Panacea Biotech files suit in Delhi HC against Sanofi for patent infringement

A suit has been filed by Panacea Biotech Limited before the Delhi High Court for restraining Sanofi Healthcare India Pvt. Ltd. from marketing Hexavelent vaccine which will infringe Panacea's patent for its fully liquid Whole-Cell Pertussis based fully liquid Hexavalent Vaccine, EasySix.

The fight between Sanofi and Panacea has been since 2017 before the Indian Patent Office which has also been fought before the Bombay and Delhi High Court in 2018 and 2019. The drug EasySix developed by Panacea Biotech is used to vaccinate against Diphtheria, Tetanus, Whooping Cough, Hepatitis B, Haemophilus influenza type b, and Inactivated Polio (DTwP-HepB-Hib-IPV).

This drug comes in a prefilled syringe and is the first of its kind Whole-Cell Pertussis-based fully liquid Hexavalent Vaccine. The EasySix has been marketed since 2017 and Panacea is planning to make this available to the government for vaccination/immunization domestically and internationally.

Sanofi received the market approval for the Whole-Cell Pertussis-based Hexavalent vaccine (DTwP-HepB-Hib-IPV) by the Drugs Controller General of India. "The suit filed against Sanofi comes at the heels of Sanofi having received marketing approval for a Whole-Cell Pertussis-based Hexavalent vaccine by the Drugs Controller General (India)," Panacea Biotec added. Recently when the matter was listed before the Delhi High Court, Sanofi undertook that it will not manufacture and market product that can infringe amended claims of Panacea patent, IN272351.

As per the Pertussis license is concerned, currently, two types of pertussis vaccine are licensed which are whole-cell pertussis (wP) and acellular pertussis (aP). Comparing both, Whole-Cell immunization has been comparatively effective and inexpensive.

In industrialized countries, aP vaccine has gradually supplanted the use of wP vaccine, nevertheless, the higher cost of development and production cost of aP vaccines made it more costly as compared to the dose of wP vaccine. The efficacy of both aP and wP vaccine remains almost the same, wP vaccine remains the upper choice due to its less cost.

Sanofi will now be providing the argument towards the Panacea Biotech Claims and the suit will follow.