Welcome to the Goodwin’s Life Sciences Perspectives Blog, a resource specifically aimed at addressing your most frequent and pressing issues and providing insights on current developments.

The challenges across the life sciences industry are as abundant as the opportunities. From tightening federal regulations and market forces to revolutionary innovations, the headwinds are stiff and shifting but they are navigable. We will be tracking emerging issues and developments on private and public company matters, licensing deals and collaborations, patent and IP matters, FDA and healthcare regulatory compliance, and European and Asian developments for life sciences companies. Sign up to receive postings from Goodwin’s Life Sciences Perspectives blog by clicking here.

 

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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Antitrust & Competition Life Sciences Year in Review 2023

Despite increasingly aggressive rhetoric from the agencies, 2022 was largely characterized as “business as usual” in the antitrust world. In contrast, 2023 featured a significant step up in enforcement activity, including multiple challenged transactions and lengthy investigations in the life sciences space. As notable, many of these enforcement activities involved…

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Recent Bayh-Dole Act News: Comments on the Draft Framework; HHS Refuses to March-In on Xtandi; and Delayed Contracting Doesn’t Avoid Bayh-Dole

U.S. universities and academic institutions rely heavily on federal grants to fund their research and generate innovations in life sciences.  Universities often out-license patents protecting inventions created using federal funding to private companies including many startups.  Hundreds of drugs have been developed by collaboration between universities and private industry. The…

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Life Sciences Companies Make Up a Small Portion of the Companies Opting-In to the Unitary Patent; Ireland Announces Referendum Date

Life sciences companies continue to make up a small portion of the companies registering for Unitary Patents. Per the European Patent Office’s statistics portal, as of January 30, 2024 there have been 18,721 registered Unitary Patents. The Uptake Rate is 17.5%. Of this, Medical Technology companies account for 2,266 (or,…

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USPTO Publishes Enablement Guidelines in view of Amgen v. Sanofi

On January 10, 2024, the USPTO published guidelines for assessing enablement in view of Amgen v. Sanofi and other recent court cases (“the Guidelines”). The Guidelines state that they are not intended to “announce any major changes to USPTO practice or procedure” but instead “incorporat[e] guidance from the Amgen decision and several post-Amgen enablement court decisions that…

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