[A2k] Day 1 of WIPO PCDA 3, talking to the India Delegation

[Malini Aisola]

http://www.cptech.org/blogs/ipdisputesinmedicine/2007/02/day-1-of-wipo-pcda=
-3-talking-to-india.html

IP Disputes in Medicine
Tuesday, February 20, 2007
Day 1 of WIPO PCDA 3, talking to the India Delegation
by Malini Aisola

On the first day of the 3rd session of the WIPO-PCDA negotiations in
Geneva, I had the opportunity to interview officials from the Indian
delegation and discuss the Indian government=92s position on a variety of
issues such as the development agenda and significant events potentially
impacting India=92s IP policy- the Novartis case, recent release of the
controversial Mashelkar report and signing of a US-India Memorandum of
Understanding (MOU).

India has been in the spotlight because of its initiative in hosting
informal discussions in New Delhi about proposals contained in the
=93Manalo document=94 which was put out after the last WIPO General
Assembly. A delegation official informed me that the various regional
coordinators were invited to nominate three countries from their group
to participate in the meeting that took place from February 5-7, 2007.
Moreover, any country expressing a desire to participate was welcomed.

The objective of the meeting, attended by 22 countries representing all
the regions, was to provide impetus to the PCDA process by consolidating
the numerous proposals into a shorter list through general consensus and
an informal, transparent process. Consequently, the 40 Annex A proposals
were distilled down to a list of 22 proposals. The Indian delegate
explained that at the end of the meeting some members still retained
=93qualifications and observations on these proposals but this provides a
good way to examine them further. Let us see how member states proceed
with it.=94

The Indian delegation stressed the importance of moving forward with
decision-making in a timely manner to avoid requests for further
extensions on the period of negotiations.
Expressing frustration at the slow pace of negotiations since the
adoption of a proposal for a development agenda, the Indian delegate
stated, =93it is imperative that the timeline is not eternal.=94

It remains to be seen if this endeavor will bear any fruit and if any
member will table the non-paper that is the outcome of the Delhi
meeting, currently being circulated informally. In this regard, it is
worth noting that on day one, a resolution was passed to format
subsequent discussions on the basis of the Manalo working paper.

India has also received a lot of attention about Swiss pharmaceutical
company, Novartis=92 challenge of section 3(b) of the Indian Patent Act
(2005) in the Chennai High Court. Novartis charges that this provision
limits the scope of patentability in a way that is not TRIPS complaint
and simultaneously violates Article 14 of the Indian constitution. The
outcome of this case will determine the ability of Indian generic drug
manufacturers to continue providing affordable medicines to patients in
developing countries who are too poor to pay for patented drugs.

While a large international community is rallying against Novartis and
demanding that the case be dropped, the Indian government has been
charged with not taking strong enough measures to defend its patent act.
Particularly conspicuous has been the absence of the Solicitor General
of India during the presentation of arguments on February 15 and 16.

Speaking in a limited capacity as the Novartis case is sub judice, a
representative of the Indian delegation responded that =93there is no
cause for concern and the Government of India is doing its job.=94
Further, he pointed out that the Additional Solicitor General, a local
lawyer, was handling the case competently. Noting =93that the Solicitor
General is called upon only in cases when the constitution of India is
challenged,=94 he stated the present position was that the Solicitor
General=92s constitutional expertise would be sought if the need arose in
the future.

The current stance would be reassuring were it not for the fact that
Novartis has hired a former Attorney General and a former law minister
of India to appear on its behalf. Novartis certainly recognizes the
implications this case has for access to medicines in India and the rest
of the world, what will it take to shake India out of its complacence?

More bad news for generic drug companies recently came in the form of
the Mashelkar report. In fact, Novartis has used this report=92s
recommendation in support of its case against the Indian patent law.
Briefly, the government-appointed committee of IP experts headed by
Mashelkar concluded that limiting the granting of patents for
pharmaceuticals with new chemical entities (NCEs) or new molecular
entities (NMEs) was a violation of the TRIPS agreement.

An Indian official confirmed that the Government of India has not taken
any conclusive view on the report. =93Given the sensitivity of the matter,
it is fully within its rights to examine all the ramifications before
accepting, partially accepting, or rejecting the report,=94 he said. The
report was made immediately available on the government=92s website and
has since generated lots of public debate which in his opinion is
facilitating and informing the government=92s decision.

Hesitation on India=92s part appears warranted considering the extent to
which the report has been criticized by academics, industry and NGOs in
India.

Yet, this is not the first time that India has been caught in an
uncomfortable situation with Mashelkar.

Mashelkar chaired the Casablanca meeting in 2005. India issued
statements distancing itself from the resolution that came out of that
meeting, which undermined the position of many developing country
delegates on the negotiations on a new WIPO substantive patent law
treaty, a project that was put on hold at the recent WIPO General Assembly.

Finally, the Indian delegates commented on the US-India memorandum of
understanding on bilateral cooperation for intellectual property and its
effects on India=92s position on IPR in a forum such as WIPO. I was
informed =93India has signed MOUs with the United Kingdom, France,
European Patent Office and the US. India has taken a very very
unambiguous position that no bilateral cooperation or agreement with any
other government shall impinge on issues relating to policy, legislation
or enforcement related issues which remain the prerogative of the
Government of India.=94

It was encouraging to learn that the areas of agreement are restricted
the =93soft issues=94 of capacity building, human resource development and
public awareness programs in IP.

posted by Malini Aisola @ 9:34 AM