IPRs Have Nearly Disappeared
Inter Partes Review Proceedings associated with Paragraph IV cases have nearly disappeared. This graph says it all:
From a high number of filings (130) in 2015, to only 1 filed in 2021, ANDA filers have nearly abandoned the IPR petition. While ANDA filers may have considered the IPR petition as a viable alternative to challenging a patent, they apparently no longer consider this pathway as worthwhile.
Reasons for the Decline
There are likely three reasons for IPRs to fall out of favor. First, ANDA filers often have better results in their PIV cases. My prior blog post covers this rationale in more detail.
Second, ANDA filers may have been reluctant to file IPRs while the U.S. Supreme Court was deciding whether IPR Board judges were constitutionally appointed. Details are covered in a prior post, but the Supreme Court held IPR proceedings in limbo for the last few years. ANDA filers may have been reluctant to file petitions while the Supreme Court case was pending.
Third, you may think that the reduction of IPR filings is simply a result of fewer ANDAs and PIV cases filed. However, this is not the case. The number of petitions filed is not strongly correlated to the number of PIV cases. While PIV cases have also declined over the past few years, it does not offer a strong reason for the disappearance of IPR petitions.
Of course, for much more details about Inter Partes Reviews, and the reasons for their rise and fall, you can always check out my book The ParagraphFour Book.
Will the IPR Return?
Of course, it is anyone’s guess as to whether ANDA filers will return to the IPR proceeding. I think that they may return to the lesser degrees we have seen over the past few years. The IPR remains an attractive alternative for an ANDA filer for the right patent.
* The USPTO uses an annual calendar starting October 1 through to September 30 of the following year. Hence, the IPRs starting October 1, 2021, are considered filings for 2022.