[Ip-health] KEI asks FTC to investigate Shire decision to abandon efforts to compete in US market for Fabry’s disease treatments

Jamie Love james.love at keionline.org
Tue Jul 15 04:48:27 PDT 2014


KEI asks FTC to investigate Shire decision to abandon efforts to compete in
US market for Fabry’s disease treatments

Submitted by James Love
July 15, 2014

Knowledge Ecology International (KEI) asks the FTC to investigate Shire
decision to abandon efforts to compete in US market for Fabry’s disease
treatments. Letter to FTC provides evidence of possible conspiracy to
segment markets, involving licensing of an NIH funded invention for use in
Europe, in return for abandoning efforts to enter US market.

For More Information:

James Love, Knowledge Ecology International
Email: james.love at keionline.org
Tel +1.202.332.2670
Cell +1.202.361.3040

On Tuesday, July 15, 2014, Knowledge Ecology International (KEI) asked the
United States Federal Trade Commission (FTC) to investigate the decision by
Shire PLC in 2012 to withdraw an application to the US FDA for marketing
approval for Replagal, a treatment for Fabry’s disease.

KEI’s request is included in a six-page letter accompanied by an
eleven-page timeline of events regarding the development of two competing
treatments for Fabry’s disease, Fabrazyme, marketed by Genzyme, now a
subsidiary of Sanofi, and Replagal, now marketed by Shire. Both products
were initially developed with support from the NIH by U.S. biotechnology

The KEI complaint focuses on events that took place between 2009 and 2012,
during the time when Genzyme’s Orphan Drug market exclusivity was ending in
the United States, and Genzyme was experiencing several manufacturing
problems, causing the company to lose global market share for Fabrazyme to
Shire’s Replagal.

Mount Sinai School of Medicine, recently renamed the Icahn School of
Medicine at Mount Sinai, was simultaneously aggressively pursuing patent
infringement actions in Europe against Shire, and facing a compulsory
licensing request in the United States and Germany, for an invention that
had been funded by the NIH. The Mount Sinai patent was subject to Bayh-Dole
Act march-in provisions as well as an NIH royalty free right to use the
patent worldwide.

During the same period, Carl Icahn, a trustee of Mount Sinai, was
controlling 4.9 percent of the shares of Genzyme, and his 2010 proxy battle
for Genzyme played a role in the 2011 sale of Genzyme to Sanofi.

In March 2012, Shire withdrew its application to the FDA to market Replagal
in the United States, even though the Genzyme Orphan Drug exclusivity had
expired, and Shire was already providing Replagal to roughly 20 percent of
U.S Fabry patients, under an FDA approved initiative to address shortages
of Fabrazyme in the United States. At the time, speculation in the United
States centered on regulatory barriers that Shire faced for a new BLA
approval. The KEI letter to the FTC focuses on a different issue: the use
of a European license to an NIH funded patent to induce Shire to withdraw
from the U.S. market.

Earlier a US Court ruled that Replagal did not infringe the Mount Sinai
patent. But in 2010 a German court ruled the opposite, creating a situation
where Mount Sinai could block competition in Europe, but not the United

In May 2012, following the Shire decision to abandon efforts to compete in
the United States, Mount Sinai granted Shire the right to practice an NIH
funded patent for Fabry’s treatment, in Europe.

KEI’s complaint asks the FTC to determine if the March 2012 withdrawal of
the US FDA application to sell Replagal was part of an agreement to segment
markets globally, to the disadvantage of U.S. patients and taxpayers.

All documents will be available at:


James Love.  Knowledge Ecology International
http://www.keionline.org, KEI DC tel: +1.202.332.2670, US Mobile:
+1.202.361.3040, Geneva Mobile: +41.76.413.6584,   twitter.com/jamie_love

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