WTO, WIPO and WHO Examine Role of Patent Information in Access to Medicines
The information in patent documents and applications can play an important role in improving access to medicines, said experts at a symposium on "Access to Medicines, Patent Information and Freedom to Operate" in Geneva last month.
Procurement agencies, research institutions, industry and other stakeholders need to know specifics about whether a product is patented in order to understand the constraints surrounding their attempts to devise strategies for the research and development of new medicines, or for improving access to these medicines in poorer countries. However, numerous gaps and challenges need to be addressed in order to ensure patent information is easily available and accessible.
The 18 February gathering was the second such symposium organised by the World Health Organization (WHO) the World Intellectual Property Organization (WIPO) and the World Trade Organization (WTO); the three joined hands last July to organise a conference on pricing and procurement practices related to access to medicines.
With the current era of austerity forcing governments to take a closer look at pharmaceutical expenditures, questions about affordability and access to generic medical products were inevitable, WHO Director-General Margaret Chan said in her opening remarks. If health officials were seeking to use their budgets efficiently by procuring lower-cost generics, they must do so with a good understanding of products' patent status. This was particularly true in the developing world, where the there was a "critical need for capacity to manage and apply intellectual property," she said.
Francis Gurry, the head of WIPO, emphasised that one of the justifications for patent protection was the technology disclosure that went with it. "While this had not functioned effectively in the age of paper copies," he said, "modern technology has made the information easily accessible." New tools were helping to overcome access barriers, he said, pointing to PATENTSCOPE, WIPO's fast-expanding searchable database.
WTO Director-General Pascal Lamy, for his part, said that "Understanding what is actually going on out there - who is patenting what, where, to what effect - is central to the kind of policy discussions that take place in the WTO and elsewhere regarding TRIPS and initiatives for access to medicines." He called for "an information platform that is accessible for all, usable by even those who lack technical or legal expertise, and which gives real-time information about the patent coverage of essential medicines." The WTO chief praised the joint meeting as an example of how careful coordination among international organization secretariats can help them pursue their respective mandates more effectively.
"Freedom to operate" was defined by one of the speakers, WIPO's Anatole Krattiger, as the ability, from a legal perspective to assemble all the intellectual property rights for a specific product for a specific market and specific use. From a business perspective, he said, it is a product development and risk management strategy, one type of input among many that managers use when making strategic decisions in relation to research and development and product launch. Whether a drug has received patent protection in a certain country is not a barrier per se to freedom to operate, Krattiger noted: such freedom could be secured by a variety of legal means such as licensing, cross-licensing, third party opposition, compulsory licensing as well as R&D strategies such as inventing around and modifying the product.
Speakers at the meeting stressed the need for publicly accessible, easy-to-use databases with information on the administrative status of health-related patents. Zafar Mirza, of the WHO's team on public health, innovation and intellectual property (PHI), said that patent information was increasingly important for public health not only in terms of "freedom to operate" vis-a-vis medicine procurement, but also in the field of technology transfer. In addition, he said "more transparent and accessible patent information would enable a more profitable use of TRIPS flexibilities," in a reference to provisions in WTO intellectual property rules that are intended to enable the pursuit of public policy objectives such as access to medicine or fairer competition.
Antony Taubman, who heads the WTO's intellectual property division, stressed the need to move "from data to accessible, trusted, neutral and relevant information that informs and illuminates policymaking processes, practical innovation and procurement strategies". Policymakers needed to be equipped to answer three important questions, he stressed: "What's going on out there? What does it amount to? What to do about it?"
A number of case studies presented during the symposium illustrated some of the challenges facing access and use of patent information. These included a joint project between the WHO, WIPO and the University of New Hampshire School of Law to determine the patent status of all 58 medicines added to the WHO's Model Lists of Essential Medicines since 2003, and a joint collaboration between WIPO and the Medicines Patent Pool to understand the patent status of anti-retroviral drugs.
According to the WHO's Richard Laing, patents do not at present appear to be a major barrier to access to essential medicines on the WHO Model List in low and middle income countries. Access was largely influenced by other factors, such as lack of knowhow or financing, and regulatory issues. However, he pointed to other non-patent barriers such as bilateral trade agreements with ‘TRIPS-plus' intellectual property rules related to data exclusivity and patent linkage.
The discussion highlighted the gaps and limitations of patent information in light of the variety of data sources both public and commercial, as well as the expertise needed to use the data.
Lutz Mailänder, a WIPO official, provided an overview of the global intellectual property body's patent information services and resources. Despite recent information technology-driven improvements, he said that patent offices, particularly in developing countries, in many cases still provided limited legal information. A ‘one stop shop' for patent information was not totally out of reach, he added, but much work would need to be done.
Sophie Logez, from the Global Fund to Fight AIDS, Tuberculosis and Malaria, underscored the impact of access to patent information on drug procurement activities. "Management of intellectual property issues is a procurement bottleneck," she said, stressed that information is often available only from the originator company, and is not always consonant with other available information. A public list of basic and secondary patents of key products, along with an online database, could facilitate the procurement process, she said.
Tahir Amin of I-MAK (Initiative on Medicines and Access to Knowledge), who has authored a step-by-step guide on conducting patent searches for medicines for a WHO regional office, underlined that ten years after developing countries implemented the WTO TRIPS agreement, the international community was still "in the dark about patent information." He highlighted the complexity in the manner patent information is presented, which in turn requires excessive time and resources to be spent on patent information searches. As a result, he emphasized, patent offices need to re-define how they present patent information, so that it is in a form that is more accessible. This would also be a useful step towards more rigorous evidence-based patent policies, he added.
While commending the WHO, WTO and WIPO for cooperating to organise a second symposium on access to medicines, Amin said such meetings "ultimately need to be translated into specific actions in order to tackle the continuing challenges ahead in order to improve access to medicines."
The role of patent information in determining access to medicines has become more important since the implementation of the TRIPS Agreement required developing countries to accord patent protection to pharmaceutical products, which many of them used not to. Bilateral and regional free trade agreements with more extensive levels of intellectual property protection have been the subject of controversy surrounding their effects on access to medicines.