Staking a Claim on the Building Blocks of Life: Human Genetic Material within the United States Patent System

By Osterlind, Alex | Missouri Law Review, Spring 2010 | Go to article overview

Staking a Claim on the Building Blocks of Life: Human Genetic Material within the United States Patent System


Osterlind, Alex, Missouri Law Review


I. INTRODUCTION

The discovery of human genetic material introduced an invaluable tool in the advancement of medicine. International efforts under the Human Genome Project have drawn to a close, identifying approximately 20,000-25,000 of the genes in the human body, thereby facilitating diagnoses of disease, predispositions to debilitations, pharmaceutical development, and numerous other fields. (1) Indeed, genetic research enables innumerable beneficial medical applications, and, predictably, such research in the united States has been commodified through patent law. In fact, it is estimated that twenty percent of the human genome is subject to patent protection, (2) prohibiting others from any unauthorized research of the patented genetic material or unauthorized utilization of it in clinical testing procedures. (3) Allowing patent protection for human genetic material has sparked a heated debate, with each side asserting diametrically opposite interpretations of how, or even if, gene patents are contemplated under the Intellectual Property Clause of the Constitution. (4) competing interests in the field are not easily reconciled. For example, incentivizing genetic research by offering patent protection encourages research and development in the field but simultaneously limits access for illuminating and potentiating additional research on patented genes.

Illustratively, patents held by Myriad Genetics, Inc. (Myriad) for the BRCA1 and BRCA2 genes provide indicators that evince an individual's predisposition to breast and/or ovarian cancer. (5) However, in the united States, only Myriad may perform testing procedures utilizing the BRCA genes due to patent protection. (6) Yet, in France, a physician not constrained by the United States patents discovered a deficiency in Myriad's testing procedures; (7) such a deficiency could not be discovered by non-Myriad researchers in the United States, who are restricted from unauthorized uses of patented subject matter. (8) However, the value of the BRCA genes as markers for certain cancers was discovered by researchers at Myriad (9)--an advance that was encouraged by the financial benefit of patent protection. The BRCA genes provided a rallying point for salient opponents of gene patents, such as the American Medical Association, the March of Dimes, and the American Society for Human Genetics, who condemn the BRCA gene patents. (10) Thus, while the American judiciary has to date taken a stance that approves the patentability of human genes, intense opposition remains.

This Article examines the place, if any, of genes within the United States patent system by first providing a broad background of the United States patent system, including the foundational cases that have shaped the system. Further, this Article briefly describes human genes to explain how genetic material is viewed within the United States patent system. Subsequently, "gene patents" within the United States are explained. Building upon this milieu, the merits of arguments in opposition to gene patents are examined by focusing on the arguments presented in an ongoing suit filed by the American Civil Liberties Union (on behalf of various parties) against Myriad Genetics, the holder of several gene patents, and the United States Patent and Trademark Office. (11) Finally, this Article concludes with a brief forecast of the fate of gene patents in the United States and how concerns about the deleterious effects of gene patents might be addressed.

II. LEGAL BACKGROUND

Charged with assessing the validity of patents, the United States Patent and Trademark Office (USPTO) will issue a patent to an applicant who "invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof." (12) Given only a cursory glance, the requirements to obtain a patent appear precisely defined. However, dramatic intellectual and technological developments in fields such as biotechnology have created substantial difficulties in applying the requirements for a patent in the United States. …

The rest of this article is only available to active members of Questia

Sign up now for a free, 1-day trial and receive full access to:

  • Questia's entire collection
  • Automatic bibliography creation
  • More helpful research tools like notes, citations, and highlights
  • Ad-free environment

Already a member? Log in now.

Notes for this article

Add a new note
If you are trying to select text to create highlights or citations, remember that you must now click or tap on the first word, and then click or tap on the last word.
One moment ...
Default project is now your active project.
Project items

Items saved from this article

This article has been saved
Highlights (0)
Some of your highlights are legacy items.

Highlights saved before July 30, 2012 will not be displayed on their respective source pages.

You can easily re-create the highlights by opening the book page or article, selecting the text, and clicking “Highlight.”

Citations (0)
Some of your citations are legacy items.

Any citation created before July 30, 2012 will labeled as a “Cited page.” New citations will be saved as cited passages, pages or articles.

We also added the ability to view new citations from your projects or the book or article where you created them.

Notes (0)
Bookmarks (0)

You have no saved items from this article

Project items include:
  • Saved book/article
  • Highlights
  • Quotes/citations
  • Notes
  • Bookmarks
Notes
Cite this article

Cited article

Style
Citations are available only to our active members.
Sign up now to cite pages or passages in MLA, APA and Chicago citation styles.

(Einhorn, 1992, p. 25)

(Einhorn 25)

1

1. Lois J. Einhorn, Abraham Lincoln, the Orator: Penetrating the Lincoln Legend (Westport, CT: Greenwood Press, 1992), 25, http://www.questia.com/read/27419298.

Cited article

Staking a Claim on the Building Blocks of Life: Human Genetic Material within the United States Patent System
Settings

Settings

Typeface
Text size Smaller Larger Reset View mode
Search within

Search within this article

Look up

Look up a word

  • Dictionary
  • Thesaurus
Please submit a word or phrase above.
Print this page

Print this page

Why can't I print more than one page at a time?

Full screen

matching results for page

Cited passage

Style
Citations are available only to our active members.
Sign up now to cite pages or passages in MLA, APA and Chicago citation styles.

"Portraying himself as an honest, ordinary person helped Lincoln identify with his audiences." (Einhorn, 1992, p. 25).

"Portraying himself as an honest, ordinary person helped Lincoln identify with his audiences." (Einhorn 25)

"Portraying himself as an honest, ordinary person helped Lincoln identify with his audiences."1

1. Lois J. Einhorn, Abraham Lincoln, the Orator: Penetrating the Lincoln Legend (Westport, CT: Greenwood Press, 1992), 25, http://www.questia.com/read/27419298.

Cited passage

Welcome to the new Questia Reader

The Questia Reader has been updated to provide you with an even better online reading experience.  It is now 100% Responsive, which means you can read our books and articles on any sized device you wish.  All of your favorite tools like notes, highlights, and citations are still here, but the way you select text has been updated to be easier to use, especially on touchscreen devices.  Here's how:

1. Click or tap the first word you want to select.
2. Click or tap the last word you want to select.

OK, got it!

Thanks for trying Questia!

Please continue trying out our research tools, but please note, full functionality is available only to our active members.

Your work will be lost once you leave this Web page.

For full access in an ad-free environment, sign up now for a FREE, 1-day trial.

Already a member? Log in now.