October 25-26, 2022
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Event Session

The Incentivizing of Pharmaceutical Innovations in the Biden Administration

October 25, 2022 @ 2:15 PM EST

2:15 PM ET
October 25, 2022

The Incentivizing of Pharmaceutical Innovations in the Biden Administration

View Session Speakers

President Biden has called for the United States Patent and Trademark Office (USPTO) and the Food and Drug Administration (FDA) to work together to leverage their collective expertise to promoting innovation and competition, while working to reduce the cost of pharmaceutical drugs for the benefit of American families.

On July 6, USPTO Director Kathi Vidal wrote on the Director’s Blog that “our patent system must not be used to unjustifiably delay generic drugs and biosimilar competition beyond that reasonably contemplated by law.” Two days later, on July 8, the USPTO filed a petition for rehearing at the Federal Circuit in ImmunoGen Inc. v. Vidal decrying the “well-documented problem of drug manufacturers receiving numerous follow-on patents for trivial modifications that end up delaying generic drugs’ entry to the market.”

Will a message be sent to patent examiners to over scrutinize pharmaceutical innovations? Will patent examiners find it easier to simply reject follow-on patents regardless of the merits of the invention? What is the appropriate balance between incentivizing pharmaceutical innovation and permitting generics to access the market? How will the USPTO work together with the FDA? These and other questions will be addressed by the panel.

Materials*

The Biden Administration is acting to promote competition and lower drug prices for all Americans

Vidal Takes Next Step on Senators’ Call to Curb Inconsistencies in USPTO/FDA Statements

Senate Judiciary Committee Advances USPTO-FDA Collaboration Bill Toward Floor Vote

USPTO to Crack Down on ‘Incremental’ Patents in Response to Biden Executive Order’s Drug Pricing Mandate

Corey Salsberg’s PowerPoint

 

* A Note on Materials: For live, in person programs we apply for MCLE in Virginia, as well as other jurisdictions (see the MCLE tab in the navigation bar above). MCLE regulations require substantive writing on the topic covered during the presentation. The materials provided, often published by IPWatchdog.com authors and contributors, relate to the topic but are not intended to pigeon-hole guest speakers in any way. They are intended to be informative and elucidate the issues that will be discussed, although not necessarily represent the point of view that will be taken by any particular panelist. To date the articles we have selected have always been sufficient to satisfy MCLE authorities. 



Add to Calendar 05/19/2024 12:12 AM America/New_York The Incentivizing of Pharmaceutical Innovations in the Biden Administration

President Biden has called for the United States Patent and Trademark Office (USPTO) and the Food and Drug Administration (FDA) to work together to leverage their collective expertise to promoting innovation and competition, while working to reduce the cost of pharmaceutical drugs for the benefit of American families. On July 6, USPTO Director Kathi Vidal wrote on the Director’s Blog…

Session Speakers

Doreen Y. Trujillo

Partner

VLP Law Group

Drew Hirshfeld

Drew Hirshfeld

Former Acting Deputy Director of the USPTO, Principal

Schwegman Lundberg & Woessner

Corey Salsberg

Vice President and Global Head of IP Affairs

Novartis

Sherry Knowles

Principal

Knowles Intellectual Property Strategies

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