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Synopsis of the Literature Review for WG 3:

Patents and Trade Regulations

 

Aims

This workgroup aims to provide insights to two major question: firstly, how the patterns of national and regional pharmaceutical production and supply are affected by the TRIPS agreement, Doha Declaration and international standards for pharmaceutical production; and secondly, the impact of other international regulations such as the procurement decisions made by international agencies and bilateral trade agreements.

Methods

We reviewed literature related to pre-TRIPS scenario, TRIPS agreement and post –TRIPS scenario with reference to pharmaceutical patents and trade. We specifically conducted the literature search from 1995 to date. However, for elucidating the pre-TRIPS scenario, we referred to some key documents before. Additionally for getting patent related information on tracer medicines relevant to specific health conditions [e.g. Reproductive Health (Oxytocin), Tuberculosis (TB) control (Rifampicin), HIV/AIDS, (Lamivudine), Malaria (Artemisinin), Mental Health (Fluoxetine) and Diabetes (Metformin)], we searched the website of patent office /relevant agencies.

Findings 

1. India

Our literature search showed that adequate information is available on general aspects of TRIPS, and its flexibilities and criteria for patentability in the context of pharmaceuticals in India. Also detailed information is available on the Indian Patent Office website with reference to patent office procedures, pre- and post-grant applications. But there is considerable variation in the interpretation of these issues vis-à-vis the domestic legislation and its implementation. Our literature search indicates the availability of information related to patent status of selected tracer medicines individually and when in combination, with a few documented legal cases of rejected patents (especially related to ARVs). 

2. South Africa

South Africa has a progressive regulatory framework with TRIPS flexibilities incorporated in three forms of legislation: the Patent Act, the Medicines Control and Related Substances Act and the Competition Act. These legislative Acts have been applied in a unique fashion to ensure access to medicines.

The Patent Act

South Africa’s patent law predates the TRIPS agreement. The Patent Act 57 of 1978 allows a life span of 20 years for patents. Compulsory licensing is permissible under patent law. However, the Patent Act as it relates to compulsory licensing can be said to be TRIPS ‘plus’ as it allows for greater provisions than required under TRIPS. Additionally, the patent law permits international exhaustion of patent rights implying that patent rights are considered exhausted if a product under patent is sold anywhere in the world. In 2002, the Act was amended incorporating the Bolar Provision and later the 2005 amendment extended Intellectual Property Rights (IPRs) to indigenous knowledge systems.

The Medicines Control and Related Substances Act

The Medicines and Related Substances Control Act (MRSCA) of 1965 was amended in the early nineties in order to pave the way for the increased access to low cost drugs. To realize this, the MRSC Act Amendment Bill was tabled in parliament in 1997, and passed into law in 1998. Sections 15C and 22C of the MRSC Act 1997 permit ministerial discretion in the issuance of compulsory licenses and permitting parallel importing, respectively.

The Competition Act

South Africa has an enabling competition law which has been invoked twice to ensure access to medicines. The first case was in September 2002 when the Treatment Action Campaign (TAC) – South Africa’s largest civil society lobby group - lodged a complaint through the AIDS Law Project on behalf of People Living with HIV/AIDS (PLWHAs). The complaint to the Competition Commission was against GlaxoSmithkline (GSK) and Boehringer Ingelheim (BI) for extreme pricing of ritonavir, lamivudine, ritonavir+lamivudine and nevirapine. The two companies were found to have engaged in excessive pricing, anti-competitive behavior and denial of access by a competitor to an essential facility. A settlement was reached between GSK and the Competition Commission with six conditions for the companies. The two companies were compelled by law to grant royalty free voluntary licences to local generic companies for the manufacture of generic versions of the stated ARVs. The use of provisions within the competition law to ensure access to medicines was unprecedented in South Africa. Even more surprising was the procurement of generic versions of on-patent drugs for mainstream commercial use.

In February 2005, the AIDS Law Project (ALP) on behalf of TAC and the Southern African HIV Clinicians’ Society threatened to lodge a complaint with the Competition Commission against Bristol-Myers Squibb (BMS) for the excessive pricing of the off-patent medicine-Fungizone ® (Amphotericin B). The letter of demand sent to BMS by ALP took issue with the former’s monopoly of marketing of Fungizone ® in the South African market as generic versions were unavailable. In addition, the prices charged in South Africa were found to be higher compared to prices in Brazil and the United Kingdom. A few months after the lodging of the letter of demand, BMS lowered the prices by between 80-85% for the public and private sectors.

This South African legislative framework has created an enabling environment that ensures access to medicines. Nonetheless, legislative reform of the Patent Act is necessary to attune it to international standards as outlined in the TRIPS Agreement if this can be done without detriment to access to medicines at affordable prices. The granting of voluntary licences to local generic manufactures resulted from the application of competition law. It can be asserted that the Competition Act is effective in ensuring access to medicines but legislative reform is urgently needed. This is necessary to empower the Competition Commission to grant compulsory licences owing to the current restrictive nature of the Patent Act under which compulsory licences ought to be issued.

3. Uganda

Our literature review identified the key laws enacted by Uganda’s legislature applicable to patents and trade regulations. These include the Trademarks Act of 2010, Trade Secrets Protection Act of 2009, Copyrights and Neighbouring Act of 2006, Uganda Registration Services Bureau Act of 2004, Patents (Amendment) Act of 2002, National Environment Act of 1995, Patents Act of 1993 and United Kingdom Designs (Protection) Act of 1937 (WIPO, 2010).

Although information on Ugandan patent requirements is available on the Ugandan Patent website, knowledge on the enforcement of patents is largely unknown. Uganda’s current Patent Act does not take into consideration the new undertakings by the WTO such as the flexibilities of the TRIPS Agreement. Uganda has limited capacity on issues of patents and intellectual property (IP), and as a result patents are examined through the African Regional Intellectual Property Organisation (ARIPO). The literature search identified a lack of information on the patent status of single dose formulations (SDFs) or fixed dose combinations (FDCs) of our selected tracer medicines, and cases where patent applications were rejected. Our literature review demonstrated that Uganda has laws governing protection of IP. However, the law relating to pharmaceutical patents that incorporates the provisions of the TRIPS agreement is yet to be finalized and its impact on access to medicines could not be evaluated.

Uganda has regulations relating to protection of IP, but the extent to which these legislative reforms have been practically implemented, specificity of the Patent law in relation to the tracer medicines and how it influences access to these medicines is unclear. Furthermore, although some of the current laws relating to IP protection have incorporated the TRIPS flexibilities, it was ambiguous how far these flexibilities have been used to promote access to essential medicines.

Our literature review identified a number of issues to be addressed in the data collection - provisions available to counteract patent infringement; the influence of patent protection of medicines on local production and procurement; the impact of TRIPS agreement and its flexibilities on Global Fund purchasing in Uganda; and the role of the African Regional Intellectual Property Office (ARIPO) in the Ugandan patent system.

Gaps identified and suggestions for AMASA field research

  • To examine the licensing deals vis-à-vis tracer medicines.
  • To look into contract manufacturing of tracer medicines
  • To explore public-private partnerships in the context of tracer medicines
  • To track the activities of committees on the price negotiation of patented medicines
  • To explore barriers in compulsory licensing of patented medicines, specifically with reference to tracer medicines.
  • To consider exceptions under TRIPS that are being used in case of patented combinations of tracer medicines
  • To analyse information on rejected applications
  • To identify possible barriers that could affect cross-border distribution of tracer medicines.
  • To understand responses to patent pools, with reference to tracer medicines
  • To determine the impact of new patent laws on tracer medicines with respect to:
    • Increase in investment in R & D
    • Export of generics and patented drugs
    • Price differences for individual drug and the same drug in patented combination and affordability of different strata of the population

 

This synopsis is a result of the collaboration within WG3, under the coordination of the WG3 coordinators: Nerges Mistry and Sachin Atre.

We appreciate all your questions and comments.