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Solicitor General Weighs in (Sort of) on Rule 9(b)

Client Alert | 1 min read | 02.27.14

In October 2013, the Supreme Court invited the Solicitor General to express the government's views on a pending petition for certiorari in U.S. ex rel. Nathan v. Takeda Pharmaceuticals, whose central issue concerns the requisite level of particularity required by Rule 9(b) in FCA cases. The Solicitor General has now asked the Supreme Court to deny the relator's petition, calling the case "not a suitable vehicle" for resolving the particularity question (because the lower court reached the correct result on other grounds), while expressing the government's view that "a qui tam complaint satisfies Rule 9(b) if it contains detailed allegations supporting a plausible inference that false claims were submitted to the government, even if the complaint does not identify specific requests for payment"(emphasis added).


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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. ...

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