Patent Reform: Issues in the Biomedical and Software Industries

Wendy H. Schacht
Specialist in Science and Technology Policy

The Leahy-Smith America Invents Act, P.L. 112-29, passed Congress following several years of legislative debate over patent reform. This attention to patent policy reflects a recognition of the increasing importance of intellectual property to U.S. innovation. Patent ownership is perceived as an incentive to the technological advancement that leads to economic growth. As such, the number of patent applications and grants has grown significantly, as have the type and breadth of inventions that can be patented.

Along with the expansion in the number and range of patents, there were growing concerns over whether the current system was working efficiently and effectively. Several studies recommended patent reform and various bills were introduced in recent congresses that would make significant alterations in current patent law. Other experts maintained that major changes in existing law were unnecessary and that, while not perfect, the patent process was adapting to technological progress.

The patent laws provide a system under which all inventions are subject to the same requirements of patentability regardless of the technical field in which they arose. However, inventors and innovative companies in different industries often hold divergent views concerning the importance of patents, reflecting varying experiences with the patent system. Innovators in the biomedical sector tend to see patent protection as a critically important way to prohibit competitors from appropriating the results of a company’s research and development efforts. Typically only a few, often one or two, patents cover a particular drug. In contrast, the nature of software development is such that inventions often are cumulative and new products generally embody numerous patentable inventions. As a result, distinct industries may react differently to the patent reform legislation enacted by Congress.


Date of Report: December 9, 2011
Number of Pages: 15
Order Number: RL33367
Price: $29.95

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