From the “one hand doesn’t know what the other hand is doing” category, believe it or not, the Food and Drug Administration (FDA) is effectively refusing to release documents it possesses relating to the approval of the Pfizer-BioNTech COVID-19 vaccine. More precisely, Public Health and Medical Professionals for Transparency (PHMPT), a group of doctors and scientists, submitted a Freedom of Information Act (FOIA) request for documents relating to the approval of the Pfizer COVID-19 vaccine. After the FDA denied a request by the PHMPT to expedite release of the documents, a lawsuit was filed. In response to that lawsuit, the FDA proposed to release 500 pages per month, which would allow the agency time to redact material as necessary. Given that there are 329,000 pages responsive to the PHMPT request, at the proposed FDA rate of 500 pages per month it would take 55 years for the FDA to fully release the Pfizer COVID-19 vaccine documents.

On November 2, Senator Thom Tillis (R-NC) sent a pair of letters regarding issues in district court patent litigation—one addressed to Drew Hirshfeld, performing the functions and duties of the Director of the U.S. Patent and Trademark Office (USPTO), and another letter co-written with Senator Patrick Leahy (D-VT) addressed to Chief Justice John Roberts of the U.S. Supreme Court. While never mentioned by name, U.S. District Judge Alan D. Albright is unmistakably the subject of both letters, which expressed serious concerns about “unrealistic trial dates” and “open solicit[ation]” of patent cases from a single judge in the Waco Division of the Western District of Texas.

Is patent litigation out of control? Has patent litigation ever been out of control? The answers to these questions largely depend upon your point of view, and as with most complex topics, the truth is nuanced. What is not nuanced are the numbers reported in the annual reports from the  Administrative Office of the United States Courts, which shows that the number of patent cases that reach trial are extremely few. In fact, the number of cases that make it to the final pre-trial conference represents a small subset of the number of cases that are filed. I initially started this research in 1997, while working on my Master’s thesis, which dealt with patent litigation and the use of alternative dispute resolution. The real growth in patent litigation over the last 40 years has taken place before trial. Between 1980 and 2020, the number of patent cases reaching trial ranged between a low of 63 (in the COVID-19 affect FY 2020) but was otherwise at a low o 64 (in FY 2019) and a high of 164 (in FY 2016). All are a remarkably low number of cases that proceed to trial given the number of patent lawsuits commenced.