The application of the data and technology resulting from the completion of the Human Genome Project to the development of new medicines and treatment methodologies (integrated genomics) has been anticipated with great expectancy. But the technology necessary to enable integrated genomics is complex and multifaceted, and subject to patent claims from multiple parties.
In addition, large patient populations are required to provide the necessary data for analysis. Thus, the development and growth of integrated genomics requires the participation of very different actors, each having a unique stake in the growth of this technology.
The diversity of technologies necessary to enable integrated genomics has created a thicket of patents covering those technologies. A patent gives the owner the right to prevent others from making, using, selling, offering to sell, or importing the claimed subject matter during the life of the patent (usually between 17 and 20 years).
The Patent Scylla
The patent holder of a basic element of a technology can command all applications of that technology by forcing parties developing the applications to acquire licenses. Moreover, multiple parties may hold different patent interests in a technology that combines diverse technical elements.
Thus, an end-user may require several licenses to use a product. Furthermore, a patent holder can simply use their patent to block any practice of the patented technology.
U.S. patent laws provide few safe harbors for using patented technologies without license. For example, the Court of Appeals for the Federal Circuit recently held that even academic institutions performing nonprofit, basic scientific research can be liable for patent infringement (Madey v. Duke University).
Another Federal Circuit opinion scaled back one safe harbor provided by Congress to protect parties from patent infringement liability in the course of performing acts for FDA clinical trials, holding that a target was too far upstream of a clinical trial to fall within the acts defining the safe harbor (Integra Lifesciences I, Ltd., et al. v. Merck KgaA et al.). These cases are pending Supreme Court review.
Parties active in integrated genomics will thus continue to be affected by patent developments for some time to come. Indeed, the threat of infringement has led to criticism of some players in the integrated genomics field.
For example, Myriad Genetics, which holds the patent to the BRACAnalysis test for the breast cancer-related gene BRCA, has been criticized for requiring that full sequence testing be done only at its laboratory and for charging a premium price for the test.
The patent holders respond that the high costs, large failure rate, and long lead times to profit necessitate such licensing terms; otherwise, basic research could not progress for lack of sufficient economic incentive.
Notwithstanding the free market rationale for patenting and licensing, some attempts have been made to reduce the risk of patent liability, and thereby reduce costs to the end users, by providing a specific safe harbor to patent infringement for using genomic technology under certain conditions.
In 2002, for example, a bill (H. R. 3967) was introduced to provide for noninfringing uses of patents on genetic sequence information for purposes of research and genetic diagnostic testing, and to require public disclosure of such information in certain patent applications. This legislative initiative appears to have stalled, however.
Another approach to avoiding patent liability or licensing costs may be to perform any infringing screening activities outside of the U.S. and relay the resulting data back on-shore for analysis.
This approach would follow the Federal Circuits recent decision in Bayer AG, et al. v. Housey Pharmaceuticals, Inc., in which the Court held that transmitting data resulting from the off-shore practice of an otherwise infringing process does not constitute patent infringement.
Another potential impediment to the growth of integrated genomics concerns limitations resulting from the need to protect the privacy of persons who utilize the technology.
The Privacy Charybdis
The federal Health Insurance Privacy and Accountability Act (HIPAA), as well as various other federal and state laws, control the ownership and use of materials and information gathered from patients including biological samples as well as the resulting genetic patterns.
Importantly, these laws limit the use and storage of the gathered materials and data that are time-sensitive.
Recently, some researchers have begun to question whether HIPAA adequately guarantees privacy, given the very fundamental nature of genetic information to personal identity.
For example, researchers at Stanford University have concluded that a third party could match and identify individuals simply by accessing both private genetic data for a set of individuals and a public database of SNPs.
The Stanford researchers see no likelihood of a scientific or technical solution to this problem, and recommend legislative action (Science 305:193, 2004). Others, such as Bartha Knoppers, of the Center for Public Law Research at the University of Montreal, believe that appropriate privacy controls can be included (Nature Reviews-Drug Discovery, 3:725, 2004).
Regardless, compliance with HIPAA and similar state laws is complex and expensive. Many commentators have wondered whether that cost will deter genomics-based research and care provision.
As with any developing technology, integrated genomics is evolving in response to the needs and constraints established by various interested parties. The interaction of these two parties presently is creating economic and legal hurdles that may ultimately hamper the fullest application of this technology without some degree of relief from lawmakers or the courts.
That relief may come in the form of safe harbors from patent infringement or a relaxation of privacy rules. When and how such relief will be presented is not yet clear.
David P. Lentini, J.D., works in the San Francisco office of Cognition IP Solutions. E-mail: email@example.com. Website: www.cognitionmeanspatents. com. Stephen A. Bent, J.D., is a partner in Foley & Lardners Washington, DC, office and chair of the firms interdepartmental life sciences industry team as well as the founder of Foleys life sciences practice. E-mail: firstname.lastname@example.org. Website: www.foley.com. The views expressed by Mr. Lentini and Mr. Bent do not represent the opinion of Cognition IP Solutions or Foley & Lardner.