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« Ultramercial, Inc. v. Hulu, LLC (Fed. Cir. 2013) | Main | Webinar on Conflicts Issues in Patent Prosecution »

June 27, 2013


Kevin, thanks for this report. If the innovator is still on the hook for state law tort claims under Wyeth, and generic manufacturers are now immunized from such claims, wouldn't it behoove consumers to insist on only getting the innovator's product? And if so, would they have any recourse against a health insurer who insists on covering only the generic version? Sounds like there might be a market for generic drug side-effect insurance.

Dear I'm:

Interesting thought - not sure how the Court would reconcile Wyeth with Mutual. The branded drugmaker has more latitude in changing the label and/or the compound/formulation but at what point do any changes make the drug fall outside the NDA? And, of course, the point of generic drugs is to make them more affordable (mostly for insurance companies and the government, of course). So I don't see people flocking to avoid generic drugs - the consequence of this ruling is that, absent express changes in state tort law generic companies are under less liability risk (which is troubling because it also removes disincentives for generics to cut corners).

And good luck collecting on generic side effect insurance, even if the premiums were something affordable. The economic analysis would need to be (total lower cost of drug) - (cost of insurance premium) > (insurance payoff amount) x (risk of side effect) x (risk of no payoff).

Seems to me (in view of the costs incurred here) that it would never be worth it.

Thanks for the comment.

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