On February 8, 2021, Ha Kung Wong was quoted in Bloomberg Law on the decline in Orange Book patent challenges being launched at the U.S. Patent and Trademark Office (USPTO).
According to the article, generic drug makers have become more selective about which patents they target for challenge in the agency’s Patent Trial and Appeal Board’s (PTAB) inter partes review (IPR) program. The reviews haven’t turned out to be as easy a method for attacking drug patents as some initially thought, forcing companies to carefully plot their approach to getting generic products on the shelves. Fewer than 20 challenges to Orange Book-listed patents were filed at the PTAB in the year ending with September 2020, an 85% drop from the same period five years before, an analysis of U.S. Patent and Trademark Office data shows.
“We didn’t get a real feel for what they were going to invalidate or not up front,” Wong said. “We thought ‘death squad, they’re going to kill everything,’ and IPRs went through the roof.” Now, companies have “better insight into what the PTAB is going to do,” Wong said.
Rather than sink money into an uphill battle at the PTAB, companies appear to be focusing the fight on hard-to-kill patents in the district court, where they have a broader array of challenges at their disposal as compared to IPR. “Parties have learned from the PTAB’s past decisions,” Wong said. “They now know what types of patents they want to target; they’re being more selective.”
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