As Supreme Court steps into tangled biosimilars law, IP experts weigh in

Justice statue with sword and scales
Could Justice Stephen Breyer's worries about interpreting BPCIA lead to a moot petition in the Amgen v. Sandoz case? That's one possible scenario IP attorneys see after analyzing Wednesday's Supreme Court arguments.

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:

  1. Whether biosimilar companies should be required to share their biosim FDA applications with reference product sponsors
  2. 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.

Free Webinar

Building a Flexible, Challenge Resistant and Patient Centric Clinical Supply Chain

The global landscape of clinical trials is rapidly changing as studies become more complex. An increasing number of sponsors are seeking enhanced flexibility in their supply chains to address a variety of clinical supply challenges, including patient demand and reducing delays. In this webinar, learn the benefits of utilizing demand-led supply and direct-to-patient distribution models in the clinical supply chain, as well as how they can be used to both improve flexibility and better align with patient needs. Register today!

RELATED: Amgen, Sandoz take closely watched biosimilars arguments to Supreme Court

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.

RELATED: In Amgen-Sandoz SCOTUS case, biosim makers lambaste ruling's 6-month exclusivity gift

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.

RELATED: Supreme Court takes up Amgen, Sandoz's market-defining biosimilars dispute

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.

Suggested Articles

Former Indivior CEO Shaun Thaxter will face six months in federal prison for his role in misleading government officials on the dangers of Suboxone.

As of Friday after local time, 36 people have died in Korea after getting flu shots provided by at least seven companies, including Sanofi.

Two prominent pneumococcal vaccines from Merck and Pfizer are running low in Europe in a possible ill omen for the coming winter: report.