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FDA Publishes SPL Guide for MoCRA Facility Registration and Product Listings

Client Alert | 1 min read | 11.01.23

On October 13, 2023 he FDA announced that two of the requirements set forth in the Modernization of Cosmetics Regulation Act of 2022 (MoCRA)— facility registration and product listing—will be included as part of the Structured Product Labeling (SPL) framework. SPL is a document formatting standard adopted by FDA for exchanging product-related information. 

The FDA previously developed Cosmetics Direct, a draft electronic portal for submissions under MoCRA. Companies who will use Cosmetics Direct may submit facility registration information and/or product listings by importing an SPL document, which contains user friendly data entry forms, performs initial validation, creates and saves the SPL submission, and submits the SPL document to FDA for internal processing.

In order to assist those who will be using and uploading SPL documents, the FDA also published a SPL Implementation Guide with technical conformance criteria for SPL documents. According to this Guide, importing an existing SPL document will be useful for bulk submissions, and users will be able to copy a successfully uploaded SPL document as a starting point for their own submission.

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Client Alert | 2 min read | 05.27.25

Federal Circuit Resolves Circuit Split on Scope of IPR Estoppel

As part of the 2012 America Invents Act, statutory estoppel was included to balance the interests of patent owners and patent challengers following an inter partes review (“IPR”).  Estoppel prevents an IPR petitioner from later asserting in court that a claim “is invalid on any ground that the petitioner raised or reasonably could have raised” during the IPR.  35 U.S.C. § 315(e)(2).  As applied, estoppel prevents petitioners from later relying in district court or in ITC proceedings on most patents or printed publications – the limited bases upon which petitioner can rely in an IPR.  But a question remained, and contradictory district court decisions arose, as to whether petitioners would be estopped from relying on a prior art commercial product (known as “device art,” which could not itself have been raised in the IPR) even if a printed publication describing the product (i.e. a patent or technical manual) was available and presumably could have been raised. ...