As FDA continues to approve biosimilar drug products, and as sponsors participate – or rather choose not to participate – in the Biologics Price Competition and Innovation Act (“BPCIA”) version of the patent dance, more questions arise about the remedies reference product sponsors have when certain steps are not followed. As we have detailed extensively (here, here, here, and really any post tagged under the “biosimilars” category of the FDA Law Blog), new questions about the BPCIA patent dance continue to pop-up and make for interesting new lawsuits. Such is the case with FDA’s April 25, 2019 approval of Samsun Bioepis’s Eticovo, a biosimilar to Amgen’s Enbrel, which has resulted in another lawsuit, this time asking the Court to enjoin marketing of Eticovo until it provides the 180-day notice required under the BPCIA.
In a Complaint filed on April 30, 2019, Amgen alleges that Samsung Bioepis infringed the multiple unexpired patents covering Enbrel. Originally licensed in 1998, Enbrel is now approved for multiple indications: rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, and plaque psoriasis. Samsung Bioepis’s Eticovo is approved for the same indications and route of administration, and it shares the same dosage form and strength as an approved version of Enbrel. The suit alleges that Samsung Bioepis infringed five patents covering Enbrel and asks for a declaratory judgment that Samsung Bioepis has infringed and/or would infringe one or more claims of each of the patents at issue, as well as injunctive relief preventing Samsung Bioepis from commercial marketing consistent with the 180-day notice period under the BPCIA.
Samsung Bioepis declined to participate in the patent dance, as it is entitled to do under the Supreme Court’s 2017 decision in Amgen v. Sandoz, so Amgen brought this declaratory judgment action to enforce its patent rights under section 351(l)(9)(C) of the Public Health Service Act (42 U.S.C. § 262(l)(9)(C)). But because Samsung Bioepis did not participate in the exchange of patent information, Amgen posits that it is “reasonable to infer that Bioepis might not provide notice to [Amgen subsidiary] Immunex in accordance with § 262(l)(8)(A).” Indeed, Amgen alleges that “Bioepis is prepared imminently to begin to use, offer, for sale, and sell in the United States, and import into the United States, its etanercept biosimilar product.” As such, Amgen seeks a temporary restraining order and injunction to prohibit Samsung Bioepis from commercial launch of Eticovo until 180 days after it provides notice of intent to market to Amgen’s subsidiary and Enbrel BLA holder (and co-Plaintiff) Immunex.
While the Supreme Court has determined that the patent dance and provision of the 351(k) biosimilar application is not mandatory, the Court further determined in Amgen v. Sandoz that the notice provision is. But the Act doesn’t contemplate failure to provide this notice, and it is not clear what remedies are available at this juncture. It’s not clear that a Court would grant injunctive relief here when there is no assurances that Samsung Bioepis is actually intending to launch in the near future (and without notice).
Patent remedies based on the submission of Samsung Bioepis’s aBLA are most likely available. Certainly, in this situation, an aBLA sponsor would be launching at risk and potentially be liable for treble damages but like with premature at-risk launch of generic small molecule drugs, the bell can’t be unrung once the product floods the market. That biosimilars are not automatically substitutable for their RLDs makes such an act less of a threat to Amgen’s market share. But chances are high that an influx of Eticovo would still undercut Amgen’s Enbrel market, at least to some extent. If there is no further recourse for Amgen other than the treble damages award arising from patent infringement, it raises questions of whether an at risk launch of a biosimilar will result in significantly smaller damages awards for reference product sponsors. Is it possible that the treble damages award could be less than attorneys’ fees (we note that Amgen here is seeking attorneys’ fees)? And if so, is treble damages enough to deter at risk launch when each biosimilar needs to find a way to get individual attention? In other words, could the publicity of an at risk launch be worth the treble damages in news coverage and publicity? Probably not but given all of the moving parts in the BPCIA and the uncharted market, it seems fair to say that “business decisions,” as opposed to legal decisions, may end up the driving force as this market develops.