Senator Hatch Proposes PTAB Exception for Orange & Purple Book Patents

As explained earlier this week in a study by my partner Filko Prugo, Orange & Purple Book patents fare no worse at the PTAB than in the courts. That said, some believe that the ability to challenge such patents in a faster, cheaper expert forum upsets the balance of power in the existing drug innovator landscape.

Today, Senator Orrin Hatch (R-UT), the Chairman of the Senate Republican High-Tech Task Force and co-author of the Hatch-Waxman Act, filed an amendment in the Senate Judiciary Committee to in his words “restore the careful balance the Hatch-Waxman Act struck to incentivize generic drug development.” Senator Hatch’s amendment, the Hatch-Waxman Integrity Act of 2018, is argued to  prevent alternative procedures for challenging drug patents from tilting the playing field contrary to Hatch-Waxman’s design. It is also argued to ensure that brand-name and generic manufacturers alike have the proper incentives to develop life-saving medications. Continue Reading Senate Moves to Exclude Orange & Purple Book Patents from PTAB

Key Bio/Pharma Assets at the PTAB

Through more focused strategy, patent owners have ensured that Patent Trial and Appeal Board (PTAB) proceedings are not overwhelmingly fatal to Orange and Purple Book patents. In fact, patent invalidity rates at the PTAB now rival those in district court litigation.

Ropes and Gray’s IP Litigation (Life Sciences) Chair Filko Prugo conducted a study that examines institution rates and final written decision outcomes for each Orange and Purple Book-related PTAB petition filed since the inception of the PTAB to May 1, 2018, as well as every validity decision rendered by a federal district court in Hatch-Waxman litigation between Jan. 1, 2013 and May 1, 2018.

I hope you find these insights helpful.

You can find the full study (here)