Evaluation of an asthma medication with once-a-day dosing

Clinic corridor in a hospital

In a Hatch-Waxman litigation involving a drug for asthma, CRA was asked to assess commercial success and its nexus to the patent. In this case, the patent involved a new once-daily dosing schedule. To assess nexus, CRA examined sales in countries that approved the patented dosing regimen to sales in countries that did not and examined any changes in sales in countries that adopted the dosing regimen after launch. CRA found that the patented feature could not explain sales. CRA submitted expert reports and deposition testimony. Following an at-risk launch, the case ultimately settled.

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