Data Exclusivity

A Look Back at India’s Top IP Developments of 2025

/ By / Competition Law, Copyright, Data Exclusivity, Design, Drug Regulation, Geographical Indication, Innovation, Patent, Plant Variety Protection, Podcast, Trade Secret, Trademark

[This post is completely human authored 🙂 These humans include – Praharsh Gour, Vasundra Koul, Arshiya Gupta, and Vikram Raj Nanda. Selection and Supervision by- Praharsh Gour, Swaraj Paul Barooah, and Bharathwaj RamakrishnanResearch Inputs from Yohann Titus Mathew, Riddhi Yogesh Bhutada, Ayush Shetty, Sumit Kumar Singh, Shailraj Jhalnia, Himanshu Mishra, Bhavya Gupta, Aali Jaiswal, Anushka Kanabar, Srishti Gaur, Arshya Wadhwa, and Daanish Naithani.] 2025 was quite an eventful year. On the judicial side, we saw a variety of novel developments, such […]

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Data Exclusivity Debate Resurfaces Amidst US-FTA Talks, Evidence Still Missing

/ By / Data Exclusivity, Drug Regulation

(Long post ahead!) A Central Drugs Standard Control Organization (CDSCO) notice has triggered fresh discussions on a data exclusivity regime for pharmaceutical products in India. The notice dated October 8 invites comments ‘to ensure a level playing field in new drug approval’. The notice reasons that  applicants obtaining approval of a new drug for the first time in the country based on clinical trial and test data do it at a higher regulatory compliance cost compared to subsequent applicants who

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SpicyIP Weekly Review (December 1 – December 7)

/ By / Copyright, Data Exclusivity, Others, Patent, Trademark

Starting the month with an analysis of the Delhi HC’s judgment in Novo v. Reddy in the Ozempic dispute. Section 3(k) in the news again in Ab Initio v. Controller, and a trademark battle over the word ‘choice’. This and much more in this week’s SpicyIP Weekly Review. Anything we are missing out on? Drop a comment below to let us know.  Highlights of the Week Part I- Novo v. Dr. Reddy: Clear the Way or Else Block The Way

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Of Clinical Trial Waivers in India: The Misses Outweigh the Hits

/ By / Data Exclusivity, Drug Regulation

In light of the executive order waiving the requirement to conduct clinical trials for new drugs approved in a few selected jurisdictions, we are pleased to bring to you this guest post by Md. Sabeeh Ahmad, discussing the implications of this executive order. Sabeeh is an Advocate and is a law graduate from AMU, Aligarh. His previous posts can be accessed here. Of Clinical Trial Waivers in India: The Misses Outweigh the Hits By Md. Sabeeh Ahmad The Drug Controller General

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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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