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Bloomberg BNA Pharmaceutical Law & Industry Report

Outlook 2016: Busy Year Expected in Drug Patent, Antitrust Law

Bloomberg BNA Pharmaceutical Law & Industry Report states that the pharmaceutical industry is expected to encounter antitrust and patent-related issues this year. On the antitrust front, there will be further consolidation of the drug industry and legal developments for allegations of so-called "product hopping." Courts will continue to deal with "reverse payments" in drug patent settlement cases in 2016.

White & Case partner Eric Grannon said he hoped 2016 might bring a little more clarity to all the issues.
"In 2016, there are likely to be several important grants of summary judgment to defendants in reverse payment cases," Grannon said. "The hope is that these grants of summary judgment will coalesce into a jurisprudence that provides guidance and potential safe harbors for settling parties going forward."
"Suits where the court set a low bar at the dismissal stage for assessing the plausibility of plaintiffs' allegations will be ripe for determinations that the facts don't support a finding of a 'large and unjustified' payment or that other circumstances demonstrate that the parties would not have reached any earlier settlement entry date even without the contemporaneous business transaction," he said.
"For example, a manufacturing deal that saves the innovator money or meets a pre-existing need could be readily justified and thereby pass muster under Actavis," Grannon said.
Plaintiffs who "hang their hat on the allegation that the innovator had cheaper alternatives than the business deal at issue are likely to be disappointed," he said. "Judges will be reluctant to send cases to juries to second-guess justifiable business decisions."