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Replies to #58610 on Biotech Values
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DewDiligence

02/04/08 7:31 PM

#58614 RE: ThomasS #58610

>TEVA/Amphastar: Wouldn't any anti-trust case infer that monetary damages are due despite no approved generic product? Or, perhaps, that the FDA was complicit by not approving a generic based on the existing patent, thus "constructively" blocking sales? Seems like a long stretch, or is there precedent?<

Good questions, but I don’t know enough about anti-trust precedents to answer.

The remark in the ft.com article that I question is the assertion that treble damages will automatically ensue if SNY is found at fault.

Edit: I see that zipjet posted some color about treble damages. Agree that SNY ought to be worried about it.
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zipjet

02/04/08 7:40 PM

#58615 RE: ThomasS #58610

>>TEVA/Amphastar: Wouldn't any anti-trust case infer that monetary damages are due despite no approved generic product?

This is not about the FDA action. FDA has the right to approve drugs regardless of whether they have patent protection.

However, if a drug carries patent protection that has been obtained by defrauding the Patent Office, then the company is able to gain profits from sales for a longer period of time due to the fraud.

Proving damages in such a case will be quite interesting.

As to trebling the damages, once you say the profits were obtained by defrauding the government and that the damages flowed directly from the fraud then you have a policy argument for trebling the damages.

ij