Columbia University's Axel Patents: Technology Transfer and Implications for the Bayh‐Dole Act

Abstract

Context The Bayh-Dole Act of 1980, which gave federal grantees and contractors the right to patent and license inventions stemming from federally funded research, was intended to encourage commercial dissemination of research that would otherwise languish for want of a patent incentive (Eisenberg 1996; Berman 2008). The case of Columbia University’s Axel patents, which claimed a scientific method to introduce foreign proteins into nucleated cells, illustrates a secondary outcome of the Bayh-Dole Act: the incentive for federal grantees and contractors to pursue royalty revenues from patented research, even in inventions for which commercial use did not require patents. Methods The authors conducted oral interviews with two of the three inventors, as well as a former high-ranking administrator at Columbia; corresponded with several faculty members at Columbia to obtain key royalty figures and information about Columbia’s licensing strategy; performed patent searches; examined legal records of court proceedings; and analyzed citation trends for the seminal papers disclosing the invention of co-transformation. Findings Columbia University and the inventors profited handsomely from the Axel patents, earning $790 in revenues through licensing arrangements that tapped profits from end-products made by biotechnology and pharmaceutical companies. Columbia’s aggressive effort to extend the patent duration also led to considerable legal expenditures and fierce controversy. Obtaining and enforcing a 2002 patent, in particular, proved costly, politically difficult, financially fruitless, and attracted intense criticism for behavior unbecoming a nonprofit academic institution. Conclusions This case study raises several important questions about the logic of Bayh-Dole and future revisions of the Act: are revenue generation and financial rewards for inventing valuable technologies legitimate goals for the Bayh-Dole Act? If so, does the federal government need credible mechanisms for oversight, or checks and balances on the rights conferred?

Public-private knowledge transfer and access to medicines: a systematic review and qualitative study of perceptions and roles of scientists involved in HPV vaccine research

“…112 studies were included for full-text review, six of these could not be retrieved and 93 were excluded (see appendix C for PRISMA flow chart). 13 studies were included in our analysis, 11 journal papers and two dissertations [65][66][67][68][69][70][71][72][73][74][75][76][77]. The quality of included studies ranged from five to nine points, indicating moderate to high quality (for a detailed description see annex C).…”

“…The reviewed studies described various methods of exchanging knowledge, including academic publications and the presentation of research findings at conferences. Often in contrast to these "academic channels" [66], studies discussed the protection of IP through patents and the subsequent licensing of the protected technologies [65,67,74]. Two papers, in particular, explored the conflict between publishing and patenting knowledge [66,67].…”

Horyzonty współczesnego zarządzania

“…Patenty dotyczyły techniki kotransformacji DNA, stanowiącej podstawę dla wielu procesów biotechnologicznych i opracowanej przez zespół Richarda Axela, pracujący na Uniwersytecie Columbia (Klincewicz, 2008, s. 143). Rzadziej wspomina się jednak, że uczelnia-właściciel patentów podejmowała przy wsparciu kancelarii prawnych bardzo agresywne działa-nia, mające na celu zmuszenie firm technologicznych do podpisywania umów licencyjnych oraz egzekwowanie odszkodowań w związku ze stosowaniem opatentowanego procesu (Colaianni i Cook-Deegan, 2009).…”

Patents in Genomics and Human Genetics

“…Stanford kept royalty rates and up-front payments relatively low to encourage licensing and discourage commercial licensees from litigation. Columbia University used a similar strategy a few years later with its cotransformation recombinant DNA technology, which generated an estimated $790 million in revenues (49). …”

“…This was not the stated rationale of the Bayh--Dole Act, but the policy did reward socially useful activity at the responsible institutions and also compensated the inventors. The just deserts rationale was not prominent in the Bayh--Dole debate, but it could have been and should have been an explicit basis for policy choice, based on evidence more credible than the “languishing invention” arguments (49). …”