[Ip-health] Bloomberg: Patients Ask Government to Open Genzyme’s Fabrazyme Patents

James Love james.love at keionline.org
Thu Aug 5 03:00:24 PDT 2010


Patients Ask Government to Open Genzyme’s Fabrazyme Patents
August 5, 2010, Victoria Slind-Flor, Bloomberg

A group of patients with a rare enzyme disorder have asked the
Department of Health and Human Services to break Genzyme Corp.’s
exclusive license to the patent for the drug that treats their illness.

The patient group, represented by C. Allen Black Jr., of Allison Park,
Pennsylvania, said Genzyme’s Fabrazyme is the only effective treatment
for Fabry disease. They submitted their petition to the government Aug.

Their disorder, the result of a genetic defect, leaves patients missing
an enzyme needed to metabolize fats properly and leads to kidney failure
and degenerative heart disease. The disease affects 1 in 40,000 to
60,000 males, and, less frequently, females, according to the National
Institutes of Health. Untreated, most patients with the disease don’t
live past the age of 50.

Genzyme, based in Cambridge, Massachusetts, and the world’s largest
maker of enzyme-replacement therapies, began rationing Fabrazyme after
production was cut following the discovery in June 2009 that the plant
where the drug was produced was contaminated with a virus. Then in
November contaminants were found in a batch of Genzyme’s Fabrazyme.
Genzyme is still unable to meet the demand for the drug, and members of
the patient group say their dosage has been cut by 70 percent, leaving
them with a return of symptoms and risk of cardiac and renal failure.

In June, the company said in a regulatory filing that it couldn’t
produce enough Fabrazyme to meet demand for the next three months. The
company agreed to pay $1.75 million to the U.S. government for
manufacturing violations at the plant, and must have special government
oversight of its manufacturing process for seven years, according to the

The patient group asked that Genzyme’s exclusive license to patents
5,356,804 and 5,560,757 be opened so that “responsible entities” could
use the technology to make, import, export and sell the drug. Under a
provision of the 1980 Bayh-Dole Act that permits entities whose research
is funded with federal dollars to retain title to inventions stemming
from that research, the patients are asking that additional licenses be

“If we are able to interest manufacturers, we can end or lessen the
shortage,” Black said in an e-mail. In the event Genzyme rectifies its
problem, a backup supplier is needed so that if the company runs into
trouble again, “there is still a drug source for patients.”

According to the database of the U.S. Patent and Trademark Office, the
two patents were issued to the Mt. Sinai School of Medicine of the City
University of New York.

Genzyme didn’t immediately respond to an e-mailed request for comment.
In a June 29 regulatory filing, the company said it would have a
shortage of the drug through September, making Fabrazyme unavailable “in
many regions.” The company said it expected the available supply of the
drug “will increase later in the year.”

The Massachusetts company has begun takeover talks with Sanofi-Aventis
James Love, Director, Knowledge Ecology International
http://www.keionline.org | http://www.twitter.com/jamie_love
Wk: +1.202.332.2670 | US Mobile +1.202.361.3040 | Geneva Mobile +41.76.413.6584

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