Patent & Regulatory Legal Issues Related to Fertilizers, Fungicides, Pesticides, & Bulk Chemicals
By: Shashank Upadhye Introduction The intersection of patent law and regulatory frameworks in the United States presents unique challenges and opportunities for industries involving fertilizers, herbicides, pesticides, rodenticides, and other bulk chemicals. This article delves into the intricacies of U.S. patent statutes, regulatory codes, landmark cases, and precedents that specifically impact these sectors. Regulatory Background […]
Intellectual Property Issues Related to Artificial Intelligence: A Deeper Dive into Patent, Copyright, & Trade Secrets Challenges
By: Shashank Upadhye Introduction Artificial Intelligence has revolutionized industries ranging from pharmaceuticals to creative arts, raising profound questions about intellectual property (IP) protection. The intersection of AI and IP law presents challenges in patents, copyrights, trade secrets, and broader policy considerations. This article explores the evolving landscape of AI-related IP, with a focus on patents […]
Pending 2025 FDA Legislation on Pharmaceutical Development & Marketing: A Comprehensive Industry Impact Analysis
By: Shashank Upadhye Introduction The U.S. pharmaceutical landscape stands at a transformative juncture with several key legislative initiatives currently under Senate consideration. These proposed bills seek to enhance the drug development process, streamline regulatory pathways, with wide-ranging implications for market competition, drug pricing, and patient access to affordable medication. This article document analyzes the expected […]
Infringing Your Own Intellectual Property: Understanding the Paradox
By: Shashank Upadhye Introduction Intellectual property (IP) is a cornerstone of modern innovation and creativity, providing creators and inventors with the legal means to protect their works, inventions, and brands. Typically, discussions about IP infringement focus on external parties unlawfully using someone else’s IP. However, there are unique scenarios where an individual or entity can […]
Proving Patent Infringement – Double Counting Pharmaceutical Ingredients When One Element Satisfies Two Claim Limitations
By: Shashank Upadhye Introduction Typically, patent infringement requires comparing the patent claims to the accused device or process. Patent claims are stylized differently but the import is the same; there must be some correspondence between what is claimed compared to the accused device or process. A simplistic way is to envision a so-called […]
The Right to Repair Versus Reconstruction under U.S. Patent Law: An In-Depth Analysis
By: Shashank Upadhye Introduction The right to repair emerged as a crucial issue in U.S. patent law, as manufacturers increasingly leverage patents to control post-sale repairs. This analysis delves into the legal framework, examining key court decisions, relevant statutes, and pending legislation that shape this right, with a focus on the court cases recent guidance on […]
On the Use of Generative AI in Patent Litigation
By: Yixin Tang and Victor Van de Wiele Back in 2021, I (Yixin) wrote down some thoughts on how the emerging “age of artificial intelligence” can change legal work and make lawyers more efficient. AI development has grown by leaps and bounds since then, and some of the systems are being “field tested” by patent lawyers. Dr. […]
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 […]