Research Paper 56. South Centre.
LINK TO FULL PAPER on SOUTHCENTRE.INT
Executive Summary: Sub-Saharan Africa (SSA) suffers from numerous communicable and non-communicable diseases, with significant socio-economic effects, and adversely impacting the development prospects of countries in sub-Saharan Africa. Many of these diseases are treatable but access to affordable medicines remains a huge challenge in the region. A particular obstacle to access to medicines is the high, prohibitive costs of medicines enabled by the existence of patents. Patents grant the right holder a monopoly on the patented pharmaceutical for at least 20 years from the date of filing of the patent application, thereby curtailing competition by giving the patent holder freedom to set prices, which in many instances is simply unaffordable to persons who need the medicines.
Competition from generic producers has been instrumental in bringing down the cost of medicines and in scaling up treatment; however such competition is only possible in an environment where patents are not obstacles.
Patenting of pharmaceuticals became globalized with the coming into force of the Agreement on Trade-Related Aspects of Intellectual Property Rights (commonly referred to as the “TRIPS Agreement) in the World Trade Organization (WTO) in 1995, which set out minimum standards on intellectual property including on patents, which WTO members have to comply with. The pressure to incorporate intellectual property protection within WTO came from a group of mainly developed countries. Although developing countries were not successful in resisting the incorporation of the TRIPS Agreement, a degree of policy autonomy was negotiated to allow countries to accommodate their own needs (also known as “flexibilities”).
The adoption of the TRIPS Agreement has led to widespread concern over the impact of patents on public health, leading to numerous international, regional and sub-regional instruments and initiatives recognizing and reaffirming the importance of TRIPS flexibilities to facilitate the importation of affordable medicines as well as to boost local production capacity. Many countries have used these flexibilities with positive health outcomes for their population.
In the SSA region, some countries have incorporated these flexibilities in their national laws while a few have gone further and utilized these options for public health purposes. However, although some progress has been made in the right direction, for a variety of reasons significant gaps remain in the full utilization of TRIPS flexibilities. An issue particularly specific to the SSA region is that regional IP offices process the majority of patent applications and administer patent grants in the region.
This paper explores the workings of the African Regional Intellectual Property Organization, also known as “ARIPO” which caters for 19 mostly English-speaking countries and assesses the impacts of ARIPO’s instruments and operations on access to affordable medicines. The paper also analyzes the extent to which ARIPO’s patent processing and grant system is supportive of sub-regional efforts of the East African Community (EAC) to fully utilize TRIPS flexibilities to facilitate importation and boost domestic manufacturing of affordable medicines. The paper discusses in detail the East African Community Regional Intellectual Policy on the Utilization of Public Health Related WTO-TRIPS Flexibilities and the EAC Health Protocol on the same, both developed to facilitate the full utilization of TRIPS flexibilities to not only improve access to affordable medicines in the EAC region but also towards the development of an efficient and effective regional pharmaceutical manufacturing industry as outlined in the EAC Regional Manufacturing Plan of Action (2012- 2016).
The paper finds that the successful use of TRIPS flexibilities by EAC States for the benefit of public health in the EAC region is much dependent on the workings of ARIPO, given that the ARIPO Office processes the majority of the patent applications. The findings in Chapters III and IV show that the current operations of the ARIPO does not facilitate full use of TRIPS flexibilities and instead erects patent barriers to the importation and local production of affordable medicines. For the effective implementation of the EAC Policy & Protocol as well as the EAC Regional Pharmaceutical Manufacturing Plan of Action (2012- 2016), and the multiple other international and regional initiatives that emphasize use of TRIPS flexibilities, effort has to be made by ARIPO Contracting Parties including EAC States to reform the patent operations of ARIPO so that it advances public health objectives. Nationally as well several immediate steps can be taken. Some recommendations are as follows:
At the ARIPO regional level:
(1) The Harare Protocol should exempt the territory of LDCs from the grant of any pharmaceutical patents. This means, in the event the ARIPO Office grants pharmaceutical patents, such patents will not be applicable to the LDC territories. LDCs that desire for the ARIPO patent to be applicable to its territory would need to communicate so to the ARIPO Office within a specific time-frame of receiving notification from ARIPO of its intent to grant the patent.
(2) ARIPO should adopt rigorous patentability standards with regard to pharmaceutical applications, with the aim of avoiding secondary patents and patent evergreening. Specific rules should be established for the examination and grant of pharmaceutical patents paralleling those adopted by Argentina.
ARIPO Contracting Parties including EAC States, and civil society should review (and if necessary, revise) the new patent examination guidelines being established by the ARIPO Office to ensure that they are sensitive to public health concerns.
(3) ARIPO Office should also improve its examination capacity in particular its infrastructure and human resources and should reduce reliance on foreign examination systems.
(4) ARIPO should increase its examination and maintenance fees to avoid proliferation of frivolous patents.
(5) The Harare Protocol should establish administrative pre- and post-grant oppositionprocedures, to enable any person to file a notice of opposition before the ARIPO Office.
For effective and workable pre- and post-grant administrative procedures: (a) any person should be allowed to file opposition either directly with the ARIPO Office as well as through national IP Offices; (b) any person should be allowed to challenge the grant not only in a particular country but its validity for the whole of the ARIPO region; (c) the grounds for opposition should include non-compliance with the patentability requirements, insufficiency of disclosure, and other reasons; (d) there should be clarity on the publication of the application and grant in each designated state; (e) the published patent applications should include all relevant data for the identification of the subject matter of the application, such as the complete specification and international non- propriety name (elaborated below) and that information should be freely accessible online; (f) the procedures for filing the oppositions should be specified clearly and preferably the procedure should be free of any charges; (g) adequate time should be provided for the submission of an opposition. The longer the period, the greater the opportunities for the patent office to receive observations/oppositions from third parties as the importance of the patent application may not be immediately recognized3; (h) there should be specific time lines and clarity on the procedures for dealing with the filed opposition (e.g. notifying the patentee, constitution of a panel to hear the patentee and the opposing party, appeal procedure etc.) (i) capacity to monitor published patent applications and grants as well as skills necessary to conduct the required analysis to mount the opposition, should be built among local pharmaceutical companies and civil society.
(6) The Harare Protocol and its regulations should require more detailed disclosure of the invention. “Person skilled in the art” should be defined as a person in the ARIPO region, having average expertise and experience in the technical field of the claimed invention. In addition to setting forth the best mode contemplated by the applicant, the applicant should also be required to disclose all embodiments of the claimed invention in order to prevent “Markush Claims”. The Harare Protocol should also require for the description in the patent applications to be adapted to the ordinary skills of the citizen of the country. Insufficient disclosure should result in the application being rejected.
(7) The Harare Protocol and its regulations should require patent applicants to declare the INN at the time of filing of the application if the INN is already allotted or immediately on allocation. Non-compliance should result in the application being rejected.
(8) The Harare Protocol and its regulations should be amended to mandatorily require the patent applicant to disclose information on corresponding foreign applications and to supplement the same on a timely basis.
(9) The ARIPO Office should make freely and publicly available on its website, patent applications published as per Rule 19bis; the notification (including the search and examination report upon which the decision to grant is based) to designated states as per Rule 18(4); complete information including the full specification and claims on patents granted, and the ARIPO Journal which contains information on all publications required under the Protocol and the Regulations.
(10) The ARIPO website should also host effective search engines and databases that facilitate access to complete information including the description of the invention, full specification, list of claims, about the patent applications and grants.
At the National level:
(11) EAC States should take steps to incorporate the policy approaches prescribed by the EAC Policy and Protocol.
(12) Pending revision as suggested in (1) EAC LDC States should take urgent action to declare that pharmaceutical patents in its territory are not enforceable.
Intellectual property offices in LDCs should also adopt an institutional policy that on receipt of a notification from the ARIPO Office of its intent to grant a pharmaceutical patent, the IP Office will immediately communicate a written objection to the ARIPO Office.
(13) EAC States should apply rigorous patentability criteria for pharmaceutical patent applications processed nationally. Specific guidelines on how properly to implement patentability criteria with regard to pharmaceuticals should be developed, and if required, changes to national patent legislation should be pursued. EAC States should also undertake rigorous examination of pharmaceutical patent applications.
(14) Civil society, intergovernmental organizations such as the South Centre and other public health advocates should implement activities that boost the capacity of EAC States and their IP officials/examiners to undertake rigorous examination of pharmaceutical patent applications, and avoid secondary patents and patent evergreening as well as to better understand the implications of the grant of monopolies for public health.
(15) EAC States with pre-grant opposition procedures in their national legislations should work to operationalizing such procedures with regard to patent applications processed by the ARIPO Office. See below (17).
(16) EAC States should also establish transparency mechanisms at the national level. EAC States should make freely available on their respective websites: complete information about ARIPO applications and grants (such as the application published by ARIPO under Rule19bis of its Regulations, full specification of patents granted, and information contained in the ARIPO Journal) as well as about patent applications processed nationally which are published and granted.
(17) Further, it is important for EAC States to make publicly available ARIPO’s notification of its intent to grant a patent (including the patent application as well as search and examination report upon which the decision to grant is based) issued according to Rule 18(4) of the Regulations and Administrative Instruction 52(1) of the Harare Protocol. This information should be made publicly available immediately on receipt of the ARIPO notification, and EAC States should invite the public to submit any observations or oppositions they may have on ARIPO’s notification.
(18) Civil society should pursue implementation of the above recommendations. They should also begin to actively monitor pharmaceutical applications processed by ARIPO as well as national IP offices and take appropriate action where the grant would be inconsistent with national interests.