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CAFC Holds Agency Standardization Decision Outside COFC Jurisdiction

Client Alert | 1 min read | 01.31.18

In a January 23 decision, AgustaWestland North America, Inc. v. U.S., the Federal Circuit reversed a COFC decision that had enjoined the U.S. Army from sole source procuring Airbus UH-72A Lakota helicopters to meet the Army’s standardized training helicopter needs.  The CAFC first held that the Army’s “Execution Order” standardizing to the UH-72A was not a procurement decision because it did not discuss procuring helicopters and instead assessed existing Army assets, and therefore the COFC lacked jurisdiction.  The CAFC then rejected the COFC’s conclusion that the Army’s decision to sole source as a “follow-on contract for . . . production of a major system” was flawed because (1) the COFC abused its discretion in supplementing the administrative record; (2) the procurement qualified as a “follow-on” even absent a preceding contract; (3) the J&A was sufficiently supported; and (4) that the CO signed before legal or competition advocate review was not prima facie arbitrary and capricious.

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Client Alert | 7 min read | 09.14.26

AI in Life Sciences: Ten Legal Considerations and Risks of AI Use in Drug Discovery and Development

Over the past several years, the biopharmaceutical industry has embraced artificial intelligence and machine learning (AI/ML) in near lockstep with the pace of AI/ML innovations. Today, industry leaders are using AI/ML to, among other things: discover and assess biological pathways, target chemical structures and sequences; design proteins; model pre-clinical and clinical trials; recruit and screen potential patient populations; evaluate clinical trial results and biomarker data; prepare regulatory filings; and manage supply chains. Deployment of new AI/ML models promises extraordinary advances in pharmaceutical development. However, as with any technological and scientific advances, the use of AI/ML also poses substantial legal risks that life sciences companies need to consider and proactively manage. ...