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

Case Name: Helsinn Healthcare S.A. v. Dr. Reddy’s Labs., Ltd., Nos. 14-4274 (SRC), -6341 (SRC) (Consol.) (D.N.J. Jan. 30, 2018) (Chesler, J.) 

Drug Product and Patent(s)-in-Suit: Aloxi® (palonosetron HCl); U.S. Patent No. 8,729,094 (“the ’094 patent”)

Nature of Case and Issue(s) Presented: The ’094 patent claimed a method for reducing chemotherapy-induced nausea and vomiting (CINV) using palonosetron. Defendant Teva had submitted an ANDA seeking FDA approval to engage in the commercial manufacture and sale of generic palonosetron hydrochloride intravenous solutions prior to the expiration of the ’094 patent.

In related litigation, Judge Cooper of the D.N.J. issued a judgment that found a number of other palonosetron patents (but not the ’094 patent) valid and infringed. Teva appealed that judgment and the Federal Circuit reversed, finding the patent claims at issue invalid under the on-sale bar of 35 U.S.C. § 102. Helsinn then petitioned for rehearing en banc. With the petition pending, Helsinn raised with this Court its concern that, should the Federal Circuit deny rehearing, Teva would immediately launch its generic palonosetron product. The parties agreed to brief the instant preliminary injunction motion while the petition was pending. The Federal Circuit subsequently denied the petition for rehearing and stated that the mandate would issue. The court denied the motion.

Why Teva Prevailed: Helsinn had not demonstrated that it was likely to succeed on the merits. Teva argued that: (i) the Federal Circuit had already decided this issue; (ii) Helsinn was precluded from relitigating it; and (iii) there was overwhelming evidence that claim 4 was invalid under the on-sale bar. Helsinn distinguished the issues litigated in the companion cases and resolved by the Federal Circuit on one ground only: “claim 4 of the ’094 patent requires administering 0.25 mg palonosetron to reduce the likelihood of delayed CINV, as opposed to acute CINV or CINV generally.” Helsinn contended that, unlike the claims invalidated by the Federal Circuit, claim 4 of the ’094 patent had not been reduced to practice before critical date of January 30, 2002, and it was therefore not invalid under the on-sale bar. Thus, the issue became whether claim 4 had been reduced to practice before the critical date.

Helsinn relied on statements from one of the ’094 patent inventors, the fact that neither of the two phase 2 CINV studies demonstrated that 0.25 mg palonosetron was effective in controlling delayed CINV, and evidence of skepticism about the usefulness of 0.25 mg palonosetron to treat delayed CINV, contending that this demonstrated that the invention of claim 4 was not ready for patenting. Teva countered with evidence in support of its contention that claim 4 was reduced to practice before the critical date, namely: (i) a 2010 declaration submitted to the PTO; (ii) certain press releases; and (iii) the phase 3 trial results available in January, 2002. After considering this evidence, the court found that Teva had raised a substantial question about this issue, which Helsinn had not shown lacked substantial merit.

The most significant piece of evidence was the PTO Declaration, which was a party admission. It represented a calculated decision by Helsinn and expressly included the subject matter of the ’094 patent. Were the PTO Declaration the only evidence showing reduction to practice before the critical date, the court might have hesitated to conclude that Teva had raised a substantial question of validity, but there was the additional supporting evidence, namely, the press releases and the phase 3 clinical results.