St. Louis Patent Litigator Doug Robinson spoke to Bloomberg Law about the declining number of Inter Partes Review challenges filed by generic drug makers against their brand name rivals.
According to Bloomberg Law reporter Matthew Bultman, generics makers filed fewer than 20 IPR challenges against patents listed in the FDA Orange Book in the fiscal year ending last September. The filings represent an 85% drop compared to the 130+ challenges filed in 2015. Having a patent listed in the Orange Book protects it from generic competition.
An initial explanation suggests that the reputation IPRs earned in their early years for being a “patent death squad” never really extended to drug patents. Generics makers are now being more strategic about how they use the PTAB to help their new products get to market.
The PTAB has also instituted new rules and precedents over the years that have eroded enthusiasm for IPRs, such as declining to review multiple challenges to the same patent or, more recently, declining to review a challenge because of a parallel infringement case.
“If the odds of success are decreasing, that’s going to discourage petitioners from filing,” says Robinson. “There’s going to be some marginal group of petitioners that won’t file that would have filed had the rules been like they were in 2014.”
Companies are also likely reviewing past decisions by the PTAB and spotting the types of patents that are more likely to survive review — those covering active pharmaceutical ingredients — and those more likely to get axed — methods of treatment.
Another explanation for the low filing rates last year: Coronavirus, of course. As Big Pharma focused on fighting COVID-19, they filed fewer patent infringement lawsuits against generics makers. Those lawsuits frequently spur the IPR challenges in the first place.
As IPR challenges tick down, savvy generics makers are still finding ways to put up a fight, including through the district courts and by thoughtfully timing their attacks.