Jeremiah Helm Comments On How Upcoming Supreme Court ‘Skinny Label’ Case Could Impact Hatch-Waxman Litigation
In interviews with Law360 and Life Sciences Intellectual Property Review, Knobbe Martens partner Jeremiah Helm offered insights into the Supreme Court’s decision to hear a petition of the Federal Circuit’s...
Sheila Swaroop Comments on USPTO Memo on U.S. Manufacturing Factors in AIA Reviews
In the Law360 article “Manufacturing Factor Adds More New Twists to AIA Cases,” Knobbe Martens partner Sheila Swaroop weighed in on the U.S. Patent & Trademark Office’s latest memo regarding...
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...