online prescription solutions
online discount medstore
pills online
buy lorazepam without prescription
xanax for sale
buy xanax without prescription
buy ambien without prescription
ambien for sale
buy modafinil without prescription
buy phentermine without prescription
modafinil for sale
phentermine for sale
lorazepam for sale
buy lexotan without prescription
bromazepam for sale
xenical for sale
buy stilnox without prescription
valium for sale
buy prosom without prescription
buy mefenorex without prescription
buy sildenafil citrate without prescription
buy adipex-p without prescription
librium for sale
buy restoril without prescription
buy halazepam without prescription
cephalexin for sale
buy zoloft without prescription
buy renova without prescription
renova for sale
terbinafine for sale
dalmane for sale
buy lormetazepam without prescription
nobrium for sale
buy klonopin without prescription
priligy dapoxetine for sale
buy prednisone without prescription
buy aleram without prescription
buy flomax without prescription
imovane for sale
adipex-p for sale
buy niravam without prescription
seroquel for sale
carisoprodol for sale
buy deltasone without prescription
buy diazepam without prescription
zopiclone for sale
buy imitrex without prescription
testosterone anadoil for sale
buy provigil without prescription
sonata for sale
nimetazepam for sale
buy temazepam without prescription
buy xenical without prescription
buy famvir without prescription
buy seroquel without prescription
rivotril for sale
acyclovir for sale
loprazolam for sale
buy nimetazepam without prescription
buy prozac without prescription
mogadon for sale
viagra for sale
buy valium without prescription
lamisil for sale
camazepam for sale
zithromax for sale
buy clobazam without prescription
buy diflucan without prescription
modalert for sale
diflucan for sale
buy alertec without prescription
buy zyban without prescription
buy serax without prescription
buy medazepam without prescription
buy imovane without prescription
mefenorex for sale
lormetazepam for sale
prednisone for sale
ativan for sale
buy alprazolam without prescription
buy camazepam without prescription
buy nobrium without prescription
mazindol for sale
buy mazindol without prescription
buy mogadon without prescription
buy terbinafine without prescription
diazepam for sale
buy topamax without prescription
cialis for sale
buy tafil-xanor without prescription
buy librium without prescription
buy zithromax without prescription
retin-a for sale
buy lunesta without prescription
serax for sale
restoril for sale
stilnox for sale
lamotrigine for sale

Regulation of Innovation Under Follow-On Biologics Legislation: FDA Exclusivity As An Efficient Incentive Mechanism

by Maxwell R. Morgan

11 Colum. Sci. & Tech. L. Rev. 93 (2010) (Published July 1, 2010)

Abstract

As part of its broader effort to reform the American health care system, Congress has recently enacted legislation that creates a statutory pathway for FDA approval of generic “follow-on” biologics products. A crucial debate leading up to the passage of this legislation was whether and to what extent it should provide originator biologics manufacturers with a period of FDA data exclusivity protection as an incentive for future innovation. This debate was particularly significant because of the ongoing reevaluation in the United States of the appropriate role of patent law in fostering technological advance, with recent Supreme Court decisions indicating a trend towards retrenchment of the scope of available patent protections. In the end, the bill adopted by Congress and signed into law by President Obama affords manufacturers of new biologics products with 12 years of data exclusivity.

The central thesis of this Article is that optimal biologics innovation policy would situate FDA exclusivity as the industry’s primary incentive mechanism, displacing patent law in that role. The inclusion of a lengthy 12-year data exclusivity period in the newly enacted legislation is a laudable step in the right direction. But reliance on patenting in the biologics innovation process would also likely have to be substantially curtailed in order to attain optimal levels of innovation. If this were achieved, FDA exclusivity would act as an adequate surrogate for the incentives offered by patents, while a number of pathologies currently associated with patenting in the biomedical research context would be eliminated.

This Article also argues that Congress should adopt a regime of market exclusivity protection instead of the data exclusivity protection presently included in the new legislation. Market exclusivity would permit the FDA to adopt rules requiring public disclosure of both basic research results (which may cease to be published absent strong patent rights) and clinical trials data (which cannot be divulged under a data exclusivity regime) in exchange for FDA approval. Such disclosure rules would contribute to efficient, disaggregated research into new and improved therapeutic approaches.

About the Author

B.Sc. McGill 2001, J.D. University of Toronto 2005, LL.M. Harvard 2009.

Important Note

For proper legal citation of this document, please cite to the following URL: http://www.stlr.org/cite.cgi?volume=11&article=4. The URL that currently appears in your browser’s location toolbar is incorrect. For more information on Bluebook citation of internet sources, click here.

View in PDF

blog comments powered by Disqus