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The red herring of human gene patents

The greatest dangers to liberty lurk in the insidious encroachment by men of zeal, well meaning but without understanding. — Louis D. Brandeis

Just a few words and little thought separate yet another stronghold of the American economy from ruin. It doesn't have to be that way. The U.S. patent system has made America's biotech and pharmaceutical industries the envy of the world.

This month, the U.S. Supreme Court heard oral arguments in a case posing the question: "Are human genes patentable?" The very way the ACLU and other petitioners have worded the question sets up an emotional red herring designed to solicit false choices. The patents at issue in the case do not cover genes in a human body. They cover man-made DNA constructs with specific properties and functions not found in nature. The artificial constructs are used to detect mutations in human genes and to diagnose a patient's risk for developing breast and ovarian cancer.

The cost of diving into the pseudo-scientific swamp created by the petitioners could be substantial. The U.S. Patent Office has been granting patents on man-made DNA constructs for nearly 30 years. Today, the United States is the world leader in biotechnology and health care — in no small part due to a long history of robust incentives for innovation investment based on stable and reliable patent protection. Yet taking the bait proffered by the ACLU would put that at risk.

The emotional red herring does not stop there. The ACLU maintains that if we continue to reward scientific progress with these patents, then researchers and health care providers will be prevented from using the patented inventions to further scientific research and medical product innovation. This, too, presents a false choice. Patents and scientific progress can coexist in genetic medicine. In fact, they already do.

Artificial DNA constructs like those at issue in the case represent the very best reasons for patent protection. Insulin, human growth hormone and erythropoietin are just three of the many synthetic protein therapies made using artificial DNA constructs. Likewise, artificial DNA constructs serve as a basis for new diagnostic tests, particularly in the field of cancer, as well as new vaccines, and have other important applications in agriculture, food safety, industrial materials, energy and environmental biotechnology. But without some means to protect the enormous investment they require, breakthrough products and services like these may never come to be.

Our Founding Fathers had the foresight to provide this means through the patent system mandated by the U.S. Constitution (Article 1, Section 8, Clause 8) securing to "inventors the exclusive right to their discoveries" for a limited time in order "to promote the progress of science and useful arts." As Abraham Lincoln explained, patents add "the fuel of interest to the fire of genius, in the discovery and production of new and useful things."

Patent protection and scientific progress go hand in hand. The marketplace has proved adept at providing access to patented DNA constructs to further scientific progress because of patent protection, not in spite of it. Since the patents in the case were granted, according to the respondents in the case, "over 18,000 researchers have conducted studies on the BRCA 1/2 genes, published over 8,000 papers, and conducted over 130 clinical trials." In short, this state of affairs illustrates the very dissemination of science and knowledge envisioned by the Constitution — a far cry from the secrecy surrounding scientific discovery and the diversion of private investment dollars to other technologies and other countries, to which the petitioners' position would lead.

What's more, forward-looking patent holders and leaders in health care research — the Johns Hopkins University, Ludwig Institute for Cancer Research, Memorial Sloan-Kettering Cancer Center, the National Institutes of Health and others — have come together to support Librassay, a private market initiative making diagnostic patent rights available on the same terms to anyone, while giving patent owners the opportunity for wide adoption of their technologies, reasonable compensation for their investments, and the incentive to invest more. The Librassay initiative is growing and is expected to accelerate innovation in diagnostics and personalized medicine.

In the gene patent case before the Supreme Court, the rhetoric does not match the reality. Working with the patent system as it has existed for 30 years, the private sector has developed ways to balance the strong incentives provided by patents with the desire for progress in the field of human genetics and medicine. It is the reason why the biotech and medical industries have thrived in America. The Supreme Court would do well to find a way to maintain the status quo and avoid the emotional appeal of false choices.

The case is Association for Molecular Pathology et al., v. Myriad Genetics, Inc., et al. (Case No. 12-398). Oral arguments were heard on Monday, April 15, 2013.

Lawrence Horn is president and CEO of MPEG LA, LLC, the Chevy Chase-based company operating the Librassay patent licensing facility. Kristin Neuman (kneuman@mpegla.com) is executive director of Librassay. and was previously a biotech patent lawyer in private practice. The authors are employed by MPEG LA, LLC, the company operating the Librassay® patent licensing facility mentioned in this piece. Lawrence Horn is President and CEO of the company. He has nearly 20 years of experience operating patent pools that have accelerated technology dissemination in other industries, such as consumer electronics. Kristin Neuman is Executive Director of Librassay®. Prior to joining Librassay, she was a biotech patent lawyer in private practice.

Copyright © 2015, The Baltimore Sun
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