generic drugs – Duane Morris Life Sciences Law

August 8, 2022 by Duane Morris

Coordinating IP and Regulatory Filings Can Minimize the Risk of Inequitable Conduct Before the PTO

On July 29, 2022, the U.S. Patent and Trademark Office (PTO) published a Notice on the Duties of Disclosure and Reasonable Inquiry During Examination, Reexamination, and Reissue, and for Proceedings Before the Patent Trial and Appeal Board. The notice was part of the PTO’s response to President Joe Biden’s July 2021 Executive Order on Promoting Competition in the American Economy. It also answered Congress’ call for PTO action following the Federal Circuit’s September 2021 ruling that a drug formulation patent was unenforceable based on a drug manufacturer’s inconsistent disclosures to both the PTO and the FDA. In view of the notice, companies should review the interface between their IP and regulatory functions to confirm that their interoperation (or lack thereof) does not run afoul of a patent applicant’s duties of disclosure and reasonable inquiry to the PTO.

To read the full text of this Duane Morris Alert, please visit the firm website.

September 8, 2020 by Duane Morris

FDA’s New MAPP Shows the Route to Changing Ownership of Generic Drug Applications

The U.S. Food & Drug Administration (FDA) recently issued a new Manual of Policies and Procedures (MAPP), in which it explains the Office of Generic Drugs’ (OGD) policy on facilitating changes to generic drug applications and updating the Orange Book to reflect those changes.

MAPP 5242.1 makes clear that the policies, processes and procedures for changing ownership of an application differ based on whether the change is effected by a simple transfer of ownership or whether it results from a corporate merger or acquisition.

To read the full text of this Duane Morris Alert, please visit the firm website.

June 26, 2019 by Duane Morris

FDA Adds Useful Information to the ANDA Paragraph IV Certifications List for Better Transparency and Predictability

The U.S. Food and Drug Administration took another step to implement its Drug Competition Action Plan on June 18, 2019, by updating the information provided in the Paragraph IV Certifications List. The updated list will provide greater transparency regarding Paragraph IV certifications and potential exclusivities. That transparency will in turn lead to greater predictability for generic manufacturers regarding the potential timing of approval for their ANDAs and the potential degree of competition. The additional information will also give the public better insight into the status of generic regulatory exclusivities and the potential future availability of lower-cost generic alternatives for specific drug products.

View the full Alert on the Duane Morris LLP website.

December 18, 2018December 18, 2018 by Duane Morris

FDA Withdraws Proposed Generic Drug Labeling Rule

The U.S. Food and Drug Administration recently announced it will withdraw a proposed rule that would have required generic drug manufacturers to independently update their drug labels with new information. The proposed rule, Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products, would have imposed on generic drug manufacturers the same labeling-update mandates that now apply only to brand-name drug manufacturers.

To read the full text of this Alert, please visit the Duane Morris website.