Pharmaceutical innovation often begins long before there is a commercial product. An academic investigator, physician, entrepreneur, or small biotechnology company may identify a promising compound,
Executive Summary The United States Court of Appeals for the Federal Circuit occupies a unique position within the federal judiciary. Unlike the regional courts of
Executive Summary On June 4, 2026, the U.S. Supreme Court unanimously reversed the Federal Circuit in Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc., holding
On April 29, the Supreme Court will hear argument in Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc., a case that may determine whether the
On 29 Oct. 2025, FDA released a new draft guidance (on the need for demonstrating comparative clinical efficacy studies) signaling a major shift in biosimilar
The Subcommittee on Intellectual Property of the Senate Judiciary Committee recently took another step towards moving forward with a redefinition of patent-eligible subject matter under
Introduction: The Centrality of Conception In patent law, conception is the cornerstone of inventorship. For pharmaceutical companies, where billions in revenue hinge on patents for
Introduction In mergers and acquisitions (M&A), legal due diligence is a critical phase where the acquiring entity evaluates the legal posture of the target, including
In the high-stakes arena of patent litigation, claim breadth often seems like power. Patent holders, eager to stake wide intellectual territory protection, may pursue and
The pharmaceutical industry is complex and expensive. Companies and investors deserve certainty. Imagine asking an agency what to do, the agency tells you to do
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,
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
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
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
By: Shashank Upadhye Introduction Typically, patent infringement requires comparing the patent claims to the accused device or process. Patent claims are
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.
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
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
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
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,
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
