An Extinction Bar to Patentability

"The human species evolved as a natural element of diversity in the living world, and it is a simple ecological imperative that humans depend on other species and communities to supply the basic requirements of existence and to maintain biosphere function."

- Brian Groombridge and Martin D. Jenkins1

I. INTRODUCTION

At the heart of the patent bargain lies a vital quid pro quo: in return for granting a patentee a limited monopoly right to exclude others from making, using, selling, offering to sell, or importing a patentee's claimed invention, the patent must provide the public with new and useful information that enables a person of ordinary skill in the art2 to make and use the claimed invention. In patent law this is known as the enablement requirement. Society generally loathes monopolies. Antitrust laws attempt to prevent and redress them. However, as part of the patent bargain society is willing to suffer the monopoly right to exclude granted to a patentee as long as the latter contributes "to the public storehouse [of knowledge]."3

The biotechnological aits have presented numerous challenges to patent laws developed with simpler, more traditional, technologies in mind. The enablement requirement has been especially challenged by biotechnological inventions because, unlike more traditional inventions, such as chairs, automobiles, and even computer software, biochemicals, cells, and organisms defy full description by way of words and diagrams. Without an alternative method of description, many biotechnological inventions would fail to meet the enablement requirement.

In response to this challenge, a system of biological "deposits" has developed over the years. If a biotechnological invention defies description by words or diagrams alone, a patent applicant may deposit a representative sample of all or part of an invention into a "biological depository" recognized by the U.S. Patent and Trademark Office ("USPTO").4 A biological deposit can contribute to the satisfaction of the enablement requirement by making a biotechnological invention, such as those involving a cell-line, a microorganism, or a gene, available to the public. As long as the biological deposit remains viable, it can help to ensure and protect the validity of any claim dependent upon the deposit for satisfaction of the enablement requirement.

What happens, however, if the biological deposit loses its viability? Logically, an inviable biological deposit can no longer help to satisfy the enablement requirement. Furthermore, loss of an enabling disclosure secondarily impoverishes society's public storehouse of knowledge. Both courts and the USPTO have noted that loss of a biological deposit upon which patent rights depend can eliminate those patent rights. Otherwise, the patent bargain would tip in favor of the patentee, and the public would be denied its quid pro quo. In short, secondary loss of a biological deposit extinguishes patent rights that depend thereon.

Not all biotechnological inventions are susceptible of deposit in a biological depository. Depositories are equipped to store biological samples of small physical size with modest maintenance requirements; they cannot accept deposits of macroscopic organisms. Nevertheless, many biotechnological inventions are derived from just such organisms. Consequently, patent law allows such inventions to rely on "in situ" deposits; that is, as long as the patentee adequately describes how the public might locate and obtain the organism in the wild, that organism can help to fulfill the enablement requirement. Thus, detailed disclosure by a patent applicant of the geography, habitat, and phylogeny of a marine tunicate found on specific tropical coral reefs can be sufficient to enable claims to biochemicals found within that taxon.5

However, just as secondary loss of viability of samples in biological deposits can lead to loss of patent rights, so too must inability of the public to find an organism "deposited" in situ. In other words, extinction of an organism upon which claims depend for their enablement leads to loss of patent rights. This extinction bar to patentability has never previously been noticed. It has strong implications not just for patent law, but for environmental law as well. For, any patent owner whose patent rights depend upon the continued existence of a taxon "deposited" in situ has a strong incentive to ensure the survival of that taxon, at least until the patent term expires.

This article discusses the law of biological deposits, elucidates a previously unrecognized extinction bar to patentability, and, finally, considers the unrealized, yet potentially significant, implications for biological conservation of the extinction bar to patentability. Part Ð reviews the importance of biological diversity as a source of natural chemicals, the role of bioprospecting in unlocking the great economic value of these natural chemicals, the skewed geographical distribution that situates most biodiversity in poor equatorial countries, and the current mass extinction crisis that threatens both biodiversity and the natural chemicals it produces. Part III highlights existing sources of biodiversity conservation law, including both domestic statutes, such as the Endangered Species Act, as well as international treaties, particularly the United Nations Convention on Biological Diversity. Part IV introduces the patent bargain at the heart of patent law, the role that the disclosure requirements of patent law, especially the enablement requirement, play in ensuring that the patent bargain balances the completing interests of inventors and the public, and the manner in which biological deposits can be used, if necessary, to satisfy the enablement requirement. Part V introduces the original concept of "in situ" biological deposits, one of whose implications is the existence of an "extinction bar" to patentability, and describes the salutary incentives for conserving biodiversity that this extinction bar creates. This article concludes by suggesting that the strong incentives created by the extinction bar to patentability not only enhance biodiversity conservation but further each of the three major aims of the United Nations Convention on Biological Diversity (that is, conservation, sustainable development, and equitable sharing of benefits).

II. BIODIVERSITY

Before discussing the principles of patent law that create the extinction bar to patentability, it is necessary to describe the wellspring of the inventions to which the extinction bar applies: biological diversity. The provenance of the extinction bar to patentability flows directly from the nature of biodiversity and the pharmacopeia of natural chemicals it produces.

A. BIODIVERSITY AND THE MOLECULES OF LIFE

Tremendous diversity characterizes life on earth. The best current estimates of the magnitude of biodiversity range from as few as 4 million to as many as 111 million extant species.6 Since life first appeared on earth about 3.6 billion years ago, the metaphorical tree of life has sprouted countless branches, each evolving along its own unique trajectory in response to the contingent opportunities afforded by genetic potential and environmental challenges. The bewildering explosion of different forms of life that resulted contain within themselves myriad genes and other natural biochemicals offering myriad solutions to the problems of survival and reproduction.

Biochemical prospecting, or "bioprospecting," involves searching for natural chemicals created through the process of natural selection, and then harnessing utilities of these chemicals to the enhancement of human health and welfare. In more prosaic, economic, terms, bioprospecting is the 'exploration of biodiversity for commercially valuable genetic and biochemical resources.'7 Such resources (hereafter, 'natural biochemicals') can take many forms, from nucleic acids (including genes), polypeptides, lipids, and carbohydrates, to chimaeric combinations of these basic categories, such as lipoproteins, peptidoglycans, and glycoproteins, to a limitless array of derivative biochemicals, such as "small molecules," whose syntheses are catalyzed by nucleic acids or polypeptides.8 Although a large number of these natural biochemicals have already been discovered within the excretions, tissue extracts, cells, and genomes of living organisms, they represent but a small sample of what awaits discovery in living nature.

Biodiversity is a rich source of useful natural biochemicals that possess prodigious market value. A recent comprehensive estimate placed the annual value of products derived from genetic resources alone at between $500 billion and $800 billion.9 Natural biochemicals derived from biodiversity form the bases for many economically useful inventions. These include medicinal drugs, botanical medicines, agricultural crops, crop protectants, ornamental plants, cosmetics, and non-medical industrial products and processes. As a notable example, almost three-fifths of the best selling prescription drugs in the United States are derived from biodiversity.10

One of the most famous bioprospecting successes involves the Rosy Periwinkle (Catharanthus roseus), a flowering plant endemic to the island of Madagascar. Biologist Edward O. Wilson provides a lyrical account of this plant's remarkable contribution to cancer treatment in his book, The Diversity of Life:

An inconspicuous plant with a pink five-petaled flower, it produces two alkaloids, vinblastine and vincristine, that cure most victims of the two deadliest of cancers, Hodgkin's disease, mostly afflicting young adults, and acute lymphocytic leukemia, which used to be a virtual death sentence for children.11

Vinblastine and vincristine have also been found effective in treating Wilms' tumor, primary brain tumors, and testicular, cervical, and breast cancers.12 Since their introduction as medicinal drugs in the 1960s, these two natural chemicals have earned a pharmaceutical giant, Eli Lilly and Company, approximately $180 million in annual revenue.13 A single kilogram of vincristine sulphate has a retail price of $11.9 million.14

Another, more infamous, example involves the Neem Tree (Azirdirachta indica), a member of the mahogany family, Meliaceae, and native to India and some other parts of tropical Asia. This single tree has yielded a pharmacopeia of useful natural chemicals, along with a motherlode of controversy. Neem extracts have long been employed in Indian folk medicine to treat numerous ailments, including fevers and infections.15 Indian researchers have isolated at least three substances from Neem Tree oil that are highly effective birth control methods: DK-I (a potent vaginal spermicide and germicide), DNM-5 (administrable orally to prevent egg implantation early in pregnancy), and DNM-7 (an abortifacient).16

By 1995, the USPTO had issued more than 50 patents based on natural chemicals derived from the Neem Tree.17 In one particularly contentious instance, W.R. Grace & Company received a U.S. patent on a method of extracting azadirachtin, a powerful insecticide found in Neem Tree seeds, and stabilizing it in solution.18 A coalition of international aid and environmental groups, most prominent among them Jeremy Rifkin's Foundation on Economic Trends, challenged the validity of the patent on the grounds that traditional Indian folk use of Neem Tree extracts to control insects constituted anticipating prior art.19 A parallel challenge was mounted to invalidate a European patent claiming a Neem Tree-based fungicide jointly owned by W.R. Grace & Company and the U.S. Department of Agriculture.20

Such is the demand generated by this single taxon21 of tree that the market value of Neem Tree seeds reached as high $300 per ton.22 In response to this great demand, one Indian company, Murkumbi Bioagro Pvt Ltd., established a private plantation of about 28,000 Neem Trees to ensure their own continued supply of the tree's natural biochemicals.23

B. ECONOMICS AND BIOPROSPECTING

Despite a wealth of anecdotal estimates, the economic value of biodiversity is difficult to estimate.24 Some critics have suggested that the economic value of biodiversity as a source of natural biochemicals is exaggerated.25 It would be unsurprising if the wildest early predictions of a "green goldrush" by bioprospectors do not ultimately materialize. However, even conservative estimates show that the market value of current, already discovered, fruits of bioprospecting approaches one trillion dollars per annum.26 This exceeds the annual gross domestic products of all but a handful of countries.27

Estimates of the economic value of bioprospecting depend on number of important characteristics of biodiversity:

1 Magnitude of biodiversity. There are approximately 10 million extant species of life on earth. Current estimates of total biological diversity range as high as 111 million distinct species, with a current best estimate of 14 million.28

2 Magnitude of genetic diversity. Across all forms of life, the current best estimate of the mean number of distinct genes per genome is approximately 10,000. Specific forms of life ranges from a minimum of SOO genes per genome in mycoplasma to a maximum of 100,000 genes per genome in mammals, with bisects (12,000 genes per genome) and plants (50,000 genes per genome) tending to be situated in between.29 Since insects and plants comprise the vast majority of extant species,30 the estimate of 10,000 genes per genome is probably conservative.31

3 Magnitude of natural biochemical diversity. Genes encode RNA, most RNA encodes polypeptides (including both structural polypeptides and enzymes, which mediate biochemical reactions within cells), and polypeptide enzymes produce myriad other natural biochemicals. There may be many times more, distinct, non-gene, non-polypeptide natural biochemicals than there are genes per genome.

Only a fraction of natural biochemicals will lead to useful and profitable inventions not duplicable by other natural biochemicals.32 The costs of locating promising natural biochemicals will often be significant, as will the research and development costs associated with assessing the value ofthat natural biochemical 'and transforming it into a valuable invention. Sometimes a natural biochemical will possess uniquely useful characteristics, while other times it will be duplicative, either wholly or in part, of other natural biochemicals.

Even under very conservative assumptions it is probable that natural biochemicals possess considerable economic value. For example, the best current estimate of the global market value "for the products derived from genetic resources" ranges from $500-800 million.33 This creates a considerable economic incentive to engage in bioprospecting.

Not all estimates have assigned a high economic value to bioprospecting. In an early attempt to gauge the importance of biodiversity as raw material for bioprospecting, R. David Simpson and his colleagues attempted to estimate the economic value of biodiversity in terms of its potential for the development of pharmaceutical products.34 Their model attempted to account for the way in which novel pharmaceuticals are discovered, characterized natural biochemicals as nonrival goods, assumed that biodiversity contains significant redundancy with respect to the provision of pharmaceutical leads, and employed the concept of the 'marginal species.'35 Using empirical data and optimistic assumptions intended to estimate the upper bound value of biodiversity for drug development, the analysis yielded a maximum value of the marginal species of only $9431, and suggested that even western Ecuador, the earth's most biodiverse region, possessed a maximum economic value for bioprospecting of only $20 per hectare, with hectares in other biodiverse regions worth even less.36 The authors concluded:

[Given reasonable assumptions] it seems quite likely that the perceived value of the marginal species will be miniscule ... the private value of the marginal species for use in pharmaceutical research and, by extension, the incentive to conserve the marginal hectare of threatened habitat are negligible.37

Thus, under this model, bioprospecting would appear to be an economically questionable endeavor.

However, a subsequent reanalysis of the Simpson et al. model by Rausser and Small vigorously faulted the results of the original analysis for failing to account for the great value that information rents hold for drug development.38 The amended analysis was structured to account explicitly for the importance of information rents for promising leads.39 Using the same numerical examples employed by Simpson et al, the improved model yielded results suggesting that biodiversity did indeed possess great economic value for bioprospecting, with western Ecuador valued at almost $9200 per hectare for purposes of bioprospecting, more than two orders of magnitude greater than its value as calculated in the Simpson et al. analysis.40 Again, these results suggest that biodiversity possesses great value for bioprospecting.

Another study attempting to assess the economic value of biodiversity for bioprospecting analyzed the sources of therapeutic drugs already on the market in the United States.41 This study, the most comprehensive such assessment conducted to date, concluded that most of the top 150 brand name drugs prescribed in the U.S. in 1993 contain a compound derived from or patterned after a natural chemical.42 The study concluded that 57% of the top 150 prescription drugs were derived directly or indirectly from biodiversity: 23% from animals, 18% from plants, 11% from fungi, 4% from bacteria, and 1% from marine organisms.43 Some individual species were found to provide the source for multiple drugs in the top 150, the most prodigious being opium poppy (Papaver somniferum) with 15, joint fir (Ephedra sinica) with 11, bread mold (Penicillium notatum) with 9, a fungus (Cephalosporium acremonium) with 7, Brazilian fer-de-lance (Bothrops jararaca) and a eubacterium (Streptomyces erythreus) with 4 each, and human (Homo sapiens) with 3.44 Especially when viewed in light of the huge research and development costs of successfully bringing a new drag to market-estimated to average $300-500 million45-these results suggest biodiversity as an important, even dominant, avenue for the discovery and development of new drags.

Clearly, most estimates suggest that natural biochemicals derived from biodiversity possess significant economic value. This strongly suggests that bioprospecting for natural biochemicals derived from biodiversity has the potential to provide significant economic incentives for biodiversity conservation.

C. BIODIVERSITY'S UNEQUAL DISTRIBUTION

Like many other sources of wealth, biodiversity is not uniformly distributed. In fact, the current geographical distribution of biodiversity is markedly uneven, reaching a zenith near the equator and nadirs at both poles.46 Explanations for this striking pattern remain one of the great mysteries of biology.47

Tropical rainforests alone account for nearly half of the described taxa of extant organisms.48 As a consequence, this extreme skew in geographical bias places a disproportionate amount of biodiversity's riches within the borders of poorer, developing countries located in or near the tropics. In fact, of the twenty-five most biodiverse terrestrial areas on earth, so-called 'biodiversity hotspots,' sixteen (or almost two-thirds) are located in these countries.49 Consequently, potential opportunities for bioprospecting tend to be greatest in those poor tropical countries most in need of economic development.

D. THE SIXTH MASS EXTINCTION

Despite its great economic value as a source of natural biochemicals, biodiversity is being destroyed at a worrying, and accelerating, rate. Current extinction rates are several orders of magnitude greater than the background rate that prevailed before humans began to dominate the earth's ecosystems.50 Edward O. Wilson, selecting "cautious parameters ... to draw a maximally optimistic conclusion," has estimated that 27,000 species suffer extinction per annum, corresponding to 74 extinctions per day and 3 extinctions per hour.51 Although the accuracy of such estimates has been loudly challenged of late,52 and obviously contemplates significant errors bounds, a broad and strong consensus exists among biologists that biodiversity is currently undergoing a mass extinction event largely caused by anthropogenic factors.53

III. BIODIVERSITY CONSERVATION LAW

Legal efforts to conserve various aspects and levels of biodiversity have a long history. In the United States, national laws specifically designed to conserve biodiversity began to flower towards the end of the nineteenth century. International treaties with similar goals appeared soon thereafter.

A. NATIONAL CONSERVATION LAW

In the United States, major conservation laws at the national level have employed three general strategies. First came efforts to protect specific areas of land. These began on a significant scale in 1872, when Congress founded the U.S. National Park System by establishing what would later be named Yellowstone National Park, inside whose borders exploitation of wildlife was strictly limited and often prohibited.54 The next category of legal conservation efforts focused on reducing economic incentives that lead to overexploitation of biodiversity. This was largely accomplished through disruption of trade in wildlife and products derived from wildlife. The exemplar of such efforts was the Lacey Act of 1900, which attempted to reduce overexploitation of wildlife by encumbering interstate and international trade in wildlife.55 Finally, a third category of efforts afforded legally protected status to specific taxa considered at risk for extinction. The most notable of these laws, and the most comprehensive in scope, was the Endangered Species Act,56 which President Richard Nixon signed into law on December 28, 1973, "[to provide] the Federal Government with needed authority to protect an irreplaceable part of our natural heritage - threatened wildlife."57

B. INTERNATIONAL CONSERVATION LAW

1. Before the Convention on Biological Diversity

International legal efforts to conserve biodiversity began as efforts to maintain stocks of particular taxa of economically valuable wildlife. Later, the foci of conservation broadened to encompass both taxa valued for their aesthetic worth and international trade in taxa. One of the earliest international environmental agreements protected seals. Beginning in 1911, and with a brief intermission during the second World War, the Interim Convention on the Conservation of North Pacific Fur Seals58 successfully established strict limits on how many eponymous, economically valuable seals could be harvested by hunters from signatory nations.59 Overhunting of migratory birds was the focus of the 1916 Convention for the Protection of Migratory Birds between Great Britain (representing Canada) and the United States, which curbed the shooting of migratory birds throughout North America.60 Suppressing international trade in endangered taxa was the focus of the Convention on International Trade in Endangered Species of Wild Fauna and Flora ("CITES"), which entered into force on July 1, 1975.61 "[By ensuring] that international trade in specimens of wild animals and plants does not threaten their survival," CITES was the most comprehensive international legal effort to conserve biodiversity for almost two decades.62

2. The United Nations Convention on Biological Diversity

In 1992, the nations of the world gathered in Rio de Janeiro, Brazil, for the U.N. Conference on Environment and Development (often referred to as the "Earth Summit").63 One of the major environmental issues of global scope motivating the meeting was loss of biodiversity.

A notable result of the Earth Summit was the U.N. Convention on Biological Diversity ("Biodiversity Convention"),64 which articulates the most comprehensive vision of biodiversity conservation ever attempted by the international community. Its ambitious, and often conflicting, triple goals are "[1] the conservation of biological diversity, [2] the sustainable use of its components, and [3] the fair and equitable sharing of the benefits from the use of genetic resources."65 The common perception that biodiversity holds great value, in large part as a source of bioprospecting opportunities, along with the accelerating rate of biodiversity destruction by human activities in poor equatorial countries, spurred the overwhelming majority of the world's nations to sign and ratify the Biodiversity Convention.66

The International Union for the Conservation of Nature ("IUCN") had a significant impact on placing on the international agenda the need for an international treaty promoting conservation of biological diversity.67 The IUCN proposed treaty provisions that "concentrated on global action needed to conserve biodiversity."68 The goal of an international treaty aimed at conserving biodiversity was supported largely by developed countries.69 However, developing countries, especially those that house the most biodiversity, balked at accepting "a convention that focused only on biodiversity conservation."70 Rather, they insisted that the convention "address issues of the sustainable use of biodiversity and biotechnology."71 This imbalance of interests between developed and developing countries had its origins in the perception by the latter than the benefits of bioprospecting for natural biochemicals among their own tropical biodiversity had theretofore been enjoyed largely by developed countries, with little or no compensation to the countries whose biodiversity had been the source of these benefits.72 Consequently, the language of the Convention contains the original objective of biodiversity conservation-"the conservation of biological diversity"-but is tempered by the two secondary objectives of "the sustainable use of its components and the fair and equitable sharing [of its benefits]."73

In spite of the Biodiversity Convention's lofty goals of conserving the earth's biological diversity and sharing its benefits equitably, developing countries still complain vigorously of "biopiracy" or "bioimperialism" at the hands of bioprospectors and patent owners.74 Meanwhile, global loss of biodiversity continues to accelerate.75 In fact, the rate at which biodiversity is being lost is now so great that effective policy and legal instruments must be implemented soon to conserve a significant portion of the biodiversity that remains.76

To date, implementation of the Biodiversity Convention has focused mainly on voluntary initiatives or hortatory statements. Many countries have instituted legal regimes to restrict access to, and exploitation of, their biodiversity resources.77 These access agreements often require bioprospectors to share any profits that may result from patented commercial products derived from natural biochemicals they discover and collect in countries to which access is granted.78

Much debate has accompanied proposals to extend the ownership of intellectual property rights in inventions derived from natural biochemicals to the countries that are the sources of those natural biochemicals.79 Access to biodiversity is difficult to restrict, however, because its richest concentrations are necessarily located within the wilder and more remote regions of countries whose capacities are low for enforcement but high for corruption.

Inability effectively to govern access to biodiversity contributes to the twin problems of enforcing biodiversity conservation and ensuring that benefits are equitably shared. Such challenges suggest the need for alternative mechanisms of conservation and benefit sharing. Fortunately, once its implications for conservation are recognized, an existing principle of patent law can contribute to a solution to both of these goals.

IV. PATENT LAW AND BIODIVERSITY

A. THE PATENT BARGAIN

Society abhors monopolies. Economic theory can justify policies against monopolies, such as antitrust laws, on the grounds that a monopoly in a particular good or service will tend to cause a deadweight loss to society due to inefficiently low output of that good or service.80 Even in the realm of technical innovation, in which patents allow monopoly rights of exclusion to their owners, critics have long advocated free access over monopolies. A prodigious inventor himself, Benjamin Franklin wrote that "[a]s we enjoy great advantages from the Inventions of others, we should be glad of an Opportunity to serve others by any Invention of ours; and this we should do freely and generously."81 Nevertheless, the monopoly right to exclude others given to the owner of a patent represents a clear exception to the general legal presumption that monopolies should be discouraged.

Patents may be tolerated by society because they are widely considered to create incentives for innovation by rewarding inventors for their efforts. To justify receipt of monopoly rights in an invention an inventor must provide society with full disclosure of that invention; inventors must "add to the public storehouse [of knowledge]."82 In many technological arts this bargain may be fairly struck, with both patent owners and society benefiting equitably. However, many critics complain that inventors in biotechnology add too little to the storehouse of knowledge to justify society's grant of a monopoly.83

One strategy to rebalance this bargain is to enhance the contents of the disclosure provided by inventors of biotechnological inventions to ensure that the disclosure standard for natural biochemicals derived from biodiversity comports with the disclosure standard for other patentable subject matter. An inventor should provide society with a contribution of information to the public storehouse of knowledge significant enough to justify the monopoly rights the inventor receives in exchange. Proper application of the legal requirements of patents to inventions based on natural biochemicals derived from biodiversity would not only ensure balance in the bargain between inventor and society, it could also confer an additional benefit by promoting conservation of biological diversity.

B. PATENT LAW REQUIREMENTS

The Patent Act84 imposes a number of statutory requirements that patent applications must meet before they can mature into valid patents. Some of these requirements are largely procedural, but several are substantive. The most significant of the latter are legal requirements of utility,85 novelty,86 nonobviousness,87 and disclosure.88

1. Disclosure Requirements

In order to obtain a patent claiming an invention, an applicant must disclose to the public-represented by the USPTO-a sufficienuy detailed description of the invention.89 The precise requirements of this disclosure requirement are set out in the Patent Act in the first paragraph of 35 U.S.C. § 112:

The specification shall contain a written description of the invention, and of the manner of making and using it, in such full and clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.90

The disclosure requirement reflects the bargain between inventor and society that is fundamental to the patent grant. In return for monopoly rights to exclude others from making, using, offering to sell, or selling the patented invention within the United States, or importing the patented invention into the United States,91 the patentee contributes new information to the public storehouse of knowledge. Although such information may be of limited immediate usefulness because the patent owner does retain the right to exclude others during the term of a patent, its teachings immediately provide society with new knowledge or techniques. These new teachings may help other inventors to develop other, unrelated inventions, improvements on the claimed invention, or noninfringing alternatives that directly compete with the claimed invention.92 In addition, once the patent term expires, so does the patent owner's right to exclude others from freely practicing the claimed invention.93 The disclosure requirement ensures the fairness of the bargain between inventor and society by ensuring that sufficient high-quality information is provided to the public storehouse of knowledge to justify toleration of the deadweight loss to society caused by the monopoly exclusion right. As the Supreme Court has stated, the disclosure requirement is "the quid pro quo of the right to exclude."94

The first paragraph of 35 U.S.C. § 112 includes three distinct requirements that the specification of a patent application must satisfy: written description, enablement, and best mode.95

An applicant for a patent must provide "a written description of the invention."96 This written description requirement serves a notice function, by providing the public with a specific indication of what the inventor considers to be the limits on his invention. Additionally, it establishes precisely what inventions an inventor possessed as of the date on which the patent application was filed, which limits the inventor from pursuing post hoc claims on inventions not disclosed in the patent application as originally filed.

The best mode requirement forces the inventor to disclose the best way of practicing a claimed invention known to the inventor at the time the patent application is filed. This subjective requirement-a unique peculiarity of the United States patent system-aims to ensure that the public storehouse of knowledge receives the highest possible quality of information, rather than only the minimum amount of information necessary to enable a claimed invention.97 Beyond acting as a barrier to receiving a patent in the first instance, failure to disclose the best mode in a patent application can later render claims in a granted patent invalid.

2. The Enablement Requirement !

The enablement requirement represents the very core of the patent bargain, and is "arguably the most important patent doctrine after obviousness."98 It is crucial for ensuring that society receives more than a de minimus description of inventions in exchange for tolerating the monopoly rights to exclude others granted to inventors.99 One of the paramount purposes of the enablement requirement is

to provide the assurance that the public will, in fact, receive something in return for the patent grant. This consideration is, of course, the full and complete disclosure of how to make and use the claimed invention. Thus, the patent adds a measure of worthwhile knowledge to the public storehouse. The incentive to give this added measure of knowledge to the public, which clearly promotes the progress of the 'Useful Arts,' is the primary justification for the existence of the Patent system.100

For a claimed invention to be enabled the specification101 of an invention must disclose "a written description of the invention, and of the manner of making and using it, in such full and clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same."102 Furthermore, as explained in In re Wright, "[ailthough not explicitly stated in section 112, to be enabling, the specification of a patent must teach those skilled in the art how to make and use the full scope of the claimed invention without "undue experimentation."103 And, deciding what level of experimentation is undue "requires the application of a standard of reasonableness, having due regard for the nature of the invention and the state of the art."104

Since the advent of patent applications claiming inventions in the field of biotechnology, it has been clear that biotechnology and the enablement requirement pose difficult challenges to one another. Compared to more traditional technical fields of invention, such as the mechanical, electronic, and even chemical arts, the biotechnological arts tend to be more complex, more complicated, and less predictable. A chair tends to be easy to understand for one having ordinary skill in the mechanical arts, and its behavior easy to predict. Consequently, it tends to be rather straightforward to provide an enabling disclosure of an invention hi the chair arts. Making and using inventions in the electronic arts, such as circuit boards or software programs, is often considered to be so routine to those having skill in the relevant arts that relatively spare written descriptions augmented by circuit diagrams or flowcharts of software function may suffice for enablement. Even chemical inventions in which simple chemical compounds are produced through a small number of controllable chemical reactions lend themselves to straightforward description with words, chemical formulae, and diagrams of syntheses. By comparison, a gene, complex biochemical, virus, cell, tissue, organ, or whole organism tends to be difficult to understand, and its behavior devilishly unpredictable. Unsurprisingly, even a person having ordinary skill in the biological or biotechnological arts may struggle to describe such an invention sufficiently to enable claims to it.

A description composed only of words and diagrams may be sufficient to enable a chair, a software program, or simple chemical synthesis, but, in many cases, may be woefully inadequate to enable a biotechnological invention. How, for example, can one adequately describe with words and diagrams a living cell, an entity orders of magnitude more complex than any device yet designed or built by humans? Yet, the great promise of biotechnological inventions for such purposes as curing or detecting diseases, developing better foods, and improving industrial processes would be denied the incentives for spurring innovation provided by of the patent system unless an alternative were provided to traditional description by words and diagrams alone. Allowing "biological deposits" to satisfy the enablement requirement has provided just such an alternative.

3. Biological Deposits

For some inventions in the field of biotechnology a written description alone may be incapable of fully disclosing, and enabling, the subject matter for which a monopoly right to exclude is sought.105 A requirement for a written description composed entirely of words and diagrams would preclude patentability for many inventions in the field of biotechnology. Rather than deprive a vital field of innovation of eligibility for patent protection, the USPTO, courts, and international community have Grafted an alternative form of description: biological deposit. If a patent applicant deposits a viable sample of a biological substance into an officially approved "biological depository" that complies with the Budapest Treaty on the International Regulation of the Deposit of Microorganisms for the Purposes of Patent Procedure,106 the substance deposited can be considered the legal equivalent of a full verbal and pictorial description of the substance itself. Allowing biological deposits comports with federal regulations governing physical exhibits ("Specimens") useful in demonstrating that inventions are operable:

When the invention relates to a composition of matter, the applicant may be required to furnish specimens of the composition, or of its ingredients or intermediates, for the purpose of inspection or experiment.107

The Manual of Patent Examining Procedure ("MPEP"),108 a practice manual used by patent examiners for examining patent applications, describes how patent examiners are to apply this federal regulation to inventions.109

Chapter 2400 of the MPEP contains detailed procedures for making biological deposits that satisfy the enablement requirement.110 It articulates the justification for allowing such deposits:

Every patent must contain a written description of the invention sufficient to enable a person skilled in the art to which the invention pertains to make and use the invention. Where the invention involves a biological material and words alone cannot sufficiently describe how to make and use the invention in a reproducible manner, access to the biological material may be necessary for the satisfaction of the statutory requirements for patentability under 35 U.S.C. [§] 112. Courts have recognized the necessity and desirability of permitting the applicant for a patent to supplement the written disclosure in an application with a deposit of biological material that is essential to meet some requirement of the statute with respect to the claimed invention.111

Federal regulations provide guidance regarding what sorts of biological materials are appropriate for placement into a biological depository in a regulation entitled "Biological material":

For the purposes of these regulations pertaining to the deposit of biological material for purposes of patents for inventions under 35 U.S.C. [§] 101, the term biological material shall include material that is capable of self-replication either directly or indirectly. Representative examples include bacteria, fungi including yeast, algae, protozoa, eukaryotic cells, cell Unes, hybridomas, plasmids, viruses, plant tissue cells, lichens and seeds. Viruses, vectors, cell organelles and other non-living material existing in and reproducing from a living cell may be deposited by deposit of the host cell capable of reproducing the non-living material.112

For example, rather than attempt a full description of an isolated or genetically modified alga using words and diagrams, claims depending for their enablement on the alga could be enabled by deposit of a viable sample of the alga to a biological depository.

Satisfaction of the enablement requirement by means other than a written or diagrammatic description was judicially approved in In re Metcalfe.113 Rather than a biological deposit, this case dealt with the issue of whether reference to a trademark in a patent specification could substitute for a verbal description supporting a claim.114 The court decided that such a reference could indeed meet the enablement requirement because the referenced trademark disclosed information equivalent to a full verbal description.115 Furthermore, it considered the enablement requirement to be satisfied despite the risk that the quality of the information conveyed by the trademark, though enabling at the time the patent application was filed, could degrade over time. However, the court did add the caveat that "there is always the possibility that sometime after the issuance of a patent, the disclosure which was initially enabling may become 'unenabling.'"116

Biological deposits have been made for purposes of supporting the sufficiency of patent disclosures since at least 1949.117 However, the legal sufficiency of a biological deposit for meeting the enablement requirement was an issue of first impression for the U.S. Court of Customs and Patent Appeals in In re Argoudelis,118 Here, the court considered whether a patent applicant could satisfy the enablement requirement by depositing into a U.S. Department of Agriculture depository a viable culture of Streptomyces sparsogenes var. sparsogenes (a specific strain of a unicellular fungus), an organism necessary to carry out the claimed process of producing two claimed antibiotic chemicals, sparsogenin and sparsogenin A.119 In explaining its reversal of a rejection of the claims by the Patent Office Board of Appeals for lack of enablement, the court explained that

a unique aspect of using microorganisms as starting materials is that a sufficient description of how to obtain the microorganism from nature cannot be given. Such a description could only detail an experimental screening program similar to the screening programs followed in discovering the microorganism in the first instance. If the microorganism involved were of very common occurrence, it might be found in a relatively short time, but if it were not of common occurrence, it might not be found for a very long time, if found at all. The microorganism involved here, of course, was not known and available to the workers in the art since it was newly discovered by appellants.

Faced with this problem, and in response to the requirements of § 112 for an enabling disclosure, appellants deposited cultures of their microorganism in a public depository in the United States. This was done before the United States patent application was filed. The written description as originally filed included the name of the depository and its designation of the deposit, in addition to a complete taxonomic description of the microorganism and detailed disclosure of the process for producing the antibiotic from the microorganism. The cultures are to be made available to the public upon issuance of a United States patent which refers to such deposit and prior to issuance of said patent under the conditions specified in Rule 14. Appellants state that the practice of depositing cultures in a public depository has been used for over fifteen years.

It is our opinion that this procedure meets the requirements of 35 USC [§] 112.120

Since In re Argoudelis, patent applicants have routinely relied upon the availability of biological deposit as a means of fulfilling the enablement requirement for claims to biotechnological inventions that are difficult to describe with words or diagrams alone. Currently, the patent section of the largest official biological depository in the United States, the American Type Culture Collection ("ATCC"), holds more than 20,000 biological deposits.121

V. IN SITU BIOLOGICAL DEPOSITS AND AN EXTINCTION BAR TO PATENTABILITY

A. IN SITU BIOLOGICAL DEPOSITS

For many biotechnological inventions, biological deposits "of living material may enable a claimed invention whose manufacture or use depends thereupon."122 However, biological deposits to depositories are feasible only in cases of biological materials of small physical size, such as viruses, microorganisms, or cells. If the taxon upon which a claimed invention depends is significantly physically larger that this, biological deposit becomes infeasible. How, for example, could an inventor successfully make a biological deposit of a multicellular animal or plant?123 Biological depositories may be capable of storing and propagating bacteria, cells, and other small samples, but they have no capacity to accept elephants or sequoias. Because there are many more taxa of multicellular organisms than of microorganisms, it is the former that are likelier to provide the living source materials necessary to the enablement of a claimed biotechnological invention.124 Thus, for claimed inventions dependent for their enablement upon physically larger taxa an alternative form of biological deposit is necessary.

A professor of chemistry, Dr. Kenneth L. Rinehart, Jr., has provided a paradigmatic example of how such biological deposits can function. In 1980, Dr. Rinehart filed a patent application claiming, among other inventions, a process for preparing a natural biochemical named didemnin.125 One form, didemnin B, was the very first natural biochemical derived from a marine organism to enter clinical trials.126 Members of the didemnin family of biochemicals tend to have strong antiviral, antitumor, and immunosuppressive activity, making them promising therapeutic candidates against such diseases as Herpes, Rift Valley Fever, and cancers.127 Didemnins are commonly derived from the colonial marine tunicates, small animals usually found in tropical coral reefs.128

The patent application filed by Rinehart followed a tortuous path through the USPTO.129 After several important claims were finally rejected by the examiner, Rinehart appealed to the Patent Board of Appeals and Interferences.130 The claims at issue in the appeal were finally rejected on enablement grounds, among other reasons "for lack of deposit of the marine tunicate."131

The Board reversed the rejection, finding that the disclosure provided in the patent application was, in fact, fully enabled.132 Although Rinehart had failed to make a deposit of the marine tunicate to a biological depository, the court found that he had provided sufficient detailed information about the source taxon to enable the claims at issue.133 The Board explained its decision as follows:

With respect to the lack of deposit of the marine tunicate, we find that the source of the marine organisms necessary for practice of the invention is described in detail in the specification by reference to specific locations in the sea.

The marine tunicate are a well known class of marine microorganisms having definitive characteristics.* Appellant has described the phylum, subphylum, class, order, and suborder as well as where the organisms are located and how they can be obtained. The marine microorganisms are neither new nor unique but are commonly known and generally available to the public without any undue experimentation. In this area of technology, the written description sufficiently discloses how to obtain the tunicata from various specified locations in the sea. Accordingly, we see no necessity for a deposit of the organism.

* McGraw-Hill Encyclopedia of Science and Technology, Volume 14, page 160(1971).134

Thus, the decision in Ex parte Rinehart recognized an alternative to conventional biological deposit. A conventional biological deposit can be described as an "ex situ biological deposit" because the source taxon is removed from (ex) its original location (situ) and placed into a biological depository elsewhere. A biological "deposit," such as the Board recognized in Ex parte Rinehart, can be referred to as an "in situ biological deposit" because the source taxon remains conceptually deposited in (in) its original location (situ). According to the reasoning of Exporte Rinehart, both ex situ and in situ biological deposits can be relied upon to satisfy the enablement requirement, provided the biological deposit ensures that the taxon so deposited remains "available to the public without any undue experimentation."135

Other courts have noted that ex situ biological deposit is not the only means to satisfy the enablement requirement when words and diagrams alone will not suffice. In situ biological deposits provide a useful, complementary alternative to traditional ex situ deposits. Ex situ biological deposits are particularly useful "[where] biological material cannot be taxonomically described."136 On the other hand, in situ biological deposits may be available where ex situ biological deposits are not because the "[ex situ biological] deposit requirement applies only to biological materials that are not readily reproducible from their written description [and diagrams]."137 Using the decision in Ex parte Rinehart as a guide, the availability of in situ biological deposit is most useful in any situation where ex situ biological deposit is infeasible but it is possible for the inventor to disclose the specific (1) in situ location and (2) taxonomic description of the source taxon upon which enablement depends.

Implications of the in situ biological deposits exemplified in the Ex parte Rinehart decision extend beyond marine tunicates. Most extant taxa of life are multicellular and considerably larger in physical size than those capable of deposit into a biological depository. Plants, animals, and fungi tend to be far too large, and the conditions required for their survival far too complex, for inclusion within a biological depository. Consequently, ex situ biological deposits are a viable option only for inventions that depend for enablement on biological samples of small physical size. Fortunately, in situ biological deposits can serve the same purpose for physically larger taxa that ex situ biological deposits do for physically smaller organisms: providing evidence of enablement when words and diagrams alone would be insufficient. Since most natural biochemicals are derived from physically larger taxa, availability of in situ biological deposits provides a vital avenue for enablement for this valuable class of inventions.

B. MINIMUM REQUIREMENTS OF IN SFTV BIOLOGICAL DEPOSITS

At the most fundamental level, for an in situ biological deposit successfully to satisfy the enablement requirement for a claimed invention it must ensure that the source taxon is "available to the public without any undue experimentation."138 This requires that several vital criteria be met by the specification of the patent application. A person having ordinary skill in the art must be able to use the information disclosed in the specification, augmented only by information that would be known to one of ordinary skill in the art, to locate, identify, and obtain the source taxon.

In accordance with Ex parte Rinehart, a patent applicant must provide detailed taxonomic information sufficient to allow one of ordinary skill in the art to identify the source taxon and to distinguish it from all other taxa. If this information is not yet known to science, it is the responsibility of the applicant to determine the detailed taxonomy of the source taxon, and then to disclose this in the patent application.

At minimum, the required taxonomic description has two components. First, the patent applicant must provide a full taxonomic description of the source taxon, which involves determining and describing the unique and distinguishing characteristics necessary to identify the source taxon. Current standard methods of taxonomic description are sophisticated and well developed, and can provide diagnostic information of sufficiently high quality to satisfy this criterion for most source taxa.139 Second, the patent applicant must determine the evolutionary relatedness of the source taxon to other, similar taxa to demonstrate the uniqueness of the source organism. Current methods of phylogenetic inference are sophisticated and well developed, and will usually involve determining the DNA sequence of representative portions of the genome of a source taxon, and then mathematically comparing these sequences to those of related taxa to infer their evolutionary family tree, or "phylogeny,"140 that links the source taxon with its related taxa.141

Providing a sufficient taxonomic description of the subject organism would be relatively easy for organisms already well known to science. Doing so for poorly understood or newly discovered taxa would require relatively more effort than for well understood taxa. However, providing such new information to the public storehouse of knowledge is a vital part of the quid pro quo of the patent grant.

Also in accordance with Ex parte Rinehart, a patent applicant must provide information sufficient to allow one of ordinary skill in the art to locate the source taxon. This information also divides into two distinct components: geographical range and habitat. First, a patent applicant must determine and disclose the precise geographical distribution of the source taxon. Ideally, the inventor would disclose a map indicating in sufficient detail where the source taxon can be found. If existing geographical data is insufficient, the patent applicant must determine the distribution of the source taxon through a program of field research. For example, a patent applicant could determine, and disclose in a patent application, the precise geographical coordinates of the boundaries within which the source taxon is found. In addition, because all taxa have specific ecological limitations on which habitats they can and cannot inhabit,142 the patent applicant would have to provide sufficient ecological information to enable a person having ordinary skill in the art to locate the subject organism within the complex matrix of habitats that abound in most areas of the world. For example, a patent applicant might determine the geographical range of a source taxon and discover that the taxon is entirely nocturnal, spends most of its time within the boles of a single taxon and age-class of tree, and that when it does emerge to forage for food, it frequents only the underside of the uppermost canopy of leaves of certain taxa of forest trees. Without both types of locational information one having ordinary skill in the art would be at increased risk of having to employ efforts rising to the level of "undue experimentation" to locate the source taxon, in which case the disclosure provided by the patent applicant would not be enabling.

There is yet a third category of information that the patent owner would be wise to determine, though there exists no legal obligation to compel the patent owner to disclose it in the patent application or elsewhere. Information regarding the conservation status of a source taxon is of vital importance in informing the patent owner of the status of the patent. For, if a source taxon becomes rare enough-or even extinct-that one having ordinary skill in the art could not locate it without employing undue experimentation, then the in situ biological deposit can no longer enable corresponding claims. Should this occur, the patent is rendered invalid or unenforceable. Thus, a logical corollary of employing biological deposits, whether ex situ or in situ, to enable claims is an "extinction bar" to patentability.

C. AN EXTINCTION BAR TO PATENTABILITY

The court in In re Metcalfe considered that a reference to a trademark m a patent application could be sufficient to enable a claimed invention, at least initially, despite the possibility that the quality of information conveyed by the trademark might degrade over time.143 However, the court then warned, "there is always the possibility that sometime after the issuance of a patent, the disclosure which was initially enabling may become 'unenabling.'"144 Thus, secondary loss of enablement can occur when a non-written and non-diagrammatic alternative to description, such as a trademark or biological deposit, loses its sufficiency. This can occur when a trademark loses its secondary meaning or a biological deposit is no longer "available to the public without any undue experimentation."145

The possibility and implications of secondary loss of enablement have been considered by both the courts and the USPTO in the specific context of ex situ biological deposits. Paralleling its reasoning of In re Metcalfe, the Court of Customs and Patent Appeals in In re Argoudelis contemplated "the possibility that at some future date one skilled in the art might no longer be enabled to practice the invention [should the ex situ biological deposit supporting enablement become unavailable]."146 Later, the Court of Appeals for the Federal Circuit, in In re Lundak, warned that "the applicant or his assigns [must provide] assurance of permanent availability of the culture to the public through a[n ex situ biological] depository [in compliance with other USPTO rules]."147

The USPTO MPEP specifically contemplates secondary loss of enablement in the case of in situ biological deposits:

If the biological material and its natural location can be adequately described so that one skilled in the art could obtain it using ordinary skill in the art, the disclosure would appear to be sufficient to meet the enablement requirement of 35 U.S.C. [§] 112 without a[n ex situ biological] deposit so long as its degree of availability is reasonable under the circumstances.

By showing that a biological material is known and readily available or by making a[n ex situ biological] deposit in accordance with these rules, applicant does not guarantee that such biological material will be available forever. Public access during the term of the patent may affect the enforceability of the patent...

... Those applicants that rely on evidence of accessibility other than a[n ex situ] deposit take the risk that the patent may no longer be enforceable if the biological material necessary to satisfy the requirements of 35 U.S.C. [§] 112 ceases to be available.148

An enabling disclosure is the most important contribution an inventor makes to society in return for a monopoly right to exclude others.149 It lies at the heart of the quid pro quo of the patent bargain. Consequently, should a disclosure become secondarily nonenabling, then secondary loss of monopoly exclusion rights is the logical and equitable outcome to prevent the patent bargain from becoming unbalanced to the detriment of society. An extinction bar to patentability ensures that society receives-and continues to receive-the benefit of its bargain with a patent applicant throughout the entire term of a patent.

Just as secondary failure of an ex situ biological deposit in a depository leads to loss of monopoly exclusion rights, so must secondary failure of an in situ biological deposit. In the case of an ex situ biological deposit, failure occurs when the deposited biological sample loses its viability. In the case of an in situ biological deposit, failure occurs when the source taxon can no longer be located due to rareness, the ultimate form of which is extinction, and is not "available to the public without any undue experimentation."150

The extinction bar to patentability creates strong incentives for any patent owner to ensure survival of the in situ deposited source taxon upon which the enablement of patent claims depends. A rational patent owner will tend to expend a significant amount of effort to ensure continued survival of the source taxon so as to maintain the monopoly exclusion rights conferred by a valid and enforceable patent. The amount of effort to ensure survival of a source taxon will tend to vary directly with the value of the patent to the patent owner. Greater patent value will tend to inspire greater efforts to monitor the conservation status and ensure survival of a source organism. For example, the owner of a patent covering a hugely profitable blockbuster drug will likely make significant efforts, and expend significant resources, to ensure the survival of any source taxon upon which enablement of the claims to the drug depend. Recognition of the extinction bar to patentability could unleash significant new resources for conservation of biological diversity.

D. A NEW INCENTIVE FOR BIODIVERSITY CONSERVATION

The vast majority of biological diversity is located in tropical, developing nations.151 The richness of biodiversity in developing nations has made them favored destinations for bioprospectors who seek new and valuable natural biochemicals. Simultaneously in these nations, a tragic confluence of poverty, low levels of formal education, primary resource-based economies, poorly developed institutions, political instability, and corruption has led not only to low levels of human development but also to wholesale destruction of biodiversity. Recognition of the extinction bar to patentability not only creates new incentives to conserve biodiversity, it also creates new opportunities for stakeholders in developing nations to share more equitably in the benefits of biotechnological inventions derived from their own biodiversity.

The extinction bar to patentability provides both direct and indirect incentives to conserve biodiversity. A rational patent owner will try to ensure the survival of any source organism upon which the continued enablement of a valuable patent depends.152 The greater the value an owner places on their patent, the greater the efforts the owner will tend to make to protect the source taxon. These efforts could include purchasing, leasing, and acquiring conservation easements to the land on which a source taxon is found, hiring guards and compensating local residents to protect the source taxon and its habitat from harm, and negotiating with local, regional, or national authorities to gain governmental assistance in ensuring survival of the source taxon. A rational patent owner would employ whatever strategies were necessary to ensure continued survival of the source organism and maximize net economic benefits.

In addition to direct incentives to conserve biodiversity, the extinction bar to patentability promotes indirect conservation of biodiversity in several ways. Few, if any, organisms can survive without a web of ecological interactions.153 Survival of an organism is best ensured if that organism remains integrated within its native ecosystem.154 Therefore, the most risk-averse and cost-effective strategy for conserving a source taxon is to conserve it as part of the habitat it requires to survive. The habitat of a source taxon would necessarily provide refuge for many other taxa unconnected to the patent. The "conservation umbrella" thus created would contribute a positive conservation externality benefiting both biodiversity itself and society.

Given the substantial number of patents claiming inventions based on natural biochemicals, recognition of the extinction bar to patentability could create a large network of private "patent parks" around the world, but especially concentrated in the developing countries richest in biodiversity. To preserve the patent potential of their biodiversity, countries would also have an incentive not to liquidate even biodiversity as yet unconnected to any patented inventions. For, once biodiversity disappeared from an area, the potential of that area to provide patent revenue-generating source taxa would disappear along with it. Regardless of the magnitude of these indirect incentives to conserve biodiversity, they can at least contribute at the margins to land use decisions that weigh biodiversity conservation against biodiversity liquidation.

The patent system is agnostic regarding what efforts patent owners would employ to ensure survival of their source taxa. As long as a source taxon remains available to one of ordinary skill in the art without undue experimentation, any patent with a claim dependent on that source taxon for enablement could remain valid and enforceable. This leaves patent owners and any other parties necessary or useful to the survival of source taxa free to negotiate whichever biodiversity conservation strategies seem most beneficial. In general, this will create a new net flow of monetary remuneration from patent owners in developed countries to parties in developing nations as consideration for biodiversity conservation efforts aimed at ensuring that patent rights endure. In essence, recognition of the extinction bar to patentability creates new opportunities for private international law to contribute to solutions to the global crisis of biodiversity extinctions.155

E. PERVERSE CONSEQUENCES OF THE EXTINCTION BAR TO PATENTABILITY

Alongside salutary effects on conservation of biodiversity, recognition of the extinction bar to patentability might create some perverse incentives. These perverse incentives might encourage competitors of patent owners, extortionate third parties, and patent owners themselves to engage in unethical or even illegal behavior. Though such perverse incentives do hold potential to weaken, or bring into disrepute, biodiversity conservation incentives created by in situ biological deposits, laws and norms in the countries of both patent owners and source taxa should mitigate such adverse outcomes.

Though an extinction bar to patentability creates an incentive for a patent owner to ensure survival of a source taxon, it also creates an incentive for competitors to cause extinction, or at least unavailability, of a source taxon. Since extinction of a source taxon would extinguish the right of a patent owner to exclude others, including competitors, from practicing a claimed invention, competitors might actively seek to cause such extinctions. Imagine a patent owner whose patent application contains the necessarily description of an Amazonian rainforest tree taxon sufficient to enable claims to a natural biochemical extracted from that tree. The patent owner develops a therapeutic drug from this natural biochemical, and, relying upon the patent claims, excludes all competitors from entering the lucrative market for this drug by aggressively asserting the patent claims against all potential and actual infringers. Competitor A, based in the United States, is extremely eager to sell the profitable drug itself, but is deterred by the risk of an expensive patent infringement lawsuit that could result in serious penalties to Competitor A. So, Competitor A decides to hire a desperately impoverished group of Amazonian botanists to locate and exterminate individuals of the rainforest tree using the enabling disclosure of the patent as a guide. Then, Competitor A begins to make and sell the drug with impunity because the claims covering the drug are no longer enabled by the in situ biological deposit of the now-extinct rainforest tree. All competitors would have a similar incentive to encourage extinction of the source taxon. Regardless of how unethical such behavior is, the incentive to cause extinction of source taxa would remain a temptation. This would be especially true if means for causing extinction violated no laws, or, if laws prohibiting such means were poorly enforced or carried weak penalties.

Third parties would also have an incentive to profit from the extinction bar to patentability. They might engage in extortionate behavior by threatening to cause extinctions of source taxa unless patent owners compensated them. These challenges would most likely occur among local residents with ready access to source taxa. However, compensation of any extortionate third parties could lead to an increase in such behavior by yet more third parties, creating a growing cascade of parties demanding compensation.

Even patent owners might respond in socially undesirable manners to incentives created by the extinction bar to patentability. The greater the incentive to ensure survival of a source taxon, the greater the temptation for a patent owner to engage in unethical or illegal behavior if such behavior is necessary or costeffective to prevent extinction of the source taxon. For example, a patent owner might engage the services of guards whose mandate-to ensure survival of the source taxon-is most effectively achieved through ruthlessness, including violence and intimidation, against parties who represent potential threats to the source taxon. Alternatively, a patent owner might use financial resources to override the rights of people perceived to represent a threat to a source taxon. Since the richest sources of biodiversity-wild areas of tropical, developing countries-also tend to overlap with the native lands of rural and indigenous peoples, the potential for significant conflicts of interest between relatively powerful patent owners and their paid agents, on the one hand, and relatively weak local residents, on the other, will tend to be significant. If a source taxon in a developing country enables lucrative patent claims, the economic incentives to protect the source taxon, if coupled with the relative disenfranchisement of locals and poor enforcement of laws, will create a situation vulnerable to inequitable results. Unfortunately, scenarios involving well paid patent park rangers, or even members of the military provided by a government receiving compensation from a patent owner, employing force or violence against poor local or indigenous people to protect source taxa, though disturbing, are far from difficult to imagine.

Legal solutions may be available from patent law and other sources of law to mitigate or prevent such perverse consequences of the extinction bar to patentability. Courts could discourage unethical or illegal biodiversity conservation strategies engaged in by patent owners by classifying such behavior as a form of inequitable conduct.156 Competitors found to have made deliberate efforts to cause extinction of a source taxon could be liable for enhanced damages on a theory of willful infringement or for all foreseeable damages caused by extinction of a source taxon. Beyond patent law, such behavior might trigger liability under existing environmental laws or other laws governing tortious or criminal behavior.157

Providing that the penalties for unethical or illegal behavior are significant enough, patent owners and defendants would both have strong incentives to uncover and report any such behavior connected to protecting, or trying to cause extinction of, source taxa.

VI. CONCLUSIONS

International treaties have thus far failed to prevent, or even slow, the destruction of biological diversity, especially in the developing tropical nations richest in biodiversity. Where public international law has failed, private international law may have a valuable role. Recognition of in situ biological deposits and the extinction bar to patentability they create represents a mechanism by which private international law can contribute to the realization of all three major goals of the Biodiversity Convention: (1) "the conservation of biological diversity"; (2) "the sustainable use of its components"; and (3) "the fair and equitable sharing [of benefits derived from biological diversity]."158

Conservation of biological diversity. The extinction bar to patentability serves the goal of conserving biodiversity in two ways. Any source taxon upon whose survival patent rights depend will benefit from a strong, focused incentive that encourages the patent owner to ensure survival of that source taxon. Countries with abundant biodiversity resources will also have incentive to protect that biodiversity to preserve the possibility of sharing in future patent revenues, an option that disappears along with biodiversity. Furthermore, because the most effective means of ensuring the survival of any taxon tends to be by preservation of its habitat throughout its geographic range, any other taxa located within this area will also benefit under the "conservation umbrella" created by the patent owner. Finally, the incentive for biodiversity conservation created by the extinction bar on patentability complements, but does not detract from, other efforts to conserve biodiversity that are not linked to patent rights.

Sustainable use of its components. The incentives to innovate created by the patent system promote bioprospecting for natural biochemicals, as well as research into, and development of, new biotechnological inventions. Many of these new inventions are therapeutic drugs or methods of diagnosing diseases and are thus capable of making significant contributions to the health and welfare of all humanity. However, but for the incentive provided by patent protection, fewer such inventions would be made available to humanity. In addition, the extinction bar to patentability provides a significant incentive to inventors to conserve source taxa, which tempers the exploitation of biodiversity necessary to produce new biotechnological inventions and ensures that the use biotechnology makes of biodiversity will tend to be, quite literally, sustainable.

Fair and equitable sharing. Patent owners will rarely have the capacity to ensure the survival of a source taxon upon which their patent rights depend without the cooperation of governments and local stakeholders. After all, these latter parties usually have sovereignty or ownership of the land on which source taxa are located. To ensure the requisite cooperation and participation of these parties in efforts to conserve source taxa, patent owners must provide these parties with incentives. These incentives will often involve sufficient levels of financial compensation to governments and local stakeholders to ensure successful conservation efforts. For example, the government of Brazil and local stakeholders, such as farmers, ranchers, rubber tappers, and indigenous tribes, might agree to ensure the protection of a particular area of land home to a source taxon in return for a share of any profits or royalties resulting from a patented invention involving a natural biochemical derived from that source taxon. In general, a patent owner and any other parties required to ensure successful conservation of a source taxon will be free to craft private agreements among themselves, thereby maximizing the probability that all parties to the negotiation are satisfied with the resulting agreements.

Biodiversity possesses significant economic value, not least as a source of natural biochemicals discoverable through bioprospecting. However, human activities are currently devastating biodiversity at a rapid and accelerating rate. Effective conservation instruments are needed to prevent this loss. Recognition of in situ biological deposits, and the extinction bar to patentability they create, provides a valuable new instrument through the unlikely provenance of patent law. The extinction bar to patentability promotes conservation of biodiversity by creating a significant incentive for any patent owner whose patent rights depend upon the survival of a source taxon to ensure the cooperation of governments and local stakeholders in preventing extinction of the source taxon.

Through the agency of private international law, the extinction bar to patentability contributes to the achievement of the three major goals of the Convention on Biological Diversity. Through the agency of the patent system, economic greed will inspire monopolists to conserve biodiversity. The invisible hand will sprout a green thumb, and even Holmes' Bad Man159 will protect nature.