Patenting Frankenstein's Monster: Exploring the Patentability of Artificial Organ Systems and Methodologies

By Goodman, Jordana R. | Northwestern Journal of Technology and Intellectual Property, January 1, 2017 | Go to article overview

Patenting Frankenstein's Monster: Exploring the Patentability of Artificial Organ Systems and Methodologies


Goodman, Jordana R., Northwestern Journal of Technology and Intellectual Property


Introduction

Every Frankenstein movie, book, comic strip, and television show demonstrates that, in biotechnology, "just because something can be done does not mean that it should be done."1 Scientific progress in the fields of tissue engineering and organ transplantation have far surpassed Mary Shelley's crude description of stitching body parts together to form a human being.2 Yet, patent law regarding artificial human engineering remains as unclear as Frankenstein's definition of "Alive."3 To truly promote the science of tissue engineering while avoiding incentivizing human experimentation, laws regarding the patentability of "human organisms" must be clarified.

Patentable subject matter should "include anything under the sun that is made by man."4 However, the discovery of something that pre-exists in nature, whether it is an element, law, or principle, cannot be the subject of a patent without further application.5 These discoveries "are manifestations of [the] laws of nature, free to all men and reserved exclusively to none."6

Patents relying on subject matter concerning a law of nature can only be patentable if the claim as a whole amounts to "significantly more" than the law of nature itself.7 For example, the creation of an artificial equivalent of an existing, natural product is not a patentable invention.8 Because the law of nature and embodiments of that law have existed before the artificial equivalent, the natural embodiment is "prior art," thus barring the artificial creation from patent-eligibility.9 However, if a device or material that is created through the use of scientific or mathematical principles is useful and novel, with substantial differences from what exists in nature, the device or material could be patentable.10

This line between patentable subject matter and laws or phenomena of nature may seem clear, but it has become far too blurry in the world of biotechnology. With the progress of CRISPR-Cas911, in vitro fertilization12, and artificial organ creation13, the ability to imitate nature in a laboratory has become less science fiction and more realistic possibility.

Not only can scientists clone animals14, but scientists can now grow artificial tissues15, print organs16 and bones17, and even transplant artificial tissue into animals.18 In years to come, scientists may progress from creating artificial tissues to artificial organs to artificial organ systems.19 These imitations of organs and organ systems are valuable for medical experimentation, pharmaceutical experimentation, and organ transplantation.20 When artificial organs are transplanted into natural humans, the line between man and patentable subject matter will become more blurred than ever before. The creation of Frankenstein's monster, an artificial man, is coming closer every day.

However, the law is at an impasse. Though in recent years, the Supreme Court, the Federal Circuit, and Congress have all endeavored to codify and clarify patent law, their combined actions often leave scientists and lawyers with more questions than answers.21 Through an exploration of the American Invents Act, 35 U.S.C. 101, and Section 33(a), this paper shows where the progress of science is promoted and where it is hindered under current patent law.22 The vague determination that claims directed to human organisms are not patentable only hinders the progress of artificial organ development.23 Either judicial or legislative action must clarify the term "human organism" to balance the need for artificial organ development, while hindering unethical scientific development of artificial humans.

Section II of this paper discusses the rights of patent owners and how, though patents convey no positive rights, patents do provide incentives to research in a particular scientific field. Section III of this paper discusses the evolution of patentable subject matter under 35 U.S.C. 101 and in the Leahy-Smith America Invents Act, both in the Supreme Court and under federal law. …

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