Paragraph IV Litigation, IPRs, and New Settlement Risks

This CLE course will guide counsel on pharmaceutical-related patent challenges from strategy to settlement. The panel will discuss the interplay between Paragraph IV litigation and post-grant proceedings, and where multiple generic challengers fit in the exclusivity scheme. The presenters will also examine critical issues in Inter partes review (IPR) challenges involving pharmaceutical patents. Finally, the presenters will discuss new risks to settlement in light of the changing landscape surrounding antitrust review of pharmaceutical patent settlements.

IPR proceedings are a powerful tool for companies to challenge pharmaceutical patents. The number of pharmaceutical-related challenges using the IPR process should continue to climb, given the advantages that IPRs offer compared to district court litigation, as well as the increasing number of abbreviated new drug applications filed with the FDA.

All of this is based on the lower standard of proof and a panel of judges with technical expertise as compared to the federal district courts. As a result, the IPR process is an attractive option for challenging pharmaceutical patents over litigating them in federal court. IPR challenges alone or in conjunction with district court litigation are becoming increasingly common concerning pharmaceuticals.

And should companies instead wish to litigate with the prospect of settlement in mind, ever changing legal rules at both the federal and state levels impact strategy and decision making.

Listen as our authoritative panel of patent attorneys and litigators examines the interplay between Paragraph IV litigation and post-grant proceedings. The panel will also discuss critical issues in post-grant challenges involving pharmaceutical patents as well as how pharmaceutical patents fare in post-grant challenges. The panel will then guide counsel on new risks to patent litigation settlements given evolving law.