Category Archives: Drug Regulation

COVID-19 Drug Regulation Patent

Indian Govt. Permits Manufacture of Covaxin by Haffkine Institute – But Why Not Others Too?


(This post has been co-authored with Swaraj Barooah) In what seems like a  whiff of good news amidst the debacle surrounding availability of  COVID-19 vaccine in India, the Central Government has permitted the Haffkine Institute to manufacture Covaxin, on  a “technology transfer” basis, for a period of one year. This is definitely needed and hopefully will address the vaccine shortage in the country to some extent. But does this mean that the Central Government had the IP and technology transfer…


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Drug Regulation Trademark

The Monopoly Purple – Colours, Shapes and Sizes in the Pharmaceutical World


Picture of Seretide Accuhaler (circular, in a pink and purple colour combination), next to its box

(This post was co-authored with Murali Neelakantan. Murali is currently Principal lawyer at Amicus. He is a dual qualified lawyer (India and UK) and among other positions, he was formerly a partner at an international law firm in London, Cipla’s first global general counsel, and Executive Director and Global General Counsel of Glenmark Pharmaceuticals. Murali has also been a long time friend of the blog.)  While the role of patents in extending monopolies over pharmaceutical products is now widely debated,…


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Copyright Drug Regulation Innovation Patent Trademark

SpicyIP Weekly Review (March 29 – April 4)


Topical Highlight Intellectual Property Rights in Covaxin – Part 2 (IP Ownership in Publicly Funded Research) In Part II of this post, Anupriya and Swaraj analyse the broader issue of IP ownership in outcomes of publicly funded research. They note that the government’s retention of IPR in Covaxin and the novel mRNA vaccine in the pipeline, would enable it to be in a position to share them with the rest of the developing world. They examine the patchwork of rules,…


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COVID-19 Data Exclusivity Drug Regulation Innovation Patent Trade Secret

Intellectual Property Rights in Covaxin – Part 3 (IP Rights over Clinical Drug Trials (CT) Data)


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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COVID-19 Drug Regulation Others Overlaps in IP Patent Trade Secret

Intellectual Property Rights in Covaxin – Part 2 (IP Ownership in Publicly Funded Research)


This post was coauthored by Swaraj Paul Barooah and myself. 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 analyse the broader issue of IP ownership in outcomes of publicly funded research. Part III explores opacity surrounding the clinical trial data generated during the Covaxin trial, which…


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COVID-19 Drug Regulation Patent

Intellectual Property Rights in Covaxin – Part 1 (Waiver of IPRs)


(This post has been co-authored by Anik Bhaduri and myself. Anik is a fourth year student at NALSAR University of Law, Hyderabad.) A recent piece in the Economic Times argued that the Indian government should buy out the intellectual property rights to Covaxin, to bolster the commitment to its WTO proposal along with South Africa, to waive all IPRs on patents, copyright, industrial design and undisclosed information pertaining to vaccines for Covid-19 (covered previously on the blog here, here and…


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Drug Regulation Others

DCGI Draws Ire of Delhi High Court for Violating the RTI Act


The Single Bench of the Delhi High Court headed by Justice Pratibha Singh, in its recent order in Prashant Reddy v DCGI, came down heavily on the drug regulator for egregious violation of the Right to Information Act. The case arose in relation to the report of Dr. T.M. Mohapatra Committee, a committee which was constituted by the Drugs Controller General of India pursuant to the scathing criticisms in the 59th Parliamentary Standing Committee Report on the existing mechanism for…


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Copyright Drug Regulation Others Patent Trademark

SpicyIP Weekly Review (December 28 – January 3)


Topical Highlight Sci-Hub and Libgen Up against Academic Publishers: A Death Knell for Access to Research? – Part I In this three-part post, Nikhil dissects the ongoing copyright litigation in the Delhi High Court by three big publishing houses, namely Elsevier, Wiley and ACM against the shadow libraries Libgen and Sci-Hub, alongwith the interpretive issues before the court. In Part I, he explains the background of the dispute and analyses the dynamic injunction plea sought by the plaintiffs. He argues that a thorough…


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Copyright Drug Regulation Innovation Patent Trademark

SpicyIP Weekly Review (November 16 – 22)


Topical Highlight The Antitrust App Store Wars Come to India In this guest post, Dr Kathuria looks into the latest ‘digital gatekeeping’ controversy that Big Tech has found itself in in India, with the Competition Commission of India having ordered an investigation into Google’s conduct relating to Google Pay and the Play Store. He notes that the CCI has prima facie correctly identified the relevant market. He then notes that even if Google Pay were to be considered in compliance…


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Copyright Drug Regulation Patent Trademark

SpicyIP Weekly Review (October 5 – 11)


Topical Highlight IPAB to Fix Statutory Licensing Rate for Radio Royalties after 10 Years In this post, Adyasha discusses the IPAB’s recent interim order which maintains the status quo of the royalty rate for radio broadcasts under statutory licensing. Subsequently, IPAB issued a public notice inviting suggestions from stakeholders regarding fixing royalty rates. Adyasha analyses the context in which Section 31D of the Copyright Act was added by way of amendment in 2012 to note that the purpose of the…


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