Paragraph IV Patent Challenges During COVID-19: What's Next?

By Molly Bowman

Just over a year ago, the conversation about generics centered on the number and pace of generic drug approvals by the FDA, including the amount of patent challenge activity that was signaling a very competitive generics marketplace for the products in question.

The FDA has prioritized increasing competition in the generics market to control costs, which has translated to prioritized reviews of ANDA applications for generic drugs. Paragraph IV (i.e., “[a generic applicant certifying] in its ANDA that the patent in question is invalid or is not infringed by the generic product”) patent challenges are a key element in the Hatch-Waxman framework for bringing generic drugs to market more quickly. While the focus on enabling access to affordable drugs has not changed, the state of the world has. As it has with many industries, the coronavirus global pandemic has ushered in extraordinary roadblocks for the pharmaceutical industry.