Patent to be broken on Genzyme drug?

Fabrazyme

While Genzyme may be dealing with a take-over bid from Sanofi-Aventis, they are now facing pressure from a petition from patients who want the US federal government to abrogate the exclusive patent rights held by the biotechnology company.

The three patients reportedly have a rare genetic disease known as Fabry disease, which is an an inherited enzyme deficiency that can cause heart and kidney problems, as well as pain and other symptoms.

Genzyme has a drug used in the treatment of the disease called Fabrazyme, but due to manufacturing problems the company has not been able to produce enough of the drug. As such, 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.

It is because of this that the patients have petitioned the Department of Health and Human Services to exercise the government's so-called "march-in'' rights, so as to force the patents covering Fabrazyme to be licensed to other manufacturers in order to help alleviate the shortage.

"Unreasonable and improper"

According to the petition, "it is unreasonable, improper and even catastrophic to limit patient access to a drug where such a limitation causes morbidity and death."

"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.

In response to the petition, Genzyme has said that it was attempt to sort its manufacturing problems and that supplies of Fabrazyme would be increased in the last quarter of 2011.

It is not known how the reported takeover of Genzyme by Sanofi-Aventis will affect the drug's porduction. Currently, it's rumoured that the pharmaceutical giant is willing to pay $19 billion for the biotech company. The two companies are in negotiations, and it is expected that it will take some time before Genzyme and Sanofi reach an agreement on price.

Until then, the patients will have to wait for a result but 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... which is when Genzyme said they'll be ready for an increase in production anyway.

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