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://do i.org/10.473 48/S AIPLJ/ 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

ABST RACT

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

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 ad vances the view th at the SADC patent law r eform agenda can le arn a lot

from its Thai c ounterpa rt on pharma ceutical patent o pposition. Most SADC m embers

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 shou ld consider emulat ing to improve acce ss to affordable ess ential

medicines. Th e Thai experie nce may provide helpful a nd practical poi nters 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: acces s to medicines; pat ent opposition; pre -grant opposit ion; post-gra nt

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 vacci nes, therapeutics

and diagnostics.1 Although the re was no evidence that intellect ual propert y

(patents) posed an access im pediment at the time, ac cess 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 t he prevention, cont ainment and t reatment of COVI D-19: Communication

from India a nd South Afric a’ is available at https://docs.wto.org /dol2fe/Pages/SS/di rectdoc.

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

(2022) IPLJ 105

© Juta and Company (Pty) Ltd

https://do i.org/10.473 48/S AIPLJ/ v10/a5

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

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

pass an access to med icines-related waiver. A similar one had been p roposed

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

against the backdrop of the H IV/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, t he Southern Afr ican Development Community (SADC) and the

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

property r ights, making them les s accessible to ordinar y patients. Many

approaches and strateg ies, such as parallel impor tation, differential p ricing,

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

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 determin ing drug pr ices.6 The pharmaceutica l industry is res earch-

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

Access to affordable medicines is esse ntial for SADC due to the massive

disease burden in t he region. The most prevalent diseases i n SADC include

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

Due to linguist ic and other limitation s, it is rare for legal writers outside

Thailand to resea rch and critique Thai legal lite rature.9 However, t his

unassumi ng jurisdiction is rich in le ssons for the rest of the world due to its

success in deploying phar maceutical patent opposition to access medicines.

This art icle uses Thailand’s pharmaceutical patent opposit ion litigation

experience to infor m patent law reforms for selected SADC members.

Botswana, Malawi, Zambia and Zi mbabwe were chosen based on the

2 On the evolution and meaning of the te rm, see, among o thers, IT Kat z et al ‘From vaccine

nationalism t o vaccine equit y – Finding a path for ward’ (2021) 384 New England Jour nal 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 De claration on the T RIPS Agree ment and Public Hea lth 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 compromi se text titled ‘Min isterial De cision on the TRI PS 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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