Supreme Court May Punt in Biosimilar Law Dispute, Attorneys Say

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By John T. Aquino

The Supreme Court could rule that Sandoz and Amgen’s dispute over the biosimilar law is moot or kick the can back to the Federal Circuit to determine available remedies, attorneys said April 26 after oral arguments.

Amgen and Sandoz presented their differing interpretations of the biosimilar statute to the Supreme Court on April 26, and biopharma attorneys have expressed hope that the court’s decision, expected in late June, will offer some clarity. But some attorneys told Bloomberg BNA that the court’s apparent unease with the complexity—and the policy consequences—of the issues suggested that clarity may not be forthcoming.

At issue are the law’s provisions requiring 180-days’ advance notice of marketing of a biosimilar—a highly similar version of an original biologic drug—and on exchange of patent and manufacturing information between the makers of the biosimilar and the original biologic.

The court could “conclude that Sandoz’s petition concerning the 180-day notice provision is moot because Sandoz has now already launched its product” and that Amgen’s cross-petition on information exchange could similarly be dismissed, Charles Steenburg, a shareholder at the intellectual property law firm of Wolf, Greenfield & Sacks, P.C., Boston, said in an April 26 email.

Donald Ware, chair of the intellectual property department at Foley Hoag LLP, Boston, told Bloomberg BNA that, while the pre-argument buzz was about the 180-day notice and the parties’ information exchanges, the court spent time talking about the issue of remedies. “One thing that may happen is they will say, ‘This is what the statute means, but we’re not going to deal with the remedy’ and leave that to the [U.S. Court of Appeals for] the Federal Circuit,” Ware said after a post-argument briefing at the Washington College of Law at American University.

Needing Tutorial

The Biologics Price Competition and Innovation Act (BPCIA) provides an abbreviated pathway for Food and Drug Administration approval of a biosimilar. The FDA has approved five biosimilars under the law. The BPCIA allows the biosimilar applicant to partly rely on the data submitted for the original biologic’s approval and outlines obligations the applicant has to the biologic patent owner.

Amgen, which makes the biologic drug Neupogen, argued the BPCIA dictates that a biosimilar must wait six months after FDA approval before being put on the market. Sandoz, a part of Novartis and maker of Zarxio, a Neupogen biosimilar, argued that the biosimilar can be released as soon as it is approved. Amgen also argued that the exchange of information between the parties is mandatory, and Sandoz said it was optional. The government sided with Sandoz on both points in an amicus brief and in the oral arguments.

The first 20 minutes of the oral argument were a tutorial in which the attorneys basically explained the statute to the justices, Ware told Bloomberg BNA after the briefing. Justice Stephen Breyer suggested having the FDA deal with the issues by writing regulations, only to be told by the attorneys that the agency says it doesn’t have the resources or the authority to do this type of rulemaking, Ware noted. “And the thing is, the provisions in dispute involve patent dispute resolution, and the FDA has no expertise in that. The Patent and Trademark Office does, but it too hasn’t stepped forward to enter the fray,” Ware said.

Breyer’s suggestion of the need for FDA involvement is indicative of the court’s unease with the issues, Steenburg said. At the oral argument, Breyer said, “Now, 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. But it’s going to have huge implications for the future.”

The tutorial aspect of the first part of the oral argument led to a long stream of questions for Sandoz’s attorney, Deanne E. Maynard, co-chair of the appellate and Supreme Court practice group for Morrison Foerster, Washington. “But I wouldn’t put too much significance in the fact that she was asked the most questions,” Ware said, “It’s part of going on first. And she was given three, solid minutes of uninterrupted rebuttal at the end and did a fine job.”

Breyer’s suggestion that the FDA take a major role in clarifying the issues before the court was in keeping with the justice’s agency-deference philosophy, Ware noted to Bloomberg BNA. “I kept looking at Justice [Neil] Gorsuch, in one of his first cases on the bench, to see his reaction because he has expressed an anti-agency-deference philosophy. But he was pretty poker-faced.”

Tentative Approval?

Breyer, Justice Anthony Kennedy and Chief Justice John Roberts seemed amenable to the idea of a “tentative approval” of a biosimilar by the FDA, Ware said. Under this idea, if the biologic owner has any of its 12 years of exclusivity left and the FDA indicates before the 12 years are up that it is ready to grant approval for a biosimilar, the agency can issue a license that becomes effective the day after the 12-year exclusivity period has expired so the biosimilar applicant doesn’t have to wait an additional 180 days.

The Federal Circuit, after it ruled on the issues now before the high court in Sandoz v. Amgen, discussed this idea in dicta, which are non-binding statements in a court opinion, in another biosimilar case, Amgen v. Apotex, for which the Supreme Court declined review, Ware noted.

What’s the Remedy?

Michael Morin, a partner in the intellectual property practice of Latham & Watkins LLP, Washington, represented the biopharma AbbVie Inc. in an amicus brief, and spoke at the briefing on the issue of the remedies available if the biosimilar applicant doesn’t follow the BPCIA’s provisions for the information exchange and/or the 180-day notice.

“Sandoz argued that the patent owner is limited to the remedies in the statute, which basically means it can file an infringement suit,” Morin said. “In our view that doesn’t seem right because it puts the patent owner in the position of a guinea pig, filing patent suits without having sufficient knowledge to do so. And as far as the 180-day notice is concerned, once the product has been launched, there is no chance of notice.”

Morin noted that the justices discussed the issue of remedies but particularly in regard to preemption and state law because Amgen had originally requested a preliminary injunction under California state law to prevent Sandoz from releasing the product.

“Suffice it to say,” Morin said at the briefing, “that there is a big fight over whether there are additional remedies and even an argument of whether that issue was even before the court today because it was never fully briefed.”

To contact the reporter on this story: John T. Aquino in Washington at jaquino@bna.com

To contact the editor responsible for this story: Randy Kubetin at RKubetin@bna.com

For More Information

The transcript of the oral arguments is at http://src.bna.com/oiG.

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