Patent first, ask questions later: morality and biotechnology in patent law.

• Author: Bagley, Margo A.

This Article explores the U.S. "patent first, ask questions later" approach to determining what subject matter should receive patent protection. Under this approach, the U.S. Patent and Trademark Office (USPTO or the Agency) issues patents on "anything under the sun made by man," and to the extent a patent's subject matter is sufficiently controversial, Congress acts retrospectively in assessing whether patents should issue on such inventions. This practice has important ramifications for morally controversial biotechnology patents specifically, and for American society generally.

For many years a judicially created "moral utility" doctrine served as a type of gatekeeper of patent subject matter eligibility. The doctrine allowed both the USPTO and courts to deny patents on morally controversial subject matter under the fiction that such inventions were not "useful."

The gate, however, is currently untended. A combination of the demise of the moral utility doctrine, along with expansive judicial interpretations of the scope of patent-eligible subject matter, has resulted in virtually no basis on which the USPTO or courts can deny patent protection to morally controversial, but otherwise patentable, subject matter. This is so despite position statements by the Agency to the contrary.

Biotechnology is an area in which many morally controversial inventions are generated. Congress has been in react-mode following the issuance of a stream of morally controversial biotech patents, including patents on transgenic animals, surgical methods, and methods of cloning humans. With no statutory limits on patent eligibility, and with myriad concerns complicating congressional action following a patent's issuance, it is not Congress, the representative of the people, determining patent eligibility. Instead, it is patent applicants, scientific inventors, who are deciding matters of high public policy through the contents of the applications they file with the USPTO.

This Article explores how the United States has come to be in this position, exposes latent problems with the "patent first" approach, and considers the benefits and disadvantages of the "ask questions first, patent later" approaches employed by some other countries. The Article concludes that granting patents on morally controversial biotech subject matter and then asking whether such inventions should be patentable is bad policy for the United States and its patent system, and posits workable, proactive ways for Congress to successfully guard the patent-eligibility gate.

INTRODUCTION

In Cloning Trevor, journalist Kyla Dunn chronicles the unsuccessful efforts of a group of scientists at Advanced Cellular Technologies (ACT) to create an embryonic clone of a two-year-old boy afflicted with a rare genetic disorder. (1) Theoretically, the development of such an embryo, made with one of the boy's skin cells and a donated human egg, could yield embryonic stem cells which, when injected back into the boy, might halt and reverse the disorder. (2) This effort is an example of therapeutic cloning--the creation of genetically modified embryos that ultimately will be destroyed in order to produce cures for various human ailments. (3) By contrast, reproductive cloning has as its aim the development, also from a genetically modified embryo, of a fully formed child. Therapeutic cloning is less abhorrent to many than reproductive cloning, but both are morally controversial, (4) and neither type of research is eligible for federal funding. (5) Instead, private sector entities, like the ACT researchers that attempted to clone Trevor, are funding work in these areas.

While federal funding may not be available for cloning research, federal patent protection, which provides an incentive for private funding, is available. For example, a cloning patent was issued to the University of Missouri in April 2001, claiming inventions directed to, among other things, methods for "producing a cloned mammal" and for "producing a cloned mammalian embryo." (6) Moreover, the patent disclosure states that "the present invention encompasses the living, cloned products produced by each of the methods described herein." (7) The patent and news reports of other human cloning activity drew critical reaction, commentary, and calls for legislative action from a variety of sources. (8) However, none of the proposed amendments, either to ban patents on cloning or to ban cloning research, have been enacted to date. (9)

Why is the federal government granting exclusive property rights, which in effect act as indirect research funding, in inventions for which it will not, for public policy reasons, provide direct research funding? Patents can be seen as a type of indirect funding because they provide incentives for parties to undertake expensive and risky research. (10) Patents induce upfront funding of projects with the expectation that monopoly profits can be generated over the long term. (11) This situation, which appears inconsistent, does not necessarily involve active and deliberate congressional authorization of patents on such morally controversial inventions. Rather, Congress simply may not appreciate the ramifications of its inaction in sustaining the current "patent first, ask questions later" U.S. patent regime.

Under a "patent first, ask questions later" approach, a patent issues, and to the extent its claimed subject matter conflicts with norms or values held by a meaningful portion of society, the patent generates, among other things, public expressions of outrage, questions of how it issued in the first place, and often calls for Congress to address the perceived problem legislatively. The U.S. "patent first" approach has the potential in areas to create problems in a variety of technical disciplines and only tangentially related to morality concerns. (12) The problems the approach creates with regard to morally controversial biotech subject matter, however, make a compelling case for why congressional action in this area is necessary and long overdue. For this reason, this Article focuses on issues raised by the lack of any morality-based limits on biotech patent subject matter. (13)

Biotechnology is an area in which many morally questionable inventions are generated. (14) Controversial patented biotech inventions include: isolated genes, sequenced DNA, medical procedures, embryonic stem cells, genetically modified transgenic animals, and methods of cloning mammals. (15) The moral controversies surrounding these and other biotech inventions stem from several concerns including those arising from the mixing of human and animal species, the denigration of human dignity, the destruction of potential human life, and the ownership of humans. (16) The availability of a government imprimatur granting exclusive rights over morally controversial inventions is especially problematic in the area of biotechnology because no one should "own" and the government should not encourage certain inventions. (17)

The U.S. patent system has not always had this "patent first" approach to moral issues. For many years a judicially created "moral utility" doctrine served as a type of gatekeeper of patent-eligible subject matter. The doctrine allowed both the USPTO and courts to deny patents on morally controversial subject matter under the fiction that such inventions were not "useful." (18) The gate, however, is currently untended, as a result of judicial decisions that interpreted the scope of the statutory utility and subject matter standards under the Patent Act of 1952 in a way that left no room for a moral utility doctrine. (19) Beginning in 1980 with Diamond v. Chakrabarty (20) and continuing to the present, (21) the Supreme Court has expansively and consistently held that Congress intended the definition of subject matter eligible for protection under the 1952 Patent Act to include any type of living or nonliving matter, as long as it is "made by man." (22) Combining these decisions with the Court's generous deference to Congress in Intellectual Property Clause matters (23) means that no explicit basis exists for denying patent protection to otherwise patentable, morally controversial subject matter, and has in fact issued several patents that encompass humans, despite its earlier pronouncements. (24)

Members of Congress may not appreciate fully this change of events because of statements by the USPTO declaring that it would deny patents on certain morally controversial inventions for public policy or, in the case of inventions comprising humans, Thirteenth Amendment reasons. (25) Members of Congress have cited such statements in arguments against specific legislation directed at banning human-cloning patents. (26) The USPTO, however, is claiming power that it does not have. The Supreme Court has already interpreted the patent statute without reference to any limits based on moral considerations and the idea that the Thirteenth Amendment could support the denial of patents, on genetically modified previable fetuses for example, is doctrinally unsound. (27) The USPTO thus lacks the authority to deny patents on morally controversial inventions, even ones that comprise human genetic subject matter, and has in fact issued patents encompassing human genetic subject matter, despite earlier pronouncements. (28)

Further complicating congressional action to address the patent eligibility of morally controversial biotech subject matter may be misunderstandings of the basic nature of the U.S. patent-grant system. The Patent Act of 1952 entitles a person to a patent her invention if it meets the statutory requirements for patentability, which include novelty, utility, and nonobviousness. (29) As most of the morally controversial biotech inventions are news (30) and targeted at curing human disease, if only tangentially such express statutory requirements have not and likely will not prove too difficult to...