[Ip-health] IP-Watch: What Does WTO Extension For LDCs To Enforce IP Mean For Pharmaceuticals?

Thiru Balasubramaniam thiru at keionline.org
Fri Aug 2 03:13:54 PDT 2013



*What Does WTO Extension For LDCs To Enforce IP Mean For Pharmaceuticals?*

Published on 2 August 2013 @ 11:45 am

By Catherine Saez <http://www.ip-watch.org/author/catherine/>, Intellectual
Property Watch

The recent extension granted by World Trade Organization members to least
developed countries giving 8 more years to implement international
intellectual property protection rules threw a shroud of confusion over a
parallel WTO waiver for pharmaceutical products conferred on least
developed countries until 2016. In an attempt to shed some light on the
issue, several experts were asked for their reflections on the consequences
of the new extension.

The June 2013 extension<http://www.google.fr/url?sa=t&rct=j&q=&esrc=s&source=web&cd=1&ved=0CCwQFjAA&url=http%3A%2F%2Fwww.wto.org%2Fenglish%2Ftratop_e%2Ftrips_e%2Fta_docs_e%2F7_1_ipc64_e.pdf&ei=BezWUfKlBaWr0AXnvoDICg&usg=AFQjCNFEiHyvAN316y6mo5y4ogvTzyFJpQ&sig2=xmzq2ozaSyz3f5pXSLaK>
LDCs to enforce WTO IP rules will end on 1 July 2021. It temporarily waives
the obligation of least developed countries (LDCs) to apply the provisions
of the WTO Agreement on Trade-Related Aspects of Intellectual Property
Rights (TRIPS), except for articles 3 (national treatment), 4
(most-favoured-nation treatment), and 5 (multilateral agreements on
acquisition or maintenance of protection) (*IPW*, WTO/TRIPS, 12 June

Since the newly passed extension is for the full TRIPS agreement, it could
be considered to apply to all products, including pharmaceutical products.

Meanwhile, there is also a separate extension for LDCs for pharmaceutical
products. The 2001 WTODoha Ministerial
TRIPS and Public Health established that LDCs “will not be obliged, with
respect to pharmaceutical products, to implement or apply sections 5
[patents] and 7 [protection of undisclosed information] of Part II
[standards concerning the availability, scope and use of intellectual
property rights] of the TRIPS Agreement or to enforce rights provided for
under these Sections until 1 January 2016…”

Industry Perspective

Sara Käch, head of communications and spokesperson of Interpharma, a Swiss
pharmaceutical association, said:

“Interpharma fully supports the position of the IFPMA [International
Federation of Pharmaceutical Manufacturers & Associations].”

“When the issue was first raised in 2011, IFPMA supported the principle of
an extension on the understanding that what was being asked was a
time-limited waiver,” she told *Intellectual Property Watch*. “The [2011
IFPMA] statement highlights the importance of TRIPS implementation and
advises that ‘such an extension should be used to align implementation
across all areas of technology, to ensure a consistent approach’.”

Advocate Perspective

According to Ellen ‘t Hoen, former director of the Medicines Patent Pool
and past head of the Médicins Sans Frontières access to essential medicines
campaign, “these two extensions live alongside.” This unusual situation
could in fact play in favour of LDCs, she told *Intellectual Property Watch*

“What LDCs will most likely do is to also ask for an extension for
pharmaceuticals and data protection closer to the 2016 deadline,” she said.
They could ask for a longer deadline than 2021 for pharmaceuticals, for
example, until they have ‘graduated’ to developing country status, “which
is what they tried to do for the entire TRIPS agreement.”

LDCs can opt to protect pharmaceutical products but they can choose not to
protect them, she said. “Many of them have already patent laws on the
books, but what paragraph 7 of the Doha Declaration has done on a very wide
scale, is to allow LDCs not to enforce the patents that they have.”

“And countries, on a much wider scale than is generally understood have
made use of that provision in their day to day procurements, in particular
for antiretroviral drugs,” she said.

Paragraph 7 “has given the generic suppliers the insurance that they have
the legal protection do supply their products.” The new extension only adds
to the important steps achieved by paragraph 7, she said. “However, until
LDCs can produce medicines they will remain dependent on the production and
export of low cost generics from elsewhere, mostly developing countries
that have the obligation to provide pharmaceutical patent protection.”

“Therefore licensing of these patents for example through the Medicines
Patent Pool will remain important. It is also crucial that countries that
grant compulsory licenses ensure the products produced under these licenses
can be exported to other countries such as LDCs that need access to these
products,” she said.

“It remains to be seen whether LDCs are going to proactively use this legal
space that has been given to them to review and amend their patent laws and
design their IP laws, not only for patents, so that it reflects their level
of technological development and their health needs.”

Academic Perspective

Prof. Fred Abbott of Florida State University Law School said: “When you
have several formal decisions covering overlapping subject matter, there
are going to be questions regarding the legal relationship between them.”

“Notwithstanding the unfortunate press release issued by the European Union
on June 11, 2013, the new extension manifestly does not establish an
enforceable WTO legal obligation on LDCs that precludes rollback of
existing intellectual property legislation and rules (except with respect
to national treatment and most favoured nations), he told *Intellectual
Property Watch*.

“The EU press release made the assertion that the June 11, 2013 decision
‘does not affect the transition period for patents for pharmaceutical
products, which was agreed in 2002; LDCs will not have to protect these
patents until 2016.’ But, the June 11, 2013 decision includes patents
within its subject matter scope, so it is rather difficult to understand
why LDCs would be required to provide patent protection for pharmaceutical
products (or any other products) in 2016 since the general extension runs
to July 1, 2021.”

“Because the June 11, 2013 decision allows LDCs to roll back existing
levels of protection, they can elect to reduce existing levels of patent
protection up until July 1, 2021, including for pharmaceutical subject
matter,” he said.

“The June 11, 2013 decision states that it is ‘without prejudice’ to the
June 27, 2002 TRIPS Council extension. ‘Prejudice’ is a negative or
pejorative term, signaling adverse effect,” he said.” “Therefore, the June
11, 2013 decision must not diminish the rights granted to LDCs under the
2002 decision. The June 27, 2002 decision made clear that patents LDCs may
have granted with respect to pharmaceutical products, and regulatory data
protections, do not need to be enforced.”

“Particularly in light of statements such as that made by the EU on June
11, 2013, there is a value to this confirmation of the right of LDCs under
WTO law not to enforce pharmaceutical patents and regulatory data
protections. LDCs will need to assess whether to seek a specific additional
extension of the June 27, 2002 TRIPS Council decision,” Abbott said. “The
process of assessment should probably be initiated soon.

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