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genisi

01/26/11 3:27 PM

#113348 RE: tinkershaw #113337

Bolar Exception

I cannot see a court going this far.

One interesting previous case law is the Integra case, where the defendant did not use the patented products for making substitution pharmaceutical but as research tools to develop a new drug in a preclinical trial and data was not even submitted in the IND to the FDA. Would you think the Bolar Exception apply in such act? Read The Supreme Court ruling.