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FDA Guidance on Quality Considerations for Clinical Research Involving Cannabis and Cannabis-Derived Compounds FDA Guidance on Quality Considerations for Clinical Research Involving Cannabis and Cannabis-Derived Compounds
February 24, 2023
IP Health Blog
Patenting Good Vibrations to Reduce Chronic Stress Patenting Good Vibrations to Reduce Chronic Stress
October 25, 2022
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FDA Draft Guidance on Evaluation of Therapeutic Equivalence FDA Draft Guidance on Evaluation of Therapeutic Equivalence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
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
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