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
Typically, brand and generic drugs stay nicely in their own lanes. The consuming public generally knows when the drug taken is branded or generic. But
In a previous article published, we discussed the role of written description and how written description should be contextualized within the meaning of the Section
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
Introduction The closest comparator for the ice hockey referee is the federal trial court judge. I am not a judge but I thought this would
Brand pharma companies invest valuable resources, time, and money in moving drugs from development to FDA approval. The new drug approval may also enjoy some
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
In April 2022, FDA released a proposed draft guidance (FDA Dock. No. 2022-D-0108) involving pH adjusters in drug development relating to ophthalmic, parenteral, or otic
