Benesch Partner Tara Raghavan Quoted in Law360 on Federal Circuit’s Wyeth Patent Ruling

Benesch Intellectual Property Partner Tara Raghavan was quoted in a recent Law360 article discussing the Federal Circuit’s decision invalidating Wyeth LLC’s cancer treatment patents based on a lack of enablement. The article examines how pharmaceutical companies can face significant patent risks when claiming broad dosage ranges without sufficient evidence demonstrating which dosages are both safe and effective.

Raghavan noted that patent drafters should be mindful of how dosage-related claim language may overlap with concepts typically associated with FDA review.

“This particular case gives you a clear line as to how the claim language can inadvertently bring in FDA-related concepts. If your language itself says you need a therapeutic dosage or a unit dosage, that implicates that FDA-related safety and efficacy standard, even if it doesn’t require it to have a workable dosing regimen.”

The article also explores the evolving landscape of patent enablement in the pharmaceutical industry, highlighting recent decisions that continue to shape how courts evaluate whether patent specifications provide sufficient support for claimed treatments and dosage ranges.

Read the full article here.