In a Hatch-Waxman litigation involving a drug for asthma, CRA’s life sciences experts were 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’s team 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’s consultants submitted expert reports and deposition testimony. Following an at-risk launch, the case ultimately settled.
IP Literature Watch: March 2024
In this month’s IP Literature Watch we include an article analyzing four case studies of controversy over license design in open-source software and hardware...