Category Archives: Data Exclusivity

Data Exclusivity Drug Regulation

Killing Me Softly: Of Data Exclusivity and Deadly Drugs!

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In a recent post, Prashant took issue with the IPA’s contention that the Indian governments’ latest move to extend the moratorium for state drug regulatory approvals from 4 years to 10 years results in a long and damaging data exclusivity. Who is right? And who is wrong? Once one begins to trudge down this rabbit hole in search of answers, one realises that the alleged data exclusivity norm is the least of our worries. We have a far more deadly…


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Data Exclusivity Drug Regulation Patent

IPA Alleges that New Rule Change will Bring in a Data Exclusivity Regime – Here’s Why I Think it Does no Such Thing

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In a report published yesterday in the Bombay edition of the Times of India it has been alleged that the government is proposing a rule change to the Drugs & Cosmetics Rules, 1945 to introduce:  “a form of ‘data exclusivity’, a provision which will potentially give protection to Big Pharma, thereby delaying generic competition and hence impacting access and affordability of drugs.” The source of this information as per the news report is D.G. Shah, the spokesperson of the Indian Pharmaceutical…


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Judging Judges: Reviewing Justice Singh’s IP Jurisprudence

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In this guest post, Prashant Reddy reflects on the major decisions by Justice Manmohan Singh of the Delhi High Court in the field of intellectual property law and on the larger question of criteria for appointment of persons to the position of Chairperson of the Intellectual Property Appellate Board. Warning: Very long post ahead. Title: A review of Justice Manmohan Singh’s judgments Author: Prashant Reddy As reported by Shamnad recently, the grapevine has it that Justice Manmohan Singh of the…


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Data Exclusivity Drug Regulation Patent

Delhi HC Imposes Strict Conditions on the Sale of Biomedicines: Part 2/2

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In part 1 of my analysis, I offered a brief summary of the Delhi High Court’s judgment imposing strict conditions on the sale of the biosimilar version of Roche’s breast cancer drug, Trastuzumab, by Biocon and Mylan. Before I delve into the findings of the single judge, I should point out that, as one of the commenters to my previous article noted, the decision has been stayed by a Division Bench and the matter is listed to be next heard…


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Data Exclusivity Drug Regulation Patent

Delhi HC Imposes Strict Conditions on the Sale of Biomedicines: Part 1/2

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In an order that is likely to have wide-ranging ramifications on the biomedicine industry, the Delhi High Court on Monday (25th April) imposed some conditions on the sale of the biosimilar version of Roche’s breast cancer drug, Trastuzumab, by Biocon and Mylan. The decision, clocking in at 227 pages, discusses a number of profoundly important issues such as data exclusivity, patent linkage, norms to be followed for patient safety and the rights of patentees after the expiry of their patent….


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Latest RCEP IP Chapter leak reveals more cause for worry

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Last night, Knowledge Ecology International (KEI) managed to leak yet another updated version of the IP chapter of the secretive RCEP negotiations. The October 2015 version is now available on their site here. We had written on an earlier (June, 2015) draft that KEI had leaked here. As per Wikipedia, this is the 12th round of negotiations, and one more round of negotiation has happened (Feb, 2016) since this Oct 2015 draft. There are an expected 14 rounds scheduled, with the last one in September, 2016. An…


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Data Exclusivity Drug Regulation Others Patent

Why the TPP could kill access to medicines

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In an article published on 16th November, 2015 in the Wire, I have analysed the Patent section of the Intellectual Property chapter of the Trans-Pacific Partnership Treaty, a regional free trade agreement involving the US and 11 other countries and 40% of the world GDP that was released earlier this month. Negotiated in secret, the Treaty has been controversial for adopting TRIP plus standards in IP, threatening internet freedom, endangering the rights of labour, health and the environment, and, largely furthering…


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Data Exclusivity Drug Regulation Uncategorized

Data exclusivity: IPA letter to Min opposes any change to Indian law

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The India-US bilateral talks starting tomorrow could mean renewed scrutiny of India’s IP regime and a letter from the Chairman and ranking members of the Ways and Means and Finance Committees to Secretary of State, John Kerry and Secretary of Finance, Penny Pritzker seeks to ensure that there is ample pressure on the Indian government to modify our laws to reflect the ‘right’ kind of policy.  Highlighting the opportunities presented by a 1.2 billion member strong free market, this letter (authored by Paul Ryan,…


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RCEP leaks reveal disastrous FTA brewing in Asia

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Another round of RCEP negotiations concluded last week. The negotiations continue in a secretive vein- there is no official word on the results of the rounds, nor any official text available for the public to read. However, KEI did manage to spite the dozen odd member countries by releasing a version of the text, right before the negotiations were about to begin. When the only two ways of knowing about your government’s deals are either to become a negotiating official…


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Data Exclusivity Innovation

Policy innovation and improvisation on pharmaceutical drug discovery

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As I sit down to pen this post, I am well aware of the complex, heavily debated policy dimensions on incentivizing innovations in the pharmaceutical industry. There is no one absolute ‘right’ answer to the various dilemmas posed by this discussion. In fact, there are several answers. Each one is right in its own way. As I see it, the only way out is to ‘try out’ which, of course, entails the ability to ‘embrace’ risks. As Paulo Coelho said,…


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