New Delhi : The Delhi High Court has warned Mumbai-based BDR Pharmaceuticals International and its top management to be careful in future regarding implementation of its orders while disposing of various applications filed by Bristol-Myers Squibb Holdings Ireland (BMS) in connection with the alleged violation of patent rights for its oral anti-coagulation drug Apixaban by the former.
In various interlocutory applications, BMS alleged that BDR Pharmaceuticals and its top management willfully infringed an interim injunction order issued by the Delhi High Court on January 30, 2020 and tried to participate in tenders.
The ad interim injunction order restrained BDR Pharma, its directors, employees, officers, servants, agents, stockists, retailers, semi-stockists, wholesaler’s, marketers, distributors, and any other entity or person in the chain of supply and all others acting for and on its behalf from using, making, selling, distributing, advertising, marketing, exporting, offering for sale, importing or in any other manner, directly or indirectly, dealing in any product including but not limited a generic Apixaban product that infringes its patent.
BMS alleged that the generics maker is a habitual violator of patent rights and multiple suits have been filed against them including suits by Pfizer, BMS, Bauer Intellectual Property, Sanofi India, F Hoffman La Roche, among others. BDR has also not placed on record any document or material to show that they had taken steps towards compliance of the High Court’s order, it alleged.
BDR Pharmaceuticals, on the other hand, argued that it has not sold any products post the order of the Court and while certain errors were made by them, neither of them were wilful disobedience. It argued that the willfulness must be proved beyond doubt.
The Court, hearing argument by both BMS and BDR Pharmaceuticals, observed that the interim injunction retrained the agents, stockists, retailers, wholesaler’s, distributors etc. the chain of supply of BDR Pharmaceuticals from making, selling, distributing, advertising, marketing, exporting, offering for sale of the products infringing the suit patent and in the absence of any specific document as to how communication was made by BDR Pharmaceuticals to their stockists, agents of not violating the interim injunction order, it is evident that proper care was not taken by the respondents (BDR Pharma) to implement the order of the Court.
However, considering the circumstances in which national lockdown was announced in March, 2020, disruption in the functioning of the company cannot be ruled out and a finding cannot be returned that there was a wilful disobedience of the order of the Court dated January 30, 2020, it added.
“..it is evident that there has been repeated violations by the respondents of the order dated January 30, 2020 which may though not be willful but even accepting the explanation offered by the respondents show the callous manner in which work is carried out by the respondents,” said the order issued by Justice Mukta Gupta.
“The conduct of the respondents though not amounting to willful disobedience but surely callous, the applications are disposed of, warning the respondents to be careful in future,” added the Judge.
It may be noted that BMS has been engaged in litigation with various Indian pharma companies to protect its patent for Apixaban. The Delhi High Court has recently issued directions to consolidate almost 14 suits and four revocation petitions pending related to the drug, to hold trials together even as the term of the drug’s patent came to an end on September 17, 2022.