Acknowledgment of patent rights by the Defendants and their undertaking not to infringe, permissible use for research and development under Section 107-A of the Patent Act, 1970

JUDGMENT

Prathiba M. Singh, J. (Oral). - This hearing has been done through hybrid mode.

2. The present suit has been filed by Plaintiff No. 1-Novartis AG. and Plaintiff No.2-Novartis Healthcare Pvt. Limited seeking permanent injunction restraining infringement in respect of their granted patent, being Patent No.233161 (hereinafter "suit patent") which relates to the invention 'bis-monoethanolamine salt of eltrombopag'. As per the Plaintiff, the same was granted protection as a New Chemical Entity (NCE). The said invention is referred to by the name 'Eltrombopag Olamine' which is the Active Pharmaceutical Ingredient (API) in the Plaintiffs' commercially manufactured and sold drug under the brand name 'Revolade' in India.

3. The suit patent was granted on 27th March, 2009 and the date ofpriority for the suit patent is 21st May, 2003. Thus, the term of the patent is set to expire on 21st May, 2023. Revolade, containing 'Eltrombopag Olamine', is stated to be approved in more than 90 countries and regions for the treatment of chronic immune (idiopathic) thrombocytopenic purpura (ITP). 'Eltrombopag Olamine' is stated to raise the platelet count in patients with ITP a plastic anemia and cirrhosis due to chronic hepatitis C during interferon therapy. Promacta, the brand under which 'Eltrombopag Olamine' is sold in the US, is stated to have been approved in 2008 by US FDA and has been approved in India by the Central Drug Standard Control Organisation (CDSCO) in 2010 for the treatment of ITP. Further, the Plaintiffs' product is claimed to be the first orally-used small molecular, thrombopoietin receptor agonist and is also sold in India as a prescription drug in different dosage strength. The product sold under the mark Revolade is shown to have large sales in India to the tune of Rs.700-800 million annually with the global sales figures to the tune of $ 1,700 million in 2020.

4. The Defendants in the present case are Medipol Pharmaceuticals India Pvt Ltd and Metrochem Api Private Limited. In September, 2021, while participating in a tender process floated by Odisha State Medical Corporation Limited (OSMCL) for the procurement of various drugs, including 'Eltrombopag Olamine', the Plaintiffs came to know that the Defendants had submitted a proposal for the supply of tablets containing the patented product.

5. It is the case of the Plaintiffs that in the said tender process, the Defendant No.1 had filed a document stating that it had obtained manufacturing and marketing approval for tablets containing 'Eltrombopag Olamine'. The Defendant no. 1 had further declared that it had manufacturing capacity for manufacturing 225 million tablets of drug containing 'Eltrombopag Olamine' monthly. An independent investigating agency was engaged by the Plaintiffs in order to verify the said information. In report that was submitted, it was averred that both Defendant No. 1 & 2 have license to manufacture 'Eltrombopag Olamine'. Thereafter, the present suit was filed by the Plaintiffs against the Defendants.

6. Vide order dated 11th January, 2022, owing to the judgment passed by the ld. Single Judge in CS (COMM) 256/2021 titled Novartis AG v. NATCO Pharma Limited, an ad interim injunction was granted. The relevant part of order is set out below:

"11. The issue on merit stands covered by my recent decision in Novartis AG' v. Natco Pharma Ltd. as the plaintiff's rights to suit patent IN 161 have been confirmed and it has been held that manufacture or marketing by any entity of Eltrombopag Olamine would infringe the suit patent.

12. In view thereof, a clear prima facie case exists in favour of the plaintiff.

13. Till the next date of hearing, therefore, the defendants, their agents or all other persons acting on their behalf, including their dealers and distributors, shall stand restrained from manufacturing, marketing, selling, importing or exporting or otherwise dealing in Eltrombopag Olamine, being the subject matter of suit patent IN 161 held by the plaintif