September 23, 2013

Comparing and Contrasting the Divergent Litigation Pathways of Small vs. Large Molecule Products: Examining the Impact of Differing Regulatory Schemes, Challenges Created Under the AIA and Lessons Learned from Recent Biosimilars Litigation in the US & Abroad

Overview

Washington, D.C. partner Mercedes Meyer spoke at the International Congress on Paragraph IV Litigation on September 23-24 in New York City. Mercedes’ panel was titled, “Comparing and Contrasting the Divergent Litigation Pathways of Small vs. Large Molecule Products: Examining the Impact of Differing Regulatory Schemes, Challenges Created Under the AIA and Lessons Learned from Recent Biosimilars Litigation in the US & Abroad.”

The discussion covered:

• Understanding the patent landscape around biologics and the particular challenges it will present;

• Preparing litigation strategies in light of strict deadlines for patent challenges

• Strategic use of preliminary injunctions;

• Considering the impact changes under the AIA will have on biosimilars litigation;

• Post-grant review;

• Reexamination;

• Collateral estoppel; and

• Appeals from a PTO decision

 

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