Empirical Studies Refute Oft Repeated Fallacies
The PTAB released two studies on historical petition filing practices this month. One directed to the frequency of so-called serial/parallel petition filings, and the other pertaining to Orange Book/Biologics patents. As with the agency’s earlier studies on these same topics (2021), the refreshed data again demonstrates that Orange Book patents are very rarely subject to AIA trial proceedings, and that abusive, serial petition filings have been effectively outlawed for years now.
Of course anyone that actually practices before the PTAB is well-aware of these realities. So, these empirical studies are primarily directed to the oft repeated criticisms of moneyed lobbyists and disingenuous critics at a time when both Congress and the agency grapple with wildly conflicting narratives.
First, the PTAB study on Orange Book Patents demonstrates that such patents constitute roughly 2% of petition filings over the past three years. This averages out to about 10-12 petition filings a year, with a petition denial rate that hovers around the 40% mark.
Second, the biologic aspect of the Study shows biologics constitute roughly 3-4% of petition filings over the past three years. This averages out to about 22 biologic petition filings a year, also with a 40% petition denial rate.
As can be appreciated, the sky is hardly falling for Bio/Pharma at the PTAB.
In a political climate where prescription drug pricing is consistently in the cross-hairs (not to mention resonating with the public), and 101 remains a significant impediment for the diagnostic and gene patenting industries, this study serves as a gentle reminder to Bio/Pharma to pick and choose its battles.
Serial/Parallel Filings?
On the serial/parallel petition front, the data shows the strong correction that followed revised agency practices starting back as 2016 in NVIDIA, and thereafter in General Plastic.
As a reminder, a serial petition is a second petition pursued by a same filer greater than 90 days from its first petition filing (presumably for a second bite at the apple). Today, serial filings constitute 1.7% of PTAB filings —not exactly the crisis scenario that critics insist exists. Even for the 1.7%, as explained in the Study, the second filing is typically pursued in response to claims being belatedly added to a litigation dispute. So, if anything, these filings are actually responsive to gamesmanship.
Parallel petitions, on the other hand, constitute 7% of PTAB filings. As a reminder, a parallel petition is defined as a same petitioner challenging a same patent in less than 90 days. Why are parallel petitions much more commonplace than serial?
Simple, here we are counting petitions that are more correctly labeled as “partial” challenges to a patent.
For example, where a petitioner needs to challenge 50 claims of a patent, that filing will need to be made with two petitions in order to confirm to petition word count requirements. So, a first petition for claims 1-25, and a second petition for claims 26-50. There is nothing nefarious or abusive in seeking to challenge every claim of a dispute. The bulk of parallel petitions identified in the study fall into this category. (As I have pointed out repeatedly, the more sensible solution to this filing nuance would be to adjust word count practices as recently proposed by the agency in its ANPRM).
What was actually abusive (pre-2018) were parallel petitions that I refer to as “pile-on” petitions. That is where a same petitioner challenges the same patent claims across multiple petition filings. For example, 8 petitions all targeting the same 10 claims. To the agency’s credit, such filings were effectively outlawed.
Still, critics consistently identify partial petitions filed against a same patent as somehow evidence that “multiple bites at the apple” are still possible at the PTAB. But, a simple review of the actual filings will demonstrate that claim to be baseless.
The Serial/Parallel Filing Study in particular will go a long way in unraveling many a counterfactual comment to the ANPRM. Similarly, this Study further highlights the unserious nature of legislative proposals blindly re-introduced year-after-year without any meaningful calibration to present agency practices.