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Patent Infringement In The Context Of Follow-On Biologics, Janet Freilich
Patent Infringement In The Context Of Follow-On Biologics, Janet Freilich
Janet Freilich
This article fills a gap in the literature by conducting a comprehensive analysis of patent infringement in the context of follow-on biologics. Patent infringement is an important topic because, like small molecule generic drugs, follow-on biologics are likely to begin their life facing infringement suits. Because it is tremendously expensive to develop a follow-on biologic, it is vital that there be consistency in how they are treated in the courts once the inevitable patent infringement suits arrive. If follow-on biologics companies cannot predict how their product will be received in court, they may decide it is not worth the risk …
The Paradox Of Legal Equivalents And Scientific Equivalence: Reconciling Patent Law’S Doctrine Of Equivalents With The Fda’S Bioequivalence Requirement, Janet Freilich
Janet Freilich
Contrary to popular perception, generic drugs often enter the market before the patents covering their brand-name counterparts have expired by making slight changes the drug to avoid the brand-name patent. These generics face a paradox: the FDA requires that the generic “not show a significant difference” from the reference product while patent law requires that the generic have “substantial differences” as compared to the reference product. The generic must be bioequivalent but not legally equivalent to the brand-name drug. This paradox occurs frequently in the courts but has never been discussed in the literature. This article analyzes every case involving …