WIPO Delegates Told Patent Information Essential, Given Revealing Data On Medicines Access and Trade 14/12/2017 by Catherine Saez, Intellectual Property Watch Leave a Comment Share this:Click to share on Twitter (Opens in new window)Click to share on LinkedIn (Opens in new window)Click to share on Facebook (Opens in new window)Click to email this to a friend (Opens in new window)Click to print (Opens in new window)World Intellectual Property Organization patent law committee delegates heard a number of presentations this week on the relationship between patents and health, and access to medicines. The importance of patent information and accurate, up-to-date databases was underlined, particularly for procurement. The weight of intellectual property rights on the issue of access to medicines and prices and generic market entry was pointed out, but so were other factors, such as the small percentage of new drugs with added benefit, tariffs, and trade delays. The 27th session of the WIPO Standing Committee on the Law of Patents (SCP) is taking place from 11-15 December. WHO, MPP and the Importance of Patent Information The SCP hosted an information session on 12 December on publicly accessible databases on patent information status and data on medicines and vaccines. Peter Beyer, group lead at the World Health Organization Intellectual Property and Public Health and Antimicrobial Resistance section, presented an overview of what the WHO is doing in the area of patent information and explained the importance of such information. Beyer cited a WIPO Patent Search Report [pdf] on pandemic influenza preparedness-related patents and patent applications in 2011, then requested by the WHO Director General during the discussions on access and benefit sharing of pandemic influenza vaccines at the WHO, which Beyer described as difficult. The document sought to answer to what extent companies and universities were filing patents on influenza viruses as such or on elements of viruses. Patent information is key for the procurement of medicines, he said, knowing whether a medicines is patented or not is important when governments are planning their procurement. Patent information is also important in the areas of research and development, and technology transfer, he said, adding that the WHO worked with a tech transfer hub at the University of Lausanne (Switzerland) transferring vaccine technology to countries where this technology was not patented. Patent information is also useful if countries want to use the flexibilities included in the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), in particular compulsory licences. It is not easy to get reliable, up-to-date patent information for health authorities because they lack the IP expertise, he said, underlining the lack of communication between government entities. The Medicines Patent Pool database, called MedsPaL, is the most used because it covers some of the most important diseases areas, Beyer said. He also underlined the “TRIPS-Plus” requirement of the Indian patent law, which requires the disclosure of all members of the same patent families in patent applications. It is then possible to see where the patent was filed and where it was not, and gives a clear indication on the freedom to procure generic versions of the medicines, or locally produce them, he said. The Medicines Patent Pool provided a presentation of MedsPaL, which provides information on the patent and licencing status of selected HIV, hepatitis C, tuberculosis and other patented essential medicines in low and middle-income countries. Esteban Burrone, head of policy at the MPP, said MedsPaL now has expanded MedsPal to include other patented medicines under WHO Essential Medicines List, for cancer. A few more will be added over the coming weeks, he said. He described the key features of MedsPaL, such as the provision of key IP data in one place: patent status, licences, and data exclusivity, and the possibility for users to download patent status data for further analysis. MedsPaL now includes approximately 70 medicines with over 130 pharmaceutical formulations, and over 210 patent families identified, Burrone said. He added that additional features would be added to MedsPaL over time, including the possibility to visualise search results through maps. Further collaboration with additional patent offices is crucial to keeping the database up to date, he said. Memoranda of understanding have been signed with seven national and regional patent offices, he said, with more under discussion. This week, the MPP announced that it signed collaborative agreements with Argentina’s National Institute of Industrial Property (INPI) and Brazil’s National Institute of Industrial Property (INPI). Access to Medicines: WHO, WTO Also on 12 December, the SCP hosted another sharing session on patents and other related issues on access to medicines. Beyer said IP is impacting competition and very often has an effect on prices. However, the issue of access to medicines is much broader than the topics of the SCP, he said. The majority of new drugs have no proven benefits over previous treatments, he said, with, according to a recent study, only 10 percent of new drugs providing a major improvement, and 17 percent a considerable improvement. It is difficult to estimate the advantage of novel drugs over existing treatments, said Beyer. The interest of companies wanting to file patents and the interests of health systems seeking new treatments with added value are misaligned, he said. Citing the case of the hepatitis C medicines, which made headlines because of their prices, Beyer said comparing the minimum production price with the cost of the medicines shows that prices can be a major barrier to access. He added that the issue does not only affect developing countries, but developed countries as well, citing some Swiss health insurance companies encouraging their hepatitis C patients to mail order generic medicines from India. That is a “serious indication that the system is out of balance,” he said. He also noted how IP could impact generic entry, through patent term extensions; secondary patents (combination patents, patents on variations of chemical molecules); data exclusivity; and other forms of market/data exclusivity practices such as “pay-for-delay.” The prices of hepatitis C medicines are dropping but there are still wide variations in prices, he said. Antony Taubman, director of the Intellectual Property Division at the WTO, said trade is part of the access to medicines package, and the TRIPS agreement is part of the solution, not an impediment. Taubman underlined the entry into force of the first amendment of “the entire package” of the multilateral trade law, last January. The amendment to the TRIPS installs a new Article 31bis brings a solution to Paragraph 6 of the 2001 Doha Declaration on TRIPS and Public Health, allowing countries producing generic medicines under compulsory licence to export all of the medicines to LDCs with no manufacturing capabilities (IPW, WTO/TRIPS, 23 January 2017). According to Taubman, some 80 percent of total pharmaceutical exports come from countries that have a legal pathway to apply this system. Global imports of pharmaceuticals in 2016 was about US$ 525 billion and the LDCs’ imports of pharmaceuticals were about US$5 billion in 2016, about one percent of the total, while the LDC population represents 13 percent of the global population, which clearly shows a structural issue, Taubman said. Those numbers do not differentiate between originator and generic products, he noted. He added that there is a sharp increase in intra-regional trade in the developing world in pharmaceutical products, with large generic exporters such as India, China and Singapore. India is supplying rich country markets, he said, in particular the United States, but also widely elsewhere. Thailand is also increasing its trade in generics with its LDCs immediate neighbours, he noted. On access constraints, Taubman said the fact that many LDCs are landlocked and some are small islands worsens the access issue, notably adding costs and delays. In 2014, according to his presentation, customs transaction time could vary from 6 to 86 days for exports, and from 4 to 130 days for imports, depending on countries. Average trade delays for imports could reach 800 hours in sub-Saharan African LDCs, compared to 1 hour in a number of higher-income countries. The average processing costs for imports climbed to up to US$3900 in sub-Saharan African LDCs, and were reported as low as US$1 in some higher-income countries, he showed. This amounts to “very high tariffs”, he said, adding that even though tariffs on imported medicines have dropped in many places, some countries still have high import tariffs in place. Taubman mentioned the WTO Agreement on Government Procurement (GPA), which is a plurilateral agreement to open government procurement markets among its parties. According to the WTO, the GPA parties have opened procurement activities worth an estimated US$1.7 trillion annually to international competition. On 11 December, the SCP examined a document [pdf] produced by WIPO on constraints faced by developing countries and LDCs in making full use of patent flexibilities, and briefly went back to the discussion at the end of the day yesterday. Member states and observers had submitted comments to the WIPO secretariat prior to the publication of the document. For example, Knowledge Ecology International provided a submission [pdf] listing examples of pressure brought against countries seeking to use the TRIPS flexibilities. Image Credits: Peter Beyer, WHO Share this:Click to share on Twitter (Opens in new window)Click to share on LinkedIn (Opens in new window)Click to share on Facebook (Opens in new window)Click to email this to a friend (Opens in new window)Click to print (Opens in new window) Related Catherine Saez may be reached at csaez@ip-watch.ch."WIPO Delegates Told Patent Information Essential, Given Revealing Data On Medicines Access and Trade" by Intellectual Property Watch is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License.