Apixaban patent Violation: HC reprimands BDR Pharma for callousness in implementing court order
New Delhi: Coming down heavily on BDR Pharmaceuticals International, the Delhi High Court has warned the Mumbai-based drug maker against its 'callous manner' regarding implementation of its orders while disposing of applications filed by Bristol-Myers Squibb Holdings Ireland (BMS) in connection with the alleged violation of patent rights for Apixaban.
Apixaban, sold under the brand name Eliquis, is an anticoagulant medication used to treat and prevent blood clots and to prevent stroke in people with nonvalvular atrial fibrillation through directly inhibiting factor Xa. The product was developed by BMS and Pfizer in 2007.
BMS has been engaged in litigation with various Indian pharma companies to protect its patent for Apixaban. The term of the drug's patent came to an end on September 17, 2022.
In the instant case, BMS alleged in various interlocutory applications that BDR Pharma 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.
However, Bristol Meyers alleged that despite ad-interim injunction granted by the court vide order dated 30th January, 2020, BDR were selling their products in the open market.
BMS further 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. It further added that 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.
On the other hand, BDR Pharmaceuticals 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 willful disobedience. It argued that the willfulness must be proved beyond doubt. Learned senior counsel for BDR, while placing his reliance on the decisions reported as (2019) 20 SCC 666 U.C. Surendranath v. Mambally's Bakery and (2010) 3 SCC Sahdeo v. State of U.P contended;
"Inadvertent error on the part of the BDR and their officers cannot be held to be contempt. BDR fairly stated that the bid should not have been filed by the them, and while it may amount to disobedience, but it was not willful."
In his contention, he further added that the "willfulness" must be proved beyond doubt.
After hearing argument by both BMS and BDR Pharmaceuticals, the court 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 willful disobedience of the order of the Court dated January 30, 2020, the court added.
Subsequently, the court in its order noted;
"In view of the facts noted above, it is evident that there has been repeated violations by the respondents of the order dated 30th January 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. 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."
Farhat Nasim joined Medical Dialogue an Editor for the Business Section in 2017. She Covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She is a graduate of St.Xavier’s College Ranchi. She can be contacted at email@example.com Contact no. 011-43720751