Biologic and pharmaceutical patent litigation differ from other types of patent litigation in important ways. Most significantly, generic drugs and biosimilar therapeutics are reviewed and approved under regulatory frameworks—the Hatch Waxman Act governing the Abbreviated New Drug Application (ANDA) process and the Biologics Price Competition and Innovation Act (BPCIA) governing the Abbreviated Biologics License Application (aBLA) process respectively—that include specific provisions for resolving patent disputes between the original NDA/BLA holders (i.e., the reference product manufacturers or branded companies) and the ANDA/aBLA holders (i.e., the generic or biosimilar manufacturers). The interplay between these regulatory frameworks and patent litigation creates unique substantive and case management issues that are explored in this Unique Aspects of Biopharma Patent Litigation Chapter. While many issues of substance and case management in biopharma patent cases are handled similarly to other litigated technologies, this Chapter focuses on those issues that are unique to or take on special significance in biopharma patent litigation. For starters, while the pleading standards for biopharma patent cases are the same as non-biopharma patent cases, the consequences of a motion to dismiss may have profound reverberations in terms of statutory remedies in the generic drug/ANDA context in particular. Likewise, this Chapter considers unique discovery issues that arise in generic drug/ANDA and biosimiliar/BPCIA cases, including how to protect and disclose a substantial amount of information before any lawsuit is filed. Furthermore, patent challenges before the Patent Trial and Appeal Board and concomitant requests for stay, which have become a normal fixture in patent litigation in recent years, have unique reverberations in the context of generic or biosimilar patent cases that, by statute, are designed to be litigated within a set period of time. Biologic and pharmaceutical patent litigations also frequently call on courts to balance the public’s interest in encouraging and rewarding the discovery and development of new drugs and biologics against that of making differentiated, life-altering, or life-sustaining therapies available to patients who may benefit from them. Not only are these public interest injunction issues relatively rare in other patent litigation, but their prevalence in biotherapeutic patent litigation has important case management implications, which we explore further in this Chapter. |
