A pending patent-infringement case, litigated under the Biologics Price Competition and Innovation Act (“BPCIA”), will present several new questions related to how the BPCIA will interact with patents on biosimilar manufacturing—not just with patents covering the biosimilars themselves. The most recent dispute in this case involves potential remedies.
Janssen Biotech sells the biologic infliximab under its brand name Remicade®—a monoclonal antibody used to treat Crohn’s disease, rheumatoid arthritis, and other inflammatory diseases. In mid-2014, Celltrion and Hospira sought (and later obtained) FDA approval for Inflectra® —a biosimilar of infliximab.
In early 2015, Janssen sued Celltrion and Hospira (“Defendants”) for patent infringement under the BPCIA, also alleging that the Defendants failed to comply with various provisions of the BPCIA’s “patent dance.” The patent-in-suit does not cover infliximab, but rather the patent claims a composition “suitable for producing . . . cell culture media”—a media used to manufacture infliximab.
Defendants use the allegedly infringing media to make Inflectra® in South Korea. Defendants originally sourced their media from both the United States and Singapore, but now obtain it only from Singapore. Because U.S. patent laws generally do not apply overseas, Janssen’s infringement allegations center on the Defendants’ prior U.S. purchases of the cell culture media. Last year, the FDA approved Inflectra®, and Defendants launched at-risk on November 21, 2016.
Recently, the Court ordered briefing on the “appropriate measure of damages, and the factual and legal issues concerning the entitlement to a permanent injunction” if Defendants are found to infringe Janssen’s patent. Janssen seeks (1) a permanent injunction to prohibit Defendants from selling Inflectra® in the United States, and (2) lost profits for lost sales of Remicade®.
(Interestingly, according to Janssen’s complaint, the parties appeared to dispute when Janssen was required to file suit to avoid the lost-profit bar of 35 U.S.C. § 271(e)(6)(B). Janssen filed within the time that Defendants allegedly argued, thereby sidestepping, for now, a dispute over the interpretation and applicability of the BPCIA’s lost-profits bar.)
For the remedies Janssen seeks, the primary dispute is about the link between the patented cell culture media and the off-patent infliximab. Generally, a patentee seeking an injunction must show a “nexus” between the act of infringement and the irreparable harm. And a patentee seeking lost profits must show that the defendant’s infringement was the “but-for” cause of the patentee’s lost sales.
Here, Janssen admits both that its patent does not cover infliximab, and that Defendants’ sourcing of cell culture media from Singapore and use in South Korea does not infringe its patent. Instead, Janssen argues that, by previously sourcing some of the media in the United States, the “Defendants’ infringement is a crucial step in the production of their infliximab biosimilar,” thereby satisfying the “nexus” requirement for an injunction. Defendants respond that Janssen has failed to show that the patented cell culture media “drives consumer demand” for Remicade® sufficient to show irreparable harm.
On its lost-profits claim, Janssen argues that it has sufficient evidence that Defendants’ infringement was the “but-for” cause of Janssen’s lost sales, such that a jury could rule in their favor. Defendants respond that, under Federal Circuit law, the extraterritorial use of the cell culture media to manufacture Inflectra® severs the causal chain, as a matter of law, necessary for Janssen to claim lost profits of Remicade®.
It will be interesting to see how parties litigate patents related to biosimilar manufacturing—rather than patents on biosimilars themselves—under the BPCIA scheme, and whether these two types of patents will be treated differently under the BPCIA. The issue over the appropriate remedies will likely be resolved in the coming weeks. A jury trial is set for February 13, 2017.