TABLE OF CONTENTS ABSTRACT TABLE OF CONTENTS INTRODUCTION I. THE INCREASING PREVALENCE OF PATENTABLE SELF-REPLICATING TECHNOLOGIES II. INNOVATION IN SELF-REPLICATING TECHNOLOGIES REQUIRES EFFECTIVE INTELLECTUAL PROPERTY III. THE HISTORIC ROLE OF INTELLECTUAL PROPERTY IN AGRICULTURAL INNOVATION IV. SELF-REPLICATING TECHNOLOGIES AND INADVERTENT INFRINGEMENT V. THE MYTH THAT MONSANTO IS SUING FARMERS FOR INADVERTENT INFRINGEMENT VI. AN INCREASING LIKELIHOOD OF ACTUAL LAWSUITS INVOLVING INADVERTENT INFRINGEMENT A. "Generic" Roundup Ready B. Passively Beneficial Traits C. Trait Stacking D. Planting of Commodity Grain VII. PROPOSED SOLUTIONS TO THE PROBLEM OF INADVERTENT INFRINGEMENT WOULD DENY SELF-REPLICATING TECHNOLOGIES EFFECTIVE PATENT PROTECTION A. Patent Exhaustion B. Patent Ineligibility C. Lack of Moral Utility D. Duty on Patent Owner to Prevent Inadvertent Infringement E. Compulsory Licensing VIII. LEVERAGING EXISTING DOCTRINE TO ADDRESS INADVERTENT INFRINGEMENT WHILE MAINTAINING THE INCENTIVE TO INNOVATE A. A Restricted Interpretation of What It Means to Make, Use, Or Sell a Self-Replicating Technology 1. Courts Are Willing and Able to Interpret Statutory Language in a Restricted Manner 2. Intent and Knowledge 3. Beneficial Use of the Invention 4. Autonomous and Indirect Infringement B. Equitable Defenses C. Remedies as a Policy Lever IX. A LEGAL RESPONSE SHOULD BE NARROW AND TAILORED TO SPECIFIC AND SUBSTANTIATED DEFICIENCIES IN THE CURRENT SYSTEM X. LEARNING FROM COPYRIGHT LAW'S RESPONSE TO THE SELF REPLICATION OF DIGITAL CONTENT XI. GENETIC USE RESTRICTION TECHNOLOGIES CONCLUSION INTRODUCTION
Under the judicially-created doctrine of patent exhaustion, "[T]he initial authorized sale of a patented item terminates all patent rights to that item" (1) In 2012, the Supreme Court of the United States granted certiorari in Bowman v. Monsanto Co., a case in which the petitioner sought a dramatic expansion of the patent exhaustion doctrine. In Bowman, the petitioner argued that the authorized purchase of a patented product not only exhausts all patent rights with respect to the item that was the subject of the authorized sale, but also confers upon the purchaser the right to make and distribute an unlimited number of perfect copies of the item without the permission of the patent owner, and without an obligation to pay any compensation to the patent owner. (2) On its face, the petition seems almost frivolous, analogous to arguing that the purchaser of a single DVD copy of a copyrighted movie should be permitted to make an unlimited number of unauthorized copies of the movie and distribute or sell the copies without any obligation to compensate the copyright owner.
Of course, copyright law is specifically aimed at preventing the unauthorized copying of protected works, but the same principles have been applied in the context of patents. It is well established, for example, that the purchaser of a patented item is generally not authorized to reconstruct the item if it becomes damaged, let alone make new copies of it. (3) The purchaser of a patented bicycle is certainly permitted to repair the bike, but once the bicycle has worn out beyond repair she is not allowed to rebuild it, and she is certainly not authorized to use the bicycle as a template for manufacturing new copies of the bicycle without the patentee's permission.
What would prompt the Supreme Court to grant certiorari in a case raising such an argument? And why would a large contingent of amici flock to support the petitioner's facially meritless position? The answer is that this was not a case involving bicycles, but instead a product having a very special attribute. The patented product at the center of the litigation was a genetically engineered soybean, and the special attribute that distinguishes soybeans from the vast majority of patented inventions is their propensity to self-replicate. (4) Unlike bicycles, or virtually any other form of technology that has historically been the subject of patent protection, seeds have the inherent ability to serve as the template for the production of a virtually unlimited number of perfect copies of themselves, with relatively minimal, if any, active human involvement and effort. And as we shall see, in the minds of many, this capability of self-replication can make all the difference in the world.
While Bowman did result in a unanimous decision clarifying that, at least as a general matter, patent exhaustion does not extend to second-generation seeds, the case should be viewed as a bellwether for an oncoming wave of controversy around the patenting of self-replicating technologies that will challenge the ability of the patent system to respond effectively. The closest analogy might be the impact that the proliferation of digitally-encoded content--e.g., movies, music, and software--has had on the copyright system. The ease with which these digitally-encoded works can be copied and distributed has enabled massive and widespread copyright infringement, and resulted in the enactment of sweeping legislation intended to bolster the copyright system. (5) Similar stresses on the patent system are on the horizon due to an increasing prevalence of self-replicating technologies. As innovators strive to appropriate the value generated by their investment in innovation, consumers and policy advocates balk at what might appear to be overly aggressive enforcement of intellectual property ("IP"), and Congress and the courts struggle to find a balance between the competing concerns.
Self-replicating technologies tend to be extremely expensive and difficult to initially create, but once developed, they are capable of directing their own replication at a low cost and with little, if any, human intervention. (6) Patents play a crucial role in incentivizing the
development of self-replicating technology, but enforcement of these patents creates significant public policy concerns. The current proliferation of infringement litigation involving patented genetically modified ("GM") seeds has already resulted in a great deal of controversy. As of yet, however, the controversy has largely been limited to a single patent owner, Monsanto, and a single first-generation transgenic technology marketed by Monsanto under the trademark, Roundup Ready[R]. (7) As subsequent generations of patented GM seeds and plants reach the market, along with non-agricultural self-replicating products that are being developed by innovators in synthetic biology and nanotechnology, the controversy will extend well beyond Monsanto and Roundup Ready. When it does, society will be confronted with a host of compelling and potentially irreconcilable policy concerns that are largely without precedent in patent law.
The Supreme Court's decision to grant certiorari in Bowman highlights the fact that it is not too early for those concerned with innovation policy to begin giving serious thought to how the patent system will respond to the challenge of self-replicating technologies in a manner that maintains adequate incentives for innovation while addressing the specific concerns associated with patent enforcement in this area. One of the most pressing issues is the potential for inadvertent infringement inherent in many self-replicating technologies, particularly seeds like the Roundup Ready soybeans that Vernon Bowman planted and which ultimately brought him before the Supreme Court. Although Bowman himself was clearly not an inadvertent infringer, since he knowingly and intentionally took full advantage of the patented Roundup Ready technology present in the soybeans he cultivated, the potential for inadvertent infringement by other farmers appears to have played an important role in the decision to grant certiorari. (8) Significantly, the Bowman Court explicitly left the door open to revisiting the issue in a future case and potentially extending the doctrine of patent exhaustion under circumstances where the intent and knowledge of an accused farmer is less clear-cut. (9)
THE INCREASING PREVALENCE OF PATENTABLE SELF-REPLICATING TECHNOLOGIES
In Bowman, the Supreme Court recognized that "[self-replicating] inventions are becoming ever more prevalent, complex, and diverse." (10) This represents a new trend in patentable innovation. As one commentator recently pointed out, prior to the advent of biotechnology, "No other field (e.g. mechanical engineering, aviation, electronics; maybe with the exception of software and computer viruses) has to deal with self-replicating entities." (11) And while biological innovation has occurred since the dawn of history, as evidenced by poodles and sweet corn--neither of which bears much resemblance to the naturally occurring wolves and wild maize from which they were derived--until relatively recently the products of this innovation have, for the most part, been denied IP protection. (12) Although the situation has not changed much with respect to agricultural animals, sui generis forms of IP for plants in the form of plant patents and plant variety protection certificates became available in the United States in 1930 and 1970, respectively. (13) More recently, the availability of utility patent protection has been extended to innovative plants and seeds, both transgenic and the products of more conventional breeding. (14) It is this extension of utility patent protection to plants that ultimately led to Bowman and the current controversy surrounding the patenting of GM crops and the enforcement of patents against farmers.
The defining characteristic of living organisms that renders them self-replicating, and thus fundamentally distinct from the vast majority of patentable technologies, is genetic material--usually in the form of DNA--that encodes instructions for their own replication. The extension of patent protection to computer programs that took root in the 1980s (15) was significant in this regard, because it...