Hospira Can't Get Helsinn Aloxi Suit Dismissed

Bloomberg BNA's Pharmaceutical Law & Industry Report helps you stay informed of regulatory and litigation developments affecting the pharmaceutical and biotech industries....

By Dana A. Elfin

April 7 — Hospira Inc. failed in its bid to get Helsinn Healthcare SA's patent infringement suit against it over the anti-nausea drug Aloxi thrown out.

In an April 5 opinion, Judge Mary L. Cooper of the U.S. District Court for the District of New Jersey found that the case couldn't be dismissed on jurisdictional grounds because Hospira and its subsidiary, Hospira Worldwide Inc. (Worldwide), had sufficient minimum contacts with the New Jersey forum to enable the court to hear the case.

Patent litigators told Bloomberg BNA that this case may be the first district court case to apply the Federal Circuit's recent holding in Acorda Therapeutics, Inc. v. Mylan Pharmaceuticals, Inc., 2016 BL 83256, No. 15-1456, No. 15-1460, (Fed. Cir. March 18, 2016) . The rule the Federal Circuit announced in Acorda effectively establishes jurisdiction in all forums over any filer of an abbreviated new drug application (ANDA) seeking approval to make and sell a generic version of a drug.

Court Cites Acorda

In her opinion, Cooper held that “specific jurisdiction may be asserted over Hospira and Worldwide because of Defendants' suit-related contacts” with the New Jersey forum, and relied heavily on the U.S. Court of Appeals for the Federal Circuit's March ruling in Acorda.

Cooper observed that Acorda addressed the same jurisdictional issues and a similar set of facts.

In Acorda, the Federal Circuit held that abbreviated new drug application (ANDA) filings establish a substantial connection with a forum state and the ANDA filer, because they predict the filer's future activities in the state, such as manufacturing or marketing a generic product.

Although Hospira and Worldwide aren't incorporated and don't have their principal places of business in New Jersey, at least one of Helsinn's subsidiaries and its distributor do have principal places of business there, Cooper said. In addition, both Hospira and Helsinn have litigated Hatch-Waxman ANDA cases in New Jersey federal court, she said.

Moreover, Worldwide is registered to do business in New Jersey and intends to market the proposed generic Aloxi in the state, the opinion said.

“Under the rationale set forth in Acorda, the Court finds that Hospira's marketing of generic Aloxi will, at least in some part, take place in New Jersey because Hospira identifies itself as ‘the world's leading provider of injectable drugs and infusion technologies', ” Cooper wrote.

“These facts lean even more strongly toward a finding of minimum contacts than in Acorda, where the court held that Mylan's ‘network of independent wholesalers and distributors' alone constitutes a minimum contact with the state,” she said.

“[U]nder Acorda's guidance, these facts establish sufficient minimum contacts to find specific jurisdiction over both Hospira and Worldwide with respect to the pending ANDA,” Cooper wrote.

Jurisdiction Isn't Unfair

The court also found that asserting specific jurisdiction over Hospira and Worldwide wouldn't be unfair or unreasonable.

“The Court does not find any unfairness here that would override the minimum contacts that Hospira and Worldwide have with New Jersey,” the court concluded.

Hospira has litigated Hatch-Waxman lawsuits in this court and has initiated at least two of those actions, she said. In addition, New Jersey has an interest in adjudicating the parties' dispute because it has adjudicated or is adjudicating many similar Hatch-Waxman cases over generic Aloxi products.

“This only weighs more in favor of judicial economy and efficiency, as the ANDA actions currently pending in this Court involve the same Aloxi patents as the ones at issue here,” Cooper said.

Accordingly, the judge said, the Hospira defendants didn't make a compelling argument as to why asserting jurisdiction in this case would be unfair or unreasonable.

First Decision to Apply Acorda?

Attorney Jake M. Holdreith, of Robins Kaplan LLP in Minneapolis, told Bloomberg BNA April 6 that the ruling in the Helsinn case may be the first time a district court has applied the Federal Circuit's holding in the Acorda case.

“This is one of the first decisions applying the Federal Circuit’s Acorda ruling, in which the Federal Circuit may have put an end to the personal jurisdiction arguments that ANDA filers have been making for the last several years,” he said.

Before the Federal Circuit decided Acorda, ANDA filers had been arguing, with some success, that if the forum lacked general jurisdiction over them and the generic product at issue hadn’t been developed or sold there, that forum also lacked specific jurisdiction over them.

But Acorda held that generic drug manufacturers are subject to personal jurisdiction throughout the country as a result of filing an abbreviated new drug application with the FDA.

“The New Jersey court’s decision in Helsinn v. Hospira is predictably in line” with the Federal Circuit’s latest ruling in Acorda,” attorney Paul A. Ainsworth, of Sterne, Kessler, Goldstein & Fox P.L.L.C. in Washington, told Bloomberg BNA April 6. The result in the case is not surprising because the Federal Circuit’s analysis relied on facts that are typical to most, if not all, ANDA filers, he said.

“We expect this to be trend for ANDA filers seeking to challenge personal jurisdiction so long as the Acorda decision remains good law,” he said.

“It seems apparent that patent holders will regain substantial control over the choice of forum in Hatch-Waxman cases for now,” Holdreith told Bloomberg BNA. It is likely that most of these cases will continue to be heard in Delaware, New Jersey and, to a lesser extent New York, he said. Patent holders perceive those forums to be more favorable to protecting patents in Hatch-Waxman cases.

Things Could Change

But things are far from settled in the jurisdictional arena, Holdreith said. For example, he said, the U.S. Supreme Court could wind up reviewing the venue rule announced in Acorda or Congress could pass legislation that affects choice of venue in patent cases . And, he said, arguments have been raised in the In Re: TC Heartland case, now before the Federal Circuit, that the patent venue provisions should be interpreted to narrow the available venues for patent suits .

“Any of these could result in yet another change in the battle for control of venue in Hatch-Waxman cases,” Holdreith said.

Claim Plausible

In addition to addressing jurisdiction, Judge Cooper's ruling also addressed whether Helsinn's complaint sufficiently stated a plausible claim for relief.

Among other things, Hospira argued that Helsinn didn't state a claim against Worldwide because Worldwide didn't submit the ANDA to make and sell a generic version of Aloxi to the Food and Drug Administration.

But Cooper said that Section 271(b) of the Patent Act doesn't explicitly require that a defendant must sign the ANDA in order for it to be a properly named defendant in a Hatch-Waxman case.

And, Cooper said, irrespective of whether Worldwide signed or submitted the ANDA, it is undisputed that it will be the sole U.S. marketer, seller, and distributor of Hospira's generic version of Aloxi and will benefit if the application is approved. Moreover, Cooper said, Helsinn alleged that Worldwide acts as Hospira's subsidiary, agent and alter ego, and that both Hospira and Worldwide will infringe the Aloxi patents by making, selling or offering the proposed generic product for sale.

Accordingly, Helsinn's allegations sufficiently demonstrate a plausible claim for relief, Cooper said, and denied Hospira's motion dismiss the complaint for failure to state a claim.

Aloxi (palonosetron hydrochloride) injection is approved for use in adults to help prevent nausea and vomiting when it happens right away or later (up to five days) with certain anticancer medicines. It's also approved to help prevent acute nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy in both adults and children.

Helsinn is based in Switzerland. Hospira is now part of New York-based Pfizer Inc.

Paul Hastings LLP in New York represented Helsinn. Jenner & Block LLP in New York represented Hospira.

To contact the reporter on this story: Dana A. Elfin in Washington at delfin@bna.com

To contact the editor responsible for this story: Brian Broderick at bbroderick@bna.com