Genzyme manufacturing woes yield patent threat

Of the many financial ramifications of drug manufacturing negligence--plant and process retooling, FDA fines, product and inventory seizure, consultant fees, shareholder and consumer suits, brand erosion and lost market share--Genzyme now faces one at the very foundation of the pharma industry: loss of patent protection. Fabry disease sufferers are trying to overthrow the company's patent rights to Fabrazyme, currently the only approved treatment in the U.S. for the genetic enzyme deficiency, reports the New York Times.

Fabrazyme is among Genzyme drugs manufactured at the company's Allston Landing facility outside of Boston, still being retooled under an FDA consent decree after an operational meltdown. Fabry patients have had their supplies rationed during the resulting shortage of the drug. Some of these patients, who say the shortage has caused them physical suffering, are attempting to rectify the demand/supply imbalance.

They have asked HHS to direct that Fabrazyme patents be licensed to other drugmakers. Their petition is based on a provision in the Bayh-Dole Act that addresses the case of a licensee unable to meet public health needs, says Pharmalot. It proposes that that Genzyme be paid a five percent royalty on sales by the other manufacturers.

Shire makes a Fabry disease treatment too: Replagal, approved in Europe but not the U.S. But it can be of little aid in any case thanks to its own supply shortage.

The patent-protection issue overshadows a more practical one here, which is whether any drugmaker could ramp up production based on the existing Genzyme patent faster than Genzyme can get its house in order and raise supply levels to meet demand. The company says it hopes to boost supplies before end of year.

- see the Times article
- here's more from Pharmalot
- read the petition