Should We Patent Human Genes? the Supreme Court Ponders the Intersection of Biology and Intellectual Property

By Bailey, Ronald | Reason, July 2013 | Go to article overview
Save to active project

Should We Patent Human Genes? the Supreme Court Ponders the Intersection of Biology and Intellectual Property


Bailey, Ronald, Reason


SHOULD HUMAN DNA be patentable? That's the central question in Association for Molecular Pathology v. Myriad Genetics, a case argued before the U.S. Supreme Court in April. The lawsuit was organized by the American Civil Liberties Union on behalf of several professional organizations that have long opposed such patents, which the U.S. Patent and Trademark Office has been granting since the 1980s.

Patent law is arcane, and arguments about it can sound a lot like squabbling over the number of angels that can dance on the head of a pin. But in this case, it affects tens of billions of dollars in research, products, and profits.

At issue are several patents related to two breast cancer genes, BRCA 1 and BRCA 2. In the 1990s, researchers at Myriad Genetics identified and isolated two genes in which certain mutations dramatically increase the risk of breast and ovarian cancer. The company then offered a product, called BRhCAnalysis, which compares patients' BRCA genetic sequences to the company's reference sequence to identify the mutations. Armed with the knowledge that they are at greater risk, patients can then engage in protective actions ranging from more frequent mammograms and ultrasound examinations to having their breasts and ovaries surgically removed.

The Supreme Court must decide if Myriad is merely using products that exist in nature (which cannot be patented) or if it has invented a "new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof" (which can).

Why do the plaintiffs want to invalidate human gene patents? As a matter of policy, mainly because they believe such patents impede rather than speed valuable research and development. The Association for Molecular Pathology, for example, cites estimates that "about 20 percent of the human genome is under patent" and argues that "scientific research has been delayed, limited or even shut down due to concerns about gene patents."

As a matter of law, the plaintiffs argue that a gene isolated by Myriad conveys the same genetic information as a gene found in a human body and that it thus "represents the same laws of nature as genomic DNA." Myriad, the ACLU concludes, "is in effect arguing that it may obtain a patent on a product or law of nature itself if it finds a new use for it."

In its brief, Myriad counters that no one would contest a patent on a new chemical that could be applied to a blood or tissue sample to detect a higher cancer risk. "That is what Myriad's patented molecules are," the company claims, "and they were never available to the world until Myriad's scientists applied their faculties to a previously undistinguished mass of genetic matter in order to identify, define, and create the isolated DNA molecules."

Who is right? It's illuminating to consider how the patent office applies the product-of-nature doctrine. In one training example, the office notes that exposure to sunlight is known to affect some people's moods. If someone tried to patent a method for treating seasonal affective disorder that involved exposing a patient to sunlight, the application would be rejected, since it "is no more than the law of nature plus telling people to 'apply it.'" Nor would the office issue a narrower patent on exposing the patient to a source of white light, since the sun is also a source of white light. But it would patent a treatment in which a patient is precisely positioned for a specified length of time near a white light source from which ultra-violet rays have been filtered.

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.
Loading One moment ...
Project items
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.

Cited article

Should We Patent Human Genes? the Supreme Court Ponders the Intersection of Biology and Intellectual Property
Settings

Settings

Typeface
Text size Smaller Larger
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?

While we understand printed pages are helpful to our users, this limitation is necessary to help protect our publishers' copyrighted material and prevent its unlawful distribution. We are sorry for any inconvenience.
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.

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.

Are you sure you want to delete this highlight?