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A recent update from Foley & Lardner attorney Courtenay C. Brinckerhoff discusses trends in Inter Partes Review (IPR) and Post Grant Review (PGR) proceedings involving Orange Book and biologic patents, based on a report released by the USPTO. The main points highlighted are as follows:
Table of Contents
1. Trends in AIA Petitions
- The number of AIA petitions challenging Orange Book and biologic patents has decreased since its peak in 2016-2017.
- Orange Book patent challenges dropped significantly from 7.5% of all petitions filed in FY 2016 to under 2% in the current year, marking an over 80% drop.
- Challenges to biologic patents have remained steadier, with levels reaching near their peak in FY 2023 after a low period between FY 2018 and FY 2022.
2. Trends in Trial Type
- While the total number of PGR petitions is low, biologic patents are most frequently challenged in PGR proceedings.
- Biologic patents have been the subject of about 90% of all PGR petitions filed.
- The nature of biologic patents might make them more prone to challenge on grounds like written description and enablement, which can only be raised in a PGR proceeding.
3. Trends in Institution Rates
- The institution rate for Orange Book patents (62%) is slightly higher than for biologic patents (59%).
- The data for Orange Book patents is based on 478 petitions with 295 institutions, while for biologic patents, it’s based on 240 petitions with 141 institutions.
- The overall institution rate for all petitions is 64%, based on 12,538 petitions with 8,063 institutions.
4. Trends in Outcomes
- Differences exist in outcomes between Orange Book and biologic patents.
- 19% of Orange Book patents survive challenge with all claims patentable, while only 7% of biologic patents achieve the same outcome.
- On a claim-by-claim basis, 17% of challenged Orange Book claims (33% of instituted claims) were found unpatentable, compared to 25% of challenged biologic claims (57% of instituted claims).
5. Interpretation of Trends
- The data suggests that biologic patents have a slightly better chance of avoiding IPR or PGR proceedings.
- However, if proceedings are instituted, biologic patents have a higher chance of having claims invalidated compared to Orange Book patents.
- It’s important to note that the data set for Orange Book patents is more limited than for biologic patents due to differences in identification criteria.