Life Sciences and Pharma IP Litigation 2025

USA Law and Practice Contributed by: Jim Hurst, Jeanna Wacker, Sam Kwon and Ashley Ross, Kirkland & Ellis

11. Collective Redress 11.1 Group Claims

Although a mediation is normally not binding, an arbitration usually resolves the case on the merits. In an arbitration, parties present evi - dence and argue their positions before a neutral arbitrator. The procedural and evidentiary rules are usually set according to an arbitration agree - ment. If an arbitration is binding, for example, a party may not be able to reject the arbitration decision.

Group claims in US life sciences litigation often proceed as class actions under Federal Rule of Civil Procedure 23. To certify a class, plaintiffs must show numerosity, commonality, typicality and adequate representation. The court must also be satisfied that common legal or factual issues predominate and that the class action for - mat is superior to other methods of adjudication. In the pharmaceutical and medical device arena, class actions frequently arise in product liability, false advertising, antitrust, and securities fraud cases. However, class actions are rare in Hatch- Waxman litigations. Instead of class actions, some cases are consolidated for pre-trial pro - ceedings through multidistrict litigation (MDL) under 28 USC Section 1407. See, eg, In Re: Aflibercept Patent Litigation, MDL No 1-24-md- 03103 (NDWV). MDLs streamline discovery and other pre-trial matters while allowing individual cases to retain their separate identities.

10. Settlement/Antitrust 10.1 Considerations and Scrutiny

The Federal Trade Commission pays particular attention to settlements in life sciences litigation, and certain state laws may furthermore restrict the scope and content of settlements between such parties. NDA applicants are not permit - ted to “pay for delay” of generic drug entry, for example (FTC v Actavis, Inc, 570 US 136, 140 (2013)). Avoiding uncertainties and litigation costs, however, is permissible. Antitrust liabilities may also attach to patent misuse, inequitable conduct, and product hopping.

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