Category Archives: Drug Regulation

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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Copyright Drug Regulation Geographical Indication Patent Trademark

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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Copyright COVID-19 Drug Regulation Innovation Patent Trademark

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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Copyright COVID-19 Drug Regulation Patent Privacy Trademark

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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Copyright COVID-19 Drug Regulation Overlaps in IP Patent Privacy Trademark

SpicyIP Weekly Review (June 28 – July 4)


Topical Highlight Delhi High Court Clarifies Law on Arbitrability of Trademark Disputes In this guest post, Rounak Doshi discusses the position of law on arbitrability of trademark disputes in light of the Delhi High Court’s recent decision in Golden Tobie Private Ltd. v. Golden Tobacco Ltd. He notes that the Court considered this dispute concerning the breach of a trademark licensing agreement as arbitrable and referred it to arbitration. He examines the Court decision and notes that the plaintiff relied upon…


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Copyright Drug Regulation Others Patent Trademark

SpicyIP Weekly Review (June 21 – 27)


Topical Highlight RMPL Registered as Copyright Society for Sound Recordings: But What about PPL, Transparency, and the Delays? In this post, Nikhil analyses Recorded Music Performance Limited (‘RMPL’) becoming the first copyright society to be granted a registration with respect to sound recordings, nine years after the 2012 amendments to the Copyright Act. He notes that the Phonographic Performance Limited India (‘PPL’) has also been attempting to obtain registration as a copyright society for the same kind of works. He…


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Copyright COVID-19 Drug Regulation Innovation Patent Privacy Trademark

SpicyIP Weekly Review (May 10 – 16)


Topical Highlight Earning Royalties off Covaxin While Demanding IP Waiver at the WTO: Saviour on the Streets, Hypocrite in the Sheets In this post, I focus on the differential pricing of vaccines for Central and State Governments. I analyse the affidavit filed by the Central Government in the case titled, ‘In Re: Distribution of Essential Supplies and Services During Pandemic’. I highlight that currently, Serum Institute of India and Bharat Biotech are selling doses of Covishield and Covaxin to private…


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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


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…


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COVID-19 Drug Regulation Patent

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


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…


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COVID-19 Drug Regulation Patent

Natco Files Compulsory Licence Application for Covid Drug Baricitinib


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…


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