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The Role Of Patent Eligibility In Policing Claim Scope, Christopher M. Holman
The Role Of Patent Eligibility In Policing Claim Scope, Christopher M. Holman
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Bilski v. Kappos (Bilski II) empowered the lower courts to deploy patent eligibility as a doctrinal tool for policing claim scope. Because Bilski II leaves the test for patent eligibility largely undefined, the lower courts and PTO, in particular the Federal Circuit, could actively invoke the doctrine as a “wildcard” to invalidate patent claims deemed unduly broad, or otherwise “unworthy” by the court. Judge Rader made a similar observation recently with respect to the Lilly written description requirement, another doctrine of patentability for which the criteria for compliance remains largely undefined. However, early indications suggest that the Federal Circuit and …
Misplaced Fears In The Legislative Battle Over Affordable Biotech Drugs, David E. Adelman, Christopher M. Holman
Misplaced Fears In The Legislative Battle Over Affordable Biotech Drugs, David E. Adelman, Christopher M. Holman
Faculty Works
Much like tort reform, the debate over recently enacted legislation on biotech drugs — and particularly regulatory supplements to patent protection — has taken on a significance that dwarfs its impact on prescription drug expenditures. Under the Health Care Reform legislation, Congress enacted two major reforms: First, creation of an abbreviated Food and Drug Administration (FDA) approval process for follow-on biologics (FOBs), which are the analogues of generics for biotech drugs. Second, establishment of a twelve-year “data exclusivity” period in which clinical testing data collected by brand-name innovators cannot be used by producers of FOBs to satisfy FDA testing requirements. …