In addition to the key legal-regulatory agencies associated with the pharmaceutical and secondary biotech markets, numerous government acts and government agencies affect virtually every worker, employee, and business in the United States. For example, the Occupational Safety and Health Administration (OSHA), which is under the U.S. Department of Labor, is tasked with saving lives, preventing injuries, and protecting the health of U.S. workers, whether they are involved in agriculture or manufacturing pharmaceuticals. Other examples of sweeping legislation that have a direct impact on defining the biotech industry are the numerous federal cooperative research and development and technology transfer acts, including those listed below.

FIGURE. Federal Cooperative R&D and Technology Transfer Acts that directly impact the biotech industry.

Bayh-Dole University and Small Business Patent Act
Federal Technology Transfer Act
National Competitiveness Technology Transfer Act
National Cooperative Research Act
National Cooperative Research and Production Act
Omnibus Trade and Competitiveness Act
Small Business Innovation Development Act
Stevenson-Wydler Technology Innovation Act
Technology Transfer Commercialization Act

Taken together, these acts encourage interactions between academia, the business community, and the government, and allow businesses to retain or gain the patent rights to technologies developed with government funding. For example, The Bayh-Dole University and Small Business Patent Act allows government contractors and grantees to retain title to inventions to encourage interactions between academia and the business. The Federal Technology Transfer Act established the Cooperative Research and Development Agreements (CRADAs) as a means of funding corporate research and development with U.S. government taxpayer money.


Please, read related posts in my blog:

  • When you start branding…
  • Experience with Direct-to-Consumer Advertising
  • Legal-Regulatory Infrastructure in Pharmacy
  • Bioterrorism at the peak of its power
  • Economics of BioTech education