Key Trends In Pharmaceutical IPRs Filed By Generic Petitioners

15 May 2017 PTAB Trial Insights Blog
Authors: Stephen B. Maebius

We reviewed a sub-group of two hundred and four (204) IPRs filed by generic drug companies against pharmaceutical patents to assess PTAB outcomes and key trends in dealing with this technology field. The survey captured IPR filings by fourteen (14) of the most active generic petitioners among the world’s top-20 generic drug companies. This study updates and expands findings from our earlier survey of this subgroup (see the June 2016 post here on PTAB Trial Insights).  Detailed findings are presented in Fig. 1 below, as well our key findings in the following sections. One surprising trend revealed by this survey is a high institution rate (75%) against pharmaceutical patents, well above the average for all technologies.

High Institution Rate, but Lower Invalidation Rate in Final Decisions

Examining this group of IPRs, we found a surprisingly high institution rate of seventy five percent (75%), which is eight percent (8%) higher than the statistics from our prior survey and is at the high end of institution rates across all technologies. Notably, generic companies are achieving a significantly higher institution rate than the sixty three percent (63%) institution rate for the combined “biotechnology/pharma” category published by the USPTO in November 2016.

The current data pool has forty one (41) cases that have reached the final written decision (FWD) stage (see Fig. 2 below), allowing us to produce more reliable statistics on the invalidation rate. Particularly, the PTAB finds all claims patentable in thrifty nine percent (39%) of the cases, and all claims unpatentable in fifty nine percent (59%) of the cases. In a minority two percent (2%) of the cases, some claims are found patentable, while others unpatentable. The sixty one percent (61%) invalidation rate (combined all and some claims unpatentable) is significantly lower than the average eighty percent (80%) invalidation rate for other technologies. Therefore, while it may be easier for generic companies to have their IPRs instituted, the overall likelihood for them to walk away from the trial with at least one claim invalidated is actually lower. However, it is important to consider the following additional finding that there is also a high rate of settlement, which may skew the adverse final decision number lower.

High Incidence of Settlement

The settlement rate remains high at about twenty two percent (22%) (combined pre- and post-institution settlements out of total outcomes) since our prior survey, with pre-institution settlements counting for fourteen percent (14%) of all outcomes (see Fig. 2 below). When multiple related patents are under attack by the same petitioner, which may be more common for pharmaceutical IPRs, patent owners tend to defend or settle them en masse. Particularly, twenty eight (28) out of the forty four (44) total settlements in the current data pool are between parties litigating multiple related patents before the PTAB. This kind of “batch” settlement may account for the higher settlement rate in our survey.

High Incidence of Parallel Litigation

Out of the 205 pharma IPRs we surveyed, 73% (150) involved a parallel litigation where the IPR petitioner was a defendant in the litigation. In some cases, there were multiple parallel litigations involving the patent that was the subject of the IPR where the defendants chose not to file IPRs or join existing IPRs of the patent.

Majority Engaged Specialist IPR Firm in Addition to or in Place of Litigation Counsel

Out of the 150 pharma IPRs with parallel litigation, 26% (39) used a combination of a new firm as IPR counsel together with the litigation counsel who represented the patent owner, 17% (25) used a different firm as IPR counsel and litigation counsel was not listed of record in the IPR, and 57% (86) used the same firm for IPR counsel and the parallel litigation.

On the petitioner’s side, out of the 150 pharma IPRs with parallel litigation, 35% (52) used a combination of a new firm as IPR counsel together with the litigation counsel, 29% (43) used a different firm as IPR counsel and litigation counsel was not listed of record in the IPR, and 37% (55) used the same firm for IPR counsel and the parallel litigation.

Thus, in the case of patent owners, 43% chose to involve an additional firm in the IPR. In the case of petitioners, 64% chose to involve an additional firm in the IPR.

A variety of factors may be behind the decisions to involve a specialist firm for the IPRs in addition to or instead of litigation counsel. The firm handling the litigation may not have sufficient IPR expertise. There may be a protective order that contains a prosecution bar, which may require a wall between the attorneys handling the IPR and the litigation (such walls can be implemented within a single firm in cases where an experienced IPR counsel is available in the same firm if they are not involved in the litigation). In all cases where an additional firm is involved, it is critical to coordinate strategy and keep arguments consistent.

The following figure shows the number of IPR petitions filed by the most active generic drug company petitioners to date:

Fig. 1: Number of IPR Petitions by Generic Drug Company Petitioners


The following figure shows the outcomes of IPR petitions filed by the most active generic drug company petitioners to date:

Fig. 2.: Outcome of IPR Petitions by Generic Drug Company Petitioners


This blog is made available by Foley & Lardner LLP (“Foley” or “the Firm”) for informational purposes only. It is not meant to convey the Firm’s legal position on behalf of any client, nor is it intended to convey specific legal advice. Any opinions expressed in this article do not necessarily reflect the views of Foley & Lardner LLP, its partners, or its clients. Accordingly, do not act upon this information without seeking counsel from a licensed attorney. This blog is not intended to create, and receipt of it does not constitute, an attorney-client relationship. Communicating with Foley through this website by email, blog post, or otherwise, does not create an attorney-client relationship for any legal matter. Therefore, any communication or material you transmit to Foley through this blog, whether by email, blog post or any other manner, will not be treated as confidential or proprietary. The information on this blog is published “AS IS” and is not guaranteed to be complete, accurate, and or up-to-date. Foley makes no representations or warranties of any kind, express or implied, as to the operation or content of the site. Foley expressly disclaims all other guarantees, warranties, conditions and representations of any kind, either express or implied, whether arising under any statute, law, commercial use or otherwise, including implied warranties of merchantability, fitness for a particular purpose, title and non-infringement. In no event shall Foley or any of its partners, officers, employees, agents or affiliates be liable, directly or indirectly, under any theory of law (contract, tort, negligence or otherwise), to you or anyone else, for any claims, losses or damages, direct, indirect special, incidental, punitive or consequential, resulting from or occasioned by the creation, use of or reliance on this site (including information and other content) or any third party websites or the information, resources or material accessed through any such websites. In some jurisdictions, the contents of this blog may be considered Attorney Advertising. If applicable, please note that prior results do not guarantee a similar outcome. Photographs are for dramatization purposes only and may include models. Likenesses do not necessarily imply current client, partnership or employee status.

Related Services


FTC shuts down bogus debt collectors of “phantom debt”!
28 September 2021
Internet, IT & e-Discovery Blog
COVID-19 Vaccinations Required for Covered Contractors by December 8, 2021
28 September 2021
Legal News: Government Solutions & Government Procurement
Foley Weekly Automotive Report
28 September 2021
Coronavirus Resource Center:Back to Business
Podcast Episode 65: Justin Talbot, Senior Patent Agent
28 September 2021
Foley Career Perspectives
17th Annual IP Conference
12 November 2021
Chicago, IL
HLTH Conference 2021
17-20 October 2021
Boston, MA
Supply Chain and Sustainability Summit
12 October 2021
30th Annual Law of Product Distribution & Franchise Seminar
7 & 20 October | 3 November 2021