'Exclusivity Without Patents: The New Frontier of FDA Regulation for Genetic Materials' by Gregory Dolin
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Over the last twenty years, the legal and scientific academic communities have been embroiled in a debate about patent eligibility of genetic materials. The stakes for both sides couldn’t be higher. On one hand are the potential multi-billion dollar profits on the fruits of research (from newly discovered genes) and on the other is the ability of scientists to continue and expand research into the human genome as well as patients’ access to affordable diagnostic and therapeutic modalities. This debate is currently pending before the Supreme Court which has under consideration petition for certiorari in Ass’n for Molecular Pathology v. USPTO.
This paper recognizes that both sides have legitimate concerns. Given the unique nature of DNA, patents that broadly cover genetic materials and prevent their use (except by the license of the patentee) create insurmountable roadblocks for future research. However, denying exclusive rights to the fruits of laborious and costly research will remove the necessary incentives for investment in these endeavors, thus delaying scientific and medical discoveries.
To remedy these problems, the paper proposes a non-patent exclusivity system administered by the Food & Drug Administration. Under such a system, the innovators who bring new therapeutic or diagnostic products to market will receive exclusive rights to market their products for a limited time. This will provide sufficient market-based incentives to continue with the research and investment in this area. At the same time, because genetic sequences will no longer be broadly protected by patents, the public will be able to access these basic research tools without fear of infringement litigation. This approach addresses concerns of the both sides to the debate, and leads to a cheaper, more predictable, and easier to administer system of exclusive rights.
Dolin concludes that -
The science of molecular genetics has challenged the long-accepted standards and rules of the patent law. The basic unit of molecular genetics – a molecule of DNA – is unlike any other chemical entity in that it has both chemical and informational properties. It is no surprise then that determining how the patent law should treat this molecule has been subject of much debate.
Ultimately though, with the scientific advancement of the last few decades, the patent law question is resolving itself. Even if DNA is treated as a patent eligible subject matter, it is unlikely to find much protection in the bosom of patent law because sequencing of genes has become so routine as to no longer be inventive. In this sense, the patent system actually under-protects and therefore under-incentivizes investment and work in the field of molecular genetics. On the other hand, to the extent that some DNA sequencing may overcome the obviousness bar, the patent system over-protects and over- incentivizes the investment in this field as it allows the patentee to essentially limit access to that which is not truly his invention.
A new system based on the desire to properly incentivize the work of pioneers in molecular genetics, while maintaining due regard for the need to permit access to genetic materials for further research is needed. That system can be built by having the Food and Drug Administration regulate market entry for the makers of genetic diagnostic and therapeutic modalities. By allowing developers of new tests and treatments to enter the market on preferential basis, as compared to later applicants, the system will permit innovators to enjoy monopoly rents much like they would under the patent system. On the other hand, by limiting the monopoly only to the market for diagnostics and therapeutics, the alternative FDA-based system would permit further research unfettered by the need to spend resources on licensing patents that encompass genetic materials. This new approach would finally resolve the debate on the patent eligibility of genetic materials and place all parties in a more advantageous position than that they currently enjoy.
