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
We previously wrote about product-by-process claims in patent law describing them as an atypical patent claim. See our article here: https://ipfdalaw.com/understanding-product-by-process-claims-in-patent-law/. Another atypical claim is
Introduction By statute, the Court of Appeals for the Federal Circuit has appellate jurisdiction over appeals from the administrative boards of the Patent & Trademark
Despite the promulgation of the American Invents Act (AIA) in 2012, the concept of prior art has basically stayed the same. Section 102 embodies two
FDA’s 505(b)(2) Application The 505(b)(2) new drug application (NDA) is an attractive regulatory and commercial strategy for clients. This hybrid NDA application helps avoid duplicative
Typical patent claims are to products or processes but not both. But product-by-process claims exist and have existed for decades. Plainly, the typical product-by-process claim
