The Selfish Patent

By Stankovic, Bratislav; Stankovic, Mirjana | Journal of Law, Technology and the Internet, Fall 2011 | Go to article overview

The Selfish Patent


Stankovic, Bratislav, Stankovic, Mirjana, Journal of Law, Technology and the Internet


INTRODUCTION

What is patentable in the United States, according to statute, dates back to the first United States Patent Act of 1790. The provisions of the U.S. patent code contain nothing specific about patenting living organisms; late nineteenth-century developments at the U.S. Patent and Trademark Office ("USPTO") both allowed (3) and prohibited (4) patents on living organisms. Fast forward a century, and the rapid advancements in biotechnology have led universities and companies conducting biotechnology research and development (R & D) to increasingly depend upon patent protections. Part of this battle has included the fight to expand the boundaries of what can be patented. Indeed, notwithstanding the recent temporary drop due to the economic crisis, the global number of patent applications has been steadily increasing. Based upon provisional date of the World Intellectual Property Organization (WIPO), 162,900 Patent Cooperation Treaty ("PCT") international patent applications were filed in 2010. (5) Of that total, it is estimated that 44,855 of those patent applications were filed by U.S. applicants. (6) According to the USPTO, 244,341 U.S. patents were granted in 2010. (7) Approximately 1.75% of those patents (precisely 4,293) had one or more claims directed to DNA. (8)

The recent biotechnological advances in genetic engineering, recombinant DNA, gene therapy, achieved potential for cloning animals and humans, and the isolation and manipulation of human embryonic stem cells (hESCs), easily capture the imagination. The prospects for their use in biomedical applications and personalized and regenerative medicine are seemingly without boundaries. Cutting and pasting genes into heterologous genomes has become a routine practice. Animals have been cloned through a variety of methods. Embryonic stem cells can be grown in Petri dishes (while maintaining pluripotency and preserving the ability to differentiate and form potentially any cell type that makes up the body), serving as a sort of repair system for the body. "Synthetic biology" offers the design and construction of new biological functions and systems not found in nature. The potential of these breakthrough biotechnological advances has made for great "Patenting Life" op-ed headlines. (9) However, the term "patenting life" is a misnomer. As "life" is not defined in the patent code, in this article it is defined as the quality that distinguishes a vital and functional being from a dead body, and further, as one or more aspects of the process of living. (10) Life is a characteristic that distinguishes objects that have signaling and self-sustaining processes (i.e., living organisms) from those that do not, either because they lack such functions and are classified as inanimate, or because such functions have ceased (through death). The fundamental principles on which a living system is based are: program; improvisation; compartmentalization; energy; regeneration; adaptability; and seclusion. (11)

The rapid developments in biotechnology have affected and significantly challenged many areas of law, in particular patent law. In 1980, the seminal decision of Diamond v. Chakrabarty, (12) in which the U.S. Supreme Court ruled that living organisms are patentable subject matter, (13) arguably helped spark the biotechnology revolution of today. While the Chakrabarty opinion was directed toward the patentability of a genetically altered micro-organism, and not genes, it is often cited by proponents of gene patents for the mantra that "anything under the sun that is made by man" may be patented. (14) In December 1982, the USPTO issued the first gene patent, which claimed the expression of genes for chorionic somatomammotropin, to the Regents of the University of California. (15) The primary examiner waited to examine the patent pending the outcome of Chakrabarty decision. (16)

Since Chakrabarty, biotech companies and academic institutions have attempted to acquire ownership of gene sequences due to their potentially high economic value. …

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