USA Law and Practice Contributed by: Rob Cerwinski, Michael Johnson, Heather M Schneider and Michael B Cottler, Gemini Law LLP
As noted in 1.7 Pre-Action Discovery/Disclosure , there is generally no pre-action discovery in the United States except for pre-suit exchanges under the Hatch-Waxman Act and BPCIA. Other than that, a patentee must conduct its own investigation using the information that is available to it and ensure that it can satisfy the requirement of FRCP 11 that it has a valid claim formed after a reasonable inquiry under the circumstances. When pre-action exchanges are made under the Hatch-Waxman Act or BPCIA, they generally cannot be used in other jurisdictions because they are gov ‑ erned by confidentiality agreements between the par ‑ ties that restrict their dissemination and use. 1.9 Declaratory Relief US federal courts may grant declaratory relief in pat ‑ ent disputes when there is an actual case or con ‑ troversy within the meaning of Article III of the US Constitution. Declaratory relief is discretionary under the Declaratory Judgment Act and requires a real and immediate dispute between parties with adverse legal interests, rather than a hypothetical or speculative disagreement. Aetna Life Ins. Co. v Haworth , 300 US 227, 239–41 (1937). A party seeking declaratory relief does not need to breach a licence or otherwise expose itself to liability before bringing suit. MedImmune, Inc. v Genentech , Inc. , 549 US 118, 127–29 (2007). In life sciences patent litigation, declaratory relief commonly takes the form of declarations of non- infringement, invalidity, or unenforceability of specific patent claims. US law does not recognise “Arrow dec ‑ larations”; declaratory relief must be tied to identified patent rights and an actual controversy. In BPCIA litigation, statutory limits apply. For exam ‑ ple, if a biosimilar applicant fails to comply with the information-exchange provisions of the patent dance, it may be barred from bringing certain declaratory judgment actions relating to patents that could have been identified during that process. 42 USC 262 (l)(9).
under which documents will be produced, then the ANDA filer can produce those documents so that the NDA holder can determine whether a lawsuit may be brought for infringement. Under the BPCIA, an aBLA filer can – but is not required to – participate in an exchange of informa ‑ tion colloquially referred to as the “patent dance.” 42 USC 262; Sandoz Inc. v Amgen Inc. , 137 S. Ct. 1664, 1675–76 (2017). If the aBLA filer elects to engage in the patent dance, it must produce the aBLA and “such other information that describes the [manufacturing] process” within 20 days of the FDA acceptance of the BLA for review. 42 USC 262 (l)(2). That produc ‑ tion can be done pursuant to confidentiality terms set forth in the BPCIA or pursuant to the parties’ private agreement. The reference product sponsor (RPS) then provides a list of patents it believes are infringed within 60 days of receipt of the applicant’s information under 42 USC Section 262 (l)(3). The parties then exchange contentions on those patents to agree on a final set of patents to litigate in a BPCIA action. 42 USC 262 (l). Pre-action discovery is otherwise not generally avail ‑ able in the United States, with the exception of asking for an order to depose someone to perpetuate his or her testimony under FRCP 27. FRCP 27 provides a means to preserve evidence, such as when an indi ‑ vidual is terminally ill and may be deceased before an infringement suit is filed. 1.8 Search and Seizure Orders Search and seizure orders are not available for patent infringement in the United States. Although the USA allows for robust discovery under the FRCP, those rules do not allow parties to search for or remove materi ‑ als from an accused infringer in the same way that search and seizure orders are available in other coun ‑ tries. Instead, parties must submit discovery requests such as requests for production of documents and information (FRCP 34), interrogatories (FRCP 33), and requests for admission (FRCP 36). Parties may seek inspections of the accused infringer’s premises under FRCP 34 (a)(2), which can be used to inspect factory equipment or other machinery that cannot easily be produced.
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