Archive for March, 2024


USPTO Emphasizes Searches of FDA Databases for Pharmaceutical Patent Applications

In response to Biden Administration goals regarding increasing pharmaceutical competition and lowering drug prices, the USPTO recently released training provided to the USPTO examining corps on utilizing publicly available FDA and NIH databases for prior art searches. The goal of the training is to ensure that all relevant prior art…

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2023-2024 Key Trends and Updates: Securities Litigation Against Life Sciences Companies Webinar

In this webinar, Caroline Bullerjahn, Tucker DeVoe, and Justin Ward from Goodwin, and Frank Schneider from Cornerstone Research will discuss key updates and recent trends concerning securities class actions filed against publicly traded pharmaceutical, biotechnology, medical device and healthcare product and services companies (collectively, “life sciences companies”), which continue to…

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FDA’s Laboratory Developed Test (LDT) Final Rule Under OIRA Review; Subcommittee on Health to Hold Hearing on Regulation of Diagnostic Tests

On March 1, 2024, the Office of Information and Regulatory Affairs (“OIRA”), Office of Management and Budget (“OMB”), Executive Office of the President received the final version of FDA’s rule on regulation of laboratory developed tests (“LDTs”) for administrative review.  Having swiftly moved to OIRA review in under 5-months from…

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USPTO’s New Guidance on AI-Assisted Inventions: The Impact on the Use of AI in the Life Sciences

On February 12, 2024, the US Patent Office and Trademark Office (USPTO) released the Inventorship Guidance for AI-assisted Inventions (the Guidance). We previously discussed the Guidance here. Following up on the Guidance, the USPTO released two examples illustrating what the USPTO considers proper inventorship analyses for AI-assisted inventions. Each example sets…

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