Alert

Recommended Alerts

Sign Up For Alerts

Can They Really Do That? The Specter of Government-Authorized Infringement of Pharmaceutical Patents

The perception that pharmaceuticals in the United States are overpriced, and that patent rights are why, has been a recurrent political theme over the last several years. This view, along with the ongoing novel coronavirus pandemic, has caused some to consider whether the U.S. government should act to ensure affordable access to potentially life-saving medicines.

Read More

Proposed Legislation Would Authorize FDA To Approve Follow-on Biologics


Time to Read: 1 minutes Practices: Life Sciences

Printer-Friendly Version

The "Access to Life-Saving Medicine Act," introduced in late September, would authorize the Food and Drug Administration to approve follow-on biologics that closely resemble previously approved biological products. In its current version, the bill provides manufacturers of follow-on biologics with virtually everything they could ask for. The bill gives FDA substantial discretion to approve follow-on biologics and, in sharp contrast to the current legislative scheme governing drugs, the bill would not afford innovator companies any period of marketing exclusivity whatsoever for their biologic products. As a result, the manufacturers of previously approved biological products would be well-served to follow the forthcoming legislative debate on this issue very closely. For more on the bill and its various provisions, please click "Download PDF" to read Ropes & Gray's client alert.

Printer-Friendly Version

Cookie Settings