Q1 2020 Biosimilar IPR Update: Drop in New Filings
At the end of 2017, inter partes review (IPR) proceedings for biosimilar products were on the rise. This was followed by a dip in the number of new filings in FY 2018 and the first half of 2019. Through Q1 2020, this downward trend has continued. Specifically, there has been one new biosimilar IPR filing in the nine-month period from the beginning of Q3 2019 through the end of Q1 2020, leading to a total of 102 total biosimilar patent IPRs. See Fresenius Kabi USA, LLC et al. v. Amgen, Inc. et al., IPR2020-00314 (December 20, 2019).
As previously reported, biosimilar IPRs have met with mixed results at the Board. Institution was denied on 41 of the 92 petitions (44%) for which the Board has issued an institution decision. The rate of institution (56%) is somewhat lower than that for challenges to biotech/pharma patents in general: 59% of those petitions were instituted between September 16, 2012 and March 31, 2020.
No new Final Written Decisions (FWDs) were issued in biosimilar IPRs in the nine-month period ending in Q1 2020. While four of the instituted IPRs are still pending, FWDs have been issued in 32 cases. Of those 32 FWDs, ten upheld the patentability of all claims, fifteen found all challenged claims unpatentable, and seven produced mixed results where some claims survived while others were found unpatentable.
In conclusion, IPR filings in the biosimilar space have declined following their peak in 2017. It remains to be seen whether the drop is temporary and whether IPR will remain a major battle ground between biologic innovators and biosimilar makers.