Drug Regulation

Letting the Plaintiff Examine Regulator’s Approvals: Unpacking the DHC’s Cadila-Hetero Discovery Order Ahead of the SC Hearing

/ By / Drug Regulation

[Thanks to Swaraj Barooah sharing an in-progress draft from a project he is working on examining cancer litigation in India. The questions in there led me to write this post.] Can a court say a company has no right to confidentiality in its regulatory data, and then hand that data to a rival’s expert in a sealed cover? The Delhi High Court decided it can. On 3 November 2026, the Supreme Court is scheduled to take up two Special Leave

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SpicyIP Weekly Review (October 12-October 18)

/ By / Copyright, Drug Regulation, Patent, Trademark

[This Weekly Review is prepared by Kaustub Boidi. Kaustub is a final-year law student at SVKM’s NMIMS, Hyderabad.] Here’s this week’s roundup of IP developments, from posts on the Kerala High Court’s Ribociclib decision, the Delhi HC’s tiered approach to patent appeals in Esteve Pharmaceuticals, the PABS Annex of the WHO Pandemic Agreement, to key judicial decisions and national and international IP updates. Anything we missed out on? Drop a comment below to let us know! Highlights of the Week

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The Ghost of Section 100’s Past!

/ By / Drug Regulation, Others, Overlaps in IP, Patent

As Halloween approaches, a particular editorial at ET seems spooked by the prospect of lawful and equitable access to medicines! In doing the opposite of what its title suggests, ‘Protect Patients and Patents Smartly’, the editorial piece published on October 15, 2026 is an unfortunate example of legal misinformation and misinterpretation, stuck in the old binary of access versus patent. This published piece runs contrary to years of judicial wisdom, contradicts itself, conflates different legal questions and advocates for a

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Ribociclib: Access to Medicine Collides with Patent, Price and Policy

/ By / Drug Regulation, Overlaps in IP, Patent

In this co-authored post, Ambika and Rishabh break down the recent Kerala High Court ruling on government use of patented inventions under Section 100 and situate it in the broader context of other Ribociclib patents and pending litigations that will impact the drug’s access; all this, at a time when patent enforcement and drug pricing rules might be changing. The judgment’s epilogue references popular cinema for recall value (see pg 56 here), but the real blockbuster of this story is

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SpicyIP Weekly Review (14 September-20 September)

/ By / Copyright, Drug Regulation, Patent, Trademark

In this edition of the SpicyIP Weekly Review, we have comments submitted by a few of our team members on the IPO’s Draft Guidelines for Examination of Patent Applications in the Field of Pharmaceuticals, 2026, along with case summaries of the orders and judgments we were able to find. If we’ve missed anything, drop a comment below and let us know. Highlight of the Week Specific Comments on the IPO’s Draft Pharmaceutical Guidelines (2026) The IPO’s 2026 Draft Pharmaceutical Guidelines

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Specific Comments on the IPO’s Draft Pharmaceutical Guidelines (2026)

/ By / Drug Regulation, Others, Patent

There is no easier way to put it – the IPO’s Draft Guidelines for Examination of Patent Applications in the Field of Pharmaceuticals, 2026 (“2026 Draft Guidelines”) released 15 days ago have severe problems and require substantial reworking. There are many concerning reasons warranting an immediate and thorough revision of this draft for it to avoid disrupting patent law and patent prosecution as we know it. The 2026 Draft Guidelines have misquoted certain statutory provisions, misinterpreted some judicial decisions, misapplied

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General Comment on the IPO’s Draft Pharmaceutical Guidelines (2026)

/ By / Drug Regulation, Others, Patent

A few days ago, we had informed our readers that they could participate in the open call for comments and suggestions on the Draft Guidelines for Examination of Patent Applications in the Field of Pharmaceuticals (2026). Several such notifications have been released by the office of the Controller General of Patents, Designs and Trademarks (CGPDTM) in the past few weeks (see here and here). The notification of the new draft of the Pharmaceutical Guidelines was released on September 4, 2026

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SpicyIP Tidbit: CGPDTM Calls for Comments and Suggestions on New Draft Pharma and Biotech Patent Application Guidelines (2026)

/ By / Biological Diversity, Drug Regulation, Others, Patent

In the time of this oncoming monsoon, it feels like its raining draft guidelines from the Controller General’s office! The office of the Controller General of Patents, Designs and Trademarks (CGPDTM) has released two new sets of draft guidelines today for the examination of patent applications related to pharmaceutical & biotechnology inventions. These draft guidelines are targeted towards streamlining the patenting procedures of healthcare inventions. All stakeholders invited to submit their comments or suggestions within 15 days from the date of

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SpicyIP Weekly Review (August 24-August 30)

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

After an action-packed week, we have posts remembering one of the most remarkable IP administrators– Mr. P. H Kurian, on the appointment of an amicus in the Vivek Oberoi personality rights case, and on the DHC decision in Array Biopharma Inc. v. Deputy Controller of Patents. This and much more in the last Weekly Review of the month. Anything that we are missing out? Drop a comment and let us know. Highlights of the Week Remembering Mr. P. H. Kurian

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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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