Academic journal article The George Washington International Law Review

Patent Eligibility of Biotechnological Inventions in the United States, Europe, and Japan: How Much Patent Policy Is Public Policy?

Academic journal article The George Washington International Law Review

Patent Eligibility of Biotechnological Inventions in the United States, Europe, and Japan: How Much Patent Policy Is Public Policy?

Article excerpt


Biotechnology, defined as "any technique that uses living organisms or substances from those organisms to make or modify a product, to improve plants or animals, or to develop microorganisms for specific uses,"1 holds great potential for improving the quality of life in the United States and around the world.2 The biotechnological revolution of the 1980s and 1990s enables scientists to isolate the genetic materials of living organisms and induce precise modifications so that organisms manifest and carry desired genetic traits.3 Biotechnology is beginning to revolutionize agriculture by developing genetically superior plants and animals.4 It is used to create solutions to difficult environmental problems and challenges.5 For example, scientists have developed genetically altered microorganisms that digest oil spills and prevent further damage to the environment after the initial crisis.6 Biotechnology is starting to have a major impact on the development of pharmaceuticals and the methods used to study and treat human disease.7 Whether the biotechnology revolution lives up to its potential depends on how well the fruits of the revolution are protected.

It has been noted that "[b]iotechnology has stimulated the creation and growth of small businesses, generated new jobs, and encouraged agricultural and industrial innovation."8 It is one of the most research-intensive and innovative industries in the scientific fields.9 In 2000, the industry employed more than 150,000 people and had invested on average ten billion-dollars a year on research and development.10 In 1994, the all-industry composite average for research and development investment per employee was $7,651.3.11 Some biotechnology industry leaders, such as Genentech, spend sixteen times the average amount for the general industry.12

In the United States, the patent system plays a critical role in the growth of the biotechnology industry. In the last few years, biotechnology has grown into a thirteen billion-dollar industry, and the number of biotechnology patent applications now exceeds 14,000 annually.13 Patent protection is vital to the biotechnology industry, particularly because small biotechnology companies invest enormous sums of money in research and development. Often, intellectual property is the only product that a young company can show its potential investors; and patents are ideally suited to protect technology-based intellectual property.

Patents help attract the investments needed to continue research and facilitate the relationship between government, academia, and the private sector. The patent system stimulates disclosure of research results that others can build on. Disclosure occurs not only via the publication of the patent document, but also by facilitating more open communication between scientists. Without patent protection, many research scientists would be less willing to publicize their work, and collaborative efforts and progressive developments would be diminished.14 Thus, the potential to protect the fruits of expensive research speeds up the research process as well.

The U.S. biotechnology industry has also led the movement toward the development of international markets for the products of biotechnology.15 Global markets evince the promise of recouping the enormous cost of biotechnology research and development. The United States is presently the world leader in agricultural biotechnology, exporting roughly seventy-five percent of the world's bioengineered materials.16 The U.S. government increasingly recognizes the importance of including intellectual property protection in international agreements and the implementation of uniform biotechnology patent protection throughout the world.17

Certain biotechnological inventions have spurred debates over their patent eligibility.18 This Note compares the patent laws in the United States, Europe, and Japan as they relate to the patent eligibility of biotechnological inventions. …

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