US Supreme Court to Consider Biosimilar Patent Process Next Week

The highest court in the US next Wednesday will take up a fight over the so-called biosimilar "patent dance" and whether biosimilar companies have to notify reference product sponsors of the impending marketing of a new product, likely leading to a decision with ramifications for all subsequent biosimilars approved by the US Food and Drug Administration (FDA).

The case, which will be decided by July, may set a precedent not only on whether the patent dance is necessary (ie. That companies must exchange patent and manufacturing information before FDA approval), but also whether biosimilars manufacturers must adhere to the so-called "notice of commercial marketing" provision, effectively meaning an additional six-month wait after FDA approval before new biosimilars can hit the market.

Amgen v. Sandoz Background

The Biologics Price Competition and Innovation Act (BPCIA) lays out the legal pathway whereby biosimilars can win approval and come to market, describing each step of the patent dance, and when a biosimilar application and information about a product's manufacturing processes must be exchanged.

Novartis' Sandoz, like a few other biosimilar developers before them, decided that this exchange of information was not necessary, leading Amgen to file a lawsuit. Sandoz then won FDA approval for its bone marrow stimulant Zarxio (filgrastim-sndz) as a biosimilar version of Amgen's Neupogen (fligrastim) in March 2015, but Sandoz's biosimilar did not actually come to market until September 2015.

A federal circuit court held that the notification of commercial marketing provision in the BPCIA is mandatory, with the 180-day period beginning only upon post-licensure notice, and that an injunction was proper to enforce the provision against Sandoz, which skipped the process of information exchange and patent-litigation channeling.

In February 2016, however, Sandoz petitioned the Supreme Court to hear the case, noting that this 180-day period actually created an additional six month delay for biosimilars from hitting the market.

At issue in the Supreme Court case are two key questions: Is a biosimilar applicant required to provide the reference product sponsor with 180 days' notice after licensure and before it begins marketing? And is a biosimilar applicant required to provide the reference sponsor with a copy of its biologics license application and related manufacturing information, and may a court issue an order enforcing that duty?

Sandoz's and Amgen's Arguments

Julia Pike, VP of intellectual property North America at Sandoz, said in a call with reporters on Thursday that the company opted to forego the dance and tried to speed the process of resolving any patent issues related to the marketing of Zarxio because, as Amgen filings with the Securities and Exchange Commission noted, Amgen did not think it had any material patents related to its reference product, which had already seen 24 years of exclusivity.

Pike explained how when Congress carefully crafted the BPCIA, the intention was to settle the patent issues before a biosimilar's entry to market, rather than as a last dash after approval.

But Amgen maintains that Sandoz did not play by the rules of the BPCIA.

"Sandoz continues to treat the BPCIA's mandatory, integrated procedures for the resolution of patent disputes like an à la carte menu from which it can pick and choose," Amgen said in reply brief over the case. "Sandoz's interpretation would make a hash of the orderly path to resolution of patent disputes that Congress created."

'Shall'

Arguments on both sides also boil down to what Congress intended with its use of the word "shall" in the BPCIA.

On the one side, Sandoz's Pike argues that Congress laid out in the BPCIA "a fully self-contained game and the consequences for what happens in each step" and if that step is not carried out. "In that context, there isn't a need for courts to go beyond what BPCIA set out," she said, noting that, "All paths lead to patent litigation."

But Amgen says that "Sandoz insists that Congress turned 'shall' into 'may,'" and that, "It is nonsensical to suggest that, whenever Congress specifies some consequences of a statutory violation, it transforms the violation into a permissible choice. For example, if a statute states that a manufacturer 'shall' not emit certain pollutants and may be fined if it does, no one would deny that a polluter (even one that pays the fine) is breaking the law."

Pike, meanwhile, argued that the BPCIA must be viewed as a well-articulated framework, rather than clauses viewed in isolation, and that the 12 years of market exclusivity was debated by Congress and agreed to, rather than the 12 years and 180 days.

All filings for the case have now been submitted and oral arguments will be heard at 10 am on 26 April.