IP Considerations Following FDA Announcement on Flexibility for Cell and Gene Therapies
Key Takeaways: Manufacturing processes of cell and gene therapies (CGTs) may remain fluid well into development and even after FDA approval, and therefore sponsors of CGTs may benefit from patent...
Wu-Tang Style – Can Music Be a Trade Secret?
Key Takeaway: Due to the unique release of the Wu-Tang Clan album Once Upon a Time in Shaolin, a federal district court in the Second Circuit has ruled that the...
New FDA Guidance Allows Biosimilar Applicants to Use Data From Outside the U.S. To Accelerate Their Approval in the U.S.
Key Takeaway: New FDA guidance released on February 23, 2026, and March 9, 2026, signals a continued shift toward regulatory flexibility aimed at accelerating approval of biosimilar treatments for rare...
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