Drug Regulation

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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Announcing 1st National Policy Brief Competition on Intellectual Property & Innovation 2025 by SpicyIP and CIPAM, DPIIT

/ By / Drug Regulation, Opportunities, Patent, Trade Secret

Kickstarting November with some good news for young IP policy enthusiasts, we are elated to announce the 1st National Policy Brief Competition on Intellectual Property & Innovation 2025! This exciting competition aims to encourage students to look beyond textbooks and statutory provisions, and to explore the dynamic relationship between intellectual property, innovation, and societal progress. By engaging with contemporary IP issues that shape India’s legal and creative ecosystem, the competition seeks to foster critical thinking and contribute meaningfully to the

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[SpicyIP Tidbit] A Heavy Dose of Litigation: Novo Nordisk sees Litigation from Natco over Semaglutide

/ By / Drug Regulation, Patent

Novo Nordisk’s blockbuster weight-loss drug Wegovy (semaglutide) continues to trigger a complex litigation landscape in India. The Danish innovator already has two civil suits pending against Dr. Reddy’s Laboratories (DRL) and OneSource Specialty Pharma Ltd (OSSPL). The first, C.O.(COMM.IPD-PAT) 9/2025, seeks revocation of a patent and has so far seen only four hearings with routine interim orders. The second, CS(COMM) 565/2025, was instituted in anticipation of Novo’s Indian launch and is more high-stakes: on 29 May 2025, the Single Bench

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Event Report of the Inaugural SpicyIP Summer School!

/ By / Copyright, Drug Regulation, Event, Patent, Trade Secret, Trademark

Last month saw SpicyIP converting a long-standing idea into reality, with the successful completion of the 2025 SpicyIP Summer School! An idea that had first been mooted maybe a decade or so ago by Shamnad, it was something that we had just not been able to get to for various reasons. This year too, as we moved close to March, we had almost given up on trying for it this year. But fortunately, a conversation with Dr Zakir Thomas took

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E.R. Squibb v. Zydus: Why the Delhi HC’s Take on Biosimilars May Set a Dangerous Precedent

/ By / Drug Regulation, Patent

In the past two months, Zydus Lifesciences has faced two legal setbacks in litigations for its biosimilar medicines. In April, the U.S. District Court of Delaware rejected Zydus’s challenge against the validity of Astellas’s patent on Myrbetriq, dealing a blow to Zydus’s plan to launch a generic version of the drug in U.S. On 18th July, the Delhi HC dealt another blow– it restrained Zydus from manufacturing, selling, offering for sale, importing, exporting, advertising or dealing in any bio-similar of Nivolumab.  The

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Comments Invited for Draft Guidelines on Similar Biologics

/ By / Drug Regulation

On May 6, the Central Drug Standard Control Organization published the draft version of the Revised Guidelines on Similar Biologics, inviting comments from the concerned stakeholders. These guidelines were prepared after a Committee composed of technical subject experts, representatives from the National Institute of Biologics, Dept. of Biotechnology, and representatives from industries manufacturing similar biologics. As explained in the introductory pages, the guidelines are revised in light of advances in scientific knowledge and to update the existing guidelines in light

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SpicyIP Weekly Review (March 31 – April 6)

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

Keep up with the ever changing world of IP with SpicyIP’s Weekly Review! Beginning April with a three-part post exposing the alarming lack of transparency surrounding public funds spent on indigenously developed COVID-19 vaccines, a two part post on the latest Kunal Kamra controversy and its copyright implications, and the difficulty in getting cancer related information in India. This and much more in this week’s SpicyIP Weekly Review. Anything we are missing out on? Drop a comment below to let

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The Great Indian Cancer Information Treasure Hunt

/ By / Drug Regulation, Others, Patent

[This post has been co-authored by Swaraj and Sabeeh. Long post ahead] Cancer incidences continue to increase in India, with over 1.46 million estimated new cases diagnosed annually as of 2022 and predicted to rise to 1.57 million cases by 2025 (More on these numbers later!). The continuous interaction of public health priorities with IP laws have been mainstream discussion for a long time now. To what extent exactly do IP laws create, shape, or impact the political economy of

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SpicyIP Weekly Review (September 30-October 6)

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

Here is our recap of last week’s top IP developments including summary of the posts on the Lenacapavir patent application and oppositions, ANRF and corporatisation of research, the copyright dispute between Jasleen Royal and T Series, and DHC’s recent order in Master Arnesh Shaw v. Union of India This and a lot 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 Patent Application for

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A Followup on Lenacapavir: Gilead enters into Voluntary Licensing Agreements in 120 LMICs

/ By / Drug Regulation, Patent

Just a day after our update on the Lenacapavir patent oppositions (here), Gilead has signed “Royalty-Free Voluntary Licensing Agreements” (VLAs) (pdf) with generic manufacturers aimed at boosting HIV prevention in “high-incidence, resource-limited countries.” The focus is squarely on low- and middle-income countries (LMICs), as highlighted in Gilead’s official reports (here) and various media outlets (here). This strategic move reflects Gilead’s commitment to expanding access to vital treatments where they’re needed most, and this post will fact-check the coverage of these

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