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Manufacturing Barriers To Biologics Competition And Innovation, W. Nicholson Price Ii., Arti K. Rai
Manufacturing Barriers To Biologics Competition And Innovation, W. Nicholson Price Ii., Arti K. Rai
Articles
As finding breakthrough small-molecule drugs becomes more difficult, drug companies are increasingly turning to "large molecule" biologics. Although biologics represent many of the most promising new therapies for previously intractable diseases, they are extremely expensive. Moreover, the pathway for generic-type competition set up by Congress in 2010 is unlikely to yield significant cost savings. This Article provides a fresh diagnosis of and prescription for this major public policy problem. It argues that the key cause is pervasive trade secrecy in the complex area of biologics manufacturing. Under the current regime, this trade secrecy, combined with certain features of Food and …
Rats, Traps, And Trade Secrets, Elizabeth A. Rowe
Rats, Traps, And Trade Secrets, Elizabeth A. Rowe
UF Law Faculty Publications
Technology has facilitated both the amount of trade secrets that are now stored electronically, and the rise of cyber intrusions. Together, this has created a storm perfectly ripe for economic espionage. Cases involving unknown or anonymous offenders who may not be in the United States and who steal trade secrets using remote access tools (“RATs”) are especially problematic. This Art-icle is the first to address and place trade secret misappropriation within the larger backdrop of cybersecurity. First, it argues that systemic issues related to technology will continue to make legislative and judicial solutions suboptimal for cyber misappropriation. Second, it explores …
Protecting Products Versus Platforms, Jacob S. Sherkow
Protecting Products Versus Platforms, Jacob S. Sherkow
Articles & Chapters
Patents have long been the most important legal assets of biotech companies. Increasingly, however, biotech firms find themselves on one side of a divide: as either traditional product companies or platform companies. Given the differences between these two types of business models, the merits of intellectual property (IP) protection vary between them. This article explores how those differences relate to biotech startups and entrepreneurs seeking to protect their inventions.