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IP Health Blog

Finnegan’s IP Health Blog provides news and information about notable IP issues relating to health and medicine, including pharmaceuticals, biologics, medical devices, digital health, fitness, wellness, and nutrition, as well as related FDA rulings and guidance.

Editors

Associate Editors

Contributors

About

Arpita Bhattacharyya, Ph.D.: Partner; Palo Alto, CA; +1 650 849 6650; Email

Paul W. Browning, Ph.D.: Partner; Washington, DC; +1 202 408 4134; Email

Justin_Hasford

Justin J. Hasford: Partner; Washington, DC; +1 202 408 4175; Email

Ryan_O'Quinn

Ryan P. O'Quinn, Ph.D.: Partner; Reston, VA; +1 571 203 2426; Email

Jeffrey_Smyth

Jeffrey D. Smyth: Partner; Palo Alto, CA; +1 650 849 6618; Email

Kelly_Horn

Kelly S. Horn: Associate; Washington, DC; +1 202 408 4313; Email

Jordan Fraboni: Associate; Palo Alto, CA; +1 650 849 6646; Email

Kathryn R. Judson: Associate; Atlanta, GA; +1 404 653 6466; Email

Megan_Meyers

Megan L. Meyers: Associate; Atlanta, GA; +1 404 653 6565; Email

Marcelo Barros: Associate; Palo Alto, CA; +1 650 849 6619; Email

Meredith_Boerschlein

Meredith H. Boerschlein: Associate; Washington, DC; +1 202 408 4454; Email

Emily_Gabranski

Emily R. Gabranski: Associate; Washington, DC; +1 202 408 4331; Email

Jordan M. Gringauz: Associate; Washington, DC; +1 202 408 4143; Email

Kenneth S. Guerra: Associate; Washington, DC; +1 202 408 4124; Email

Yoonhee Kim

Yoonhee Kim: Associate; Washington, DC; +1 202 408 4214; Email

Kassandra_Officer

Kassandra M. Officer: Associate; Washington, DC; +1 202 408 4270; Email

Jessica_Roberts

Jessica L. Roberts, Ph.D.: Associate; Washington, DC; +1 202 408 4323; Email

Sonja_Sahlsten

Sonja W. Sahlsten: Associate; Washington, DC; +1 202 408 4329; Email

Christopher W. Weber, Ph.D.: Associate; Washington, DC; +1 202 408 4432; Email

Jason Y. Zhang, M.D.: Associate; Palo Alto, CA; +1 650 849 6732; Email

About This Blog

Recent Insights in IP Health Blog

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IP Health Blog

A Survey of Patents Filed on Methods and Products for Overcoming Jet Lag A Survey of Patents Filed on Methods and Products for Overcoming Jet Lag

September 12, 2022

IP Health Blog

FDA Draft Guidance on Evaluation of Therapeutic Equivalence FDA Draft Guidance on Evaluation of Therapeutic Equivalence

August 4, 2022

IP Health Blog

A Brief Summary of Patent Proceedings Involving Cannabis Patents A Brief Summary of Patent Proceedings Involving Cannabis Patents

June 23, 2022

IP Health Blog

Smart Baby Monitors May Be Considered Medical Devices by FDA Smart Baby Monitors May Be Considered Medical Devices by FDA

June 16, 2022

IP Health Blog

Final FDA Guidance on Safety Considerations for Medication Container Labels and Carton Labeling Final FDA Guidance on Safety Considerations for Medication Container Labels and Carton Labeling

June 10, 2022

IP Health Blog

Defendants Allowed to Hide the Ball on Their Combination of Prior Art References Defendants Allowed to Hide the Ball on Their Combination of Prior Art References

May 5, 2022

IP Health Blog

Considerations for Protecting Trade Secrets in FDA Correspondence Considerations for Protecting Trade Secrets in FDA Correspondence

April 12, 2022

IP Health Blog

ANDA Specification Controls Infringement Analysis, Not Expert Testimony ANDA Specification Controls Infringement Analysis, Not Expert Testimony

March 10, 2022

IP Health Blog

“Show More of You”: Amgen v. Sandoz, Battling it Out on Amgen’s Otezla® Drug “Show More of You”: Amgen v. Sandoz, Battling it Out on Amgen’s Otezla® Drug

January 18, 2022

IP Health Blog

Formulation and Administration Claims Asserted in Hatch-Waxman Pass Muster Formulation and Administration Claims Asserted in Hatch-Waxman Pass Muster

November 8, 2021

IP Health Blog

Federal Circuit Crystallizes BMS’ Apixaban District Court Win Federal Circuit Crystallizes BMS’ Apixaban District Court Win

September 27, 2021

IP Health Blog

Testing the Limits of Therasense: Patent Owner’s Decision Not to Appeal Obviousness Holding Created But-for Materiality and Knowledge of Withheld References Established Intent Testing the Limits of Therasense: Patent Owner’s Decision Not to Appeal Obviousness Holding Created But-for Materiality and Knowledge of Withheld References Established Intent

September 20, 2021

IP Health Blog

Update to the Purple Book in Recent COVID-19 Stimulus Bill and Implications for BPCIA Litigation Update to the Purple Book in Recent COVID-19 Stimulus Bill and Implications for BPCIA Litigation

December 23, 2020

IP Health Blog

FDA Final Guidance on Enhancing the Diversity of Clinical Trial Populations FDA Final Guidance on Enhancing the Diversity of Clinical Trial Populations

November 19, 2020

IP Health Blog

FDA Final Guidance on Amendments and Requests for Final Approval to Tentatively Approved ANDAs FDA Final Guidance on Amendments and Requests for Final Approval to Tentatively Approved ANDAs

November 3, 2020

IP Health Blog

FDA Draft Guidance on Failure to Respond to an ANDA Complete Response Letter Within the Regulatory Timeframe FDA Draft Guidance on Failure to Respond to an ANDA Complete Response Letter Within the Regulatory Timeframe

November 2, 2020

IP Health Blog

A Major Decision Evaluating the Effect of a Skinny Label in a Post-Launch, Non-Hatch Waxman Litigation, Jury Trial World A Major Decision Evaluating the Effect of a Skinny Label in a Post-Launch, Non-Hatch Waxman Litigation, Jury Trial World

October 13, 2020

IP Health Blog

Modernization of the Orange Book Modernization of the Orange Book

September 15, 2020

IP Health Blog

IPO Recommendations for Changes to the Orange Book Listing Form 3542 IPO Recommendations for Changes to the Orange Book Listing Form 3542

September 9, 2020

IP Health Blog

FDA Draft Guidance on Drug-Drug Interaction Assessment for Therapeutic Proteins FDA Draft Guidance on Drug-Drug Interaction Assessment for Therapeutic Proteins

August 21, 2020

IP Health Blog

The Interplay Between the FDA Regulatory Process for Medical Devices and Patent Law – Considerations for 510(k) Submission The Interplay Between the FDA Regulatory Process for Medical Devices and Patent Law – Considerations for 510(k) Submission

August 4, 2020

IP Health Blog

The Interplay Between the FDA Regulatory Process for Medical Devices and Patent Law – FDA Premarket Review of Medical Devices The Interplay Between the FDA Regulatory Process for Medical Devices and Patent Law – FDA Premarket Review of Medical Devices

July 28, 2020

IP Health Blog

Proposed Revisions to Form 3542 with Explanations Proposed Revisions to Form 3542 with Explanations

July 8, 2020

IP Health Blog

FDA Draft Guidance on the Orange Book - Questions and Answers FDA Draft Guidance on the Orange Book - Questions and Answers

June 8, 2020

IP Health Blog

CAFC Holds Medical Device Claims Patent Eligible in CardioNet v. InfoBionic CAFC Holds Medical Device Claims Patent Eligible in CardioNet v. InfoBionic

May 4, 2020