Open Access. Powered by Scholars. Published by Universities.®
Articles 1 - 3 of 3
Full-Text Articles in Law
Fda Approval Of Generic Biologics: Finding A Regulatory Pathway, Kathleen R. Kelleher
Fda Approval Of Generic Biologics: Finding A Regulatory Pathway, Kathleen R. Kelleher
Michigan Telecommunications & Technology Law Review
Biologics are becoming increasingly important for the potential treatment of widespread diseases such as cancer, anemia, and diabetes. As hundreds of biologics are going off-patent, the market has become ripe for the introduction of generic biologics. A regulatory pathway for biogenerics, however, is virtually nonexistent. The purpose of this paper is thus to analyze how a successful legislative pathway for generic biologics might be designed. The current regulatory scheme, economic concerns, health and safety concerns, and the need to provide proper incentives for innovation are analyzed. Finally, recent Congressional bills are outlined and critiqued, through which the structure of a …
Patents And Diversity In Innovation, Brian Kahin
Patents And Diversity In Innovation, Brian Kahin
Michigan Telecommunications & Technology Law Review
Over the past quarter-century, the patent system has expanded in scope and significance, claiming a central position in a U.S. economy increasingly based on knowledge and intangible assets. This historic expansion has come at the cost of controversy and, within the past five years, growing public scrutiny from outside the system--from the press, business, Congress, and finally the Supreme Court. However, proposed reforms are marked by deepening divisions between sectors of the economy. The information technology (IT) and services industries favor strong reforms while pharmaceutical and biotech industries, as well as the patent bar, favor modest, incremental reforms. This yawning …
Diversifying Without Discriminating: Complying With The Mandates Of The Trips Agreement, Graeme B. Dinwoodie, Rochelle C. Dreyfuss
Diversifying Without Discriminating: Complying With The Mandates Of The Trips Agreement, Graeme B. Dinwoodie, Rochelle C. Dreyfuss
Michigan Telecommunications & Technology Law Review
Since the Patent Act was revised in 1952, patent law has expanded to cover an array of novel endeavors--new fields of technology (notably computer science and business methods) as well as the activities of researchers engaged in fundamental scientific discovery. These changes have been accompanied by shifts in the organizational structure of the technological community, with smaller firms and universities emerging as important players in the patent system, and by new marketplace expectations arising from consumer demand for interoperable technology and converging functionality. As a result of these developments, structural flaws in the legal order have become evident. Although the …