Patenting and Licensing in Genomics: Impact on Access to Genetic Tests and Debates about Patenting in the Public Interest

Intellectual property rights, such as patents, award inventors a temporary (generally 20 year) right to exclude others from making, using, selling, or importing their invention. They are granted to individuals and institutions by governments to encourage public disclosure of their inventions, and as an incentive to invent. Disclosure is thought to stimulate both follow on research and, in some cases, public benefit. By enabling the collection of fees when a patent holder licenses their rights to others, patents also offer inventors an opportunity to transfer a package of rights, creating an incentive for licensees to invest in further development. There can be wrinkles in the system, however. For example, if an invention is covered by two patents in the hands of different owners, both are prevented from using the invention unless they can come to an agreement. Clarity in the patenting system is also important. Uncertainty about the patentability of an invention may induce the inventor to keep it as a trade secret, instead of filing a patent and then disclosing the details about their invention to others. A series of U.S. Supreme Court decisions, and a parallel case in Australia, invalidated patents on molecules with naturally occurring DNA (or RNA) sequences, and associations between sequence variants and health conditions. A controversy erupted that remains unresolved, with some urging statutory reversal of the Court decisions and others opposing restoration of patent-eligibility. As a government-granted right to exclusively exploit an invention, patents can increase prices and restrict use. This is a cost society pays to motivate invention and disclosure of discoveries. Intellectual property rights can also be used in ways that do not foster social benefit from the discovery. For example, they have been used to clear the market of existing genetic tests, thereby limiting rather than promoting availability of testing. An ongoing concern is whether patents and/or licensing practices negatively affect research and commercial development efforts for new genetic diagnostics and therapies. Patents and licensing practices can have an impact on genetic research and genetic test development if researchers have limited access to existing inventions; patent enforcement via litigation can affect patient access to genetic tests by raising costs; and patents and licensing practices can impact the quality of genetic tests by limiting incentives for others to improve upon the genetic test, or to verify results from the laboratory with exclusive patent rights. Where patents and licensing practices have created a sole provider of a genetic test, patients have been unable to obtain access to a sole provider’s test when the provider does not accept the patient’s insurance or health plan (a problem in particular for those covered by Medicaid). Patents and liscensing practices can also limit the exchange of materials and information between researchers, which can lead to reductions in subsequent scientific research and product development. They can also delay the widespread adoption of new technologies. Evidence that would guide policymakers and the courts about the effects of patents and licenses on patients’ access to tests, and the costs and quality thereof, is still accumulating. According to the most thorough empirical analysis to date, it appears that patenting genomic inventions is only one factor—often not the most important—that can impede information flow in biomedical research, although a few cases of restrictive licensing practices have caused controversy due to their potential negative effects on public health. A few scholars are calling for Congress to consider a research exemption to patent infringement that would enable research uses of patented inventions (such as to allow for independent verification of genetic tests). The application of intellectual property rights in biotechnology also raises several normative questions. Among them are the appropriateness of applying the traditional system of intellectual property rights directly to biotechnology, without modification to incorporate relevant values. Patent criteria could be used to exclude processes such as human germline genetic modification or patenting of embryos (which is, for example, explicitly proscribed in Europe). Some argue the patent system is unfair to U.S. taxpayers who fund federally conducted and federally sponsored research, and then pay higher prices for patented goods and services through federal health programs (e.g., Medicare, Medicaid, the Veterans Health Administration, Children’s Health Insurance Program, the military health system and TriCare, Indian Health Service, and Federal Employees Health Benefits Program). Further, the research institution that employed the researcher will receive some of the royalties that accrue from the patent on that invention. What does this revenue do for universities? There are also concerns that unpatented contributions that are nonetheless instrumental to team-based discoveries are not equitably compensated. When the use of genetic material from a particular individual or a particular small group of people is of special value, there are more questions about whether researchers and their commercial sponsors should share financial benefits from the resulting intellectual property rights with them. The pricing of products based on federally funded research and development, conflicts of interest for inventor/entrepreneurs that could motivate the pursuit of profitable over socially-beneficial research, and the ability of the patent system to recoup the public investment in research for members of the public are ongoing concerns. The overall societial welfare generated by biotechnology patents depends on the outcome of the tradeoff between government incentives for research innovation, patient access to technologies, and any effects of intellectual property on subsequent innovation. A simplistic “patents good, patents bad” framing gets in the way of formulating policies that will stimulate innovation while ensuring broad and fair access to genetic testing and other applications. The following rich literature amply makes that point.