Dr. Stephanie Schonewald Quoted in Law360 about Patent Specification Concerns at the PTAB

Dr. Stephanie Schonewald was recently quoted in Law360 about takeaways from her IP Watchdog PTAB Masters 2022 virtual panel “Life Sciences and IPR: Orange Book & Biologic Patents at the PTAB.” The panel discussed the pros and cons of using the PTAB as a forum to challenge Orange Book and biologic patents and why institution rates for such petitions remain low. To read the full article, click here.

From the article:

Choate Hall & Stewart LLP partner Stephanie Schonewald said this delicate line is why parties need to be careful in choosing their experts. 

"When you're balancing 103 with 112, oftentimes it comes down to, 'Was this or was this not predictable?' and you can't always tell from the art that you have in front of you," Schonewald said. "Having that expert who is able to drill into that fact, help you decide which direction this should go and provide you with the evidence that pushes you one way or the other, is really helpful."

The PTAB does allow Section 112 arguments in post-grant reviews, which is an IPR alternative available only for the first nine months after a patent is issued. Schonewald said clients have asked for PGRs to be argued "in the alternative," meaning that multiple, sometimes inconsistent theories can be presented. While that may work in district courts, she said it doesn't at the PTAB.

"It really does get to be tricky and problematic from the petitioner side," Schonewald said. "You're asking your expert to simultaneously say, 'You have a reasonable expectation of success, but no, you wouldn't have predicted it.' That clash gets to be pretty intense, and there really isn't a great way to present it in the alternative when you have to put all your positions, all your cards out there right away in the petition."