[Ip-health] Changes Coming to South Africa’s Patent System

Riaz K Tayob riaz.tayob at gmail.com
Mon Dec 16 05:32:48 PST 2013

  Changes Coming to South Africa’s Patent System

By Brendon Bosworth <http://www.ipsnews.net/author/brendon-bosworth/> 
Reprint <http://www.ipsnews.net/reprinting-articles/> | | Print 

Patented drugs limit patients’ access to public health care. Credit: 
Kristin Palitza/IPS

CAPE TOWN, South Africa, Dec 12 2013 (IPS) - Paul Anley, chief executive 
officer of Pharma Dynamics, one of South Africa’s leading generic drug 
companies, wants to sell a cheaper version of popular birth control pill 
Yasmin. But he legally cannot because German multinational Bayer has 
patent protection on the drug in South Africa, even though its initial 
patent expired in 2010.

Generic versions of the contraceptive are available in the United States 
and Europe, where Bayer’s patent has been revoked.

Anley says South Africa’s patent system makes it easy for multinational 
pharmaceutical companies to make minor changes to their products and get 
multiple patents, each spanning 20 years, and keep generics off the market.

“Multinational pharmaceutical companies undertake a process of what we 
call patent ‘evergreening,’” Anley told IPS. “They will literally flood 
the patent office with hundreds of patents for every single molecule or 
product they sell, and they do it over a protracted period.”

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Pharma Dynamics lost a court case against Bayer over the validity of 
Bayer’s patent, which relates to the rate at which the drug’s active 
ingredient dissolves, in March 2013. It is barred from selling its 
generic and has filed an appeal against the decision.

“Bayer will continue to vigorously defend its patents,” Bayer’s medical 
director, Dr. Gené van den Ende, told IPS in an emailed response. Van 
den Ende did not comment on allegations of evergreening.

Since 2002, Bayer has filed for 11 different patents in South Africa for 
one of the active ingredients in Yasmin.

*Plenty of patents?*

In September, South Africa’s Department of Trade and Industry released a 
draft national policy on intellectual property 
<http://www.gov.za/documents/download.php?f=198116> that proposes 
changing South Africa’s patent system.

Anley and patent reform advocates like HIV advocacy group the Treatment 
Action Campaign 
and Médecins Sans Frontières hope the proposals will curb the number of 
patents granted and increase access to cheaper medicines.

“We grant far more patents than other countries, both developing and 
developed,” Catherine Tomlinson, a researcher with Treatment Action 
Campaign, told IPS. “A lot of what we’re providing patents on is not 
actually meeting patent standards to provide something new and innovative.”

In 2008, South Africa granted 2,442 pharmaceutical patents, according to 
research <http://www.law.fsu.edu/events/documents/Correa.docx> by Carlos 
Correa at the University of Buenos Aires’ South Centre. Brazil granted 
just 278 patents between 2003 and 2008.

Supporters of patent reform point to the price difference between 
originator drugs in South Africa and generics available in countries 
like India – which has been strict in denying patents for formulations 
of new medicines – as a consequence of South Africa’s patent laws.

The Treatment Action Campaign found that generic versions of popular 
cancer drugs are available in India for between four percent and 44 
percent of the cost of originator versions in South Africa, based on a 
comparison of 2012 prices <http://www.fixthepatentlaws.org/?p=482>.

India has made also use of compulsory licencing. 
<http://www.wto.org/english/tratop_e/trips_e/public_health_faq_e.htm> In 
cases where government feels the price of a drug is too high, it can 
grant licenses that allow generics manufacturers to produce versions of 
drugs under patent protection without consent of the patent owner. The 
World Trade Organisation’s Trade-Related Aspects of Intellectual 
Property Rights Agreement 
<http://www.wto.org/english/tratop_e/trips_e/t_agm0_e.htm> allows for 
compulsory licencing.

As a signatory to the WTO agreement, South Africa can grant compulsory 
licences but has not done so in the past.

The draft national policy recommends introducing the use of compulsory 
licenses. But whether or not these are granted in the future depends on 
the interpretation of the courts, patent attorney Madelein Kleyn, who is 
the intellectual property manager for Oro Agri and a research fellow at 
Stellenbosch University’s Anton Mostert Chair of Intellectual Property 
Law, told IPS.

*Long road to reform*

Government’s draft intellectual property policy recommends introducing a 
search and examination process to the South African patent office that 
involves having experts assess the novelty or original merit of an 

Currently, those applying for patents in South Africa need to fill out 
the application documents correctly and pay the required fees. If a 
company or individual wishes to challenge the validity of a patent after 
it’s granted, the challenge must be done through the courts.

Intellectual property lawyers note that government does not have the 
staff required to perform search and examination procedures.

“The patent office, as it stands, currently lacks skilled force to 
implement such a system,” said Kleyn. “Patent examiners are highly 
qualified people who specialize in the different areas of technology and 
require an in-depth understanding of the patentability requirements to 
assess a new filed invention against the prior art of the specific 
technical area.”

Outsourcing this work to international or regional offices, as suggested 
in the draft policy, would make sense, she said.

Since patents can be revoked through the courts, and intellectual 
property professionals advise patent applicants to amend their claims 
based on foreign patent cases, the system in South Africa allows for 
strong and tested patents despite the lack of a search and examination 
process, Kleyn explained.

She recommended focusing on educating judges who deal with patent cases 
to make the legal system work more effectively instead. This shift would 
also be cheaper.

If introduced, the search and examination procedure would take a long 
time to alter the patent landscape.

“The system will not eliminate the weak patents that will be on the 
register by the time the system is introduced in say (being kind) five 
years,” wrote former deputy president of South Africa’s Supreme Court of 
Appeal Louis Harms in his comments 
<https://www.dropbox.com/s/jjgtz72oiykhcgl/HARMSComment%20IP%20POLICY%20%282%29.pdf> on 
the draft policy. “This means that weak patents will still be around for 
25 years.”

Anley, of Pharma Dynamics, agreed that the proposed changes would take 
time to take effect.

“We’re very encouraged that government recognises the problems facing 
generic pharmaceutical companies and has addressed most of them in the 
draft,” he said. “Our concern would be that the process of capacity 
building is a very long and difficult process.”

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