Patents and University-Industry Interactions in Pharmaceutical Research before 1962: An Investigation of the Historical Justifications for Bayh-Dole

By Mazzoleni, Roberto | The Journal of High Technology Law, July 2010 | Go to article overview

Patents and University-Industry Interactions in Pharmaceutical Research before 1962: An Investigation of the Historical Justifications for Bayh-Dole


Mazzoleni, Roberto, The Journal of High Technology Law


I. Introduction

The relationship between academic research and research and development within the pharmaceutical industry has been the focus of recent debates over the justification for the Bayh-Dole Act. (1) This relationship served as a critical prism through which many scholars argued for federal patent policy reform. (2) Supporters and opponents of patent reform, ultimately codified in the Bayh-Dole Act, presented diametrically opposed views regarding the impact of the patent policies implemented by the Department of Health, Education, and Welfare (HEW) in the late 1960s. (3) The Bayh-Dole Act was the embodiment of arguments promulgated by patent reform promoters who asserted that citizens would ultimately lose the benefits of federal funding of biomedical research in the absence of policies facilitating collaboration between academic scientists and pharmaceutical firms. (4) This collaboration would only be possible if the government protected industrial companies' exclusive rights to any inventions resulting from federally funded research. (5)

Private acquisition of rights in federally funded inventions received support from two reports on current patent policy released in the 1960s as well as the testimony of numerous scientists at congressional hearings. (6) Many scholars infer from these reports that the collaboration between universities and the biomedical research industry had been mutually beneficial until the 1960s. (7) However, knowledge of the history of collaborations between the National Institute of Health (NIH) grantees and industry referred to in such statements is currently very limited. Beginning in 1962, HEW started requiring that NIH grantees and third party laboratories solicited by the grantees (most often pharmaceutical companies and commercial testing laboratories), enter into formal patent agreements. (8) The terms of the agreements proved unacceptable to pharmaceutical companies, who consequently stopped screening compounds synthesized by academic scientists. (9) The terms of the HEW-mandated patent agreement did not substantially alter HEW's policy regarding exclusivity terms in the licensing of government-funded inventions. (10) However, the negative response by many researchers to the change in NIH policy underscored the pharmaceutical industry's need for exclusive rights in order to collaborate with NIH grantees in the development of their inventions. (11)

Two fundamental questions emerge from a study of the critical events in the years leading up to the formulation and enactment of the Bayh-Dole Act. First, how extensively did pharmaceutical firms collaborate with NIH grantees before 1962, and what motivated them to do so? (12) Second, why did reactions to the 1962 patent agreement emphasize the pharmaceutical industry's need for a guaranteed exclusive license as a quid pro quo for collaborating with NIH grantees? (13)

To address these questions, it is important to understand the different perspectives in the debate over federal government patent policy. (14) Additionally, it is critical to provide an historical account of the specific policies adopted by HEW and its predecessor, the Federal Security Agency (FSA). (15) As will become apparent, the formal policies left considerable discretion to the Surgeon General to promote the public interest through the disposition of government-sponsored inventions. (16) The reported collaborations between NIH grantees and industry, from which few patents resulted, combined with HEW's hostility to exclusive licenses on government-sponsored inventions, appear to contradict the pharmaceutical industry's claimed dependence on exclusive licensing arrangements. (17)

This paper then presents a few approaches to the resolution of this apparent contradiction based on the available evidence. In particular, it will be noted that the large pharmaceutical firms demanded, with great vigor, exclusive rights to government-sponsored inventions after 1962. …

The rest of this article is only available to active members of Questia

Sign up now for a free, 1-day trial and receive full access to:

  • Questia's entire collection
  • Automatic bibliography creation
  • More helpful research tools like notes, citations, and highlights
  • Ad-free environment

Already a member? Log in now.

Notes for this article

Add a new note
If you are trying to select text to create highlights or citations, remember that you must now click or tap on the first word, and then click or tap on the last word.
One moment ...
Default project is now your active project.
Project items

Items saved from this article

This article has been saved
Highlights (0)
Some of your highlights are legacy items.

Highlights saved before July 30, 2012 will not be displayed on their respective source pages.

You can easily re-create the highlights by opening the book page or article, selecting the text, and clicking “Highlight.”

Citations (0)
Some of your citations are legacy items.

Any citation created before July 30, 2012 will labeled as a “Cited page.” New citations will be saved as cited passages, pages or articles.

We also added the ability to view new citations from your projects or the book or article where you created them.

Notes (0)
Bookmarks (0)

You have no saved items from this article

Project items include:
  • Saved book/article
  • Highlights
  • Quotes/citations
  • Notes
  • Bookmarks
Notes
Cite this article

Cited article

Style
Citations are available only to our active members.
Sign up now to cite pages or passages in MLA, APA and Chicago citation styles.

(Einhorn, 1992, p. 25)

(Einhorn 25)

1

1. Lois J. Einhorn, Abraham Lincoln, the Orator: Penetrating the Lincoln Legend (Westport, CT: Greenwood Press, 1992), 25, http://www.questia.com/read/27419298.

Cited article

Patents and University-Industry Interactions in Pharmaceutical Research before 1962: An Investigation of the Historical Justifications for Bayh-Dole
Settings

Settings

Typeface
Text size Smaller Larger Reset View mode
Search within

Search within this article

Look up

Look up a word

  • Dictionary
  • Thesaurus
Please submit a word or phrase above.
Print this page

Print this page

Why can't I print more than one page at a time?

Full screen

matching results for page

Cited passage

Style
Citations are available only to our active members.
Sign up now to cite pages or passages in MLA, APA and Chicago citation styles.

"Portraying himself as an honest, ordinary person helped Lincoln identify with his audiences." (Einhorn, 1992, p. 25).

"Portraying himself as an honest, ordinary person helped Lincoln identify with his audiences." (Einhorn 25)

"Portraying himself as an honest, ordinary person helped Lincoln identify with his audiences."1

1. Lois J. Einhorn, Abraham Lincoln, the Orator: Penetrating the Lincoln Legend (Westport, CT: Greenwood Press, 1992), 25, http://www.questia.com/read/27419298.

Cited passage

Welcome to the new Questia Reader

The Questia Reader has been updated to provide you with an even better online reading experience.  It is now 100% Responsive, which means you can read our books and articles on any sized device you wish.  All of your favorite tools like notes, highlights, and citations are still here, but the way you select text has been updated to be easier to use, especially on touchscreen devices.  Here's how:

1. Click or tap the first word you want to select.
2. Click or tap the last word you want to select.

OK, got it!

Thanks for trying Questia!

Please continue trying out our research tools, but please note, full functionality is available only to our active members.

Your work will be lost once you leave this Web page.

For full access in an ad-free environment, sign up now for a FREE, 1-day trial.

Already a member? Log in now.