Category Archives: Data Exclusivity

The CoViD-19 pandemic may well be humanity’s biggest collective challenge in a post-globalisation era. In the midst of this global emergency, the artificial scarcity produced by international and domestic intellectual property laws and norms is revealing itself to be a scourge to public health systems around the world – from restraining drug research and development to denying access to medical devices. The responses of various stakeholders will certainly have an immediate impact on CoViD-19 related public health responses, but its…

Corona and IP – Looking for the Right(s) Answers

by Swaraj Paul Barooah March 26, 2020

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The Covid 19 pandemic has now changed the way most of us are going about our day to day lives. In India, we are now on day 2 of our 21 day nation wide lock-down. In the midst of all that is going on now, Intellectual Property enthusiasts with a keen eye, would have noticed several IP related issues that have been cropping up, even if relatively under-discussed. For this current post, I thought I would do a round-up of…

Data Exclusivity Patent

Patent Politics in the Time of Corona

by Swaraj Paul Barooah March 13, 2020

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The new coronavirus threat/scare seems to be increasing with every passing day. At the time of writing this, it is reported that there are 138,941 cases (of which 80,815 are in China), of which 70,727 have recovered, 57,317 in mild condition, 5,786 are serious, and 5,111 have died. India has 81 cases of which 4 have recovered and 1 person has died. The new Coronavirus, or COVID 19 as it is technically known is, is now the 7th known coronavirus (other…

Competition Law Data Exclusivity Overlaps in IP Patent

Shogun Organics: Burden of Proof and Follow On Registrations

by Aparajita Lath August 25, 2019

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Shogun Organics Limited v. Gauri Hari and Others is a curious case concerning burden of proof and an apparent conflict between the Patents Act, 1970 and the Insecticides Act, 1968. Facts Shogun Organics Limited (plaintiff) filed a suit seeking a permanent injunction to restrain the defendants from infringing its process patent. The patent relates to the manufacturing of d-trans Allethrin (an active ingredient in mosquito repellants). Shogun had also obtained an ‘original’ registration for the manufacture of this product under the…

Data Exclusivity Drug Regulation

Killing Me Softly: Of Data Exclusivity and Deadly Drugs!

by Shamnad Basheer November 28, 2016

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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…

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

by Prashant Reddy November 4, 2016

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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…

Judging Judges: Reviewing Justice Singh’s IP Jurisprudence

by Rupali Samuel June 10, 2016

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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…

Data Exclusivity Drug Regulation Patent

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

by Rahul Bajaj May 9, 2016

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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…

Data Exclusivity Drug Regulation Patent

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

by Rahul Bajaj May 2, 2016

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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….

Latest RCEP IP Chapter leak reveals more cause for worry

by Swaraj Paul Barooah April 20, 2016

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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…