USA Law and Practice Contributed by: Rob Cerwinski, Michael Johnson, Heather M Schneider and Michael B Cottler, Gemini Law LLP
4.3 Paediatric-Use Marketing Authorisations In the USA, there is no paediatric-use marketing authorisation exclusivity analogous to that available under the EU system. 4.4 Orphan Medicines Extensions The USA has orphan drug exclusivity as indicated in 2.2 Regulatory Data and Market Exclusivity and 3.2 Data and Regulatory Exclusivity .
Section 271 (e)(4)(A) specifies that, with respect to an infringing ANDA or 505 (b)(2) product that has yet to receive final approval, “the court shall order the effective date of any approval of the drug or veterinary biological product involved in the infringement to be a date which is not earlier than the date of the expiration of the patent which has been infringed.” If an ANDA or 505 (b)(2) product has already received final approval and launched, however, the traditional four-factor test would apply instead. Section 271 (e)(4)(D) specifies that, with respect to an infringing biosimilar, “the court shall order a per ‑ manent injunction prohibiting any infringement” until patent expiration, so long as the regulatory exclusivity of the reference product has yet to expire. If the exclu ‑ sivity period has expired, however, the court would apply the four-factor test. A permanent injunction is enforceable pending appeal unless stayed. Courts have discretion to grant a stay pending appeal and may condition a stay on the post ‑ ing of a bond. 5.3 Discretion to Award Injunctive Relief (Final or Preliminary) US courts have discretion to deny injunctive relief and award damages, even where infringement is estab ‑ lished. Injunctive relief is not automatic and must sat ‑ isfy equitable principles. eBay Inc. v MercExchange , L.L.C., 547 US 388, 391 (2006). Monetary damages and injunctive relief are not mutu ‑ ally exclusive. Courts may award damages for past infringement while denying or limiting injunctive relief for future conduct. In life sciences cases, public inter ‑ est considerations may be particularly significant, including patient access to medicines, availability of alternative therapies, and public health considera ‑ tions. 5.4 Damages Under 35 USC 284, a court shall award the patent owner damages adequate to compensate for infringe ‑ ment, but not less than a reasonable royalty, plus inter ‑ est and costs fixed by the court. The primary methods for calculating damages in US patent cases are lost profits and reasonable royalties.
5. Relief Available for Patent Infringement 5.1 Preliminary Injunctive Relief
Section 1.3 Preliminary Injunction Proceedings dis‑ cusses the availability of PIs, including under the Hatch-Waxman Act and the BPCIA. As a condition of granting a PI, the court may require the movant to post a bond sufficient to cover costs and damages sustained by any party later found to have been wrongfully enjoined. FRCP 65 (c). The amount of the bond is within the court’s discretion. A PI is enforceable upon issuance of the court’s order, subject to satisfaction of any bond requirement, and is enforced through the court’s contempt powers. A stay of a PI pending appeal may be granted in the court’s discretion, applying equitable considerations. 5.2 Final Injunctive Relief A permanent injunction, if ordered upon a finding of infringement, is issued as part of a final judgment and is ordinarily effective upon entry, unless stayed. Unlike PIs, permanent injunctions generally do not require the posting of a bond. eBay Inc. v MercExchange , L.L.C., 547 US 388, 391 (2006). In general, in deciding whether to grant a permanent injunction, courts apply the traditional four-factor equi ‑ table test to determine whether a permanent injunc ‑ tion is appropriate. Weinberger v Romero-Barcelo , 456 US 305, 311–13 (1982); eBay , 547 US at 391. However, 35 USC 271 (e) has special considerations for drug products under the Hatch-Waxman Act and BPCIA.
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