Fewer IPR Filings in 2020
As I reported in a prior post, ANDA filers are filing fewer Petitions for Inter Partes Reviews (IPRs). The most recent data for the 2020 IPR filings* add additional support.
In the 2020 IPR filings, ANDA filers submitted only 15 Petitions. The IPR patent challenges are typically associated with a PIV patent case. Fifteen filings is literally half of the filings made in the previous year (34 IPRs), and the 2020 filings are only a fraction of the peak filing year of 2015 with 130 filings.
Why are ANDA filers using the IPR process with less frequency?
One 2020 IPR filing data point offers up what is the most likely reason. Of the 15 filings in 2020, the USPTO Patent Trial and Appeal Board denied institution for 7 petitions. It has instituted 6 of them for trial and has yet to decide the remaining 2 petitions.
As of now, the Board has rejected nearly half of the petitions and may go on to deny the remaining two petitions from 2020. With the denial, the Board has upheld the patent as valid (patentable) in half of these petitions.
After the Board denies institution, the brand company’s attorney is more than happy to send that decision to the judge presiding over the associated PIV case. With a ruling in its favor, it weakens the ANDA filer’s defenses in its PIV case and may also weaken its settlement position.
What will become of IPRs in PIV cases?
I doubt the IPR will disappear entirely from the PIV Market. However, ANDA filers will use the IPR more strategically and employ them in limited circumstances.
* The USPTO uses an annual calendar starting October 1 through to September 30 of the following year. Hence, the IPRs starting October 1, 2020, are considered filings for 2021.