U.S. Supreme Court justices took their shot at picking apart the knotty Biologics Price Competition and Innovation Act on Wednesday, questioning Amgen and Sandoz attorneys about the “patent dance” leading up to a biosimilar market launch.
The attention centered on two issues:
- Whether biosimilar companies should be required to share their biosim FDA applications with reference product sponsors
- When, exactly, biosim developers can provide “notice” of their intent to market a biosim, thus triggering a six-month waiting period.
Offering takeaways on Wednesday’s arguments, four IP lawyers wrote to FiercePharma to weigh in on what’s at stake and offer clues about a potential decision and its ripple effects in the market.
While Courtenay Brinckerhoff, intellectual property partner in the biosimilars practice of Foley & Lardner LLP, said she’s “always reluctant” to predict a winner, she said she wouldn’t be surprised if the court ruled against Sandoz on both issues, based on Wednesday’s questioning.
For his part, Kevin Noonan, partner at Chicago-based McDonnell Boehnen Hulbert & Berghoff, noticed that the court’s “ease” with Amgen’s attorney was “evident,” and vice-versa. He pointed out that multiple justices “seemed to appreciate Amgen’s argument” that a biosimilar developer can’t provide marketing notice until after its biosim wins FDA approval, at which point it can provide the exact details of its license.
Sandoz has already launched its biosimilar in this case, Zarxio, after idling through 180 days after FDA approval, fighting a series of legal skirmishes along the way. But the company plans to launch several other biosimilars in the coming years, and the case will help shape an industry just starting to ramp up in the U.S.
Each of the experts observed uneasiness from Justice Stephen Breyer about ruling in a technical and emerging field. Chris Mikson, M.D., partner at Mayer Brown, said that the justice “candidly” discussed that concern Wednesday.
“We are being asked to interpret very technical provisions that I find somewhat ambiguous and I am operating in a field I know nothing about,” Justice Breyer said during the arguments on Wednesday.
Those statements, plus Justice Breyer’s suggestion that the FDA could offer input in the case, were a “clear manifestation of the Court’s struggle with the complexity of the statute,” Mikson wrote.
Charles Steenburg, shareholder at Wolf Greenfield, sees the possibility of Sandoz’ petition yielding no ruling at all. He figured Breyer’s concerns “raise the possibility” 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.”
Calling the statute a “riddle wrapped in a mystery inside an enigma,” a Federal Circuit court back in 2015 ruled against Sandoz on one issue and Amgen on the other. The drugmakers took their dispute to the high court, with various other companies and organizations supporting either side through amicus briefs.
Looking ahead, Brinckerhoff said it’s an important case in the industry as it’s the first time the top court is being asked to interpret patent implications for biosimilars. If either company is unhappy with the decision, they “would need to lobby Congress to change or clarify the law in their favor,” Brinckerhoff wrote.