USPTO Director to Consider U.S. Manufacturing and Small Business Status When Instituting or Denying IPR and PGR Petitions
Key Takeaways Effective immediately, the USPTO will consider whether a patent challenger’s accused products or a patent owner’s products are manufactured in the United States as additional factors in the...
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...
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...