USA Law and Practice Contributed by: Jim Hurst, Jeanna Wacker, Sam Kwon and Ashley Ross, Kirkland & Ellis
Under FRCP 4(m), a defendant must be served within 90 days after the complaint is filed. Ser - vice can be delayed if service cannot be effect - ed, and the remainder of the deadlines in the case do not run until service is effected. A party can waive formal service in return for an auto - matic extension on the deadline to answer the complaint (FRCP 4(d)). The usual time to a final decision varies great - ly by district. In the District of Delaware, for instance, termination by judgment takes an aver - age of 36.1 months based on data in the past four years; however, it takes 24.1 months in the Eastern District of Texas. 1.6 Requirements to Bring Infringement Action A patent can only be asserted in an infringement action after it is granted. The type of patent asserted varies by type of action. In Hatch-Waxman actions, process pat - ents are not permitted to be listed in the Orange Book and are therefore typically not litigated. However, process patents (eg, process claims for manufacturing biosimilars) can be – and often are – litigated in BPCIA actions. Generally, in order to maintain an action for infringement of a process patent, the process must occur in the USA. Regardless of patent type, the burden of prov - ing infringement remains with the entity assert - ing the patent. 1.7 Pre-Action Discovery/Disclosure Pre-action discovery is generally not available. The closest alternative is asking for an order to depose someone to perpetuate their testimony under FRCP 27. This is a means to preserve evidence that may not be available later. Under
FRCP 27(a)(4), a deposition to perpetuate testi - mony may be used under FRCP 32(a) in district court actions involving the same subject matter if the deposition is admissible. Such depositions are exceedingly rare. However, there are pre-action exchanges in Hatch-Waxman and BPCIA cases. In Hatch-Waxman actions, an ANDA holder chal - lenging an Orange Book-listed patent is required to send a notice letter along with an offer of con - fidential access. This offer of confidential access defines the terms under which the ANDA holder is willing to provide access to their ANDA so the brand company can determine whether a lawsuit may be brought. In BPCIA actions, aBLA holders can – but are not required to – participate in the aforementioned patent dance governed by 42 USC Section 262 (Sandoz Inc v Amgen Inc, 137 S Ct 1664, 1675– 76 (2017)). aBLA filers who do participate in the patent dance must provide their application and manufacturing information within 20 days of the FDA accepting their application for review (42 USC Section 262(l)(2)). The RPS then provides a list of patents they believe are infringed within 60 days of receipt of the applicant’s information under 42 USC Section 262(l)(3). The parties go on to exchange contentions on those patents to then settle on a final set of patents to litigate in BPCIA actions (42 USC Section 262(l)). 1.8 Search and Seizure Orders Search and seizure orders are not available in US patent litigation. Even in discovery, parties are not permitted to search for or remove mate - rials in the same way that search and seizure orders are conducted in other contexts. Instead, parties must use discovery requests – such as
344 CHAMBERS.COM
Powered by FlippingBook