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<a data-mce-href="https://www.federalregister.gov/documents/2024/01/10/2024-00259/guidelines-for-assessing-enablement-in-utility-applications-and-patents-in-view-of-the-supreme-court" href="https://www.federalregister.gov/documents/2024/01/10/2024-00259/guidelines-for-assessing-enablement-in-utility-applications-and-patents-in-view-of-the-supreme-court" data-mce-selected="inline-boundary">﻿USPTO Provides enablement guidelines in light of the U.S. Supreme Court decision in Amgen Inc. et al. v. Sanofi et al.</a>

USPTO Guidelines on Enablement

EU Flags in front of European Commission European Union Flags

Blocking effect and License Agreement considerationsAccording to Art. 83(3) UPC, opt outs can be requested "Unless an action has already been brought before the Court".&nbsp;Any action relating to the patent brought by the patent proprietor, the applicant, the entitled person, and the licensee before the UPC blocks an opt-out. Naturally, an action brought before a national court does not block an opt-out. It should be noted that the date of filing documents instituting the proceedings with the Court is decisive and not when the defendant is served directly by the claimant (Art 32(1)(a) Brussels Ia Reg. See Rules 270-275 RoP for service inside and outside of the contracting member states). &nbsp;&nbsp;Art. 47 UPCA provides parties that are entitled to bring an action according to Art. 32UPCA. The holder of an exclusive license in respect of a patent is entitled to bring actions before the UPC, provided that the patent proprietor is given prior notice (Art. 47(2) UPCA). The holder of a non-exclusive license is not entitled to bring actions before the UPC, unless the patent proprietor is given prior notice and expressly permitted by the license agreement (Art. 47(3) UPCA).&nbsp;However, what if the licensee violates its contractual agreement and initiate a proceeding before the UPC without giving notice to the patent proprietor? Although this action is not admissible, it is not clear whether an inadmissible action brought by a party (e.g. exclusive licensee) before the UPC would still block the patent proprietor from opting out. Thus, it is recommended revisit the agreements and amend related clauses to state clearly the obligations of the licensee subject to penalty. &nbsp;

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USPTO Guidelines on Enablement

UPC: Blocking effect and License Agreement considerations