Category Archives: Drug Regulation

COVID-19 Data Exclusivity Drug Regulation Innovation Overlaps in IP Trade Secret

Earning Royalties off Covaxin While Demanding IP Waiver at the WTO: Saviour on the Streets, Hypocrite in the Sheets

by Anupriya Dhonchak May 11, 2021

A frontline worker setting fire to funeral pyres at a cremation site.

As news broke out on May 3, 20201 regarding the Indian Council of Medical Research (ICMR) earning royalties out of every dose of Covaxin sold, many were quick to chide the government for embarrassing itself by profiting off vaccines sold in its own country while seeking a waiver of all IPRs on patents, copyright, industrial design and undisclosed information pertaining to vaccines for Covid-19 (covered previously on the blog here, here and here) at the WTO. In this post, I focus on the differential…

COVID-19 Drug Regulation Patent

Delhi HC Issues Order on Tocilizumab Shortage, Seeks Patent Working Information from Roche

by Adyasha Samal May 5, 2021

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This evening, the Delhi High Court passed an interim order issuing important directions on the shortage of the drug Tocilizumab in Delhi hospitals. The case arose from a petition by the brother of a Covid-19 patient, who had been prescribed a tocilizumab injection (Actemra 400g) by the doctor, but could not be administered the same due to the unavailability of the drug. Owing to the rapidly deteriorating condition of the patient, the petitioner had approached the court with the urgent…

COVID-19 Drug Regulation Patent

Natco Files Compulsory Licence Application for Covid Drug Baricitinib

by Swaraj Paul Barooah May 5, 2021

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pic of package cover for olumiant baricitinib

In an interesting development, Natco has approached the Controller of Patents for a Compulsory Licence under Section 92 of the Patents Act, for the drug Baricitinib. The 12 page application is available here. Baricitinib is generally used to treat diseases like rheumatoid arthritis and has been “reportedly approved” (as per the application) for such use in EU and India in 2017 and 2018 respectively. The application goes on to quote studies that indicate the Baricitinib in combination with Remdesivir is…

COVID-19 Drug Regulation Patent

SC Issues Interim Order in Suo Motu COVID-19 Case: Raises Questions on Vaccine Procurement Process, Compulsory Licensing and More

by Adyasha Samal May 4, 2021

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A couple of days ago, I wrote about the Supreme Court’s first hearing in the suo motu Covid-19 case that took place on 30th April, discussing the questions raised by the bench. The interim order resulting from this hearing is now out. The order discusses the implementation of the Disaster Management Act, medical infrastructure, oxygen supply, vaccines, compulsory licensing, and supply of essential drugs. The court has examined the existing government policy on these issues and then asked questions and/or…

COVID-19 Drug Regulation Patent

Supreme Court Weighs in on the Crisis: Vaccine Price Equity, Compulsory Licensing and Free Speech Online

by Adyasha Samal May 2, 2021

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After being heavily criticized for taking matters into its own hands by transferring matters related to the Covid-19 crisis from High Courts, the Supreme Court had its first hearing in the suo motu case on 30th April. A three-judge bench consisting of Justices DY Chandrachud, L Nageswara Rao and Ravindra Bhat looked into a wide variety of issues such as Oxygen & Covid drugs shortage, (the lack of) equitable pricing of vaccines, protection of health workers, possibility of invoking compulsory…

SpicyIP Weekly Review (April 19 – 25)

by Anupriya Dhonchak April 26, 2021

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Topical Highlight Compulsory License for Covid Drugs on the Table, Says Delhi High Court In this post, Swaraj discusses the recent Delhi High Court order in the case of Rakesh Malhotra v. Govt of National Capital Territory of India and Others, in light of the worsening pandemic situation in India. The Court hauled up the government on various issues regarding the response to the pandemic so far, concerning oxygen use, ramping up of testing facilities, shortage of drugs and black…

COVID-19 Drug Regulation Patent

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

by Praharsh Gour April 16, 2021

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(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…

Drug Regulation Trademark

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

by Swaraj Paul Barooah April 15, 2021

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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,…

SpicyIP Weekly Review (March 29 – April 4)

by Anupriya Dhonchak April 5, 2021

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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,…

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)

by Anupriya Dhonchak March 29, 2021

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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…

Pratik Vora { Without Approval or notification of the Central Government, how can the Controller of Patents consider the Compulsory License Request under Section 92? }
Guest One { Informative and well articulated }
Amit Tailor { Thanks Mr Swaraj for a detailed post. How the Controller and the Cent. Govt. would deal with this application should not be anything less than a thriller movie.... }
Himanshu { Exceedingly interesting and helpful }
Jagdish Sagar { Footnote: I suggest you check out Chinese law on the question of fixation. }