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Not All Grace Periods Are Created Equal: Building A Grace Period From The Ground Up, Renee E. Metzler
Not All Grace Periods Are Created Equal: Building A Grace Period From The Ground Up, Renee E. Metzler
Marquette Intellectual Property Law Review
The grace period for patent application filing is the amount of time a patent applicant has to file the application after the invention has been disclosed to the public. The rules and amount of time allowed vary greatly among countries. This comment explores the theoretical justifications for a grace period, the structural elements of a grace period, and other approaches to a grace period used in countries outside of the United States. The author proposes an ideal grace period model that would create international harmonization.
Why Fdca Section 505(U) Should Not Concern Us Greatly, Kyle Faget
Why Fdca Section 505(U) Should Not Concern Us Greatly, Kyle Faget
Michigan Telecommunications & Technology Law Review
Among the many amendments found in the Food and Drug Administration Amendment Act of 2007 (FDAAA) is a provision at the end of the act, Section 505(u), which grants chiral switches five years of market exclusivity under certain circumstances. Prior to Congressional enactment of the FDAAA, the Food and Drug Administration (FDA) refused to award new chemical entity (NCE) status to enantiomers of previously approved racemic mixtures. The FDA defines a new chemical entity ("NCE") as a drug that contains no active moiety that has been approved by the FDA in any other application submitted under Section 505(b) of the …