Normally, the FDA monitors the improper distribution of drugs, but the ITC might also enter the fray if complainants can demonstrate injury.
By: Yury Kalish and David Maiorana – Late last week, the International Trade Commission (“ITC”) finalized changes to its rules, which changes were first proposed in late 2015. The new rules are expected to be published in the Federal Register in early May 2018 and will go into effect 30 days later.
The ALJ noted that the pending expiration of the ’340 patent is not disputable and the ITC does not have the authority to alter the expiration date.
By: Yury Kalish and David Maiorana – In a recent order, the Commission again declined to institute an Early Disposition Pilot Program (100-day Pilot Program), this time citing the complexity of the issues raised in the request.
In a recent Order setting the procedural schedule for a 100-Day Pilot Program proceeding, Judge Lord provided a helpful outline for proofs necessary to establish the economic prong of domestic industry. Certain Solid State Storage drives, Stacked Electronics Components, and Products Containing Same, Inv. No. 337-TA-1097, Order No. 3.
In two recent orders, the Commission denied respondents’ requests for entry into its Early Disposition Pilot Program (100-day Pilot Program). It has now been over two years since the ITC issued its proposed rulemaking for the program, and such proceedings remain rare.