Delhi High Court orders in favor of Novartis AG’s patent

Wednesday April 13, 2022 at 12:49 pm

The Delhi High Court issued a permanent injunction until May 21, 2023, against the two Indian companies protesting Novartis AG’s patent for eltrombopag olamine. eltrombopag olamine is an active pharmaceutical ingredient (API) in its brand Revolade.

Novartis approached the High Court of Delhi against two domestic pharma companies of India, namely Medipol Pharmaceuticals India and Metrochem API Pvt Ltd, after these companies had submitted a proposal for the supply of tablets that would contain eltrombopag olamine. The proposal in question was submitted while participating in a tender process that Odisha State Medical Corporation Ltd floated to procure various drugs in September 2021.

Novartis’ Revolade, which contains the said API, is approved in more than 90 countries and regions of the world to treat various chronic immune (idiopathic) thrombocytopenic purpura (ITP). The ingredient, it is claimed, can raise the platelet count in patients with ITP aplastic anemia and cirrhosis due to chronic hepatitis C in interferon therapy.

The drug is currently sold under the brand Promacta in the united states after it was approved in 2008 by the US drug regulator. The company has received a patent for this new chemical entity on March 27, 2009, with the date of priority of May 21, 2003. The patent term is going to expire on May 21, 2023, said the High Court order.

Revolade has made sales of around Rs. 70-80 crore annually in India with global gross sales figures of $1.7 billion in 2020. It is also claimed to be the first orally-used small molecular thrombopoietin receptor agonist. While the drug has these fantastic health benefits, its patent ensures that the drug manufacturer is rewarded for investing in research and development and for coming up with this powerful drug. The reader must note that intellectual property (IP) rights over pharma products have come under the limelight ever since the covid-19 pandemic started vaccine politics. Even now, the governments of India and South Africa are fighting to make all covid-19 related vaccines and treatments free of IP rights.

According to Novartis’ legal argument, Medical Pharmaceuticals claimed that it had the manufacturing capacity of producing 225 million tablets of the drug-containing eltrombopag olamine monthly. Metrochem, in its affidavit, claimed that it has no relationship or concern with Medipol and has never supplied even Research and Development (R&D) quantities of the patented drug. It also added that it does not have a commercial manufacturing license but only had a test license on Form 29.

Metrochem has also submitted an undertaking that it will not, either by itself “or through its partners, directors or other activists for and on its behalf from making, using, selling, distributing or offer for sale” the drug which infringes Novartis’ Indian patent.

Medical also informed the High Court that it had not received the tender from the Government of Odisha and it had never manufactured the drug or dealt with the same in India. It has also currently acknowledged the Novartis’ patent and submitted its undertaking that it will not manufacture or sell any product infringing the patented drug.

Taking note of these submissions, Justice Prathiba M Singh, in his order on April 7, has imposed that a permanent injunction would be liable to be granted in terms of the plea of Novartis, during the period of the patent, which ends on May 21, 2023.

“However, it is made clear that any use of the product, by the Defendants, for the purposes of research or development strictly in terms of Section 107-A of the Patent Act, 1970 would be permissible,” the order clarified.