Key Trends from the Study of the Orange Book and PTAB Biological Patents in 2021 | Rothwell, Figg, Ernst & Manbeck, CP


[author: Sheena]

The United States Patent and Trademark Office, the Patent Trial and Appeal Board (PTAB) recently released an update of the Orange Book Patent / Biological Patent Study on August 11, 2021. It s This is the third report providing data on post-grant applications filed against the Orange Book and organic patents. published by the PTAB, and it covers AIA petitions filed between September 16, 2012 and June 30, 2021. The first study covering these topics was published on March 13, 2018 and the second on July 18, 2019.

The updated Orange Book Biological Patent / Patent Study (“Study”) identifies a petition as challenging a patent listed in the Orange Book by cross-checking the patents challenged in a PTAB petition with the electronic database Orange Book of the United States Food and Drug Administration (FDA). . This study classified biologic patents as any patent aimed at treating a disease or condition that was not listed in the Orange Book and any patent that potentially covers a biologic listed in the Purple Book.

Overall, data from the PTAB Orange Book 2021 Organic Patent / Patent Study shows that petitions challenging the Orange Book and organic patents represent only a small fraction of the total number of petitions filed. Only 4% of AIA petitions during this period contested Orange Book patents, and 2% of petitions contested organic patents. This statistic likely reflects the strength, or perceived strength, of these types of patents for potential challengers. It also reflects the patent challengers’ preferences for a different forum due to the availability of special litigation procedures available under the Hatch-Waxman Act and the Biologics Price Competition and Innovation Act (BPCIA ) for Orange Book patents and biological patents, respectively.

Trends over time

After the enactment of the AIA in 2013, data from this study shows that the percentage of petitions challenging the Orange Book and organic patents peaked in FY (FY) 2016 and FY 2017 and has declined since. Interestingly, the study shows that the decline has been more pronounced for Orange Book patents than for organic patents. This trend may be due to the strength of the Orange Book patents remaining after the initial wave of challenges since the enactment of the AIA. The drop could also reflect the relatively lower institution rate and higher post-institution success rate for Orange Book patents, which together create an unfavorable forum for challengers.

Institutional rates for the orange book and organic patents have also fallen. When it comes to institutional rates since September 2012, both the Orange Book and organic patents are currently slightly below average. Throughout the study period (from 2012 to the third quarter of 2021), the average rate of patent institutions in all technology fields is 64%, while the rate of institutions for orange book patents and organic products is 62% and 55% respectively. In the third quarter of fiscal 2021, the rate for Orange Book patents fell to an all-time low of 27% since fiscal 2013. Although slightly higher than for Orange Book patents, the rate was The institution of biological patents has also hit an all-time low of 33% since fiscal 2014.

AIA petitions results

After being instituted, Orange Book patents tend to fare better than organic patents. From September 16, 2012 to June 30, 2021, only 15% of the petitions filed against Orange Book patents concluded that all of the contested claims were not patentable. In contrast, 21% of requests against biological patents resulted in a final written decision in which all of the contested claims were found to be unpatentable. These differences may be due in part to the types of patents challenged. Orange Book patents only cover claims for compounds, formulations, and drug methods. See 21 CFR § 314.53 (b). In contrast, the definition of biologics defined in this PTAB study is broader and may include manufacturing practices, packaging, metabolites and intermediates. Overall, when challenged, 56% of Orange Book patent applications and 62% of biological patent applications are either refused by the institution or found to be unpatentable.

Another interesting statistic when it comes to Orange Book trends and biologics patent trends is the low settlement rate. Compared to the overall settlement rate of 33% in FY2021 according to the AIA PTAB trials for the third quarter of FY2021, the Orange Book and Biologics settlement rate of 23% and 18%, respectively, is very low. However, it is difficult to draw definitive conclusions from this statistic as it is unclear whether the settlement of PTAB disputes tends to be more favorable to the challenger or the patentee.

Based on these data, it appears that the balance is currently tilting in favor of patent holders in PTAB proceedings. Notably, the number of petitions challenging both organic patents and Orange Book patents has declined since their peak in 2016 and 2017; the institution rate has fallen for both types of patents; and there is a slight increase in the number of Orange Book and Biologics patents receiving a final positive written decision.

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