Category Archives: Data Exclusivity

Data Exclusivity Drug Regulation Others

Data exclusivity back on the table for India


D.G. Shah, Secretary General of the Indian Pharmaceutical Alliance sends us news that will be of interest to many of our readers. He says, “… Government plans to introduce a Pesticides (Amendment) Bill in the Parliament during the current session. The Bill has a provision that not only makes India’s Intellectual Property (IP) regime TRIPS Plus but would also eliminate competition and create legal monopoly for agro-chemicals and pesticides making them unaffordable to small farmers. The Bill proposes to introduce…


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Data Exclusivity Patent

Worrying Developments in Indo-US IP negotiations – Data Exclusivity and Patent Linkages


In a deeply worrying development, Senior Advocate and former UN Special Rapporteur Anand Grover reports in an email alert that “From inside sources it appears that PM Modi is very keen to assure the US President Barack Obama and US multinational companies (MNCs) that India will agree to the changes proposed by them. Inside sources also reveal that two issues likely to be worked upon are Data Exclusivity[1] and Patent Linkage[2].” We have covered the recent developments in the Indo-US…


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Copyright Data Exclusivity Others Patent

GIPC IP Index: India ranked last


The U.S. Chamber of Commerce Global Intellectual Property Centre recently released the latest ‘International IP Index’. As per this report, India has been placed last in terms of protection and enforcement of Intellectual Property practices out of 25 countries. India scored only 6.95 points out of 30. US ranked the highest, scoring 28.5 on 30. Even in the previous GIPC Index, India was ranked last. However, the findings of this report need to be examined. As Swaraj pointed out (here), even…


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Data Exclusivity Patent

Prices of cancer drugs to rise?


According to various tweets (sources mentioned at the bottom) coming in from Salt Lake City, where the current, and possibly last round of the TPP negotiations are happening, MSF’s prediction may be coming true – that the TPP may become the most harmful trade pact ever for access to medicines for developing countries. The USTR is going all out to get their way in the IP and Medicines round. [For our readers who want some background on the TPP, see…


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Copyright Data Exclusivity Innovation Others Patent

Wikileaked! Leaked IP Chapter of TPP shows that US could be an IP Terrorist


On 13th November, Wikileaks released a leaked copy of the consolidated IP negotiating chapter for the Trans-Pacific Partnership Agreement (TPP). [A big thanks to whoever leaked it to Wikileaks!]. This post will look into the contents of that leaked chapter and describe exactly how messed up it is – but first a tangential observation. In a couple of earlier posts (here and here) we had discussed certain (earlier) leaked provisions of the draft chapter US had put forth in the negotiations….


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Data Exclusivity Drug Regulation Innovation Patent

Ranbaxy finally gets approval for Synriam – Can it keep out the competition?


The Mint and other Indian media outlets have reported that India’s drug regulator has finally given marketing approval to Ranbaxy for its new anti-malarial drug Synriam. We had previously blogged about Synriam over here, here and here. The drug is a Fixed Dose Combination (FDC) of “arterolane maleate 150 mg and piperaquine phosphate 750 mg drug”. Arterolane was invented by a global team headed by Prof. Vennerstrom consisted of researchers from University of Nebraska (USA), Monash University (Australia), the Swiss…


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Data Exclusivity Innovation Patent

The Draft Intellectual Property Policy of South Africa


The South African government released its much awaited ‘Draft National Policy on Intellectual Property, 2013’ (“Draft Policy”) for public consultation. According to the news report, the pro-reform civil society collective cautiously welcomed the release of the Draft Policy. The civil society collective inter alia advocated for reforming the South Africa’s IP laws such as a) adoption and implementation of an examination system for all pharmaceutical patent applications; b) strengthening patentability criteria to prevent evergreening; and c) promoting high standards for…


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Data Exclusivity Patent

Part I: Pfizer’s testimony leads the way as US pressure on India increases


Readers may remember our recent coverage of Pfizer’s Chief IP Counsel, Roy Waldron’s testimony before a hearing of the US House of Representatives and the heated exchange that followed between Waldron and the Indian Pharmaceutical Alliance (IPA) thereafter. Waldron’s main allegations were that the Indian Pharmaceutical patent regime flouted international trade rules and abused the compulsory license system and recommended that the US government use all means at its disposal to get India in line. IPA responded with a strong…


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Data Exclusivity

‘Rethinking the data exclusivity debate in India’ – A request for comments


Image from here Around two years ago, I had written a post on the need to balance the data exclusivity debate in India (Shamnad has responded to that post over here). I wanted to expand that post into a full length academic essay and I finally got the time to do so, after a lot of procrastination. The article is available for download over here from SSRN.  I’m yet to submit it for publication to any journal and was hoping…


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Data Exclusivity

Anand Sharma gives a No to Data Exclusivity


Picture Credit: Kevin Dean from www.betaart.com As we’ve highlighted several times on this blog, the pharmaceutical lobby in EU and US have (through their governments) tried to push India into accepting many stronger IP rights, including data exclusivity. As we’ve also highlighted several times, data exclusivity has been consistently been opposed by the Indian Pharmaceutical Alliance as well as several NGOs; however we haven’t been as sure as to what position the government was going to take in the EU-India…


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