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SCOTUS urged to take up 1st biosimilars case

In siding with Sandoz Inc., a division of Swiss drugmaker Novartis AG, the top litigator for the U.S. government urged the Supreme Court to take up the company's lawsuit against rival Amgen Inc. in a case he said could have a significant impact on the market success of biosimilars, drugs meant to be cheaper versions of biological medicines.

While the lawsuit involves Sandoz's biosimilar Zarxio — a version of Amgen's Neupogen, a leukocyte growth factor used to treat the depletion of white blood cells caused by cancer — the case centers on the interpretation of the Biologics Price Competition and Innovation Act, a law passed by Congress in 2010 as part of the Affordable Care Act to give the FDA the regulatory authority to approve biosimilars.

If the Supreme Court decides to hear the case, it would be the first time a lawsuit involving biosimilars and the BPCIA goes before the justices.

In addition to Zarxio, which was licensed in March 2015, the FDA has approved only three other biosimilars — Sandoz's Erelzi, Pfizer Inc. and Celltrion Inc.'s Inflectra and Amgen's Amjevita — so the market is considered to still be in its infancy in the U.S., which is about a decade behind Europe in selling those types of products.

Under the BPCIA, makers of biosimilars are permitted to use an abbreviated licensing process. While some have likened the authority the law granted to the FDA to that of the approval pathway for generics, the BPCIA is much more complicated in how it goes about resolving patent disputes because of the nature of the drugs involved: Biologics, which are derived from natural sources and generally take many more years to develop than chemical-based medicines.

Judge Alan Lourie of the U.S. Court of Appeals for the Federal Circuit described the BPCIA as a "riddle wrapped in a mystery inside an enigma," borrowing from a popular quote from former U.K. Prime Minister Winston Churchill.

"[W]e do our best to unravel the riddle, solve the mystery and comprehend the enigma" that is the BPCIA, Lourie said in the Federal Circuit's July 2015 ruling in the case, in which the court gave Amgen and Sandoz each a win.

But Ian Heath Gershengorn, the acting U.S. solicitor general, who was asked in June by the Supreme Court to weigh in on the case, succeeds in unwrapping that mystery, said Elaine Herrmann Blais, a partner and head of litigation at Goodwin Procter LLP's Boston office.

Gershengorn's amicus brief, which he filed with the court Dec. 7, "was the clearest recitation of what the statute does that I've ever read," Herrmann Blais told S&P Global Market Intelligence.

"If somebody is trying to understand the statute," she added, the solicitor general has "broken it down in a way that is digestible," which she said may help the Supreme Court better flesh out whether to take up the Amgen-Sandoz lawsuit.

Because the provisions in the BPCIA are so integrally related, Gershengorn said the court should grant not only Sandoz's certiorari petition, filed in February, but a cross-petition filed the next month by Amgen, so that all of the questions are presented together.

In their applications, biosimilar makers are permitted to rely on the brand-name company's data, although the BPCIA provides 12 years of protection of that information, meaning the FDA cannot grant approval of follow-on versions of the innovator drug until that exclusivity period runs out.

Gershengorn noted the BPCIA's patent dispute resolution process involves four phases, which includes the biosimilar maker sharing its application and manufacturing details with the brand-name firm under specified disclosure and negotiation procedures so it can determine whether it has claims of patent infringement to assert — a process dubbed the "patent dance." The four phases also include two types of patent litigation.

The BPCIA mandated the biosimilar applicant "shall provide" not later than 180 days before the date of the first commercial marketing of its product a notice to the brand-name company.

The questions before the Supreme Court are whether that 180-day notice must come before or after the FDA approves a biosimilar and whether the patent dance is optional.

In July 2015, a three-judge panel from the Federal Circuit ruled 2-1 the patent dance was optional and biosimilar makers could choose not to disclose their application and manufacturing details, which was a victory for Sandoz.

The same Federal Circuit judges, however, also ruled 2-1 that when a biosimilar applicant does not dance, 180 days' notice of commercial marketing of biosimilars was mandatory and may only be given after FDA licensure, a win for Amgen.

Gershengorn said the Federal Circuit erred in interpreting the ruling on the 180-day notice, but it correctly construed the BPCIA language concerning the patent dance, although Herrmann Blais said the solicitor general came to that conclusion "a little bit differently" than the judges.

If the Supreme Court takes up the case and rules the way the solicitor general has indicated it should, the outcome would be favorable for all biosimilar companies with pending litigation, Herrmann Blais said.

The Supreme Court has another cert petition pending before it in a case involving Apotex Inc.'s yet-to-be-approved biosimilar of Amgen's Neulasta, a longer-acting form of Neupogen.

Unlike Sandoz, Apotex engaged in the patent dance. But in the Amgen-Apotex case, a different three-judge panel from the Federal Circuit in July ruled that the 180-day notice of commercial marketing applies to all biosimilar makers, regardless of whether they turned over their application to the brand-name firms and engaged in the patent dance.

Gershengorn did not suggest the Supreme Court should combine the Apotex case with the Amgen-Sandoz lawsuit, but it is a route the justices could take. If the court puts one or both cases on its schedule for the spring, it could render a decision by the close of its term at the end of June 2017.