Navigating Administrative Law: Understanding the Basics of Challenging Federal Agency Decisions

Introduction In the complex landscape of governance, federal agencies wield significant authority in executing and enforcing laws enacted by Congress. These agencies, however, are subject to oversight through administrative law, which provides a structured framework for individuals and entities to contest agency decisions. This article aims to explain some foundational principles of challenging federal agency […]

Recent Developments in Medical Device Patent and FDA Law

Patent litigation in the medical device area continues. Along with pharmaceutical patent litigation, medical device patent litigation continues to provide important rulings and case law precedent. Because of the large-scale investment needed to bring medical devices to the market, device sponsors need certainty about the law and its application to ensure a return on the […]

Patent Infringement Damages and Injunctions – The Basics

Patents, as one part of intellectual property protection, provide a valuable property right and play an important role in economic development, a reward for innovations, add to the technological knowledgebase, and increase the general welfare. Patentees obtain patents for defensive purposes (file applications for publication and issuance to create prior art against others); commercial purposes […]

Why Patent? Ways to Monetize Patents

Patents, as one part of intellectual property protection, provides a valuable tool for protecting ideas, R&D, and business growth. It is a political policy decision of how patents are obtained, maintained, enforced, etc. Different countries have different views on patent policy. For many, though, patents are a driving force for economic development. And for other […]

Life Sciences Hot Issues from 2022 and Upcoming 2023 Ones

Introduction Life sciences patent and FDA law had its fair share of events in 2022. We highlight several interesting areas in 2022 and then profile some upcoming issues in 2023. Some of the issues are related to drug policy, some about FDA’s operations, and some about patents. Supreme Court Updates The US Supreme Court was […]

Billion Dollar Verdicts Wiped Out Due to Patent Law’s Written Description

Imagine your billion dollar win wiped out later. You’d be mad. You’d wonder how that happened. You’d ask if you did anything wrong to deserve that wipe out. You’d ask if you could have done something different. Patent law’s “written description” invalidity has wiped out wins by ruling the patent was indeed invalid. Naturally each […]