DNA as Patentable Subject Matter and a Narrow Framework for Addressing the Perceived Problems Caused by Gene Patents

By Schilling, Stephen H. | Duke Law Journal, December 2011 | Go to article overview

DNA as Patentable Subject Matter and a Narrow Framework for Addressing the Perceived Problems Caused by Gene Patents


Schilling, Stephen H., Duke Law Journal


ABSTRACT

Concerns about the alleged harmful effects of gene patents--including hindered research and innovation and impeded patient access to high-quality genetic diagnostic tests--have resulted in overreactions from the public and throughout the legal profession. These overreactions are exemplified by Association for Molecular Pathology v. U.S. Patent and Trademark Office, a 2010 case in the Southern District of New York that held that isolated DNA is unpatentable subject matter under 35 U.S.C. [section] 101. The problem with these responses is that they fail to adequately consider the role that gene patents and patents on similar biomolecules play in facilitating investment in the costly and risky developmental processes required to transform the underlying inventions into marketable products. Accordingly, a more precisely refined solution is advisable. This Note proposes a narrowly tailored set of solutions to address the concerns about gene patents without destroying the incentives for companies to create and commercialize inventions derived from these and similar patents.

INTRODUCTION

Gene patents (1) have always been controversial. Some commentators object to gene patents on the ground that genes and the human genome are "the common heritage and inheritance of mankind." (2) Others object to gene patents because of ethical considerations, arguing that gene patents restrict patient access to genetic diagnostic tests developed using patented genes. (3) Still others object to gene patents on the ground that they potentially impede foundational research rather than stimulate innovation. (4)

These collective concerns have engendered overreactions exemplified by a 2010 case in the Southern District of New York, Association for Molecular Pathology v. U.S. Patent and Trademark Office (Myriad I), (5) which held that "[b]ecause ... isolated DNA is not markedly different from native DNA as it exists in nature, it constitutes unpatentable subject matter under 35 U.S.C. [section] 101." (6) Similarly, the U.S. government has taken a position against the patentability of isolated DNA, at least in the context of a genomic DNA sequence. (7) Other responses, though less extreme, have still been excessive. For example, a 2010 report on the impact of gene patents by the Secretary's Advisory Committee on Genetics, Health, and Society (SACGHS) for the Department of Health and Human Services (8) suggests the creation of broad exemptions from liability for anyone who infringes gene patents "while making, using, ordering, offering for sale, or selling a genetic test for patient care purposes" or while "us[ing] patent-protected genes in the pursuit of research." (9)

The problem with these responses is that they fail to adequately consider the role that gene patents and patents on similar biomolecules play in facilitating investment in the costly, lengthy, and risky developmental processes required to transform the underlying biological discoveries and inventions into marketable products. (10) Because the patent system provides the incentive for translating basic research into marketable products in this context, a more precisely refined solution is advisable. (11)

Part I of this Note provides background information on the underlying biology of genes and the appeal of gene patents, summarizes the objectives and patentability requirements of the U.S. patent system, explains how those requirements have been applied to gene patents, and discusses the alleged problems created by gene patents. Part II describes and critiques two noteworthy responses to those problems: the Myriad case--including the response of the U.S. government to that case--and the SACGHS gene-patent report. Finally, Part III proposes a narrowly tailored set of solutions to address the concerns about patients and innovation without destroying the incentives required to create and commercialize inventions derived from gene patents. …

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

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
Notes
Cite this article

Cited article

Style
Citations are available only to our active members.
Buy instant access to cite pages or passages in MLA 8, MLA 7, APA and Chicago citation styles.

(Einhorn, 1992, p. 25)

(Einhorn 25)

(Einhorn 25)

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

Note: primary sources have slightly different requirements for citation. Please see these guidelines for more information.

Cited article

DNA as Patentable Subject Matter and a Narrow Framework for Addressing the Perceived Problems Caused by Gene Patents
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?

Help
Full screen
Items saved from this article
  • Highlights & Notes
  • Citations
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.”

matching results for page

    Questia reader help

    How to highlight and cite specific passages

    1. Click or tap the first word you want to select.
    2. Click or tap the last word you want to select, and you’ll see everything in between get selected.
    3. You’ll then get a menu of options like creating a highlight or a citation from that passage of text.

    OK, got it!

    Cited passage

    Style
    Citations are available only to our active members.
    Buy instant access to cite pages or passages in MLA 8, MLA 7, 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." (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

    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.

    Buy instant access to save your work.

    Already a member? Log in now.

    Search by... Author
    Show... All Results Primary Sources Peer-reviewed

    Oops!

    An unknown error has occurred. Please click the button below to reload the page. If the problem persists, please try again in a little while.