The US Supreme Court will hear oral arguments on April 26, 2017, in the case of Amgen vs Sandoz, which concerns the so-called biosimilar “patent dance” of information exchange between biosimilar makers and sponsors of reference drugs about the impending marketing of a new (biosimilar) product. The decision, expected in July, will have important consequences for all subsequent biosimilars approved by the FDA.
Analysts believe the case may set a precedent on whether the patent dance is necessary, but also whether biosimilar makers must obey the “notice of commercial marketing” provision of the Biologics Price Competition and Innovation Act (BPCIA), the law that sets out the legal pathway for biosimilar approval and marketing. If the Supreme Court finds that biosimilar makers must adhere to the notice of commercial marketing provision, it will give an additional 180 days of market exclusivity to the reference drug maker after FDA approval of the biosimilar, thus adding 6 months after FDA approval until the biosimilar can reach the market.
Amgen filed a lawsuit against Sandoz/Novartis because Sandoz did not exchange patent and manufacturing information with Amgen for Sandoz’s filgrastim-sndz (Zarxio), biosimilar to Amgen’s filgrastim (Neupogen). According to Sandoz’s attorney Julia Pike, the company decided to forego the patent dance and tried to speed the process of resolving any patent issues related to marketing Zarxio because in Amgen’s filings with the Security and Exchange Commission, Amgen noted that it did not believe it had any material patents related to Neupogen, which already had 24 years of exclusivity. Pike said that when Congress created the BPCIA, its intention was to settle the patent issues before a biosimilar was marketed rather than as a last dash after FDA approval. Zarxio received FDA approval in March 2015 and was marketed in September 2015.
In response to Amgen’s suit, a federal circuit court judge ruled that the notification provision in the BPCIA is mandatory, with the 180-day period beginning only upon post-licensing notice, and that an injunction was correct to enforce the provision against Sandoz, which skipped the process of information exchange.
In February 2016, Sandoz petitioned the Supreme Court to hear the case, arguing that the federal circuit turned the requirement for notice into a “grant of 180 days of additional exclusivity for all biological products beyond the exclusivity period Congress expressly provided—delaying the launch of all future biosimilars by six months.”
Sandoz also claimed that not only had the company given Amgen more than 180 days’ notice of intent to market Zarxio, giving Amgen time to bring forth a suit and seek a patent-based injunction, but Amgen’s exclusivity period for Neupogen had expired because Amgen already had enjoyed 24 years of exclusivity. Pike added that Congress had already debated 12 years of market exclusivity—not 12 years plus 180 days. Amgen counters that Sandoz did not follow BPCIA rules and treats the BPCIA’s mandatory procedures for the resolution of patent disputes like an á-la-carte menu from which to pick and choose.
The Supreme Court must decide whether: