ARTICLES BY PATRICK C. GALLAGHER
-
![legal_law_scales_justice]( "Biosimilar Regulatory Inefficiencies: Would Data Sharing Violate The U.S. Constitution?")
Biosimilar Regulatory Inefficiencies: Would Data Sharing Violate The U.S. Constitution?10/11/2018One of the regulatory inefficiencies the FDA is trying to address is the current requirement for bridging studies to submit data comparing a biosimilar to a non-U.S. licensed product.
-
![Will EU Patent System Changes Speed Market Entry For Biosimilars?]( "Will EU Patent System Changes Speed Market Entry For Biosimilars?")
Will EU Patent System Changes Speed Market Entry For Biosimilars?11/21/2017In October 2017, the European Commission issued a consultation seeking input from the public regarding whether improvements can be made to the patent system. The policy questions underlying patent extensions and research exemptions could have a far-reaching impact.
Patrick C. Gallagher
Patrick C. Gallagher, Ph.D., is a partner in Duane Morris’ Boca Raton office. He chairs the firm’s Pharmaceuticals and Biopharmaceuticals Litigation and Regulatory group. Gallagher practices in the area of intellectual property and regulatory law assisting pharmaceutical companies, compounding pharmacies, and others in the agricultural, chemical, and biotechnology industries with intellectual property and regulatory matters.