No claims for monetary damages: Dr Reddy's on patent infringement

Claims sought injunctive relief to prohibit manufacturing, use, import, sale of palonosetron product

After receiving an unfavourable ruling in a US court, Dr Reddy's Laboratories (DRL) has said that there are no claims against the company for monetary damages in Helsinn Healthcare's patent infringement case over an anti-nauseant agent Aloxi.

As for 'quantum of claims', the claims only sought injunctive relief against the company to prohibit the manufacturing, use, import and sale of the company's palonosetron product prior to the expiration of the patents-in-suit. There is no monetary compensation or penalty damage owed to Helsinn because the proposed product palonosetron has not been marketed, DRL said in a statement.

Aloxi is the trade name of palonosetron used in the prevention and treatment of chemotherapy-induced nausea and vomiting. The market size of this injection is estimated to be around $750-800 million globally and approximately $500 million in the US and Canada.

"The US District Court of New Jersey has found that DRL's proposed palonosetron hydrochloride 0.25 mg/5 ml infringes on certain claims of the US patents, and the asserted claims were not valid. We intend to pursue an appeal in due course," the company said in another statement.

DRL had proposed palonosetron product (Aloxi), pursuant to a paper new drug application (NDA) under the Section 505(b) (2) of the Food, Drug and Cosmetic Act. Almost three years back, Helsinn had challenged this in the US court.

In March 2016, DRL had received an approval from the US Food and Drug Administration (FDA) for Aloxi after the settlement of the patent litigations. This will allow the company to market Aloxi in the US market on or before September 30, 2018, under certain circumstances.