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Full-Text Articles in Law
Improving Patent Quality Through Post-Grant Claim Amendments: A Comparison Of European Opposition Proceedings And U.S. Post-Grant Proceedings, Jennifer Turchyn
Improving Patent Quality Through Post-Grant Claim Amendments: A Comparison Of European Opposition Proceedings And U.S. Post-Grant Proceedings, Jennifer Turchyn
Michigan Law Review
Congress enacted the Leahy-Smith America Invents Act to encourage innovation, strengthen U.S. patents, and achieve greater uniformity with foreign patent systems. The America Invents Act introduced two new post-grant patent validity proceedings: inter partes review and post-grant review. The new U.S. proceedings are similar to European opposition proceedings, but there are significant differences in the extent of the patent owner’s ability to amend claims, the patent’s claim construction, the patent owner’s evidentiary burden, and the procedural requirements. The U.S. proceedings result in a very limited opportunity for amendment and a high percentage of invalidated patents. In contrast, European opposition proceedings …
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 …