Panacea Biotec and Sanofi reached settlement agreement for Shan6

Sanofi would not manufacture or market any product which infringes the amended claims of Panacea patent, IN272351

Panacea Biotec Limited and Sanofi Healthcare India Private Limited (Sanofi) have reached a settlement agreement for Shan6, a whole cell Pertussis based hexavalent vaccine (DTwP-HepB-Hib-IPV).   

Panacea Biotec Limited has instituted a suit before Delhi High Court seeking to restrain Sanofi Healthcare India Private Limited from marketing a fully liquid hexavalent vaccine that would infringe the company’s patent for its wP-IPV based fully liquid hexavalent vaccine, EasySix.

The aforesaid suit was filed against Sanofi after Sanofi received marketing approval for a Shan6, a whole cell Pertussis based hexavalent vaccine (DTwP-HepB-Hib-IPV) by the Drugs Controller General (India).

When the suit was listed before the Delhi High Court, after elaborate submissions from both parties, Sanofi undertook that it would not manufacture or market any product which infringes the amended claims of Panacea patent, IN272351.

Both the parties have reached a settlement agreement, and pursuant to the joint application filed by the Parties, the said suit has been disposed of by Delhi High Court on September 13, 2024, in terms of the settlement agreement entered between the Parties.

Under the terms of settlement agreement, Sanofi has inter-alia, agreed that at present Sanofi would not directly or indirectly commercially launch its fully liquid hexavalent vaccine Shan6 in India and shall also withdraw the Opposition under Section 25(2) and Opposition under Section 57(3) against amendment application filed against Panacea Biotec’s Patent IN 272351 on hexavalent vaccine before the Indian Patent Office.

The aforesaid, in the interest of complete disclosure, is without prejudice to the rights and contentions of both parties, should Panacea Biotec subsequently decide to revive the suit proceedings in the event the circumstances so demand. Panacea Biotec has also agreed to forgo its claim for damages and rendition of accounts in the proceedings against Sanofi as prayed for in the suit.

EasySix is the first innovative fully-liquid hexavalent vaccine from India which is protected by patents in several countries including India. A first of its kind lawsuit wherein an Indian company in the vaccine industry has asserted violation of its registered patent. The Patent IN272351 in favour of Panacea Biotec is also a testament to our ability to innovate and to protect that innovation.