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’s position on a variety of issues such as the development agenda and significant events potentially impacting India’s 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 “Manalo document” 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 “qualifications and observations on these proposals but this provides a good way to examine them further. Let us see how member states proceed with it.”

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, “it is imperative that the timeline is not eternal.”

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’ 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 “there is no cause for concern and the Government of India is doing its job.” Further, he pointed out that the Additional Solicitor General, a local lawyer, was handling the case competently. Noting “that the Solicitor General is called upon only in cases when the constitution of India is challenged,” he stated the present position was that the Solicitor General’s 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’s 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. “Given the sensitivity of the matter, it is fully within its rights to examine all the ramifications before accepting, partially accepting, or rejecting the report,” he said. The report was made immediately available on the government’s website and has since generated lots of public debate which in his opinion is facilitating and informing the government’s decision.

Hesitation on India’s 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’s position on IPR in a forum such as WIPO. I was informed “India 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.”

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


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