Federal Circuit Extends 'Good Faith' Shield of Agencies
Client Alert | less than 1 min read | 08.12.13
In Croman Corp. v. U.S. (July 31, 2013), the Federal Circuit upheld the reasonableness of an agency's corrective action after expanding the protestor's argument into a "bad faith" allegation. When the protestor complained that the cancellation of several CLINs was without a rational basis and put forward evidence that indicated the agency's rationale was pretextual, instead of requiring the agency to put forward proof to support its stated rationale, the court relabeled the challenge as a "bad faith" allegation, which it held the protestor had not shown by clear and convincing evidence.
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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.
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