Improving access to medicines in the SADC region through patent opposition: Law reform inspirations from an unlikely jurisdiction

• Citation: (2022) IPLJ 105
• DOI: https://doi.org/10.47348/SAIPL/v10/a5
• Published date: 23 February 2023
• Pages: 105-130
• Author: Ndlovu, L.
• Date: 23 February 2023

105

https://doi.org/10.47348/SAIPLJ/v10/a5

IMPROVING ACCESS TO

MEDICINES IN THE SADC REGION

THROUGH PATENT OPPOSITION:

LAW REFORM INSPIRATIONS FROM

AN UNLIKELY JURISDICTION



Associate Professo r and Interim Director, School of Law, Universit y of Venda,

Thohoyandou, South Africa

ABSTRACT



the import ance of patent opposition for acces s to essential medicines by SA DC citizens.

The article us es Thailand as a comparat ive jurisdiction and, af ter taking a closer look at

the patent opposit ion provisions of the laws of Botswa na, Malawi, Zambia a nd Zimbabwe,

the article advances the view that the SADC patent law reform agenda can learn a lot

from its Thai counterpart on pharmaceutical patent opposition. Most SADC members

with patent opp osition provisions in thei r laws provide for pre-gr ant rather than po st-grant

opposition. Gene rally, pre-grant and post-g rant patent opposition proce dures ensure that

only deserv ing patents may be succe ssfully applied for and g ranted. The ar ticle concludes

that the Thai p re-grant opposition proced ures are an example of progressive law, which

the SADC region should consider emulating to improve access to affordable essential

medicines. The Thai experience may provide helpful and practical pointers for some

SADC members whe n their patent opposition pr ocedures are eventu ally tested before the

courts an d intellectual prope rty tribuna ls.

KEYWORDS: access to medicines; patent opposition; pre-grant opposition; post-grant

opposition; pha rmaceutical patent s

 

A public health emergency caused by the COVID-19 pandemic led South

Africa and Ind ia to sponsor the drive to introd uce a TRIPS waiver in 2020. The

waiver was considered a possible enabler of access to vaccines, therapeutics

and diagnostics.1 Although there was no evidence that intellectual property

(patents) posed an access impediment at the time, access to vaccines was

heavily skewed in favour of developed countries, leadi ng to complaints about

 

1 The full tex t of the original waiver pr oposal titled ‘Waiver from cer tain provisions of the T RIPS

Agreement for the prevention, containment and treatment of COVID-19: Communication

from India and South Africa’ is available at https://docs.wto.org/dol2fe/Pages/SS/directdoc.

aspx?filena me=q:/IP/C/W669.pdf (accessed 15 November 20 22).

(2022) IPLJ 105

© Juta and Company (Pty) Ltd

https://doi.org/10.47348/SAIPLJ/v10/a5

vaccine nationalism.2

World Trade Organisation (WTO) and the TRIPS Cou ncil were called upon to

pass an access to medicines-related waiver. A similar one had been proposed

in Doha, Qatar, in 2001 and act ualised through the 30 Augu st decision of 20033

against the backdrop of the HIV/AIDS epidemic.4 WTO members eventually

adopted a revised and water ed-down version of the original COVID-19 waiver

in June 2022.5 It is common cause that e ssential medicines required by pat ients

in Africa, the Southern African Development Community (SADC) and the

rest of the developing world are mostly imported and prote cted by intellectual

property rights, making them less accessible to ordinary patients. Many

approaches and strategies, such as parallel importation, differential pricing,



proposed as possible access to med icines solutions. The other possible solution



to deploy patent opposition, as Thaila nd has successfully done since 1999.



role in determining drug prices.6 The pharmaceutical industry is research-

based and high-tech, s pecialising in innovation protected throug h patenting.7

Access to affordable medicines is essential for SADC due to the massive

disease burden in the region. The most prevalent diseases in SADC include

HIV/AIDS, tuberculosis, malaria , heart disease, cancer and hepatitis.8

Due to linguistic and other limitations, it is rare for legal writers outside

Thailand to research and critique Thai legal literature.9 However, this

unassuming jurisdiction is rich in lessons for the rest of the world due to its

success in deploying phar maceutical patent opposition to access medicines.

This article uses Thailand’s pharmaceutical patent opposition litigation

experience to inform patent law reforms for selected SADC members.

Botswana, Malawi, Zambia and Zimbabwe were chosen based on the

2 On the evolution and meaning of the term, see, among others, IT Katz et al ‘From vaccine

nationalism to vaccine equity – Finding a path for ward’ (2021) 384 New England Journal of

Medicine 1281; N Hassoun ‘Against vaccine natio nalism’ (2021) 47 Journal of Medi cal Ethics

773; TJ Bollyky & CP Bown ‘The tr agedy of vaccine nation alism: Only cooper ation can end the

pandemic’ (2020) 99 Foreign Affairs 96.

3 See the WTO 2003 decision o n the Implementation of Parag raph 6 of the Doha Declaration o n

the TRIPS Ag reement and Public Health WT/L/540 2 September 20 03 (03-4582), available at

https://docs.wto.org/dol2fe/Pages/FE_Search/FE_S_S009DP.aspx?CatalogueIdList=51809,254

8,53071,70701&CurrentCatalogueIdIndex=1 (accessed 5 December 2022).

4 WTO Declaration on the TRIPS Agreement and Public Health WT/MIN(01)/DEC/2,

20 November 2001, available at https://www.wto.org/english/thewto_e/minist_e/min01_e/

mindecl_t rips_e.htm (access ed 15 November 2022).

5 A full version of the compromise text titled ‘Ministerial Decision on the TRIPS Agreement’

is ava ilable at https: //docs.wt o.org/do l2fe/Pa ges/SS/d irect doc.as px?file name= q:/WT/ MIN22/ 30.

pdf&Open=True (access ed 15 November 2022).

6 Y Hu, Y Bian & Y Wang ‘Opening t he black box of pharmaceutica l patent value: An empirica l

analysis’ (2008) 42 Drug Information Journal 561.

7 Ibid.

8 L Ndlovu ‘Lessons for t he SADC from the Indian c ase of Novartis AG v Union of India’ (2015)

18 Potchefstroom Electronic Law Journal 782.

9 I was fortu nate to have visited Tha iland and toured its I ntellectual Pro perty and Trade Cou rts in

2013, thus establishi ng initial networks w hich I have maintained a nd put to good use.

106 South African Intellectual Property Law Journal (2022) 10

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