USA Law and Practice Contributed by: Jim Hurst, Jeanna Wacker, Sam Kwon and Ashley Ross, Kirkland & Ellis
1.2 Defendants/Other Parties to an Action Typically, the entities named in life sciences law - suits are those that are named as sponsors of US Food and Drug Administration (FDA) filings such as New Drug Applications (NDAs), Abbre - viated New Drug Applications (ANDAs), abbre - viated Biologics Licence Applications (aBLAs), and Biologics Licence Applications (BLAs). In a typical Hatch-Waxman suit, for example, paten - tees will sue the entity that filed the ANDA. Beyond this, determining which entities will be sued is fact-dependent. Entities such as sup - pliers, distributors and doctors are rarely sued in typical Hatch-Waxman or Biologics Price Competition and Innovation Act (BPCIA) actions because these actions often occur before the accused products are approved and distributed. Suppliers are more likely, for example, to be the subject of subpoenas for discovery where the accused product is not approved. 1.3 Preliminary Injunction Proceedings PIs are available in ANDA proceedings. Under the ANDA framework, a 30-month stay ensues if a brand product patent owner files an infringe - ment suit against generics applicants within 45 days of receiving an ANDA notification (21 USC Section 355(j)(5)(B)). In addition, infringement by submitting an ANDA under Section 505(j) of the Federal Food, Drug and Cosmetic (FD&C) Act could result in a court-ordered delay of prod - uct approval until at least the expiration of the infringed patent under 35 USC Section 271(e) (4)(A). Otherwise, PIs are ordered if the four-factor test is met. A plaintiff must establish that: • they are likely to succeed on the merits;
• they are likely to suffer irreparable harm in the absence of relief; • the balance of equities tips in the plaintiff’s favour; and • an injunction is in the public interest (Win - ter v Natural Res Def Council, 555 US 7, 20 (2008)). The Federal Circuit has held that “no one fac - tor, taken individually, is necessarily dispositive” (Chrysler Motors Corp v Auto Body Panels of Ohio, Inc, 908 F.2d 951, 953 (Fed Cir 1990)). A strong showing of likelihood of success and irreparable harm can overcome a weaker show - ing, for example, on balance of hardship or adverse public interest. Demonstrating a tendency that is somewhat peculiar to life sciences cases, a court may con - sider whether the accused product provides a patient population with a unique role that cannot be replaced (Hybritech Inc v Abbott Laborato - ries, 849 F.2d 1446, 1458 (Fed Cir 1988)). On the other hand, courts may also consider whether an ANDA filer’s launch will irreparably harm the market otherwise dominated by a brand product (Abbott Lab’ys v Sandoz, 544 F.3d 1341, 1361- 62 (Fed Cir 2008)). Factors such as the impact on patient populations and changes in paten - tees’ market shares are considered even if the subject matter of the cases differs (eg, cases involving pharmaceutical products or medical devices). See, for example, Abbott, 544 F.3d at 1361-62 and Hologic, Inc v Senorx, Inc, 2008 WL 1860035 at *19 (ND Cal 25 April 2008). Courts may issue preliminary injunctions (PIs) only after notice has been provided under FRCP 65. Alleged infringers can file evidence to oppose motions for PIs. The average timing from filing to a decision for a PI varies across districts – for instance, based on data in the past four years,
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