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Bowman V. Monsanto: A Bellwether For The Emerging Issue Of Patentable Self-Replicating Technologies And Inadvertent Infringement, Christopher M. Holman
Bowman V. Monsanto: A Bellwether For The Emerging Issue Of Patentable Self-Replicating Technologies And Inadvertent Infringement, Christopher M. Holman
Christopher M Holman
The inherent tendency of patented seeds to self-replicate has led to fears that farmers might face liability for inadvertent patent infringement. To address the perceived problem, some have proposed severely limiting the availability of effective patent protection for self-replicating technologies, for example by denying patent rights to “second generation” self-replicating products, or even by broadly declaring such technologies ineligible for patent protection. The fact is, lawsuits against inadvertently infringing farmers remain of largely hypothetical concern. However, changes in the market could soon render such lawsuits a reality. In addressing the resulting policy concerns, the courts and/or Congress have at their …
Maintaining Incentives For Healthcare Innovation: A Response To The Ftc's Report On Follow-On Biologics, Christopher M. Holman
Maintaining Incentives For Healthcare Innovation: A Response To The Ftc's Report On Follow-On Biologics, Christopher M. Holman
Christopher M Holman
Congress is considering legislation that would create an abbreviated FDA approval process for follow-on biologics (FOBs), which proponents anticipate will promote competition and lower prices in the market for biologic drugs. In June of 2009 the FTC published a report on FOBs (“the FTC Report”), which attempts to forecast the nature of competition between innovator biologics and FOBs, and offers a number of substantive recommendations regarding specific provisions of the various FOB bills. In particular, the FTC Report concludes that there is essentially no justification for the inclusion of a substantial data exclusivity period (“DEP”) for innovators in pending FOB …