Data Exclusivity

Orange Book & Inaccurate Patents: US Federal Trade Commission in Action

/ By / Data Exclusivity, Drug Regulation, Patent

[This post is co-authored by SpicyIP Intern Pranav Aggarwal and Swaraj Paul Barooah. Pranav is a second-year student pursuing B.A.LL.B.(Hons) at Rajiv Gandhi National University of Law, Punjab. He has a keen interest in commercial laws, especially in IP and allied fields. His previous posts can be accessed here.] On 7th November 2023, the Federal Trade Commission (“FTC”) issued a press release announcing its challenge to more than 100 patents listed in the ‘Orange Book’. These patents which belong to ten […]

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Compulsion for Compulsory Licenses for Covid Vaccines Climbs: But Are They the Cure?

/ By / COVID-19, Data Exclusivity, Patent, Trade Secret

On 11th May, it was reported that Kerala High Court has sought a response from the Central government on a PIL seeking direction to the government to invoke the compulsory license (CL) provisions for the COVID-19 vaccines. In the PIL, the Petitioner (Adv. Gopakumar GV) argues that in the present crisis resorting to CL will assist the nation to ramp up the quantity of vaccine output and thus overcome its scarcity. As reported before, the government is already facing a

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A frontline worker setting fire to funeral pyres at a cremation site.

Earning Royalties off Covaxin While Demanding IP Waiver at the WTO: Saviour on the Streets, Hypocrite in the Sheets

/ By / COVID-19, Data Exclusivity, Drug Regulation, Innovation, Overlaps in IP, Trade Secret

As news broke out on May 3, 20201 regarding the Indian Council of Medical Research (ICMR) earning royalties out of every dose of Covaxin sold, many were quick to chide the government for embarrassing itself by profiting off vaccines sold in its own country while seeking a waiver of all IPRs on patents, copyright, industrial design and undisclosed information pertaining to vaccines for Covid-19 (covered previously on the blog here, here and here) at the WTO. In this post, I focus on the differential

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

/ By / COVID-19, Data Exclusivity, Drug Regulation, Innovation, Patent, Trade Secret

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

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

/ By / Competition Law, Copyright, Data Exclusivity, Privacy, Trade Secret

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

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

Patents for Pharmaceutical Innovation – Basic Concerns

/ By / COVID-19, Data Exclusivity, Innovation, Patent

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

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Corona covid 19

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

/ By / COVID-19, Data Exclusivity, Patent

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

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Corona covid 19

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

/ By / COVID-19, Data Exclusivity, Innovation, Others

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

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3D medical depiction of coronavirus

Patent Politics in the Time of Corona

/ By / COVID-19, Data Exclusivity, Patent

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

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Shogun Organics: Burden of Proof and Follow On Registrations

/ By / Competition Law, Data Exclusivity, Overlaps in IP, Patent

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

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