Dr Reddy’s rocked by negative patent infringement ruling, shares hit one-year low

pharmafile | February 16, 2017 | News story | Sales and Marketing Dr Reddy's Laboratories, Helsinn Healthcare 

India-based pharmaceutical firm Dr Reddy’s Laboratories has been hit by an unfavourable ruling in a legal case claiming it infringed existing patents of Swiss firm Helsinn Healthcare with its drug Aloxi (palonosetron hydrochloride).

The company stated: “The United States District Court for the District of New Jersey issued its opinion regarding Helsinn Healthcare’s patent infringement claims against Dr Reddy’s proposed palonosetron product. The court found that Dr Reddy’s proposed palonosetron hydrochloride 0.25 mg/5 ml infringes on certain claims of US patents…and that the asserted claims were not valid”.

Dr Reddy’s filed a new drug application (NDA) for the drug three years ago; Aloxi is a palonosetron HCI injection designed to treat nausea and vomiting caused by chemotherapy in cancer patients and has generated approximately $650 million in US sales and an estimated $800 million globally.

Helsinn brought the patent infringement case against the Indian firm, challenging their NDA for Aloxi. Dr Reddy’s claimed in its defence that it had tweaked the original drug slightly in order to secure marketing authorisation. The news of the court’s decision sent Dr Reddy’s shares to their lowest point in a year.

The company hopes to apply for marketing approval of a generic version of the drug in September 2018; it will have to compete with Novartis’ generics branch Sandoz, with whom it was also previously embroiled in patent dispute over the drug.

A spokesperson for Dr Reddy’s added: “We are disappointed in the decision and intend to pursue an appeal in due course.”

Matt Fellows

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