digital rights management.

Third, the SCCR would discuss and evaluate the justifications and implications of exceptions and limitations in areas prioritised by member states.

Finally, the committee would select specific exceptions and limitations that could form part of a prescriptive minimum global framework, and identify best practices for other exceptions.

As per the work plan, these four phases would culminate in a formal commitment to creating mandatory minimum exceptions and limitations to copyright protection, for instance, through a recommendation adopted by WIPO’s annual General Assembly.

During the SCCR session, Uruguay underlined the importance of exceptions and limitations in achieving a fair balance between the rights of authors and those of society at large, as envisaged in the Universal Declaration of Human Rights (article 27). Brazil affirmed that preserving the fundamental notion of balance between the public interest and the interests of property rights holders was particularly important for developing countries.

The proposal was also supported by South Africa, Ukraine, El Salvador and Paraguay. Algeria, on behalf of the African Group, said it supported the 2005 Chilean proposal and was looking favourably upon the proposed work plan.

Some developed countries, while acknowledging the relevance and importance of the issue, were more reserved about some aspects of the proposed work plan, and asked for more time to study it.

New Zealand and Canada largely supported the information gathering activities provided for in the plan.

Switzerland argued that the committee should focus on unfinished work such as the protection of audiovisual performances and broadcasting organisations. It opposed establishing a catalogue of minimum mandatory exceptions and limitations, claiming that this ran counter to the historic logic of the Berne Convention.

The US said that although it had a long and rich history of exceptions and limitations at the national level, it was not convinced that international norms needed to be set. An evidence-based case needed to be made for doing so, it said, warning that a global instrument might limit traditional national flexibility in setting exceptions and limitations. It expressed opposition to the proposed work plan’s call for analysis of the sort of exceptions and limitations that would be necessary to promote creation and innovation, and questioned whether the plan should be a priority for the SCCR at this time.

Slovenia, on the behalf of the EU, expressed support for further studies into existing exceptions and limitations, particularly at the national and regional levels.

The SCCR ultimately agreed to request the WIPO secretariat to conduct a study on exceptions and limitations for the benefit of educational activities, and to hold an information session on the issue during the committee’s next meeting. It also decided that at its next session, member states would consider a more detailed work plan on this subject, as a number of developed countries requested more time to examine some elements of the proposal presented by the four countries.

The meeting also addressed the question of whether to proceed with negotiating a “broadcast treaty.”

Even though decade-long discussions at WIPO on an international treaty to update broadcasters’ rights in the internet age broke down last summer after governments failed to agree on what the agreement should protect, last September’s General Assembly decided to keep the issue on the SCCR’s agenda. However, it specified that members should consider convening a ‘diplomatic conference’ to finalise a treaty “only after agreement on objectives, specific scope and object of protection has been achieved.”

Nevertheless, Japan expressed hoped that a diplomatic conference would be held soon for the early adoption of a broadcast treaty. Slovenia, on behalf of the EU, said that the protection of broadcasting was among the SCCR’s current priorities.

In contrast, India and the African group pointed out that the committee had been unable to agree on the objective and scope of a possible treaty, despite lengthy discussions.

Ultimately, members agreed that the chair of the SCCR would prepare an informal paper outlining his understanding of delegations’ main convergences and divergences on the committee’s new mandate. The paper is to be discussed at the next SCCR session.

As for the protection of audiovisual performances, the secretariat was requested to prepare a factual document summarising the outcome of activities; compile members’ views; and organise seminars at the national and regional levels, as well as an information meeting, before the next session.

Regarding the SCCR’s future work, the EU suggested that it consider resale rights, collective management, orphan works and applicable law. The US, Switzerland, Australia and New Zealand supported these priorities. Brazil and Chile requested further information on the objectives and scope of these proposals.

The committee ultimately concluded that a decision on its future work would be considered at its next session, tentatively scheduled for 3-7 November. It decided to retain on its agenda the three main discussion items: exceptions and limitations, the protection of broadcasting organizations and audiovisual performances.

Chile and the other proponents of the work plan on exceptions and limitations expressed cautious optimism about the outcome of the meeting despite the committee’s failure to adopt the plan, saying that it was a concrete first step in a long process of work on the issue.

Almost the entire first day of the three-day session was spent on electing the chair of the committee. The long-time chair, Finland’s Jukka Liedes, was ultimately re-elected, despite signs from some delegations that they would like to see changes in the way the committee’s work was conducted.

ICTSD reporting.

The sluggish pace of the 3-7 March discussions prompted one developing country delegate to worry that the talks might become bogged down in committee deliberations, as has happened to other issues at WIPO. Another official, from an industrialised country, noted that the process would have to be a long-term one anyway.

WIPO members created the Committee on Development and Intellectual Property (CDIP) last fall, and charged it with developing a work programme for implementing and monitoring some 45 recommendations agreed on after two years of intense debates on the establishment of a ‘development agenda’ for WIPO. Barbadian Ambassador Trevor Clarke was elected to chair the committee.

The 45 development agenda recommendations cover issues such as technical assistance; ensuring that WIPO norm-setting reflects countries’ different development levels, and broadening the institution’s focus on issues including public domain, competition, and access to knowledge. They also address technology transfer, assessment and evaluation, and the organisation’s mandate and governance. Nineteen of the 45 were identified for immediate implementation since they would not require additional human and financial resources. The resources required to implement the remaining 26 need yet to be evaluated. Governments were unable to agree on WIPO’s budget, last year as it became the subject of a row related to the organisation’s leadership

The six recommendations discussed at the meeting dealt primarily with making the WIPO secretariat’s technical assistance more responsive to the concerns and needs of the developing country recipients, Some focused on helping countries boost the capacity of national-level intellectual property authorities to pursue the public interest and to better carry out patent searches.
At the outset of the meeting, several developing countries, in particular the African Group and the ‘Friends of Development’ group that backed the development agenda from the outset, emphasised that the implementation of the recommendations was even more important than the negotiation phase.

India affirmed that the real challenge was effectively mainstreaming the development dimension in all of WIPO’s activities, a task which went well beyond the recommendations.
Many developing countries stressed the need for a holistic approach to implementation, saying that the CDIP should discuss and propose activities for all the 45 recommendations.
The US said that the CDIP must implement proposals in a manner consistent with its specific mandate and the general mandate of WIPO, and specifically with the organisation’s regular budgetary procedures. It called for information to be provided immediately for proposals that require additional financial and human resources.

Slovenia, in the name of the EU, insisted that the committee’s work programme could not be approved without an examination of similar information for proposals requiring additional financial and human resources.

A number of international organisations and civil society groups also spoke at the meeting. The Office of the United Nations High Commissioner for Human Rights (OHCHR), said it was willing to contribute to the work of the CDIP, drawing on the work of UN human rights bodies that have addressed the impact of intellectual property policies on various human rights.
Non-governmental organisations such as Knowledge Ecology International (KEI), Electronic Information for Libraries (eifl), the Electronic Frontier Foundation (EFF) and Third World Network (TWN) made observations about how to improve transparency and balance in WIPO’s technical assistance activities. They also suggested how WIPO could expand its work on public interest and development aspects in relation to intellectual property, such as improving access to knowledge and expanding the public domain.

Following lengthy discussions on procedures and working methods, the committee agreed to address the recommendations one by one, and by each of the six clusters, starting first with the 26 recommendations requiring additional resources, and then the 19 for immediate implementation.

The discussions were based on a number of documents circulated at the meeting, notably the chair’s preliminary implementation report describing activities implemented or planned by the WIPO Secretariat with respect to the 19 recommendations identified for immediate implementation, and an initial working document containing a list of the Secretariat’s proposals for implementing the remaining 26.

Different countries and groups also put forward suggestions for how the recommendations could be implemented; these included the Friends of Development, the Central European and Baltic States, and the Republic of Korea.

Ultimately, the committee was only able to discuss six recommendations in a single cluster, technical assistance. Five were in the list of 26 (recommendations 2, 5, 8, 9 and 10), and one in the list of 19 (recommendation 1),

At the end of the meeting, the CDIP agreed that for the list of 26 recommendations, the proposed activities, with appropriate modifications, would be sent to the Secretariat for an assessment of human and financial resource requirements before the committee’s next session in July. For the list of 19 recommendations, the WIPO Secretariat is now set to furnish a progress report to that meeting, taking into consideration suggested changes and new activities.

Given the slow progress made at this first session, the CDIP decided that the chair would organise informal consultations before the next session in July. These would focus particularly on the recommendations that need additional resources in order to enable the secretariat to make the necessary assessments.

Commenting on the meeting, several delegates noted that the chair’s initial working papers had been circulated a short time before the meeting, leaving member states insufficient time to react to them. Many countries seemed not to have been adequately prepared to provide concrete suggestions for activities to implement the development agenda recommendations.
Many developing countries said that the Secretariat’s list appeared to be confined to activities it had already undertaken or planned, often without a clear link to the goal of achieving a more balanced, inclusive and development oriented intellectual property system — the ultimate purpose of the development agenda.

Brazil emphasised that it was not the task of the CDIP to give a “certificate of development agenda compliance” to ongoing activities. Instead, it said that the committee should focus on proposals for future work that would orient WIPO activities towards fulfilling the development agenda’s goals.

A delegate from another member of the Friends of Development group expressed concern that the CDIP deliberations might end up like discussions in WIPO’s Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore, which have been bogged down in conceptual disagreements and semantic arguments for over seven years.

Many delegates expressed hope that the informal consultations by the chair would help accelerate the development agenda discussions.

ICTSD reporting.

Biofuels have long been considered ‘carbon-neutral’, as the emissions from consumption are believed to be offset by the plants from which the fuel is made. The studies argue that this conception is overly simplistic, and fails to account for the carbon costs of biofuel-related land use changes.

Both studies focus on cropland. The first study finds that converting rainforests or grasslands to produce biofuels releases much more carbon dioxide into the air than the plants are able to absorb. Similarly, using currently productive farmland to grow biofuel crops will also use more carbon then it saves, according to Princeton’s Timothy Searchinger, the lead author of the other study.

Ten prominent ecologists authored a letter to US President George W. Bush in response to these new findings, asking for new a policy “that ensures biofuels are not produced on productive forests, grassland or cropland,” according to the Los Angeles Times. Last year, legislation was passed calling for the production of ethanol, derived mostly from maize, to double over the next 10 years.

The UN announced the formation of a panel to analyse the study’s findings, saying that biofuels could still be useful in the global environmental effort. Bob Dinneen, the president of the Renewable Fuels Association, issued a statement saying that, despite the new studies, “we must all remember where we are today, how world demand for liquid fuels is growing, and what the realistic alternatives are to meet those growing demands. Biofuels like ethanol are the only tool readily available that can begin to address the challenges of energy security and environmental protection.”

Searchinger’s study says that the “extraordinary productivity” of Brasilian sugarcane means that it would need only four years to “pay back the upfront carbon emissions” when grown on tropical grazing land. However, this payback period would rise more than ten-fold if displaced ranchers then proceed to convert rainforest to grazing land.

“The Science articles underscore the great risks of unintended consequences associated with subsidising and mandating biofuels”, noted Tara Laan, Assistant Researcher of the Globbal Subsidies Initiative. “The implications of the study by Searchinger et al. are especially important — namely, that developing sustainability standards for biofuels that do NOT account for indirect GHG emissions arising from the displacement of crop production is about as effective as re-arranging deck chairs on the Titanic.”

The abstracts of the two papers can be found online at www.sciencemag.org.

ICTSD Reporting; “Biofuel crops increase carbon emissions,” LOS ANGELES TIMES, 8 February 2008. “Simplistic View of Land Use Change Excludes Consequences of Continuing Petroleum Dependence,” RFA NEWS RELEASE, 7 February 2008.

The amendment makes permanent a 2003 waiver setting out the conditions under which it would be legal for Members to issue compulsory licences for the production and export of cheap generic copies of patented medicines to poor countries unable to manufacture drugs. Echoing civil society critics such as Médecins sans Frontières (MSF), several members of European Parliament (MEPs) have complained these conditions are unduly onerous, making the proposed amendment difficult to use.
The European Parliament’s July resolution said that ratifying the TRIPS amendment “represents just part of the solution to the problem of access to medicines and public health,” stressing that “other measures to improve healthcare and infrastructure are equally indispensable.”
Portugal, which currently holds the rotating presidency of the Council, responded to the parliament’s concerns in an August letter reiterating EU member states’ support for public health-related flexibilities in WTO intellectual property rules, specifically naming the 2001 Doha Declaration on the TRIPS Agreement and Public Health. Manuel Lobo Antunes, Portugal’s secretary of state for European affairs, wrote “the Council believes that this amendment is the best solution at the moment to attempt to solve the specific issue of facilitating exports to poor developing countries that do not have the production capacity for generic drugs.” Referring to the European Parliament’s demands, he pointed to existing programmes by EU members to support research and development and build drug manufacturing capacity in developing countries.
The parliament’s trade committee, however, remains unimpressed. The disagreement is one of several discordant notes sounded in recent months by different levels of government in the EU on the broader connection between TRIPS flexibilities and the pursuit of public health goals.
Most notable was a sharp exchange between EU Trade Commissioner Peter Mandelson and Thai Health Minister Mongkol Na Songkhla over Thailand’s decision to issue compulsory licences suspending the patents on two HIV/AIDS drugs and one heart disease treatment BRIDGES Weekly,31 January 2007
Lauded by public health advocates, the move was criticised by industry groups, though its legality under WTO rules for compulsory licensing was rarely disputed.BRIDGES Weekly14 March 2007

In his letter, dated 10 July, Mandelson expressed concern that “the Thai government may be taking a new approach on access to medicines.” Pointing to the recent compulsory licences and a statement by Bangkok saying that drug companies “should offer their drugs for no more than 5 percent above the generic cost,” he argued that a “systematic policy of applying compulsory licences” would “be detrimental to the patent system”, risked scaring away pharmaceutical investment, and did not appear to be justified by TRIPS rules and associated flexibilities.
Moreover, the EU trade chief said that the Thai government should explore “other means” to boost access to essential medicine “before resorting to such exceptional measures.” On behalf of the EU, he encouraged the Thai government to seek “direct discussions” with the patent-holding companies, particularly with France’s Sanofi-Aventis, the makers of Plavix, a blood thinner used to treat a non-communicable heart disease. Mongkol countered that the 5 percent premium applied only to the three medicines for which compulsory licences had been issued to secure generics for government health programmes. He emphasised that it was not applicable to the private market for the three drugs or to any drugs not under compulsory licence. Nor was the premium a criterion used to determine whether to issue compulsory licences, he said, asking Mandelson for evidence in support of his allegations that this was the case. Bangkok has maintained that it had tried to negotiate lower prices with the companies in question - even though not required to do so by WTO rules - but to little avail. A March report by the Thai government concluded that such discussions were more likely to be successful under threat of a compulsory licence In his letter, Mongkol pointed to the European Parliament’s July resolution reaffirming countries’ right to use TRIPS flexibilities.
Noting that EU member countries had often made use of compulsory licences, the Thai minister also asked Mandelson to demonstrate how they had been isolated from the global biotechnology investment community. The EU trade chief replied to Mongkol last week, but failed to provide any such examples. He did express satisfaction that Thailand was not pursuing a systematic compulsory licence policy, and reiterated his call for negotiations with the patent-holders.
When Mandelson faced the European Parliament’s trade committee on 12 September, his correspondence with the Thai minister faced heavy criticism for appearing to discourage compulsory licensing, particularly from Ignasi Guardans Cambo, a Spanish liberal MEP. One source said that committee members were only “partially satisfied” with the commissioner’s explanation that his letter had been misinterpreted.
MSF and Oxfam noted that Mandelson’s message to Thailand on compulsory licensing was very different from that set out by the European Parliament. “We are surprised that your intervention made in the name of the European Union comes at the very moment the European Parliament is requesting the Council and the Commission to find ways to solve issues around access to medicines,” they wrote in a letter to the trade commissioner.
The parliamentary trade committee’s next opportunity to approve the TRIPS amendment will be at its 8-9 October meeting. If committee members are satisfied by then with EU members’ response to their demands, their assent would set up a parliament-wide vote two weeks later.
ICTSD reporting.

Public health advocates greeted the move with relief. “It means Kenya can continue to buy medicines from the cheapest source and make them widely available for patients,” said James Kamau, coordinator of the Kenya Treatment Action Movement.

The WTO Agreement on Trade-related Aspects of Intellectual Property Rights (TRIPS) allows governments under certain circumstances to issue compulsory licenses on patented inventions without the authorisation of the patent-holder, which effectively suspends the patent. Developing countries have used these flexibilities to produce or import affordable generic copies of patented drugs to treat HIV/AIDS and other diseases. Industrialised nations have a long history of issuing compulsory licenses for patents ranging from car parts to medicines, in order, for example, to combat anti-competitive practices.

According to the United Nations, 1.3 million people are living with HIV/AIDS in Kenya. Ellen t’Hoen of Médecins Sans Frontières said that “our ability to provide AIDS medicines to over 10,000 people in Kenya depends on the availability of affordable generic medicines… [which] would have been in jeopardy if the amendments had gone through.”

The amendment in question, contained in the Miscellaneous Amendments Bill debated late on 12 September, would have amounted to deleting Section 80 of the Industrial Property Act of 2001, which covers compulsory licensing. Without laws allowing compulsory licensing, the government would have been left with no recourse to authorise the production or even importation of generic copies of patented products without the patent-holder’s consent. It would, for instance, have been forced to negotiate drug prices with brand name pharmaceutical companies rather than continue to purchase generic AIDS drugs from India, even in the context of Kenya’s health emergencies.

Ahmed Ogwell, head of international health relations at the Kenyan health ministry, told Bridges he was relieved by the outcome. He praised the parliament “for seeing the huge public health problem that these amendments posed and therefore rejecting the proposals.” Ogwell added that “we shall remain vigilant on [these] matters… because we know that vultures who smell profits to the detriment of public health abound out there.” It remains unclear how the proposals had found their way into the proposed legislation before parliament. Peter Munyi, a Kenyan intellectual property expert, told Intellectual Property Watch that amendments to the Industrial Property Act would normally come under the remit of the Ministry of Trade. However, it had denied responsibility, as had the Kenyan Industrial Property Institute (KIPI).

On the question of the source of the proposed amendment, Ogwell said “it is not clear,” noting that the government had started internal investigations “to identify the source.” Munyi thought the interests of those who would gain politically or commercially from the amendments were ultimately telling. “From previous experience, it is perhaps not necessary to continue asking that question,” he hinted darkly.

Public health-related provisions in the Industrial Property Act of 2001 have kept lawmakers busy in recent years. Rules on ‘parallel importation’, which refers to the importation of cheaper brand products from other countries, were controversially deleted in 2002, only to be later reinstated. Proposed amendments on compulsory licensing and parallel importation re-surfaced in 2005 and 2006 but were delayed. Unlike compulsory licensing, parallel importation was not part of the proposed legislation that was defeated last week.

ICTSD reporting; “Kenya Rejects Bid to Remove Government’s Compulsory Licensing Flexibilities,” INTELLECTUAL PROPERTY WATCH, 14 September 2007.

The stringent standards of patentability upheld by the court mean that fewer medicines will be eligible for patents. This in turn broadens the scope for the production of generic drugs.

The decision was welcomed by health activists, who had warned that an expansive interpretation of patent eligibility would have stopped India from producing inexpensive medicines for the world’s poor. “This is a huge relief for millions of patients and doctors in developing countries who depend on affordable medicines from India,” said Tido von Schön-Angerer, director of the Médecins Sans Frontières (MSF) campaign for access to essential medicines.

But Novartis announced it would divert research and development (R&D) funding planned for India to China instead. Daniel Vasella, the Swiss multinational’s CEO, said: “This [ruling] is not an invitation to invest in Indian research and development, which we would have done. We will invest more in countries where we have protection. It’s not a punishment. It’s just a question of the culture for investment.”

The court reaffirmed a section of Indian patent law requiring inventions to be significantly improved before they can be eligible for another patent, a clause designed to counter the undue prolongation of patent terms through only minor tweaking. It said it did not have jurisdiction to rule on whether this was compliant with the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), as Novartis had charged.

The case followed the Chennai Patent Office’s rejection of Novartis’ patent application for the beta crystal form of cancer drug imatinib, marketed as Glivec (or Gleevec in the US). The office said it did not satisfy legal requirements for ‘novelty’ and ‘inventive step’, two of the main criteria used to evaluate patent applications. Novartis, however, had been granted the patent in almost 40 other countries, including China. Consequently, Novartis took its case to the Chennai High Court in May 2006, appealing the decision and challenging the Indian Patent Act

The crux of the Patent Office’s argument rests on Section 3(d) of the Indian Patent Act, which denies patentability to “a new form of a known substance” unless it results in “enhancement of the known efficacy of the substance”. Brought in with the 2005 legislation that made Indian patent law compliant with the WTO TRIPS Agreement, the clause was intended to stop patent “evergreening”, whereby minor changes to already-patented molecules are used as a basis for acquiring fresh patents and hence extended periods of protection. These, in turn, delay the entry of generic competitors into the market.

Indian Health Minister Anbumani Ramadoss said in April that the government was “very concerned” that the case’s outcome might restrict India’s ability to produce medicines cheaply. Along with former Swiss President Ruth Dreifuss, Archbishop Desmond Tutu, and members of the European Parliament and the US Congress, Ramadoss was among the nearly half a million people who signed an MSF petition urging Novartis to drop the case.

MSF, which purchases 84 percent of the AIDS drugs it distributes from Indian generic producers, said that “a ruling in favour of the company would have drastically restricted the production of affordable medicines in India that are crucial for the treatment of diseases throughout the developing world” because the Novartis challenge became a test case for Section 3(d).

How to define “enhancement of efficacy”?

The original form of imatinib, developed in 1992, cannot be patented in India since pharmaceutical products were ineligible for such protection there until 1995. The ‘beta crystalline’ form of the molecule was developed for patients to take as a pill and launched as Glivec in 2001.

As a developing country, India was not required to fully comply with TRIPS rules, which include pharmaceutical product patents, until 2005. In the interim, however, it introduced a temporary system of ‘exclusive marketing rights’ for new products that would then be considered for patents with the advent of full TRIPS compliance. When Novartis was granted one of the first such exclusive marketing rights, for Glivec in November 2003, the price increased from $230 to $2,740 per year.

After India reformed its patent laws to make them compliant with WTO rules in 2005, Novartis was refused a patent for Glivec on the basis that the beta crystalline form did not provide a significant enough “enhancement of efficacy” of the original imatinib molecule. Novartis responded with a writ to the High Court appealing against the ruling. It argued that Section 3(d) of the Indian Patent Act was “unconstitutional as it is vague, arbitrary and violative of Article 14 of the constitution (right to equality)”, and alleged that it contravened India’s obligations under the TRIPS Agreement.

Defending the patent-worthiness of Glivec, Novartis research chief Paul Herrling said “medical progress occurs through incremental innovation. If Indian patent law does not recognise these important advances, patients will be denied new and better medicines”.

A different view came from Brian Druker, the key researcher behind imatinib. Most scientists he worked with are “primarily motivated by the pursuit of knowledge as a means to help patients,” he said, and “it is, therefore, of great concern that the results of their efforts can’t reach patients and save lives because of pricing strategies and patent policies such as ‘patent evergreening’… used by partners further down the drug development process.”

India attempts to differentiate genuine innovation from evergreening by using the “enhancement of efficacy” concept, says Health GAP’s Brook Baker, a professor at Northeastern University. However, the definition of “enhancement of efficacy” remains unclear. The High Court suggested only that efficacy can be defined as “the ability of a drug to produce a desired therapeutic effect.” It did not provide any guidance on how enhancements might be quantified, such as in terms of fewer side-effects or lower dosages.

Novartis maintains that Glivec boosts bioavailability (i.e. the degree to which the drug is absorbed by the patient) by 30 percent over the original form of imatinib, which should constitute an enhancement of efficacy. The Chennai Patent Office disagreed in rejecting the application, but more guidance to the definition may be provided during Novartis’ appeal, which has been referred to the Indian Patent and Trademark Appellate Board (IPAB).

Tahir Amin, director of the Initiative for Medicines, Access and Knowledge (I-MAK), told Bridges that “the real issue lies in how the IPAB will define efficacy. This is what will determine the scope of patenting in India and thus the extent to which incremental innovations will be protected”.

TRIPS compliance unlikely to surface at WTO

The Chennai High Court declined to rule on Novartis’ assertion that Section 3(d) of the Indian Patent Act contravened TRIPS rules, saying it had no jurisdiction to rule on international treaties. In effect, it said that only the WTO was fit to make that decision.

If Novartis wants the WTO to rule on the matter, it will have to persuade the Swiss government to bring a case against India at the global trade arbiter’s headquarters in Geneva.

However, Felix Addor, Deputy Director General of the Swiss Federal Institute of Intellectual Property, said “the issue of a WTO panel is not on the agenda of the Swiss Government at this point of time”. Meanwhile, Indian Commerce and Industry Minister Kamal Nath insisted that “Our patent laws are WTO compliant”.

In a press release issued after the court announced its decision, Novartis asserted that “during the India Trade Policy Review in late May 2007, the WTO urged India to strengthen its intellectual property rights system. It commended India for taking steps to align its national standards with international requirements but added that ‘effective implementation of IPR-related legislation would be in the interest of India itself’.”

Professor Baker said that Novartis had quoted selectively from a summary of individual Members’ comments on the review, and that the extensive report itself contained “no discussion even questioning the legality or TRIPS-compliance of the India Patent Act generally or of section 3(d) in particular”.

Baker also found it unlikely that Novartis had changed its R&D investment strategy on the basis of the court’s ruling. He told Bridges that “it’s virtually impossible to imagine this decision [to shift investment to China] turned on Section 3(d)” given the other business conditions taken into consideration, such as the low cost of clinical trials and researchers.

According to Indian press reports, at least a dozen large international pharmaceutical companies have invested heavily in the country since the amendment of the Patent Act in 2005.

ICTSD Reporting; “Indian Law on Generic Drugs is Upheld,” INTERNATIONAL HERALD TRIBUNE, 6 August 2007; “Novartis Case May Not Reach WTO,” HINDUSTAN TIMES, 8 August 2007; “Don’t Abuse Patents: Scientists,” LIVE MINT, 15 August 2007; “Novartis to move Indian R&D,” FINANCIAL TIMES, 21 August 2007; “MNCs Still Bullish on India R&D,” BUSINESS STANDARD, 27 August 2007.

The forty-one page document, dated 31 July, contains a wide range of ideas for how to identify research needs, ramp up pharmaceutical development and innovative capacity, and improve access to medicines. Notably, it highlights the relationship between intellectual property and pharmaceutical innovation, both through the use of flexibilities in WTO rules and the exploration of incentives outside the traditional patent system. The suggestions in the draft plan were based on a text developed at the last meeting of the WHO’s Intergovernmental Working Group (IGWG) on Public Health, Innovation, and Intellectual Property as well as written comments submitted by 22 countries and regional groups (see BRIDGES Weekly, 25 April 2007).

Although critics called the new draft vague and unfocused, WHO officials defended the decision to include most proposals rather than discarding several to produce a more targeted plan of action. There is “a thin line to be walked between including too little or too much,” argued one vice-chair of the committee. Another official told Bridges that a less inclusive text would not have been consonant with the secretariat’s approach to the talks in the IGWG. “We have sought to sort out the concerns of all parties with a passionate interest in advancing research and development for neglected diseases,” added WHO Assistant Director-General Howard Zucker.

GlaxoSmithKline’s Jon Pender said that the text formed “a reasonable basis for discussion.”

Health activists say that only a small share of global spending on medical research focuses on problems faced predominantly by developing countries, even though they account for the bulk of avoidable ill-health. Some see the ongoing deliberations at the WHO as an opportunity to explore alternatives to drug patents as a means of encouraging innovation and the development of new and affordable drugs.

Nuts and bolts of the new draft

The draft global strategy states that despite recent progress on innovation and access to medicines, the sheer scale of “avoidable suffering and mortality” means that “more must be done.” To this end, it aims to “provide a medium-term framework for an enhanced sustainable basis for needs-driven, essential research and development relevant to diseases that disproportionately affect developing countries.” It focuses on “diseases or conditions of significant public health importance in developing countries for which an adequate treatment for use in resource-poor settings is not available.”

Like the previous version, the revised plan of action is structured around eight elements: prioritising research and development needs; promoting research and development; building and improving innovative capacity; technology transfer; managing intellectual property; improving delivery and access; ensuring sustainable financing mechanisms; and establishing monitoring and reporting systems. It simplifies parts of the earlier text, and incorporates many — though not all - suggestions by governments. The new draft presents the plan in table format, linking specific actions to stakeholders, time frames, and measurable indicators of progress.

Additionally, the draft proposes a focus on 14 diseases, including diabetes, cardiovascular disease, cancer, HIV/AIDS, tuberculosis, Chagas disease, dengue, leishmaniasis, and malaria. One source admitted that he was “puzzled” about where this came from, especially since as it was not raised in the country submissions.

Another close observer of the process noted that the plan failed to include concrete instructions on precisely how to accomplish the various priorities, such as identifying research gaps. Also absent were details on how any of this would be funded.

Alternatives to patents discussed

The new draft softens language on the appropriate level of intellectual property protection in bilateral trade agreements, following questions from the US and Australia about whether the WHO text should address issues dealt with in other international fora. For instance, a phrase saying that governments should “assure that bilateral trade agreements do not seek to incorporate ‘TRIPS-plus’ protection” is replaced with “promote bilateral trade agreements that do not incorporate ‘TRIPS-plus’ protection.”

As highlighted by several country submissions, the draft calls for greater collaboration between the WHO, the WTO and the World Intellectual Property Organization for purposes such as strengthening education and training in the management of intellectual property. In this regard, sources at WIPO and the WTO have indicated that they are providing technical advice to the WHO upon request. However, they added that implementing proposals that assign tasks to other international organisations might require further reflection, since institutions have their own mandates and accountability structures.

At the same time, the revised text added items suggested by countries, such as Brazil’s proposal to assess the impact of data-exclusivity regulations. In response to the South-East Asia region’s call for the WHO “to compile good practice and lessons on the implementation of TRIPS flexibilities,” the new draft highlights the dissemination of best practices as a means of promoting legislation that makes use of TRIPS flexibilities.

The draft does not change the element entitled, “management of intellectual property.” The US government, a traditionally strong proponent of far-reaching intellectual property rights, had called this “unclear.” Brazil, on the other hand, criticised it for “mistakenly assum[ing] that the problems faced by developing countries on this matter are circumscribed to administrative concerns” alone, rather than obstacles to innovation and access arising from the structure of existing intellectual property protections.

However, the draft does not adopt some specific suggestions by countries, such as the South-East Asia Region’s call for an “operational interpretation of ‘inventive steps,’” relating to the technical term used in the evaluation of whether a patent applicant’s invention is sufficiently innovative to deserve a patent. Nor does the draft adopt Egypt’s suggestion for a set of guidelines for the transfer of technology.

Guilherme Patriota, a counsellor at Brazil’s mission in Geneva, said that he was “not dissatisfied” with the draft and called it a “fair start.” He noted that it contains two important elements: the use of flexibilities under the 2001 Doha Declaration on TRIPS and Public Health, and work on new models for innovation, especially those that aim to decouple drug prices from research funding, such as the prize fund model.

The draft also calls for further discussion of ‘patent pools’, a medical research and development treaty, advanced market commitments and public-private partnerships, as ways of encouraging innovation and lowering drug costs. Patent pools, for instance, are created when patent owners agree to licence their innovations as a package, allowing third party licensees to exploit the technology encompassed by the entire bundle. Although such arrangements can lead to economies of scale, lower prices, and increased innovation, no pharmaceutical patent pool has yet been formed. Advanced market commitments are binding promises, generally by governments, to purchase a vaccine or medicine if and when it is developed. Canada, Italy, Norway, Russia, and the UK this year launched one such attempt, encouraging research targeting pneumococcal diseases, a major cause of pneumonia and meningitis.

The new text also makes strong links between trade-related issues and access to medicines, including support for generic production of essential medicines, the removal of tariffs and taxes on health care products, and the use of best manufacturing practices.

Spring Gombe and Thiru Balasubramaniam of Knowledge Ecology International were mixed in their response to the draft. They noted that it “contains some welcome statements of access to medicines, support for the use of TRIPS flexibilities and new methods to create incentives for research and development for new medicines,” but said that “the plan of action is vague with neither a clear sense of ownership nor any sense of urgency.”

Médecins Sans Frontières’ Ellen ‘t Hoen was similarly lukewarm, telling Intellectual Property Watch that “the document lacks clear direction and allocation of responsibilities. However, it is encouraging to see that it does not shy away from including new proposals such as a patent pool to deal with immediate access issues and new rules to incentivise R&D.”

Several member governments were reluctant to comment on the text, as they will soon have to enter into negotiations on it. Regional consultations are scheduled for August and September, and the second meeting of the IGWG is scheduled for 5-10 November.

In principle, the final plan of action should be ready for members to adopt at the May 2008 meeting of the World Health Assembly, though members such as Bolivia and Bangladesh, have recommended a one-year extension.

The WHO’s Zucker anticipates “a very lively discussion” at the committee’s meeting in November.

ICTSD reporting; “WHO Draft Negotiating Text on IP Cautiously Received,” INTELLECTUAL PROPERTY WATCH, 8 August 2007.

With negotiations on potential treaties stalled, the recent session - supposed to be the committee’s last - focused primarily on the IGC’s “future work.” The week was taken up by informal negotiations and what delegates called “informal informal” meetings between the Africa Group, Australia, Brazil, Canada, Japan and the US. Several indigenous peoples’ groups and other organisations also participated, though some expressed frustration at their lack of access to the negotiations between states BRIDGES 11 July 2007

Agreement on how to proceed was only reached late during the final plenary session. The IGC will ask WIPO’s September General Assembly to renew its mandate once more, with the committee reminded “to accelerate its work and to present a progress report to the [2008] General Assembly.” The renewed mandate also maintains that “no outcome of its work is excluded, including the possible development of an international instrument or instruments.”
IGC Chair Ambassador Gusti Agung Wesaka Puja (Indonesia) described the decision as a “new direction” to “further explore” issues. However, Peruvian delegate Alejandro Neyra said the renewed mandate was “basically the same” as the previous one. Where developing countries had sought a commitment to “work towards a common position”, for instance, developed countries, particularly the US and Canada, were careful to avoid language that might expand the mandate, Neyra said. They ensured the final text calls only for “work towards further convergence of views.”
Sources report that the renewal of the committee’s mandate was never really in question. In fact, one suggested that developed countries were keener to renew the mandate than some developing nations, as an easy and inconsequential gesture of commitment to deal with the misappropriation of genetic resources and traditional knowledge.
The decisions of the IGC are available at
ICTSD Reporting; “WIPO Committee Extends, Adjusts Mandate on Traditional Knowledge, Folklore”, INTELLECTUAL PROPERTY WATCH, 13 July 2007.

The parliament’s international trade committee announced on 17 July that promises of monetary and political support from the EU’s 27 member governments remained insufficient.

Five days earlier, European Parliament members from across the political spectrum passed a resolution identifying the complementary policies they deemed necessary to ensure that ratifying the amendment would promote access to medicines in poor countries. They also demanded that the EU stop seeking WTO-plus intellectual property protections for pharmaceuticals in bilateral and regional trade negotiations with developing countries.

However, EU member states’ inadequate response to these objectives made it impossible to approve the amendment, the trade committee said. With the committee’s decision pushed back to10 September, the issue will not come up for a parliament-wide vote later that month or in October. Under EU procedures, the European Parliament must assent to the potential amendment before each of the member states can ratify it.

WTO Members agreed on the formal changes to the Agreement on Trade-related Aspects of Intellectual Property Rights (TRIPS) in December 2005. For the amendment to enter into force on schedule, two-thirds of WTO Members - some 100 countries - need to ratify the changes by 1 December. Thus far, however, only seven have done so (seeBRIDGES Weekly , 27 June 2007).

The amendment makes permanent a 2003 waiver from TRIPS rules setting out the conditions for Members to legally issue compulsory licences for the production and export of cheap generic copies of patented drugs to poor countries.

Echoing civil society critics of the proposed amendment such as Médecins sans Frontières (MSF), several members of European Parliament (MEPs) have complained the waiver on which it is based is so complex that it has never once been used to export medicine.

The resolution MEPs adopted on 12 July stressed that the TRIPS amendment “represents just part of the solution to the problem of access to medicines and public health.” In it, they urged the Council of EU member governments to “support the idea… that other measures to improve healthcare and infrastructure are equally indispensable.”

The entry into force of the TRIPS Agreement in 1994 had hampered developing countries’ ability to produce and afford generic drugs, the resolution suggested, and the amendment’s mechanism was difficult, if not impossible to use effectively.

Arguing that “EU policy should aim at maximizing the availability of pharmaceutical products at affordable prices in the developing world,” the parliament called on the European Commission and member states to commit funding for transfer of pharmaceutical-related technology to poor countries. It also asked them to boost financial support for the development of drugs to treat diseases that disproportionately affect developing countries, and to play a more active role in the World Health Organisation’s intergovernmental working group (IGWG) that is seeking to develop alternatives to patents to spur pharmaceutical innovation (seeBRIDGES Weekly , 23 May 2007).

Financial assistance aside, the resolution also called for the European Commission and member states to provide political support for governments that seek to “provide essential medicines at affordable prices under their domestic public health programmes” by using flexibilities in TRIPS rules permitting the suspension of patents in exchange for a royalty payment.

Such support is not always forthcoming in practice. Alexandra Heumber, a spokesperson for MSF in Brussels, said that compulsory licences for HIV/AIDS medicines recently issued by Brazil and Thailand provided Brussels with an opportunity to reaffirm its support for the use of the flexibilities highlighted in the 2001 Doha Declaration on TRIPS and Public Health. Instead, however, the European Commission questioned their decisions, even though they were well in line with WTO rules (see BRIDGES Weekly, 31 July 2007).

MSF believes that compulsory licensing and the ensuing generic competition could help make expensive second-line HIV/AIDS treatment more widely affordable in developing countries such as Thailand. Heumber noted that after Thailand suspended the patent on HIV/AIDS drug efavirenz, enough of the medicine was imported in a single day in January to allow 20,000 additional patients to be treated.

Several of the parliament’s demands echoed recommendations made by Frederick Abbott, a professor of international law at Florida State University, and Jerome Reichman, a law professor at Duke University, in a report on the TRIPS amendment commissioned by the EU. In that paper, they warned that making the amendment functional for access to medicine would require vigilant and deliberate government action, including a “combination of political will, good lawyering, financial support for appropriate implementation efforts and collective action.” They wrote that the effectiveness of the amendment could be enhanced through regional cooperation on procurement and compulsory licensing, as well as the creation of funding mechanisms other than patent rights to encourage the development of new drugs.

In a recent interview with Bridges, Abbott suggested that attempts to re-negotiate the TRIPS amendment would likely end in a stalemate, and potentially risked producing even more restrictive provisions.

Targeting EU policy vis-à-vis bilateral free trade agreements, the parliament asked member states to explicitly mandate the Commission not to “negotiate pharmaceutical-related TRIPS-plus provisions affecting public health and access to medicines, in the framework of the negotiation of the Economic Partnership Agreements with the ACP [African, Caribbean, and Pacific] countries and other future bilateral and regional agreements with developing countries.”

This prompted EU Enlargement Commissioner Olli Rehn to insist that the EU was “committed” to not including provisions affecting access to medicine in either the EPAs or other trade agreements. Intellectual Property Watch reports that Rehn, speaking in the place of Trade Commissioner Peter Mandelson, said that the fact that the waiver had not been used was not very significant, since it had strengthened the hand of developing countries in price negotiations with pharmaceutical companies. However, the study by Abbott and Reichmann said that on the basis of draft agreement texts in the EPA negotiations, the European Commission had been pushing for intellectual property provisions that risked impairing the availability of generic drugs.

MSF’s Heumber welcomed the “strong coalition” of support from all political groups for the resolution, describing it as proof that the parliament was aware that many policies would need to be pursued to safeguard access to medicine for patients in the developing world. She reiterated that all governments that signed on to the Doha Declaration on TRIPS and Public Health should support developing nations’ efforts to use compulsory licences in order to support public health programmes.

ICTSD reporting; “Parliament Delays WTO IP Health Deal Till EU Boosts Bilateral Drug Access,” INTELLECTUAL PROPERTY WATCH, 12 July 2007; “EU pledges easier drug access for poor nations,” REUTERS, 11 July 2007.