High Court Grapples With Biosimilars Law

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By John T. Aquino

Drugmakers April 26 offered the U.S. Supreme Court their differing interpretations of the 2010 law allowing biosimilar approvals and when the drugs can be marketed ( Sandoz, Inc. v. Amgen, Inc.; Amgen, Inc. v. Sandoz, Inc., U.S., Nos. 15-1039 and 15-1195, oral arguments 4/26/17 ).

Amgen, which makes the biologic drug Neupogen, argued the Biologics Price Competition and Innovation Act (BPCIA) dictates that a biosimilar can’t be put on the market for six months after approval by the Food and Drug Administration. Sandoz, maker of Zarxio, a Neupogen biosimilar, argued that the biosimilar can be released as soon as it’s approved. The government sided with Novartis’s generics unit Sandoz in an amicus brief and in the oral arguments.

Biosimilars are highly similar and less expensive versions of biologic drugs. The FDA has approved a handful so far. Industry and attorneys are looking to the court to issue a decision by the end of June that could firmly establish how quickly biosimilars can be released to market and how long the owner of the original biologic can sell their product without competition.

Justice Stephen Breyer asked several times if the best way to address the BPCIA’s ambiguous language was to ask the FDA to use its expertise to redo its regulations, but the government’s attorney said the agency wasn’t in a position to initiate such rulemaking.

Too Close to Call?

Elaine Herrmann Blais, the head of the litigation department in Goodwin Procter’s Boston office, told Bloomberg BNA after the oral arguments that the justices asked both Amgen’s and Sandoz’s attorneys tough questions. “Consequently, it’s impossible to tell what a probable outcome would be.”

Her colleague Willy Jay said, “Take for example Justice [Anthony] Kennedy’s line of questioning about whether the FDA could issue a ‘tentative approval’ of a biosimilar. It could be read to mean that he thought making an applicant wait for the 12 years of data exclusivity for the original biologic to expire and then wait an additional 180 days was too much. Or it could be read to mean the opposite, that he was just eliminating the possibility.”

Lisa Ferri, a partner in Mayer Brown’s intellectual property department, said the bench seemed relatively quiet in terms of questioning. “Looking at it from the perspective of brand biologics, if the appeals court decision were allowed to stand, it would gut the balance Congress was trying to achieve between the biosimilar applicant and the owner of the original biologic and cause biopharmas to have to rethink the way they develop their products.”

Blais acknowledged that the justices seemed to ask more questions of Sandoz’s attorney Deanne E. Maynard, co-chair of the appellate and Supreme Court practice group for Morrison Foerster, Washington, than of Seth P. Waxman, co-chair of the appellate and Supreme Court practice for Wilmer Hale, Washington. “We noticed that Seth got to speak in whole paragraphs,” she said.

The U.S. Court of Appeals for the Federal Circuit agreed with Sandoz and the district court that the BPCIA’s information exchange provisions are optional but disagreed with its ruling on the 180-day notice, favoring Amgen’s interpretation that the applicant can’t give notice of commercial marketing until after the FDA has approved the biosimilar for market, thus delaying Zarxio’s release for six months.

Let’s Ask FDA

These were the questions before the court: whether the BPCIA’s exchange of manufacturing and patent information between the biosimilar applicant and the owner of the original biologic is optional and when the 180-day notice can start.

Breyer emphasized his view that the BPCIA provisions in question are ambiguous. When Maynard said that the statute requires notice at least 180 days before the date of the first commercial marketing, Breyer responded that maybe it said that but “it’s not even a complete sentence. [And] how could you do that if you don’t know what the product licensed is?”

Breyer continued, “Now, we are being asked to interpret very technical provisions that I find somewhat ambiguous and am operating in a field I know nothing about. But it’s going to have huge implications for the future. So why isn’t the way to go about this case to ask the agency to issue some regulations? Then when we see their interpretation, you all will be able to argue that their interpretation exceeds the statutory delegation. And by doing that, we would have a better picture.”

Waxman, arguing for Amgen, said the 180-day notice was important for the owner of the original biologic because the product as described in the application can be different from the product the FDA approves. The biologic owner “needs time to determine what FDA approved and whether or not it infringes the owner’s patents. Until the FDA decides what it is, what is the compound that it is going to authorize—which, by definition, won’t be identical—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.”

Biosimilar Specifics Unknown

Some justices seemed to agree with Amgen’s position about needing the exchange of information between the parties.

Maynard said that, even without the information about the manufacturing process or about what patents the applicant thought its product might infringe, the owner of the original biologic could sue on a good faith basis on the fact that the biosimilar is a version of the original biologic.

“But it doesn’t know the specifics of the biosimilar,” Chief Justice John G. Roberts Jr. said. “I mean, by definition, the biosimilar is similar; it’s not identical. And whether or not it infringes might have something to do with the ways in which it is different.” He added, “Well, you’re suing, saying this thing infringes our patent. We don’t even know what ‘this thing’ is.”

Maynard, representing Sandoz, was given the last word in rebuttal. “Congress would not have extended the 12-year exclusivity period in such a bizarre way. That was a very hotly debated item, and it would extend the exclusivity period in every case, even when there are no patent rights to litigate,” she said.

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

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