Category Archives: Drug Regulation

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Spicy IP Weekly Review (November 22- November 28)


It’s been another IP heavy week for the Indian IP landscape! Here is the last week’s review, discussing the 5 posts published on the blog along with summaries of 16 IP cases from Delhi High Court and a few national and international IP developments. (Important IP cases that we’re missing out on? Especially from other High Courts? Please let us know so we can include them!)   Highlights of the Week Copyright and Classical Music: Not the Best Fusion? Akshat…


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Drug Regulation

Book Review: ‘The Truth Pill: The Myth of Drug Regulation in India’


We are thrilled to review Prashant Reddy’s new book on the Indian drug regulatory system! Co-authored with Dinesh Thakur their book – The Truth Pill – The Myth of Drug Regulation in India  was released this October. Given that drug regulation has a direct nexus to public health, maybe even more than patents, several years ago, Shamnad, Prashant and Sai started a new initiative on SpicyIP to throw more light on India’s drug regulatory framework. Since then such issues have…


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SpicyIP Weekly Review (November 1- November 7, 2022)


Dear readers, as you may have noticed, after a bit of a slowdown, SpicyIP is once again picking up steam and we will be looking to bring you the spicy IP updates that you have been used to! On that note, SpicyIP is happy to let our readers know that we’re restarting our weekly reviews. The weekly reviews will consist of short reviews of the past week’s blogposts, as well as caselaw from the previous week that we have been…


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Leaked Draft of IP Chapter of India UK FTA Shows Ridiculous TRIPS plus norms in Negotiating Text


India’s negotiations for a new Free Trade Agreement (FTA) with the UK has been the talk of the town for a better part of 2022. From the widely popularized Diwali deadline, agreed by Prime Minister (s) Modi and Johnson, to the controversial comments by the UK Home Secretary Braverman on Indians overstaying their visas, the FTA negotiations have constantly been in the news. However, in the surrounding talk of progress and supposed benefits of the FTA, coverage of contentious issues…


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Drug Regulation Overlaps in IP Patent Trade Secret

IP Reveries: Class 5.1 – Drugs, Secrets, and Innovation: Brooding Over The Basics


Prof Antilegend’s classes are back! After a few sessions on conceptual and theoretical ideas around IP, this set of sessions will now take the class on a different not-so-theoretical topic and deliberates upon IP issues that crop up around clinical trial test data, drug innovation, Indian drug regulatory regulation etc. If this is your first time coming across the IP Reveries series, you can see what its about as well as get links to our previous classes in the introductory…


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Drug Regulation Innovation Others

AI/ML Medical Devices, Regulation and Sunrise in the West


Policy makers have often been caught off guard with new age technology. Technology emerges and evolves rapidly and regulations are slow to catch up. This cat and mouse game continues with another fast emerging and disruptive technology – AI / ML based medical devices. The US and EU are seeing waves of regulatory and policy level curiosity in AL / ML medical devices. The timing for these interventions also seems right. While many devices have been launched, this technology is…


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Drug Regulation Innovation

Drug Price Controls in the US: Same, Same but Different?


In 2017, when India introduced price controls on coronary stents, the United States Trade Representative (USTR) had requested the Prime Minister to not extend price controls to additional medical devices. When India refused to heed to the request, amongst other things, the National Trade Estimate Report on Foreign Trade Barriers reported the measure of price capping to be without a sense of differentiation between newer and older products (here, p. 235), India’s eligibility for US’ Generalized System of Preferences (GSP)…


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SpicyIP Weekly Review (September 27 – October 3)


Zolgensma and the Inadequacies of the Compulsory Licensing Regime In a guest post, Akhil wrote about Zolgensma, Novartis’ gene therapy medication prescribed for treatment of Spinal Muscular Atrophy (‘SMA’). Akhil discusses the compulsory licensing provisions in the TRIPS Agreement, as well as the objectives and principles relating to safeguarding public interest in Articles 7 and 8 and how they find reflection in India’s Patent Act. Breaking down the 3 tests of reasonably meeting the requirements of public, reasonable affordability and…


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SpicyIP Weekly Review (August 23 – 29)


Topical Highlight Sun Pharma v. Cipla: Madras HC Rejects COVID as an Excuse for Passing Off In this guest post, Kedar Ganesh Dhargalkar analyses the recent case of Sun Pharmaceuticals Industries Ltd. v. Cipla Ltd., and the socio-legal opportunism of the defendants’ arguments for condonable trademark infringement, set in the backdrop of the ongoing global pandemic. The Defendant Sun Pharmaceuticals Industries Ltd. allegedly infringed the Plaintiff Cipla Ltd.’s copyright and registered trademark by thrusting its deceptively similar goods and flooding the…


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SpicyIP Weekly Review (August 9 – 15)


Topical Highlight Ensuring Access to TB drugs: Is Compulsory License the Way? In this post, Rahul Bajaj and Praharsh Gour analayse the underutilisation of Indian patent law’s robust flexibilities to promote patient interest. They highlight that this failure is typified by the stark realities that have come to light in a pending public interest litigation before the Bombay High Court [BHC], regarding access to life saving drugs. They discuss the facts and figures surrounding multidrug-resistant tuberculosis in India as well as…


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