USA Law and Practice Contributed by: Rob Cerwinski, Michael Johnson, Heather M Schneider and Michael B Cottler, Gemini Law LLP
Inc. v Amgen Inc. , 2019 WL 3290167 at *2–3 (D. Del. 18 July 2019). PIs rarely rise or fall solely based on balancing hard ‑ ships or public interest. With respect to the former, courts generally consider potential harm to the pat ‑ entee, including potential loss of market exclusivity, price erosion, and downstream financial impacts on, eg, R&D, and compare that to harm that an injunction would impose on the defendant, including potential loss of investment in manufacturing and marketing. In evaluating public interest, courts often weigh, eg, the importance of protecting patent rights, the pub ‑ lic’s interest in patients being afforded access to lower cost medicines, and whether the accused product provides a patient population with a unique role that cannot be replaced even by the brand. Courts may issue PIs only after notice has been pro ‑ vided under Federal Rule of Civil Procedure (FRCP) 65. Motions for PIs are filed as part of a federal pat ‑ ent case, either with a complaint or later in litigation. The defendant is immediately provided notice of the request and, pursuant to any applicable local rules and/or court order, can submit an opposition. The opposition, like the motion itself, generally includes expert declarations and other evidence. Often, PI pro ‑ ceedings will amount to “mini trials,” with depositions, live testimony, and oral argument. The court will weigh the evidence and decide whether a PI is warranted. Although they are available in the Hatch-Waxman context, requests for PIs are not common. Under the ANDA framework, a 30-month stay ensues if a brand product patent owner files an infringement suit against generic applicants within 45 days of receiving an ANDA notification. 21 USC 355 (j)(5)(B). Because of the 30-month stay, the parties usually have time to litigate any patent disputes before the ANDA filer can receive final approval and be able to launch. That said, PI motions are possible after the expiration of the 30-month stay and final approval, depending on what patent disputes are outstanding at that point and whether the defendant threatens to “launch at risk.” Requests for PIs are more common in biosimilar cases under the BPCIA. In BPCIA cases there are no auto ‑ matic 30-month stays of approval or automatic stays
of approval after a finding of patent infringement (but see 35 USC 271 (e)(4)(D)). Requests for PIs are nor ‑ mally triggered by a notice of commercial marketing (NCM) by the aBLA applicant to the reference sponsor, which must be given no less than 180 days before commercial marketing begins. The notice gives the patentee time to seek a PI and for the court to pre ‑ side over PI proceedings, if requested by the sponsor, before a product launch. 1.4 Structure of Main Proceedings on Infringement/Validity In the United States, infringement and validity pro ‑ ceedings are generally handled together. For example, a patent holder may sue a defendant for infringement, and the defendant may raise affirmative defences or counterclaims related to non-infringement and invalid ‑ ity. The defendant may also raise equitable defences such as laches, estoppel, or patent misuse. These defences are typically tried together although it is pos ‑ sible that certain equitable defences may be bifur ‑ cated at the discretion of the court. If damages are at issue, a defendant generally has a constitutional right to a jury trial under the Seventh Amendment to the US Constitution. However, most cases brought under the Hatch-Waxman act are insti ‑ tuted before a product has been launched during a 30-month stay of approval, and thus damages are not at issue. These cases are typically tried to the court rather than a jury (which is referred to as a “bench trial”). When damages are at issue, they may be han ‑ dled at the same time as other issues or in a bifurcated manner, either upon request of the parties or by sua sponte order of a court. It is possible to file patent actions while the Patent Office is conducting an IPR, in which the court may decide whether to stay the case. The impact of a potential IPR will be discussed below in 1.16 Require- ments to Bring Infringement Action . 1.5 Timing for Main Proceedings on Infringement/Validity There is no formal statute of limitations for patent infringement actions in the United States, although a patent holder may only recover for damages going back six years from the filing of the complaint. 35 USC
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