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Full-Text Articles in Law
Bilski: Assessing The Impact Of A Newly Invigorated Patent Eligibility Doctrine On The Pharmaceutical Industry And The Future Of Personalized Medicine, Christopher M. Holman
Bilski: Assessing The Impact Of A Newly Invigorated Patent Eligibility Doctrine On The Pharmaceutical Industry And The Future Of Personalized Medicine, Christopher M. Holman
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The patent eligibility doctrine serves a gatekeeper role in excluding from patent protection natural phenomena, principles of nature, abstract ideas, and mental processes. Beginning around 1980, the U.S. patent system embarked upon a pronounced expansion in its definition of patent eligible subject matter, particularly with respect to software and business method inventions, but also in the life sciences. In recent years, however, we have seen a backlash, with many critics from the public and private sectors arguing that the threshold for patent eligibility needs to be raised in order to ensure that patents fulfill their constitutional objective of encouraging innovation …
Maintaining Incentives For Healthcare Innovation: Response To The Ftc's Report On Follow-On Biologics, Christopher M. Holman
Maintaining Incentives For Healthcare Innovation: Response To The Ftc's Report On Follow-On Biologics, Christopher M. Holman
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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 …