Reinventing the double Helix: a novel and nonobvious reconceptualization of the biotechnology patent.

Author:Demaine, Linda J.
 
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INTRODUCTION

A quiet revolution has taken place during the past two decades in the federal law governing property rights in the biological and chemical constituents of living organisms. The Patent and Trademark Office (PTO) now routinely grants, and federal courts consistently uphold, patents on newly discovered, naturally occurring genes, DNA fragments, proteins, and other biochemicals (1) in contravention of long established principles of patent law. The PTO's position is reflected in an essay by John J. Doll, the PTO's Director of Biotechnology Examination, published in Science magazine. In the essay, Doll asserts that DNA sequences "isolated and purified" from their natural state are "products of human ingenuity" (2) and must be patentable because

[w]ithout the incentive of patents, there would be less investment in DNA research, and scientists might not disclose their new DNA products to the public. Issuance of patents to such products not only results in the dissemination of technological information to the scientific community for use as a basis for further research, but also stimulates investment in the research, development, and commercialization of new biologics. It is only with the patenting of DNA technology that some companies, particularly small ones, can raise sufficient venture capital to bring beneficial products to the marketplace or fund further research. A strong U.S. patent system is critical for the continued development and dissemination to the public of information on DNA sequence elements. (3) Doll's statement reflects PTO policy more generally. In July 2000, Todd Dickinson, the Director of the PTO, declared to the Subcommittee on Courts and Intellectual Property of the House Judiciary Committee:

there are so many chemicals in the human body that, if we ruled them all off limits to patenting, we would rule out an extraordinary number of valuable and important inventions.... Without the funding and incentives that are provided by the patent system, research into the basis of genetic diseases and the development of tools for the diagnosis and treatment of such diseases would be significantly curtailed. (4) Neither Doll nor Dickinson has offered an explanation as to how chemicals found in the human body can be "inventions" under the positive law of patents; their comments instead present policy rationales for the PTO's treatment of newly discovered biochemicals and organic tissues. (5)

The vast majority of commentators have adopted the same perspective, acclaiming the patentability of naturally occurring biochemicals after "isolation and purification." To illustrate, two members of the patent bar have written: "There is little dispute that defined, functional DNA sequences obtained through research in the human genome project will be, and should be, patented." (6) Other authors have opined that a patent on a purified, naturally occurring biochemical is consistent with patent law if the purification was difficult. (7) Yet another asserts: "Virtually cost-free to the public fisc, making patents slightly easier to get will satisfy the policy needs of the biotechnology industry and will be logically defensible." (8) Still others insist that DNA and other natural products should be patentable "lest we eliminate patent incentives for the development of important medicines." (9)

Concerns over potential impediments to biochemical patenting derive from the significance of biotechnology to the future of medicine. From a medical perspective, developments in genetics could hardly be more consequential. (10) The legal revolution referenced above began with a scientific breakthrough--the development in 1972 of recombinant DNA technology. (11) This invention spawned further advancements in genetic research, including the discovery in 1983 of a generally applicable method for cloning genes for polypeptides where the amino acid, DNA, and mRNA sequences were not completely known; (12) the availability beginning in 1986 of computer controlled sequencing machines for the DNA base pairs that form genes; and the development of polymerase chain reaction technology the same year. (13)

These advancements have powerfully boosted the ability of scientists to locate and sequence genes. As the president of one major biotechnology company noted, a few decades ago it might have taken ten years to find a particular gene, but, with modern gene maps, a gene can now often be found with a fifteen second computer search. (14) Sequencing has also become far less laborious. The ability of scientists to rapidly sequence DNA has resulted in an explosion of discoveries of DNA sequences--both meaningful and meaningless scientifically--that, in turn, has caused a deluge of patent applications claiming DNA sequences and the proteins and other biochemicals for which these sequences code. (15)

Researchers have now sought and obtained patents on human DNA sequences that play an important role in understanding and diagnosing, and perhaps some day treating, the most common and serious of human diseases, including: tuberculosis, diabetes, cancer, multiple sclerosis, Alzheimer's disease, (16) and even immune system maldevelopment. (17) Researchers have also patented the entire genomes of important pathogenic bacteria affecting public health, including Streptococcus pneumoniae, the leading cause of bacterial pneumonia and meningitis. (18) In March 2001, the drug company Geron Corp. obtained a patent covering genes coding for human embryonic stem cells. (19) There is currently a similar race for the discovery of genes relating to less medically critical but equally profitable DNA sequences, such as those affecting baldness and snoring, and, under the current trend, this may be expected to continue for remaining DNA sequences and other components or derivatives of the human body, (20) particularly proteins and hormones. (21) Researchers are now scouring the human genome and the genomes of other species with powerful computers in the hope of finding and monopolizing DNA sequences that may someday be used in product development.

Research on DNA sequences and their corresponding proteins is considered to represent the future of diagnostic and therapeutic medicine. Genetic research has led to the mass production of human pharmaceuticals, biologics, and vaccines that previously could be obtained only by the laborious process of extracting them from the natural tissues or secretions of living beings. Increasingly, such therapeutics and vaccines are made available through plants, bacteria, yeasts, and animals genetically engineered to produce the desired protein, hormone, or other substance like a living factory. (22) A patent on the critical genes or the entire genome of these organisms may confer a significant advantage on the patentee in producing biochemicals compared with competitors who obtain the same or similar chemicals through more traditional processes.

Ownership (23) of rights to a single gene or, in some cases, a single brief DNA sequence could also result in a near monopoly on diagnostic tests and treatments for widespread and serious ailments. While most disorders and diseases are caused by a combination of genetic and environmental variables, private ownership of any causative factor could create an opportunity to extract rents from those wishing to develop a diagnostic test, therapy, or pharmaceutical, resulting in higher medical costs and decreased availability to those in need. Indeed, private ownership of a DNA sequence or natural biochemical could allow a company to preclude its use in developing a diagnostic test or therapy altogether if, for example, licensing the use of the gene to develop a vaccine for a debilitating disease were less profitable than manufacturing and selling a treatment for the disease. On the opposite side are arguments, already alluded to, that patents are a precondition to the development of such diagnostics and therapies in the first place.

The ownership of preexisting genes and other biochemicals raises important questions about the scope and purpose of the patent law--what it is designed to accomplish and how biotechnology (24) fits within that design. More fundamentally, whether patent law is properly applied to products not independently created by a patent applicant implicates questions about the limits of intellectual property ownership, policy decisions about whether natural substances and processes should reside in the public or private sphere, choices about the value placed upon publicly available knowledge, and the microeconomic effects of limiting patents to some kinds of biotechnological innovations while excluding patents on others. Are patents on naturally occurring phenomena, such as discovered DNA sequences, proteins, plasmids, and other biological chemicals, truly as uncontroversial and "simply necessary" as a matter of public policy as many legal commentators, the biotechnology industry, and the PTO Director himself have argued? Equally important, are patents on naturally occurring substances of any kind authorized by the relevant legislation and case law? The answers are far from obvious, and their importance merits a more careful and detailed examination of the legal and policy underpinnings of the patenting of genes and other biotechnological innovations than has so far been undertaken. American public figures and the media have just begun an informed debate in the last five years about the moral and policy issues raised by highly publicized biotechnological advances such as animal cloning (25) and human embryonic stem cell research. (26) Public consideration of the limits, if any, on private ownership over biochemical discoveries remains incipient. This Article provides the first comprehensive examination of this issue.

We begin by noting that gene patenting raises novel, but not entirely unprecedented, legal and policy issues that have been hotly debated in a wide...

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