By Charles Steenburg, Shareholder at Wolf Greenfield & Sacks, P.C.
Many of the questions from the justices during oral argument clearly reflected a sense of unease over the complexity of the issues and the potential consequences, For example, Justice Breyer repeatedly expressed a desire for agency input and continued to press the point even in response to Sandoz’s assertion that neither the Food & Drug Administration nor the Patent Office had rulemaking authority. Instead, he suggested that even “informal” guidance would be helpful.
Such concerns raise the possibility that the Court may ultimately kick the can down the road and conclude that Sandoz’s petition (concerning the 180 day notice provision) is moot because Sandoz has now already launched its product. Under that scenario, Amgen’s conditional cross-petition (concerning whether the “patent dance” – the information exchange between the applicant and reference product sponsor – is optional or mandatory) may also be dismissed. The two issues are interconnected in a number of ways. The current dispute over the 180 day notice provision turns on the particular contours of the dispute, in which Sandoz declined to exchange information and proceed with the patent dance. At the same time, there is reason to think that most if not all future disputes will involve situations in which biosimilar applicants do voluntarily exchange information with the reference product sponsor.
In particular, it was striking that Sandoz’s counsel emphasized today that biosimilar applicants are “highly incentivized” to participate in the patent dance, notwithstanding the particular facts of this case. While there is an exception to mootness when a dispute is “capable of repetition yet evading review,” Sandoz’s briefing focuses on the fact that Sandoz is going to be a “repeat biosimilar applicant.” What they do not say, however, is that Sandoz is likely to continue deciding not to participate in the exchange of information. In that sense, the briefing is consistent with counsel’s comment during the argument. However, it may open the door for the Supreme Court to pass on the underlying issues for the time being.