Supreme Court jumps into biotech drug fight

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This story originally appeared in The Hill Extra.

Drug giants Amgen and Sandoz faced off at the Supreme Court this week, debating the process used to bring to market copies of highly complex and pricey biotech drugs.

The court on Wednesday weighed two key issues that could reshape the rules and timeline for creating cheaper versions of drugs known as biologics, which offer the potential to help curb drug costs. Some of the most eye-popping drug prices in recent years have been biotech.

{mosads}Sandoz, part of European drug giant Novartis, argued that its interpretation “would enable patient access to important, potentially life-saving medication and help to reduce rising healthcare costs, sooner.”

One key issue is when a manufacturer must notify the brand-name company it is making a copy, known as a biosimilar. The law requires 180 days notice before a company begins to market the copy.

The issue is when that clock starts ticking.

Sandoz’s attorney Deanne Maynard argued the law doesn’t require the drug be FDA approved before notification, although a federal court ruled otherwise.

Associate Justice Anthony Kennedy seemed to side with the lower court. 

“The 180-day period has to run from some time. It seems to me, it has to run from the time of licensing,” Kennedy said.

Maynard argued that the 180-day period should come after the 12-year data exclusivity that brand-name companies get for creating biologics, outlined in the law to incentivize drug innovation.

“That ruling will wrongly delay the marketing of every biosimilar, even when there are no patent rights left to be [litigated],” Maynard said. “Congress would not have extended the 12-year exclusivity period in such a bizarre way,” Maynard added.

Amgen’s attorney Seth Waxman argued that without the agency’s approval, the notice doesn’t hold weight.

“Until the FDA decides what it is … and until it decides for what therapeutic purposes that will be used, and until it specifies what the manufacturing process in what location will be approved — you can’t give notice of anything,” Waxman said.

The industry is watching this issue most closely, according to intellectual-property partner Courtenay Brinckerhoff at Foley & Lardner.

“It’s hard to tell from today’s transcript, but it seems like the justices might affirm the Federal Circuit on this issue, and agree that notice cannot be given until the product is approved,” she said.

Patent dance.

The court weighed a second issue regarding whether both the brand-name and biosimilar companies need to participate in an exchange of proprietary information to anticipate possible patent disputes.

Waxman argued the law mandates both parties participate. Sandoz bypassed this exchange.

Associate Justice Sonia Sotomayor said rather than a mandate, what the law outlines is “if you want to enter the federal process, this is what you have to do.”

Maynard said the information exchange, known as a “patent dance” that can take 250 days, could be unnecessary in some cases if the brand-name no longer holds relevant patents.

Amgen’s biologic cancer drug, Neupogen, was first licensed in 1991 and Sandoz argued skipping the patent dance allowed Amgen to move to inevitable patent litigation sooner.

“The purpose of this statute is to allow early resolution of patent [disputes],” Maynard said.

Just five biosimilars have gained FDA approval, two of which have made it to market, including the Sandoz drug Zarxio.

Associate Justice Stephen Breyer argued the problem might be better solved through FDA regulation, stating there were many aspects of the process to bring biosimilars to market that he didn’t understand.

“We are being asked to interpret very technical provisions that I find somewhat ambiguous and am operating in a field I know nothing about,” he added.

“But it’s going to have huge implications for the future,” he added.

The court is expected to issue a ruling in June. 

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