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« USPTO Proposes Rules Changes for Implementing AIA Provisions -- Preissuance Submissions Provision | Main | Webinar on AIA First-to-File Provisions »

January 12, 2012

Comments

I think the comment of:

"this study and others bolster the common-sense sentiment that generic drug challenges to branded drugs increase uncertainty in the development of new drugs and are a cost that squanders resources better spent developing new drugs"

should be juxtaposed next to:

"acknowledging the beneficial effects of generic alternatives to branded drugs for consumers and drug providers/payors (citing a study by the Generic Pharmaceuticals Association published by IMS Health that generic drugs saved consumers $800 billion from 2000-2009"

You bet there are "distributional effects." If the consumers gain $800 billion, that is a, $800 billion loss to the pharma giants.

I still struggle with the idea of data exclusivity ON TOP OF the patent period. What I would rather see is the folding into the patent approval process any other governmental regulation process. If you claim a certain drug, part of the necessary utility that earns you the patent is the fact that the drug actually works as intended. If time is necessary to prove that out, then the patent clock should not be ticking until it is proven. If it does not prove out, then you should not have been granted a patent to begin with. If it does prove out, then you should have full term of your patent right.

Skeptical, thou art too logical.

The comments to this entry are closed.

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