Category Archives: Data Exclusivity

Data Exclusivity

The Death of Data Exclusivity?


After several months of secretive deliberations, intense politicking and protests, sophisticated debates and powerful op-eds, apparent volte faces, subtle media subterfuge and various other things that might have made for a good Bollywood blockbuster, it appears that the Minister of Commerce, Anand Sharma has finally nailed the coffin and buried the data exclusivity (FTA) debate once and for all! During a recent meeting of a Parliamentary Committee dealing with intellectual property, the Minister, who chaired the meeting announced that India…


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Data Exclusivity

The Curious Case of the "Data Exclusivity" Volte Face


In an earlier post, we referred to a rather curious article by Financial Express (FE) which claimed that some of our biggest generic names, namely Dr Reddys and Glenmark executed a stunning volte face and were now cosying up to the idea of data exclusivity. Certainly had my alarm bells ringing, as I’m sure it did for many of you tracking this space. I spoke immediately with that tireless crusader and one man army that goes by the name of…


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Data Exclusivity

Domestic pharma firms say ‘yes’ to data exclusivity?


In an interesting development, the Financial Express has reported that several Indian pharmaceutical companies have demanded a data exclusivity law in order to protect their invesments in global clinical trials. The report identifies the pharmaceutical companies as Glenmark, Dr. Reddy’s, Glenmark, Lupin, Bharat Biotech and ‘many others’. The report however does not mention the source for this comment. (Image from here) If this report is true, it is significant for three reasons: (i) It represents a major fissure amongst the…


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Data Exclusivity

March 2nd marks aggravated protests against FTA


While the government continues to march on with the EU-India FTA, protester’s have also continued to voice their concerns over the impact that the IP provisions of the draft Agreement will have on making medicines inaccessible. March 2nd marked a day of protest by health activists from across India including PLHIV Networks and Network of People who use Drugs, as well as activists from affected countries such as Nepal, Indonesia, Thailand and Philippines who came to New Delhi to voice their concerns…


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Data Exclusivity

Data Exclusivity Debate: Whither Context?


In this wired world of ours, they say that content is king. After reading Prashant’s impressively articulated post on data exclusivity, I’m inclined to supplement this with : “context is also king”. And unless content situates itself within context, it risks a painful dethroning. For context is one thing that he missed in an otherwise persuasive post: the “context” of the current EU-India FTA negotiations, where it is abundantly clear that the clarion call for data exclusivity comes from European…


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Data Exclusivity

An attempt to ‘balance’ the data exclusivity debate


Warning: Long post – you’ve been warned.Image from here. The ToI and the Indian Express have recently carried an op-ed, each, on why India should resist the ‘data exclusivity’ demand being thrust upon it through the Indo-E.U. Free Trade Agreement (FTA). Strangely the Op-eds although written by different people, carry the same title – ‘Don’t Swallow this Pill’. The ToI piece was written by Unni Karunakara, International President of the reputed ‘Doctors Without Boundaries’, while the IE piece was written…


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Data Exclusivity

EU-India closer to FTA-hampered public health regime?


Draft IP chapter made available The chapter on IP in the draft EU-India FTA has been made publicly available for the first time. As Malini Aisola has pointed out in her blogpost at CIS, the draft shows India’s rebuff of EU’s stand on several key IP provisions. There is a copy of the draft available here for those interested. [CIS-India has also helpfully compiled a chart comparing the language put forth by India and that put forward by EU, available here]. There seems…


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Data Exclusivity

PMO, MNC, CL and Indian IP Policy Making: Whither Representation and Transparency?


A note circulated by the Prime Ministers Office (PMO) asking various government ministries to consider a representation made by OPPI (the Indian pharmaceutical body representing the interests of innovator pharmaceutical companies, mainly MNC’s) has stirred a hornet’s nest. Was it legitimate for the PMO to consider a representation from big bad MNC’s? Of course, it was! This is a democracy and all stakeholders are entitled to be heard. Would a smaller IP stakeholder representation have merited this kind of attention…


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Data Exclusivity

Parliament misses opportunity to discuss ‘data exclusivity’ for agro-chemicals


The ET and the FT have both recently reported that Parliament was scheduled to debate the question of data exclusivity for agro-chemicals (The Pesticides Management Bill, 2008) in the last week of the Budget Session which ended yesterday. A perusal of the website of the Rajya Sabha indicates that the Pesticides Management Bill, 2008, was never taken up for debate on the specified dates A. Data exclusivity for the agro-chemical industry – A brief history (i) The Inter-Ministerial Committee on…


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Data Exclusivity

Article 300A of the Constitution: A constitutional right to ‘data exclusivity’?


A. Introduction: Over the last few weeks there have been an increasing number of media reports on the Free Trade Agreement (FTA) that is being negotiated by the governments of the European Union and India. While there are several hurdles that are yet to be cleared before the signing of this Treaty that is expected to bring huge trade benefits to both countries, the focus in the recent past seems to be on the IP-related provisions that are allegedly going…


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