On July 8, 2021, Ha Kung Wong was quoted by Managing Intellectual Property on a possible surge in post-grant reviews for biologics. According to the article, more than three-quarters (78%) of the post-grant petitions filed against biologics between October 1, 2020 and April 30, 2021 were PGRs, as opposed to inter partes reviews (IPRs), which traditionally account for most PTAB challenges.
PGRs allow counsel to challenge patents on eligibility (Section 101) and written description and enablement (Section 112) grounds – whereas IPRs only allow for prior art attacks – and biologics are particularly vulnerable to the latter.
“If the industry were heading towards PGRs, it's likely Section 112 would be the reason,” says Wong. “Biologics generally have broad and hard-to-define genus claims, and because of that they’re vulnerable to written description and enablement challenges, which you can’t raise explicitly in an IPR.”
He says that most of the PGRs he’s seen that were filed for biologics contained Section 112 arguments, although so far he has seen none for Section 101.