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COMMENTARY

Gene patenting: A threat to the development of molecular diagnostics?

Is gene patenting a threat to the commercial development of molecular diagnostics? The answer to this question is an emphatic no! The ultimate goal of the U.S. patent system is to provide a balance between the interests of the public and the private sector.

The Patent System

The patent system has its basis in the U.S. constitution, in which the federal government is given the mandate "(to) promote the Progress of Science and Useful Arts by securing for a limited time to Authors and Inventors the exclusive right to their respective Writings and Discoveries." In exchange for a full disclosure of their inventions, the government grants inventors the right to exclude others from making, using, selling, or offering to sell their inventions for a limited period of time. This quid pro quo is intended to give inventors an incentive to invent.

A product is eligible to be patented only when it meets all of the following criteria. It must be new, nonobvious, have real-world applicability, and can be described in such a way that someone skilled in that area of technology could make and use it as intended. The inventor's use privilege does not preclude a second party from discovering and patenting another real-world use or even a nonobvious useful variation of the same product. The current patent environment serves to attract financial investment in potential products. In turn, this investment can be the impetus for the movement of products, such as molecular diagnostics, into the marketplace.

In the absence of patent law, discoverable inventions would be freely available to anyone who wanted to use them. In this scenario it could be argued that since inventors would not be able to benefit from the product, fewer would be made, leaving society worse off for the lack of such products.

Opponents of gene patents suggest that the patent system puts the interests of the private and public sectors at odds. These individuals imply that the public is not as well served as it could be because the system allows the patent holder or exclusive licensee to prevent others from performing a patented test. They argue that, without patents, any molecular biology laboratory would be able to perform DNA-based diagnostic tests. Therefore the public would have greater access to these technologies.

In fact, historical evidence shows that just the opposite is true. Patents have provided the incentive for commercial organizations to create and develop markets for diagnostic testing services based on DNA discoveries. The patents provide the motivation for companies to make the test available to as wide an audience as possible in order to maximize their profit.

Financial Concerns

Commercial organizations are often the only entities that are fully equipped with the resources necessary to widely distribute these diagnostic tests. However, no company would devote resources if, once the market had been established, their competitors would be able to also offer the test. This is true whether the competitors are other commercial organizations or laboratories operating within academic institutions.

Because it is much easier and cheaper to follow than it is to innovate, competitors would receive an unfair advantage. They would not have to devote resources to market development, and would therefore be able to offer the tests at lower prices. The end result would be that commercial organizations would not be willing to develop these testing technologies, because they would not profit from such development activities. As a result, patients would have reduced access to important medical advances—exactly the opposite of the effect intended by the opponents of gene patents.

Other Concerns

A number of other problems could result if the genes on which molecular diagnostic tests are based were not patented. There would be a patchwork quilt of quality assurance and quality control measures because each lab would carry out its own version of the test. Additionally, only those "in the know" would have access to molecular testing, because there would be no incentive to provide educational support, and fewer tests would move out of academia and into clinical practice. In short, physicians and patients would be denied access to the benefits of the latest scientific and medical advances.

Notwithstanding the question of access, in the absence of intellectual property protection and the option of exclusive licensing, many discoveries would languish. A prime example of this is the lack of availability of a test for Creutzfeldt-Jakob disease (CJD). Researchers at two institutions jointly discovered a protein marker that could be developed as a technology for diagnosing CJD. In an attempt to make a test as widely available as possible, the institution responsible for licensing the discovery decided not to license the technology on an exclusive basis. This strategy had the opposite of its intended effect. To date, no commercial organization has demonstrated a willingness to devote the resources necessary to transform the discovery into a diagnostic assay without intellectual property protection.

Conclusion

Gene patenting is not a threat to the commercial development of molecular diagnostics. On the contrary, it is crucial to its survival and success. The U.S. model for the commercial genetic testing market—the funding of basic research, transferring technology from the academic sector, taking advantage of the availability of risk capital, and leveraging the fact that investors are willing to take risks—has paid off. The United States currently leads the world in this area; without the opportunity to patent DNA-based discoveries, this component of our healthcare system would deteriorate significantly.

Biotechnology, like any other progressive industry, recognizes that it raises unique issues that must be addressed as new technology is introduced. The biotechnology industry supports the efforts of the U.S. Patent and Trademark Office (PTO), which has taken great strides in balancing public and the private sector needs. The PTO is finalizing guidelines that will address many of the concerns raised by opponents of gene patents. The guidelines are expected to be available in late fall 2000. The preliminary documents can be accessed via the Internet.

The ultimate beneficiaries of the patent system are patients with deadly and disabling diseases who rely on the innovation, the resources, and the capital of the biotechnology industry to provide new diagnostic and therapeutic products.

Lila Feisee is the director of federal government relations and intellectual property at Biotechnology Industry Organization (BIO; Washington, DC).