Gene Patent: For Mankind's Good, or For Profit?
Groundbreaking suit raises issues
By Mary Kugler, BSN, RN,C
About.com Guide to Rare/Orphan Diseases
The Suit
A lawsuit was filed in Federal District Court in Chicago
on October 30, 2000, against Miami Children’s Hospital and
Dr. Reuben Matalon on behalf of families afflicted with Canavan disease,
the Canavan
Foundation, Dor Yeshorim, and the National Tay-Sachs and
Allied Diseases Association (NTSAD).
The six-count lawsuit, the first of its kind, alleges breach of
informed consent, breach of fiduciary duty, unjust enrichment,
fraudulent concealment, conversion, and misappropriation of trade
secrets.
The Story
Your baby, at three months old, is having trouble
holding his head up. He doesn’t look at you like he used to,
or put toys to his mouth any more. None of the specialists you
see can tell you what’s wrong, until finally a geneticist
spells it out: your child has Canavan disease, a rare genetic
disorder that causes degeneration of the brain. There is no cure.
Your child will lose functions over time, and probably won’t
live to be a teenager.
This is the sad news Dan Greenberg and his wife learned when their son Jonathan was 9 months old. Not only was there no treatment for Jonathan, there was no prenatal testing available to help the Greenbergs have other healthy children. They risked another pregnancy and had a daughter, Amy, who unfortunately also had Canavan disease.
The Greenbergs were moved to help find a means of carrier and prenatal testing. Like Tay-Sachs disease, Canavan disease occurs most frequently in Ashkenazi (European) Jewish families. The Greenbergs founded the Chicago chapter of the NTSAD. They met a researcher name Dr. Reuben Matalon, whom they convinced to focus his work on Canavan disease, in particular isolating the gene for the disease.
The Greenbergs provided Dr. Matalon with numerous blood, urine, and tissue samples from their children, and convinced other affected families to do the same. They started a registry to keep track of the families and samples. They enlisted the help of Dor Yeshorim, a non-profit organization that provides carrier screening and counseling for Jews, as well as the assistance of the Canavan Foundation.
Dr. Matalon’s team at Miami Children’s Hospital (MCH) was able to identify the gene for Canavan disease in 1993. The Canavan Foundation and Dor Yeshorim began to offer free screenings. However, unbeknownst to these organizations or to the Greenbergs, Dr. Matalon and MCH obtained a patent in 1997 for the gene and related applications, including carrier and related testing.
The Complaint
The suit states that MCH is now limiting the number of
labs that can offer the screening test and is requiring those
labs to pay fees for a license. Based on the patent, too, a
doctor cannot test for Canavan disease using traditional genetic
screening even though that testing would not use any method
invented by MCH. Dor Yeshorim has stated that the royalties for
the Canavan test may force it to drop the test from its screening
program.
Therefore, the Canavan families and organizations are seeking injunctive relief to prevent MCH from restricting access to Canavan testing and to any future research on the disease.
What is your opinion about this suit? Participate in our poll on this site about the ethics of patenting, and selling, gene information.
Information for this article was taken from:
Sherrid, Pamela. Can patents harm patients? U.S. News &
World Report, January 8, 2001.
Canavan Foundation. Canavan Foundation joins lawsuit against
Miami Children’s Hospital. Online at www.canavanfoundation.org/news/miamihospital.html
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