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Ben Stern Analyzes Debate Over FDA Safe Harbor in Law360

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Ben Stern, a partner in Nutter’s Litigation Department and a member of the firm’s IP Litigation practice group, commented on U.S. Circuit Judge Alan Lourie urging the Federal Circuit to reconsider its precedent over the FDA safe harbor in Law360. In the article, “Judge Lourie's Dissent Revives Debate Over FDA Safe Harbor,” Ben provided the lead quote, saying, “I’m not sure ultimately which way an en banc Federal Circuit would go, but I do think this is something important enough that it should be heard en banc.”

In regards to a Federal Circuit ruling, Ben continued, “Ultimately, this is a grammar exercise. What does the word 'solely' and the phrase 'reasonably related' mean in terms of what modified what?”

He added that the interpretation focusing on "reasonably related" calls for the law allowing the safe harbor to be broadly viewed, while the strict use of "solely" would be more of a bright-line rule. "I think both Judge Lourie and the majority recognize those two possibly contrasting poles," Ben said.

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