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Helsinn Healthcare S.A.’s blockbuster chemotherapy treatment Aloxi is safe from competition from a Dr. Reddy’s Laboratories Inc. generic until 2024 ( Helsinn Healthcare S.A. v. Dr. Reddy's Labs., Ltd. , 2017 BL 46643, D.N.J., 12-2867 (MLC) (DEA), 2/14/17 ).
Dr. Reddy’s Laboratories’ proposed version of the drug infringes Helsinn’s patents, Judge Mary L. Cooper of the U.S. District Court for the District of New Jersey ruled in an opinion unsealed Feb. 15.
Cooper’s ruling blocks the FDA from approving Dr. Reddy’s version until the patents and their associated pediatric exclusivity periods expire in July 2024.
Protecting exclusivity on Aloxi is critical for Helsinn because the drug brings in about 90 percent of the company’s revenue. Aloxi (palonosetron) has roughly $500 million in annual U.S. sales. Helsinn shares the proceeds with its marketing partner Eisai through a confidential arrangement.
Dr. Reddy’s filed a new drug application (NDA) for its generic version of Aloxi through an abbreviated approval pathway under the Federal Food, Drug, and Cosmetic Act’s 505(b)(2) process. The 505(b)(2) process is an abbreviated pathway that allows the Food and Drug Administration to rely on data not developed by the applicant for approval of an NDA.
Cooper upheld the three Helsinn patents in the case, rejecting Dr. Reddy’s arguments that the patents were invalid.
“Helsinn is gratified that Judge Cooper has once again agreed with us on both the infringement and validity issues in this second trial involving our client’s very important Aloxi drug franchise,” Joseph O’Malley, an attorney with Paul Hastings LLP in New York who represented Helsinn in the case, said in a Feb. 16 statement.
Helsinn won a similar victory against Teva Pharmaceutical Industries Ltd. in 2015 when Cooper rejected Teva Pharmaceutical’s challenges to Helsinn’s Aloxi patents. Teva appealed the court’s decision to the U.S. Court of Appeals for the Federal Circuit in March 2016. The appeals court heard oral arguments Oct. 4, 2016, but the court hasn’t ruled yet.
Bloomberg BNA contacted Dr. Reddy’s for comment, but the company didn’t respond.
Paul Hastings LLP in New York and Saul Ewing LLP in Newark, N.J. represented Helsinn. Helsinn is based in Switzerland.
Lerner David Littenberg Krumholz & Mentlik LLP in Westfield, N.J. and Budd Larner PC in Short Hills, N.J., represented Dr. Reddy’s. Dr. Reddy’s is based in India.
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