E-DRUG: NYT: Patients Want Patent Broken on Genzyme Drug
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http://prescriptions.blogs.nytimes.com/2010/08/02/patients-want-patent-broken-on-genzyme-drug
August 2, 2010, 4:37 pm
Patients Want Patent Broken on Genzyme Drug
By ANDREW POLLACK
Updated: Three patients with a rare genetic disease are asking the
federal government to abrogate the exclusive patent rights held by the
biotechnology company Genzyme on the only drug now approved to treat the
illness.
Because of manufacturing problems, Genzyme has not been able to produce
enough of the drug, called Fabrazyme. The drug is used to treat Fabry
disease, an inherited enzyme deficiency that can cause heart and kidney
problems, as well as pain and other symptoms.
Fabry patients have been getting only about one third of their usual
dose and many say they are experiencing increased pain, gastrointestinal
problems and other symptoms. At least one patient might have died from
heart problems exacerbated by the drug shortage.
In their petition, the patients urge the Department of Health and Human
Services to exercise the government’s so-called “march-in’’ rights to
force the patents covering Fabrazyme to be licensed to other
manufacturers to help alleviate the shortage.
The government has such a right, the petition says, because the National
Institutes of Health financed the research at the Mount Sinai School of
Medicine in New York that led to the drug’s development. Mt. Sinai gave
an exclusive license to Genzyme.
“It is unreasonable, improper and even catastrophic to limit patient
access to a drug where such a limitation causes morbidity and death,’’
the petition states. “Limiting access instead of encouraging others to
make up the shortfall in manufacturing is the worse conceivable public
health solution to supply shortages of publicly funded inventions.’’
The petition proposes that Genzyme be paid a 5 percent royalty on sales
by the other manufacturers. Bo Piela, a spokesman for Genzyme, said the
company could not comment immediately since it was not aware of the
petition. But he said the company was making progress in fixing its
manufacturing problems and hoped to be increasing the supply of
Fabrazyme in the fourth quarter of this year. A new manufacturing plant
is expected to be in operation late next year to ensure adequate supply
of the drug, he said.
The petition was filed by Joseph M. Carik of North Las Vegas, Nevada,
his cousin, Anita Hochendoner of Pittsburgh and her daughter Anita Bova,
also of Pittsburgh. They are being represented by C. Allen Black, a
lawyer in Pittsburgh, with the support of Knowledge Ecology
International, a Washington advocacy group that has worked to limit
patent rights that it views as interfering with public health.
The request appears to be an uphill battle. According to the petition,
there have been three previous requests for march-in rights on other
drugs, and all were rejected.
But James Love, director of Knowledge Ecology International, said that
in two other cases – involving human embryonic stem cells and a
technique for making flu vaccines — federal pressure led to more liberal
patent licensing without need to resort to use of march-in rights.
Another question is whether granting such rights would even help
alleviate the shortage. Given the time it takes to develop and test a
drug, it is unlikely another supplier of Fabrazyme could be ready by
late next year, when Genzyme says it will have a new factory in
operation.
A nearer term alternative is Shire’s drug Replagal, which has long been
approved in Europe to treat Fabry disease. Shire is trying to get
approval in the United States. In the meantime, given the shortage of
Fabrazyme, American patients have been able to get Replagal on an
experimental basis.
But now Shire’s supply is strained as well, so it is no longer accepting
new patients in the United States.
The shortage of Fabrazyme as well as of Cerezyme, a drug for another
rare illness called Gaucher disease, have hurt Genzyme’s earnings and
stock price, leaving it vulnerable to being taken over. Sanofi-Aventis
is said to be preparing a bid.
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For more on this March in Request case, see: http://www.keionline.org/fabrazyme
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Judit Rius Sanjuan
Attorney
Knowledge Ecology International (KEI)
www.keionline.org
NYC Phone: 212 222 5180
Washington DC Phone: 202 332 2670