Category Archives: Data Exclusivity

In Part I of this post, Anik and I argued that the government should waive the IPR in Covaxin in order to ensure that the vaccine can be rapidly accessed by the public. In Part II of this post, Swaraj and I explored the broader issue of IP ownership in outcomes of publicly funded research. In Part III, I analyse the opacity surrounding the clinical trial data generated during the Covaxin trial, which has not been publicly shared on grounds…

Competition Law Copyright Data Exclusivity Privacy Trade Secret

Revised Non-Personal Data Governance Framework and Intellectual Property Implications – Part I

by Anupriya Dhonchak February 9, 2021

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The Committee of Experts on Non-Personal Data (NPD) Governance Framework headed by Kris Gopalakrishnan, constituted by the Ministry of Electronics and Information Technology had released its first Report in July, 2020. I had written about the Report for SpicyIP here. In December last year, a revised Report (“the Report/Revised Report” hereinafter) was released by the Committee with the goal of unlocking economic benefit from non-personal data, creating a data sharing framework, establishing community-based rights over NPD and addressing potential harms to privacy…

COVID-19 Data Exclusivity Innovation Patent

Patents for Pharmaceutical Innovation – Basic Concerns

by Swaraj Paul Barooah June 9, 2020

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Comparison of BRICS countries Public Health spending. Please contact author if you want breakdown of details

Covid 19 seems to have done what public health activists have been crying hoarse about for years – that is, shine a bright spotlight on the various inadequacies of the public health systems around the world, and its related issues. With several public calls for letting patent rights on pharmaceuticals take a back seat vis-a-vis this pandemic, this bright spotlight has also shone on those who’ve been lobbying for ever-restrictive patent rights on pharmaceuticals. For example, as KEI has pointed…

COVID-19 Data Exclusivity Patent

CoViD-19 Pandemic Spurs Calls for ‘Openness’ in IP

by Divij Joshi March 31, 2020

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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…

COVID-19 Data Exclusivity Innovation Others

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…

COVID-19 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…

Adyasha Samal { Thank you for bringing out that point, sir. Indeed, implementing a mandatory registration system would unfairly deprive Indian authors of the rights that foreign authors would continue to... }
Jagdish Sagar { Under Article 5(2) of the Berne Convention, copyright protection in works originating in other member countries of the Berne Union cannot be subject to any formalities. If India... }
Praharsh Gour { Hey Megha, Thank you for your comments and pointers. The scenario suggested by you are exactly the same thing we have raised concern about. Seemingly the whole business... }
Megha Banerjee { The only reason that government (ICMR) does not allow other pvt. Drug manufacturing companies to manufacture may be restrictions on ICMR and other other govt. Agencies to create... }
Akshat Agrawal { Hi Adarsh. Thank you. Continuing the conversation. Okay so I think step 1 is important. Copyright exists- but on what does copyright exist? The court has many times... }

De-Coding Indian Intellectual Property Law

Category Archives: Data Exclusivity

Intellectual Property Rights in Covaxin – Part 3 (IP Rights over Clinical Drug Trials (CT) Data)

Revised Non-Personal Data Governance Framework and Intellectual Property Implications – Part I

Patents for Pharmaceutical Innovation – Basic Concerns

CoViD-19 Pandemic Spurs Calls for ‘Openness’ in IP

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

Patent Politics in the Time of Corona

Shogun Organics: Burden of Proof and Follow On Registrations

Killing Me Softly: Of Data Exclusivity and Deadly Drugs!

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

Judging Judges: Reviewing Justice Singh’s IP Jurisprudence