Drug Regulation

Mavyret Patent Abandonment Does Not Open the Field for Hepatitis C Generics

/ By / Drug Regulation, Patent

July 28, 2026 marked eight years of the National Viral Hepatitis Control Program (NVHCP). Launched under the National Health Mission, the program aims to eliminate Hepatitis C from India by 2030 through free testing and access to generic versions of direct acting-antivirals (DAAs). One of the most effective drugs for curing patients of Hepatitis C virus (HCV) currently in the market is AbbVie’s Mavyret. It is recognised as the first and only DAA approved to treat both acute and chronic […]

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SpicyIP Weekly Review (27 July-2 August)

/ By / Copyright, Drug Regulation, Others, Patent, Trademark

Stepping into August with posts on the DHC’s order in ANI v. OpenAI, Interdigital v Transsion, the Ribociclib saga, and digital archive. This and much more in this week’s SpicyIP Weekly Review. Anything we are missing out on? Drop a comment and let us know. Highlights of the Week ANI v. OpenAI: User Rights, Fair Dealing, and the Future of AI in Indian Copyright Law (Part I) The Delhi High Court’s much-awaited interim order in ANI v. OpenAI addresses several

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Part II: To CL Or Not To CL: That Ought Not Be The Question

/ By / Drug Regulation, Patent

Continuing from Part I, Rishabh Upadhyay explains that making a patented medicine free on paper does not necessarily make it accessible in practice. Through Rajasthan’s procurement and distribution model for Ribociclib, he argues that India’s access-to-medicines challenge is ultimately an infrastructural one, not merely a patent-law problem. Rishabh is an LL.M. candidate at South Asian University, having completed his undergraduate legal studies at the Faculty of Law, Banaras Hindu University. His interest lies in intellectual property jurisprudence, with particular emphasis

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SpicyIP Weekly Review (July 13- July 26)

/ By / Copyright, Drug Regulation, Patent, Trademark

A round-up of all the important developments from the last  2 weeks, here is the SpicyIP Weekly Review featuring discussions on the Delhi High Court decision in the OpenAI case, the comments submitted to CDSCO on brand name extension, and the missing public consultations on the proposed Copyright Act amendments. This and much more in this week’s Weekly Review. Anything we are missing out? Drop a comment and let us know. Highlights of the Weeks Training ChatGPT on Copyrighted Works

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Comments on CDSCO’s Brand Name Extension Policies

/ By / Drug Regulation, Trademark

Earlier this month, we had shared the news of CDSCO inviting comments on the long standing problem of Brand Name Extensions (BNE) practices. While this problem is one with severe consequences, it appears to have very little public discourse around it. Thanks to the quick work of 2 very industrious SpicyIP Summer School alumni, Rishabh Upadhyay and Umeshawari Ranjan, we were able to put together and send some comments just in time for the deadline. Instead of putting out the

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Brand Name Extensions by Pharma May Finally Be Receiving Scrutiny? 

/ By / Drug Regulation, Trademark

On July 6, the Directorate General of Health Services, Central Drugs Standard Control Organization (CDSCO), published a notice inviting comments on the use of brand name extensions by Pharma Companies. This stems from a representation made before the Drugs Consultative Committee alleging that a pharma company was selling different formulations under one brand name with different extensions. However, this problem has been a long-standing one, as explained by Prashant and Dinesh Thakur.  In effect, this notice seems to be towards

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SpicyIP Weekly Review (29 June – 5 July)

/ By / Biological Diversity, Copyright, Drug Regulation, Patent, Trademark

What an eventful week it was, with the post announcing the long-awaited results of the SpicyIP-jhana Blogpost Writing Competition, and posts on legal deposits, black-box AI, and house marks. This and much more in this week’s SpicyIP Weekly Review. Anything we are missing out on? Drop a comment and let us know.    Highlights of the Week Announcing the Results of SpicyIP-jhana Blogpost Writing Competition 2025 After carefully reviewing a range of thoughtful and insightful entries from participants across the

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SpicyIP Weekly Review (January 19 – January 25)

/ By / Copyright, Drug Regulation, Geographical Indication, Others, Patent, Trademark

This Weekly Review is authored by Md. Sabeeh Ahmad. Entering the final week of January with the announcement of Pre-finalists for 1st National Policy Brief Competition on IP & Innovation! A post on the recent Zydus v. ER Squibb clarifying biosimilarity is not infringement. A post on the Madras HC’s decision in Rangaraj and Kamal Hassan, shifting India’s personality-rights jurisprudence. This and much more in this week’s SpicyIP Weekly Review. Anything we are missing out on? Drop a comment below

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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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