A first of its kind lawsuit wherein an Indian vaccine company Panacea Biotec defended the exclusive marketing rights of its patented vaccine against the attempt of French pharmaceutical multinational Sanofi to launch a competing product in India has been settled out of court.
The patent infringement case was filed by Panacea against Sanofi’s Indian arm Sanofi Healthcare India Private Limited in the Delhi High Court.
As part of the settlement, Sanofi will not launch its fully liquid hexavalent vaccine Shan6 in India and shall also withdraw the opposition it had filed against Panacea’s Patent IN 272351 on hexavalent vaccine before the Indian Patent Office. Panacea has agreed to forego its claim for damages and rendition of accounts in the proceedings against Sanofi as prayed in the suit it had filed in the Delhi High Court.
Panacea had approached the Court seeking to restrain Sanofi from marketing a fully liquid hexavalent vaccine claiming that it would infringe the company’s patent for EasySix, its whole cell pertussis inactivated polio vaccine (wP-IPV) based fully liquid hexavalent vaccine. EasySix is a vaccine against Diphtheria, Tetanus, Whooping Cough, Hepatitis B, Haemophilus influenza type b and Inactivated Polio (DTwP-HepB-Hib-IPV).
The suit was filed after Sanofi received marketing approval for Shan6, a whole cell Pertussis based hexavalent vaccine (DTwP-HepB-Hib-IPV) by the Drugs Controller General (India).
Pursuant to the joint application filed by Panacea and Sanofi, the suit has been disposed of by the High Court on September 13, 2024, in terms of the settlement agreement entered between the parties.
Panacea’s EasySix is the first innovative fully liquid hexavalent vaccine from India. It is protected by patents in several countries including India. Panacea stated that the settlement in favour of the company is a testament to its ability to innovate and to protect that innovation.
The company states that wP-IPV-based hexavalent vaccination is an innovative immunisation alternative to the current pentavalent and standalone IPV vaccines, which will lead to less vaccination sessions and higher coverage. In October 2021, World Health Organisation and Strategic Advisory Group of Experts on Immunisation approved adoption of this hexavalent vaccine in the global immunisation programme.
Following this, Gavi and the Pan American Health Organization also adopted the hexavalent vaccine in June 2023 and May 2023 respectively. UNICEF forecasts the demand for a wP-IPV-based hexavalent vaccine for Gavi countries to be 19 million doses in 2025 and over 100 million doses by 2030.
