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

Kirsten Myhr myhr at online.no
Thu Jan 2 08:51:11 PST 2014


Well, since Yasmin, Yasminelle and Yaz, all containing ethinylestradiol and
drospirenone, are not first choice combined hormonal contraceptives because
of the increased risk of venous thromboembolism compared to the older and
cheaper combined hormonal contraceptive with ethinylestradiol and
levonorgestrel or norethisterone or norgestimate. I would in this case be
happy for less competition and rather put my energy into stopping Bayer's
marketing of their products.


Kirsten Myhr
RELIS Medicines Information and Pharmacovigilance Centre
Oslo, Norway

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Fra: Ip-health [mailto:ip-health-bounces at lists.keionline.org] På vegne av
Riaz K Tayob
Sendt: 16. desember 2013 14:33
Til: ip-health at lists.keionline.org
Emne: [Ip-health] Changes Coming to South Africa’s Patent System

  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Europe, where Bayer’s patent has been revoked.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

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
%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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