Helsinn Healthcare S.A. v. Dr. Reddy’s Labs., Ltd.

All of the patents-in-suit were valid and enforceable, and all but one—because of a different dosage strength associated with the proposed ANDA product—were infringed.

January 22, 2016

GENERICally Speaking: A Hatch Waxman Litigation Bulletin

Case Name: Helsinn Healthcare S.A. v. Dr. Reddy’s Labs., Ltd., Civ. No. 11-3962, 2015 U.S. Dist. LEXIS 167048 (D.N.J. Nov. 13, 2015) (Cooper, J.)

Drug Product and Patent(s)-in-Suit: Aloxi® (palonosetron); U.S. Patents Nos. 7,947,724 (“the ’724 patent”), 7,947,725 (“the ’725 patent”), 7,960,424 (“the ’424 patent”), and 8,598,219 (“the ’219 patent”) 

Nature of the Case and Issue(s) Presented: Plaintiffs are the assignees of the patents-in-suit, which cover the drug Aloxi. Aloxi is an intravenous solution used for treating chemotherapy-induced nausea and vomiting. Defendants filed ANDAs with the FDA seeking to manufacture and market generic versions of Aloxi. The ANDAs included Paragraph IV certifications against the patents-in-suit. In response to the ANDA filings, Helsinn filed suit alleging patent infringement. After a series of dismissals that occurred before and after an 11-day bench trial, Teva was the lone defendant remaining in the case. The issues here concerned invalidity based on (1) failure to meet the written-description requirement, (2) obviousness, and (3) the on-sale bar. Additionally, there was a dispute that even if the patents-in-suit were valid, the asserted claims were not infringed because Teva’s ANDA product contained a dose different from that claimed in the asserted patent. The court found that all of the asserted patents were valid and enforceable, and that Helsinn’s patents were infringed by Teva’s proposed ANDA product. The lone exception was the ’219 patent, which was not infringed by Teva’s proposed 0.075 mg product.

Why Helsinn Prevailed: Teva argued that its ANDA disclosed two different versions of the drug, at two different doses, for treatment of two different illnesses. Specifically, Helsinn’s ’219 patent claims were directed towards a 0.25 mg dose of palonosetron in 5 mL of solution for use in treating chemotherapy-induced vomiting. This formulation resulted in a concentration of 0.05 mg/mL. While both of Teva’s disclosed ANDA formulations resulted in a concentration of 0.05 mg/mL, the ANDA also disclosed a treatment dose of 0.075 mg for use in treating post-operative nausea and vomiting. The ’219 patent did not disclose such a dose or a use, even though the concentration was the same, at 0.05 mg/mL. Accordingly, Teva argued that its proposed 0.075 mg dose for treating post-operative nausea and vomiting did not infringe the claims of the ’219 patent.

Firstly, the court found that it would not have been obvious for a person of skill in the art at the time of invention to have selected 0.25 mg as a dose, or to arrive at a concentration of 0.05 mg/mL using routine experimentation. The court also noted that secondary considerations such as commercial success and long-felt need favored a finding of non-obviousness. Secondly, the court found that the each of the asserted patent specifications had an adequate written description. Thirdly, concerning Teva’s on-sale bar defense, the court found that Helsinn did in fact offer the drug for sale more than a year before the patent applications were filed. But the court found that the drug was not “ready for patenting” at that time, and therefore a sale could not have occurred. Thus, the court concluded that each of the asserted claims of the patents-in-suit was valid and enforceable.

With respect to infringement, the court found that the asserted claims of the ’724, ’725, and ’424 patents would have been infringed by the sale of Teva’s proposed 0.25 mg/5 mL chemotherapy-induced vomiting product and 0.075 mg/1.5 mL post-operative nausea and vomiting product. However, the court sided with Teva in relation to whether its generic drug infringed the ’219 patent. It determined that that Helsinn failed to prove that the 0.075 mg dose generic product specified in Teva’s ANDA would infringe the ’219 patent.

Oren D. Langer


Managing Partner, New York Office
Member of Executive Board

Ryan M. Schultz


Pronouns: he/him

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