The Gene Suit

May 21st, 2009 - 1 Comment

A patent lawsuit filed this month by the ACLU and the Public Patent Foundation at Benjamin N. Cardozo School of Law (PUBPAT) on behalf of scientific organizations, researchers, and individuals has garnered a great deal of attention due to its unusual approach and controversial subject matter.  According to an ACLU news release, the lawsuit charges that “patents on two human genes associated with breast and ovarian cancer stifle research that could lead to cures and limit women’s options regarding their medical care.”

Smeal’s Dan Cahoy, a patent lawyer and associate professor of business law, says the case appears to be a long shot, legally speaking, but that it could accelerate reform in intellectual property law.

Below, Cahoy explains the case and the legal arguments in greater detail:

If successful, this lawsuit would alter the balance between intellectual property ownership and public access.  At the very least, it serves to highlight aspects of our innovation system that many believe should be reformed.

The case involves patents owned or exclusively licensed by Myriad Genetics related to the gene fragments known as BRCA1 and BRCA2.  Screening tests for mutations in these genes can identify an increased risk of breast and ovarian cancer.  Because it is not possible to conduct the screening tests without infringing the patents, they have generated controversy since issuing.  Adding fuel to the fire is the fact that Myriad does not license the technology, but rather offers its own screening test for what some consider a premium price.  The ACLU/PUBPAT suit is merely the latest attempt to tame this limited monopoly.

One reason this dispute has evoked a strong emotional response outside of the intellectual property legal community is certainly the fact that some of the patent claims at issue cover fragments of human DNA.  Casual observers wonder, “How can you patent existing human genes?”  The legal explanation is that that DNA patents actually cover only the isolated, purified genetic material, which does not exist in nature.  This is the same rationale for granting a patent on a chemical compound or enzyme isolated from a plant.  But even with this explanation in mind, people are still skeptical; this case seeks to channel some of that discontent to foster a change in the rules permitting such patents.

A second reason for the visceral response is the fact that the BRCA-gene technology relates to the treatment of a significant medical condition—one that affects thousands of women—instead of, say, a can opener or computer chip.  The idea that a single company can control access to a potentially life-saving test through a common property right strikes many as improper and perhaps immoral.  On the other hand, some argue that the investment incentives provided by property rights are actually more important in essential medical technologies.  They take great exception to the notion that rights should be relaxed in cases like this.  This is part of a larger theme in intellectual property disputes, pitting long-term policy goals against emergent needs.

Apart from the controversial subject matter, the ACLU/PUBPAT lawsuit is also unusual in that it names the Patent and Trademark Office as a defendant and bases its argument in part on a civil rights claim: conflict with the First Amendment.  According to the complaint, the patents at issue prevent the production and dissemination of breast cancer information.  Only Myriad has the right to develop the information, and it retains proprietary control.  In general, property rights that incidentally restrict speech rights—such as ownership of a computer that offers access to a database—are not in violation of the First Amendment in and of themselves.  So this would appear to be a long shot as legal arguments go.  A victory on these grounds would definitely be striking.

In the end, it is possible that this case will spark a change in the law regarding human gene patents.  In fact, it has gotten progressively harder to patent genes, but for reasons different than advanced in this case.  However, it appears that the more important point of the lawsuit is to focus public attention on this particular patent monopoly.  As a result of public pressure, Myriad may be compelled to offer greater access to the technology through licensing.  Alternatively, perhaps the plaintiffs hope that the government officials will employ eminent domain powers to nationalize the invention (something that has actually occurred in past cases involving military technology). 

Whatever the outcome of this particular case, it’s yet another battle being fought over an innovation system that has been under attack for some time.  Intellectual property legal reform is a notoriously slow process, but this case may have pressed the accelerator down just a little bit more.

Tags: Business Law, Cahoy, Health Care

This entry was posted on Thursday, May 21st, 2009 at 8:27 am and is filed under News. You can follow any responses to this entry through the RSS 2.0 feed. Both comments and pings are currently closed.

One Response to “The Gene Suit”

1. Judge: No Gene Patents « Business Casual Blog says:

   March 31, 2010 at 11:20 am

   [...] year on this blog, Cahoy, a patent lawyer and associate professor of business law, outlined the case, saying that [...]