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
Life Sciences Perspectives
Life Sciences Perspectives, published by Goodwin Procter, focuses on legal and regulatory developments affecting the life sciences sector. The blog covers topics such as pharmaceutical and biotechnology transactions, regulatory compliance for drugs, biologics, medical devices, diagnostics, and laboratory testing. It also addresses antitrust issues, healthcare fraud enforcement, data privacy regulations like the EU Data Act, and FDA programs impacting drug development and approval. The blog provides updates on policy changes, enforcement trends, and strategic considerations for companies and investors operating in the life sciences and medtech industries.
Latest from Life Sciences Perspectives - Page 6
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…
FDA’s Laboratory Developed Test (LDT) Final Rule Under OIRA Review
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. …
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…
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…
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…
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…
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
By Miho Kaneko
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…
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…
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…