IP Health Blog

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

IP Health Blog

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

IP Health Blog

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

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

IP Health Blog

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

IP Health Blog

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

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

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

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

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

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FDA Draft Guidance on Failure to Respond to an ANDA Complete Response Letter Within the Regulatory Timeframe FDA Draft Guidance on Failure to Respond to an ANDA Complete Response Letter Within the Regulatory Timeframe

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

IP Health Blog

Modernization of the Orange Book Modernization of the Orange Book

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

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

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

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

IP Health Blog

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

IP Health Blog

FDA Draft Guidance on the Orange Book - Questions and Answers FDA Draft Guidance on the Orange Book - Questions and Answers

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

IP Health Blog

CAFC Vacates District Court’s Finding of Indefiniteness in Nevro v. Boston Scientific CAFC Vacates District Court’s Finding of Indefiniteness in Nevro v. Boston Scientific

IP Health Blog

FDA Final Guidance on Competitive Generic Therapies FDA Final Guidance on Competitive Generic Therapies

IP Health Blog

FDA Guidance on Safety Testing of Drug Metabolites FDA Guidance on Safety Testing of Drug Metabolites

IP Health Blog

FDA Draft Guidance on Licensure of Biosimilars and Interchangeable Biosimilars for Fewer Than All Conditions of Use for Which the Reference Product Has Been Licensed FDA Draft Guidance on Licensure of Biosimilars and Interchangeable Biosimilars for Fewer Than All Conditions of Use for Which the Reference Product Has Been Licensed

IP Health Blog

FDA Draft Guidance on Biosimilar and Interchangeable Insulin Products FDA Draft Guidance on Biosimilar and Interchangeable Insulin Products