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21 August 2017
On March 31 2017 the US Patent Trial and Appeal Board (PTAB) released updated statistics(1) showing the fate of resolved inter partes review proceedings. These statistics show that a total of 4,563 inter partes review petitions were resolved as of March 31 2017, including 1,577 final written decisions. In 81% of these final written decisions (27% of the total number of petitions filed), at least some instituted patent claims were found to be unpatentable. This statistic has contributed to concerns that the PTAB is a patent 'death squad'.
Some reports suggest that such concern is unjustified for drug patents. On the contrary, inter partes review statistics for this subset of patents are significantly more favourable: a smaller percentage of drug patent inter partes reviews are instituted; and of those that reach a final written decision, a higher percentage of patents survive with at least some claims remaining patentable. This is welcome news to the pharmaceutical industry.
The March 2017 the PTAB statistics show that across all technologies:
Orange Book inter partes review
Of the 4,563 resolved inter partes review petitions, 222 petitions (5%) concerned patents that were listed in the US Food and Drug Administration's Orange Book (Orange Book inter partes reviews). Focusing on only these Orange Book inter partes reviews:
Biologic drug patent inter partes reviews
Looking instead at the 29 inter partes review petitions (0.6% of the total number of resolved inter partes reviews) challenging patents that have been identified as reading on Centre for Drug Evaluation and Research (CDER)-listed biologic drugs (biologic drug inter partes reviews),(2) it has been reported that:
Higher percentage of biologic drug inter partes reviews settled before an institution decision
While the dataset for biologic drug inter partes reviews remains very small, to date, a smaller percentage of Orange Book and biologic drug inter partes reviews have been instituted as compared to inter partes reviews across all technologies (44% and 41%, compared to 53%). Further, a higher percentage of biologic drug inter partes reviews settled before an institution decision – 21% compared to 12% for Orange Book inter partes reviews and 17% across all technologies – and a higher percentage of Orange Book and biologic drug inter partes reviews were denied institution (38% and 34%, as compared to 29% across all technologies).
Higher percentages of Orange Book and biologic drug inter partes reviews survive final written decisions unscathed
Another notable difference between Orange Book and biologic drug inter partes reviews and inter partes reviews across all technologies is the number of final written decisions in which all instituted claims were found unpatentable. For Orange Book inter partes reviews, all instituted claims were found unpatentable in 16% of final written decisions. This percentage is 17% in biologic drug inter partes review final written decisions, as compared to 23% across all technologies.
Higher percentages of Orange Book and biologic drug inter partes reviews survive institution with some challenged claims intact
Finally, higher percentages of both Orange Book and biologic drug inter partes reviews survive institution and final written decisions with at least some of the claims that were challenged in the petition intact. Considering only institution decisions and final written decisions (ie, PTAB determinations) – and omitting determinations made by the parties, for example to disclaim challenged claims or resolve a challenge by settlement – 60% of Orange Book inter partes reviews survived with at least some challenged claims remaining patentable. This compares to 45% of biologic drug inter partes reviews and 41% of inter partes reviews across all technologies. Pooling the data for Orange Book and biologic drug inter partes reviews to consider drug patents as a category, this number is 58%, as compared to 41% across all technologies.
In short, the PTAB is not a 'death squad' for Orange Book listed patents and patents that have been identified as reading on CDER-listed biologic drugs. On the contrary, these patents have fared notably better than the data disclosed by the PTAB across all technologies. This is welcome news for the pharmaceutical industry.
For further information on this topic please contact Corinne E Atton or April Breyer at Fitzpatrick, Cella, Harper & Scinto by telephone (+1 212 218 2100) or email (email@example.com or firstname.lastname@example.org). The Fitzpatrick, Cella, Harper & Scinto biologics group website can be accessed at www.BiologicsHQ.com.
(2) In determining the statistics for biologic drug inter partes reviews, inter partes reviews filed against manufacturing patents that potentially read on multiple CDER-listed biologic drugs were not included – for example, inter partes reviews concerning US Patent 6,331,415 (a 'Cabilly' patent).
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