Deciding Between PTAB & District Court Venues for 112 Challenges

With an increasing number of issued patents eligible for Post Grant Review (PGR), patent challengers find themselves assessing whether PGR is worth the added estoppel risk.  That is, where a first-inventor-to-file patent is still within 9-months of issuance (PGR window), should a challenger opt for PGR, or await the availability of IPR after the 9th month?

As with many legal questions, the answer is —”it depends.”

Because PGR allows for more than just patent and printed publication based challenges (most notably, 112 and 101), the “reasonably could have been raised” estoppel of PGR has a much larger footprint relative to that of IPR.  As such, a patent challenger may opt to wait out the 9-month window to instead pursue IPR, especially in the predictable arts where prior art challenges are typically the best form of validity challenges.  However, in the unpredictable arts, 112 challenges such as written description and enablement may be the best path to invalidity success.

According to one PTAB study, 83% of challenges to Orange Book patents fail when based on patents and printed publication.  As PGR becomes more widely available, this begs the question as to whether 112 challenges would be more effective for challenging patents in the unpredictable arts.  But, should you save your 112 case for the district courts, or pursue it in PGR?

Preliminary PGR statistics indicate that, not surprisingly, challengers may be best served before the expert agency.

Surveying PGR cases in the unpredictable arts (bio/pharma and chemistry) yields a limited data set of 28 cases to date.  While admittedly a small sample, these cases appear to be of typical complexity relative to the 112 grounds presented in these petitions.  This first wave of 112 cases yield the following outcomes (as of 4/30/20)

Roughly a 64% institution rate for petitions in the unpredictable arts with at least one 112 ground. Of the instituted PGRs, only 9 cases have received a final written decision.  Other instituted cases were either settled or have not yet reached a final written decision.  Of the 9 final written decisions, 78% were successful where the challenged claims were held to be unpatentable.

Because one of the instituted PGR cases did not institute on the § 112 ground (pre-SAS Institute), there were only 8 final written decisions deciding on at least one 112 ground.  The success rate of the 112 ground in these final written decisions was 62%.

As only 3-4% of cases make it to trial in the district courts, a comparison to the success rate of 112 motions in the district courts is perhaps a more helpful comparison.  As shown below, (not filtered by technology) 112 motion practice is a mixed bag from year-to-year.  Moreover, given these outcomes are not technology specific, the win rate in the unpredictable arts will necessarily be less.

Of course, the window for PGR challenges (within 9-months from issuance) prevents some challengers from taking advantage it as an option given the timing realities of many disputes.  Nevertheless, given the early success for 112 challenges, it may be that PGR filing numbers may start to increase to a more substantial number going forward — especially amongst competitors of lucrative pharmaceutical markets.