API and IP Newsletter
Contents
List of DMF filed in February 2021 by Indian Companies and our analysis.
General information.
Bombay High Court Rejects Plea To Restrain Serum Institute Of India From Using 'COVISHIELD' Trademark.
From pipeline to prescription: New drug approval process.
Intellectual Property.
Compulsory License (CL) application by Natco for Baricitinib.
List of DMF filed in February 2021 by Indian Companies and our analysis
As usual, among all DMFs, more than 50% have been filed by Indian companies in the month of February. Most of them are old products or the products where there are already too many players.
General information
Bombay High Court Rejects Plea To Restrain Serum Institute Of India From Using 'COVISHIELD' Trademark
The Bombay High Court on Tuesday refused to grant interim relief to pharmaceutical company Cutis Biotech and restrain Serum Institute of India (SII) from using Trademark “Covishield”. Cutis Biotech and Serum Institute of India Pvt. Ltd. applied for registration of the Covidshield trademark on April 29, 2020, and June 6, 2020, respectively. (Read more)
From pipeline to prescription: New drug approval process
How does a molecule developed in a laboratory end up as an innovative therapeutic agent that we prescribe to our patients? What is the role of the FDA in the process? Do all drugs go through an identical clinical trial and evaluation process? And why are some drugs approved more quickly than others? From bench to Rx pad (Read more)
Intellectual Property
Compulsory License (CL) application by Natco for Baricitinib
The Indian Patent Act provides for compulsory licenses at the expiration of three years from the date of a patent grant, on any of the following grounds:
1. reasonable requirements of the public with respect to the patented invention have not been satisfied; or
2. patented invention is not available to the public at a reasonably affordable price; or
3. patented invention has not worked in the territory of India.
Baricitinib (Innovator: Eli Lilly) was approved in India for rheumatoid arthritis. On 3 May 2021, Natco has received emergency use approval for Baricitinib tablets, 1mg, 2mg and 4mg strengths (in combination with Remdesivir) from Central Drugs Standard Control Organization (CDSCO) in India. News here.
IN 270765, relates to Baricitinib compound, expiration 2029. So, despite approval by CDSCO, Natco would not be able to sell finish dosage formulation in India. It would infringe Eli Lilly’s patent IN 270765. Hence, Natco is exploring CL route and agreed to pay 7% royalty on net profits.
To counter Natco, Eli Lilly is offering donations of Baricitinib to the Indian Government. The company is also working with local Indian pharmaceutical companies for licensing agreements. News here and here.
It would be interesting to see whether CL will be issued to Natco and if they would be able to sell the product under CL provision in India.
Disclaimer
Sidvim LifeSciences Private Ltd has taken due care and caution in developing this document. Since the data used for analysis in this document is based on the information available in the public domain, its adequacy or accuracy or completeness cannot be guaranteed. This document is for information only and Sidvim is not responsible for losses that may or may not arise due to any decisions made based on the same. No part of the document shall constitute or be represented as a legal opinion of any kind or nature. No warranties or guarantees, expressed or implied, are included in or intended by the document, except that it has been prepared in accordance with the current generally accepted practices and standards consistent with the level of care and skill exercised under similar circumstances by professional consultants or firms that perform the same or similar services.
