As 2024 has come and passed, we saw another year of significant developments in litigation involving biologics and biosimilars. The following is a recap of the top four legal developments that we covered on the Big Molecule Watch last year.
As was the case with last year’s recap…
The recent decision by the Federal Circuit in Honeywell International Inc. v. 3G Licensing, S.A., issued on January 2, 2025, overturned the Patent Trial and Appeal Board’s (“the Board”) factual and legal holdings in the final written decision of IPR2021-00908. In this article, we delve into the court’s holding and its impact on upcoming patent…
J.P Morgan states that the JP Morgan Healthcare Conference (“JPM”) “is the largest and most informative health care investment symposium in the industry which connects global industry leaders, emerging fast-growth companies, innovative technology creators and members of the investment community”.
On January 15, 2025, Goodwin and KPMG will host their 6th Annual Symposium. Life sciences…
Anyone who attempts to predict the future of intellectual property does so at their own peril: Shattered legal precedents, amended district court policies and procedures, and unexpected new governmental guidance were commonplace this year – and that’s just in the world of patents. Fortunately, BakerHostetler’s IP Practice Group has the talent and experience to not…
On October 16, 2024, the Federal Trade Commission (FTC) announced a revision to its negative option rule. The rule, formally entitled the “Rule Concerning Recurring Subscriptions and Other Negative Option Programs,” is a robust governmental intervention into the marketing and sales of products or services that involve “negative option features.” A “negative option…
A jury will decide if Apple TV+’s Servant infringed Francesca Gregorini’s 2013 indie film The Truth About Emanuel as a rare substantial similarity trial begins this week.
While much of Los Angeles grapples with the devastating destruction and displacement caused by recent wildfires (here’s how to help), a dozen or so lawyers have…
Link to PDF of Ceramtec decision
Google NotebookLM summary:
This document is a court opinion from the United States Court of Appeals for the Federal Circuit in the case of CeramTec GMBH v. COORSTEK BIOCERAMICS LLC, decided on January 3, 2024. The appeal originated from a decision of the United States Trademark Trial and Appeal…
Congratulations to Judge David Leibowitz on his investiture. It was a truly lovely event with great speakers, including Ben Greenberg, Ron Dermer, and Judge Michael Farbiarz. Sen. Marco Rubio (pictured below with Stephanie Casey and Lindsey Lazopoulos Friedman) and his wife Jeanette were also in attendance. Lots of great stories, including about Judge Leibowitz as…
As 2025 begins, we would like to reflect on last year’s regulatory developments in the biologics and biosimilars space.
Here are some of the top regulatory developments from 2024.
1. FDA Approvals in 2024
There were 17 FDA approvals of Biologic License Applications (“BLAs”), including for Autolus Inc.’s AUCATZYL (obecabtagene autoleucel) for the treatment…
As we previously reported, in April of last year, GlaxoSmithKline Biologicals SA and GlaxoSmithKline LLC brought a lawsuit against Pfizer and BioNTech in the District Court for the District of Delaware, alleging that the COVID-19 vaccine, Comirnaty®, infringed five of their U.S. patents directed to mRNA vaccine technology—specifically, U.S. Patent Nos. 11,638,693; 11,638,694; 11,666,534;…
