Normally, the FDA monitors the improper distribution of drugs, but the ITC might also enter the fray if complainants can demonstrate injury.
While the ITC rarely issues general exclusion orders, two recent cases illustrate the importance of seeking such relief in appropriate circumstances.
By: Yury Kalish and Vishal Khatri – Thirty nine (39) new Section 337 complaints have been filed at the International Trade Commission (“ITC”) in the first half of fiscal year (“FY”) 2018. The ITC is on pace to have one of the busiest years in its history and if the rate of filings increases slightly, the ITC may even exceed its FY 2016 record of 79 filings in a single year.
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.
The Commission has determined to review an initial determination finding that Respondent Ford is estopped under 35 U.S.C. § 315(e)(2) from asserting certain invalidity defenses previously adjudicated by the Patent Trial and Appeal Board (PTAB) in an inter partes review (IPR) proceeding. Certain Hybrid Electric Vehicles And Components Thereof, Inv. No. 337-TA-1042, Notice (Dec. 8, 2017). The underlying initial determination raises nuanced issues regarding the application of IPR estoppel in Section 337 investigations.
This week the ITC stood firm in its position that final PTAB rulings of unpatentability in IPR proceedings are not grounds to modify, suspend, or rescind remedial orders. In Certain Foam Footwear, Inv. No. 337-TA-567, the ITC issued a short order denying a petition for such relief. In the Order, the ITC cited its precedent in Certain Network Devices, Related Software and Components (II), Inv. No. 337-TA-945, Order (Sept. 11, 2017) which we discussed here.