[Panel 5] WG10 Chapter on Biopharma Patent Litigation

Biologic and pharmaceutical patent litigation differs from other types of patent litigation in significant ways. They are frequently the result of statutory provisions for resolving patent disputes that are part of the generic drug or biosimilar approval framework. These provisions create unique substantive and case management issues. Where innovative biologic and pharmaceutical products requiring first-time FDA approvals are involved, other unique legal and case management issues often arise. 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 and/or life-sustaining therapies available to patients who may benefit from them.