One Battle After Another: Broad Institute Wins at PTAB in CRISPR Dispute
Key Takeaways: Interference proceedings, though increasingly rare, are heavily evidence-based and determine which party is the first inventor when two or more applicants claim the same patentable invention. Sometimes, an...
USPTO Introduces Pre-Order Papers for Patent Owners in Ex Parte Reexaminations
Key Takeaway: With the decline of inter partes review (IPR) proceedings and the significant increase in ex parte reexamination (EPR) proceedings, the U.S. Patent and Trademark Office (USPTO) is allowing...
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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