Fabrazyme March-In Request

NIH rejects Fabrazyme March-In Petition

For additional context

The Fabrazyme March-In

On August 2, 2010, Joseph M. Carik, Anita Hochendoner, and Anita Bova requested the Secretary of DHH to exercise Bayh-Dole march-in rights and grant an open license to use patents related to the manufacture of Fabrazyme® (agalsidase beta). The grounds for the request are that the patent owner and its exclusive licensee have harmed the public health by severely rationing the supply of agalsidase beta, the only approved therapeutic treatment for Fabry disease.

The lawyer for the petitioners is Alan Black. He has a web page on the complaint here.

As described in the petition to DHHS Secretary Kathleen Sebelius:

Joseph M. Carik, Anita Hochendoner, and Anita Bova are private individuals who have Fabry disease. They are prescribed Fabrazyme® to treat the disease, but they have not (and are not) receiving the prescribed dosage due the patentee’s and licensee’s inability to produce enough drug to treat all of the Fabry patients that have been prescribed Fabrazyme®. Their symptoms have worsened, and they are at greater risk of morbidity and death due to complications from the disease because of the severe and ongoing restriction in the supply of Fabrazyme®. Their position is identical to all Fabry patients because all patients are being rationed the drug by Genzyme.

Key Documents

Statement by KEI on Fabrazyme March-In Request:

“Persons who have Fabry's disease are at risk today because of legal barriers to the competitive supply of agalsidase beta, marketed by Genzyme under the tradename Fabrazyme at a price of roughly $700 per day, or more than $250,000 per year. The Obama Administration officials who have the responsibility of approve or reject this petition will set a standard for the degree to which the holders of a patent on an NIH funded invention can be held accountable, when there are abuses of the patent monopoly. The petitioners seek the freedom to obtain independent competitive suppliers for this medicine. Genzyme has already earned billions of dollars on Fabrazyme. The NIH needs to end the legal monopoly, and permit greater competition in the supply of agalsidase beta. This will not only enhance the supply of this medicine, but it will send a message that the NIH will not tolerate abuses of patent rights for government funded inventions. Taxapyers and employers who pay for this expensive drug will also likely benefit in the longer term, as competition is expected to result in lower prices." James Love, Director, KEI, 2 August 2010.

Reporting and commentary on the March-In Request

Reports on other aspects of the dispute

AttachmentSize
fabrazyme_cover_2aug2010.doc29 KB
fabrazyme_petition_2aug2010.doc412.5 KB
Fabrazyme_Press_Release_Aug_2.doc25.5 KB
francis_collins_rejection_fabrazyme_marchin_1dec2010.pdf531.48 KB
NIH2Black_3dec2010.pdf34.8 KB
PR2_7dec2010_Fabrazyme.doc34.5 KB
amsa_kei_pc_pirg_uaem_Fabrazyme_letter_27aug2010.pdf115.54 KB
nih2amber_britton_22oct2010.pdf48 KB