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 be a primary
Latest from Life Sciences Perspectives - Page 6
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 the publication of the proposed
Major Life Sciences Licensing Deal Trends in China in 2023
This is the first of two articles focused on 2023 life sciences deals in China. The second article, which is coming soon, looks at trends in M&A.
In 2023, there were 240 reported life sciences licensing deals in China, an increase of almost 50% compared to 2021.
That includes 70 out-license deals involving Chinese companies
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 forth
Goodwin’s Annual Rare Disease Symposium
Goodwin’s Life Sciences team will be hosting an upcoming event in our Boston office on March 13, 2024 to spotlight the critical work being done to address the 7,000+ rare diseases that impact more than 300 million people globally.
Join us in person in our Boston office or attend virtually for our Annual Rare Disease
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 more “novel” theories of harm
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 Bayh-Dole Act of 1980 governs
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, 11.8%) of the registrations. This
K-Fee Provides a Warning to Life Sciences Companies – What You Say in Foreign Prosecution May Affect Your U.S. Claim Scope
On December 26, 2023, the United States Court of Appeals for the Federal Circuit issued its decision in K-Fee System GMBH v. Nespresso USA, Inc. While nominally a case related to coffee makers, its teachings are highly applicable to life science companies as they tend to file large numbers of ex-U.S. patent cases. The lesson:
Master(ing) Protocols for Randomized Umbrella and Platform Trials
The U.S. Food and Drug Administration (FDA) recently issued a draft guidance, “Master Protocols for Drug and Biological Product Development”, that echoes and builds on principles that the Agency previously set forth in guidance for COVID-19 master protocols (2019), master protocols in oncology (2022) and clinical trials for multiple versions of cellular