It has long been known that different individuals react to the same drug differently. Matching the right therapy with the right individual, commonly know as “personalized medicine,” could improve treatment, reduce side effects, and ultimately save healthcare dollars.
This idea has captured the attention of not only research scientists, but also healthcare providers, the pharmaceutical industry, pharmacy benefits managers, venture capitalists, and the FDA. Progress is being made in this area, and a number of personalized medicine products are already on the market. Though sales numbers are still quite small, diagnostic tests and targeted treatments aimed at enabling personalized medicine are expected to become part of mainstream medical practice within 10 years. Yet, passage of pending legislation that is purported to promote medical advances will likely have the opposite effect, hindering much-needed venture capital investment in this emerging field.
At the heart of personalized medicine are diagnostics tests that reveal, for example, a patient’s risk of a particular disease or likelihood of responding well or poorly to a particular drug—often based on gene expression or gene mutations. But there are many hurdles that a diagnostic company must overcome before bringing a diagnostic to market. It is estimated, for instance, that it could cost as much as $100 million to bring a broad-based screening test successfully to market. Who will fund such work remains uncertain.
There are other uncertainties. Costs and volatility could increase even more if proposed FDA regulations are enacted. Questions still remain as to who will pay for this technology when it reaches the clinic. Will it be the patient? Will it be insurance companies? Will such technology even be accepted by healthcare professionals?
As with any emerging technology, if risk and uncertainly are outweighed by the potential for profits, investment and development will continue. And as with any emerging technology, the potential for profit in the diagnostics and personalized medicine space is protected by strong patents. However, recent congressional action would prevent patent protection on inventions critical to personalized medicine.
On February 9, 2007, Representative Xavier Becerra introduced the Genomic Research and Accessibility Act, a bill that, once enacted, is purported to put an immediate end to the practice of patenting any and all portions of the human genome. The legislation proposes to amend chapter 10 of title 35, United States code, by adding the following new section:
“Notwithstanding any other provision of law, no patent may be obtained from nucleotide sequence, or its functions or correlations, or the naturally occurring products it specifies.”
According to a press release from Congressman Becerra’s office, “The practice of gene patenting is preventing critical research from advancing because scientists are wary of trespassing patent laws.” Congressman Becerra adds that “enacting the Genomic Research and Accessibility act does not hamper innovation, indeed, it encourages it. The proliferation of scientific prowess, medical innovation, and economic advancement will all occur if the study of genes is allowed to happen unabated. Incredible manifestations of intellectual property will result: medicines, machines, processes—most deserving of recognition, some potentially life-saving, and all worthy of a patent.”
While Representative Becerra’s statements promise innovation, enactment of his simple bill into law will have the opposite effect with respect to personalized medicine. Enactment of the bill would not just prevent patenting DNA, which itself is harmful to the biotechnology industry. It would also prevent patents on gene correlations, e.g., the association of gene mutations with risk of disease or response to treatment—associations that form the basis for personalized medicine’s diagnostic tests.
While Congressman Becerra and others argue with few facts that gene patents stifle scientific research, the inability to obtain intellectual property protection in the field of diagnostics and personalized medicine will stifle a nascent industry.
Becerra’s bill, a political move in response to popular press attacks on gene patenting, appeared likely to fail, but like other aspects of patent reform, the subject is still alive in Congress.
On October 30, 2007, the House Judiciary Committee held a hearing on “Stifling or Stimulating—The Role of Gene Patents in Research and Genetic Testing.” It was no surprise that not all witnesses spoke in favor of patenting DNA-based inventions. What was surprising and encouraging was that representatives of the Biotechnology Industry Organization (BIO) and the Association of University Technology Managers (AUTM) testified that the Becerra bill or similar legislation altering patent rights in nucleic acid inventions would harm commercialization of genetic medicine.
As discussed at the October 11th conference “Personalized Medicine: Breaking Down the Barriers and Achieving Results” that my firm, Nixon Peabody, cosponsored, companies looking to invest in nucleic acid inventions and personalized medicine need to realize that the public relations battle may affect future legislation. And as such, all stakeholders in the personalized medicine industry should be planning and implementing their public outreach now to decrease the risk of legislation that may threaten the future of personalized medicine. Failure to act may result in erosion of IP protection and a commensurate decline in investment in biotechnology and diagnostics.
