SOFTGEL HEALTHCARE PRIVATE LIMITED Vs. PFIZER INC

JUDGEMENT

(1.) M/s.Pfizer Inc., a company incorporated in New York, USA, is the holder of the patent for the crystalline forms of TAFAMIDIS 61 mg, sold under the brand name 'VYNDAMAX' in USA. On submission of Abbreviated New Drug Applications ('ANDA') before the US Patent Office by M/s.Cipla and M/s.Hikma (formerly Zenara). Pfizer asserted that, their Patent No:9,7770,441 (441 patent), protected by United States Patent law, is under threat of infringement. M/s.Ffizer filed suit Civil Action No:23-879 (GBW) (CJB) before the District Court for the District of Delaware, claiming that Cipla's submission of ANDA No:218409 and Zenara's (now Hikma's) ANDA No:21805 are before the expiry of the Pfizer Patent 441 and hence it constitutes infringement. As the plaintiff, Pfizer also asked the defendants, Dexcel Pharma Technologies Ltd and others through application for discovery disclosure of information. M/s.Cipla and M/s.Zenara (now Hikma) disclosed the names of the Indian Companies as third party contractors and manufacturers of their ANDA products.

(2.) The United States District Court at Delaware referring on the Hague Convention, 1970, issued Letters Rogatory on 13/5/2024 requesting the Indian Courts to obtain deposition and documents from the Indian manufacturing Company, M/s.Softgel Health Care Private Limited having its manufacturing unit within the territorial jurisdiction of Madras High Court. As a consequence and follow up, Pfizer Incorporation along with three others filed joint petition before this Court as Intellectual Property disputes in O.P.(PT).Nos.5 & 6 of 2024.

(3.) The relief sought in these applications are:-