Jiazhong (Jason) Luo, Ph.D.

Duane Morris LLP

Articles

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District Court of Delaware Rules for Generic Pharma's Use of Skinny Label, but Permits Induced Infringement Suit to Proceed Against Insurer

USA - February 10 2022 In the recent opinion of Amarin Pharma v. Hikma Pharms. U.S. (No. 20-1630-RGA-JLH), the District Court of Delaware dismissed Amarin's complaint…

Frederick R. Ball, Patrick C. Gallagher

FDA's Additional Draft Guidance on Biosimilarity and Interchangeability to Seek Comments and Suggestions by January 19, 2021

USA - December 11 2020 This guidance, when finalized, will facilitate the development of biosimilar and interchangeable products as FDA intends. The U.S…

Frederick R. Ball, Patrick C. Gallagher, Ph.D.

Federal Circuit Holds That, for Venue Purposes, Patent Infringement Occurs Only in Districts Where Actions Related to ANDA Submissions Occur

USA - November 18 2020 The Valeant holding further narrows choices of venue in Hatch-Waxman cases after TC Heartland, and may benefit domestic generic…

Frederick R. Ball, Anthony J. Fitzpatrick, Patrick C. Gallagher, Ph.D.

Federal Circuit Finds Induced Infringement of Drug Patent, Even When Skinny Label Was Used

USA - October 30 2020 The majority’s holding is likely to bring uncertainty to generic companies’ use of skinny labels to avoid infringement claims. In a…

Frederick R. Ball, Patrick C. Gallagher, Ph.D.

FDA Publishes Redraft of 510(k) Third Party Review Program

USA - November 20 2018 Section 523 of the Federal Food, Drug, and Cosmetic (FD&C) Act codifies the 510(k) Third Party Review Program (3P Review Program), which authorizes…

Carolyn A. Alenci, Frederick R. Ball, Lisa W. Clark, Stephen M. Honig, Jennifer A. Kearns, Vicki G. Norton, JOHANN YI-DER LIN, PH.D., Ryan Smith