DRL gets unfavourable patent ruling in US court

By: |
Hyderabad | Published: February 17, 2017 5:25:18 AM

Dr Reddy’s Laboratories has received an unfavorable ruling in a US court in the patent infringement case over anti-nausea injection Aloxi.

dr-reddy-1DRL had filed a new drug application (NDA) for Aloxi about three years ago, and Helsinn had challenged it.

Dr Reddy’s Laboratories has received an unfavorable ruling in a US court in the patent infringement case over anti-nausea injection Aloxi. The injection is used to help prevent nausea and vomiting due to chemotherapy. However, Dr Reddy’s is now looking to make an appeal in the US court following the verdict.

“The US 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 the US patents…And that the asserted claims were not valid.”

Helsinn Healthcare is a Switzerland-based pharma company. The size of the Aloxi drug is estimated to be at $750-800 million globally and worth around $500 million in the US and Canada alone. Dr Reddy’s had filed an application for the release of a modified version of the drug under the rule 505(B)(2), meaning that a favourable ruling could have given it an opportunity to launch the drug in the US.

The company said it intends to pursue an appeal in due course of time. Following this, shares of the company fell by nearly 4% after opening at R2,920 on the BSE.

DRL had filed a new drug application (NDA) for Aloxi about three years ago, and Helsinn had challenged it. The court found that DRL proposed drug — palonosetron hydrochloride 0.25 mg/5 ml — infringes on certain claims of US patents. Later, DRL received an approval from the USFDA for generic Aloxi in March 2016 after it settled patent litigations relating to its anti-nausea injection Aloxi. The settlement will allow it to market the generic version of Aloxi in the US on September 30, 2018, or earlier, under certain circumstances.

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