Most drugs are covered by multiple patents, with initial patents directed broadly to the compound and later patents directed to increasingly narrower uses of the compound. This provides opportunities for the compound to be approved as a generic drug before expiration of all of the patents, based on a “skinny” label – i.e., a label … Continue Reading
The U.S. is generally viewed as “behind” in its regulation of AI compared to the European Union and Asian countries. Yet ChatGPT’s release triggered a tsunami of U.S. legislation in 2023 from federal and state legislators seeking to address perceived concerns with the emerging and fast evolving technology. State legislatures have introduced nearly 200 AI … Continue Reading
E-commerce platforms are full of Chinese traders selling foreign cosmetic products they purchased at a lower price outside China. These branded goods are sold without the trademark owner’s consent for a much lower price than that of the official retailer. The consequences of such so-called “parallel imports” are well-known: the foreign brand and its official … Continue Reading
On July 28, 2021, the Food and Drug Administration (FDA) announced the approval of the first “interchangeable biosimilar”—in this case Mylan Pharmaceticals Inc.’s Semglee® (insulin glargine-yfgn), which is both biosimilar to, and interchangeable with, its reference product Lantus® (insulin glargine), a long-acting insulin analog. Acting FDA Commissioner Janet Woodcock, M.D. called it a “momentous day.”… Continue Reading
