[Ip-health] Ed Silverman in Pharmalot on Fabrazyme March-In Request

James Love james.love at keionline.org
Thu Aug 5 03:41:37 PDT 2010


* "The intended beneficiaries of the government funds (Fabry victims)
are ‘marching in’ because they have been physically harmed," their
lawyer, Allen Black, who is working with the Knowledge Ecology
International advocacy group, tells us. "Also, the march-in is in
response to a massive drug shortage which has never occurred before. The
obvious practical solution is to let others step in to make up the
deficit. To my knowledge no manufacturer of a public invention has
actually had to ration access to drugs. Consequently, this is the exact
situation that the Bayh-Dole act contemplates where ‘a licensee cannot
reasonably meet the public health and safety needs of the public.’
Moreover, Genzyme is under an FDA consent decree for $175 million. It is
possible that they may be tempted to make up the lost profits by raising
the drug price due to the sort supply. In other words the patent could
be used to undermine the FDA sanctions. If there was a second source,
this behavior would be deterred." 

http://www.pharmalot.com/2010/08/patients-ask-hhs-to-break-patent-on-genzyme-drug/

Patients Seek To Break Patent On Genzyme Drug
By Ed Silverman // August 3rd, 2010 // 8:10 am

Frustrated by the ongoing shortage of Genzyme’s Fabrazyme medication for
Fabry’s disease, three patients have petitioned the US Department of
Health and Human Services to override the use patents held by the
troubled biotech. Their hope is to find a way to produce the drug, which
is the only such treatment currently available for a rare, inherited
disorder that causes kidney and heart problems.

The move comes after a year of turmoil at Genzyme, which recently agreed
to pay $175 million as part of a consent decree for a raft of
manufacturing problems, including viral contamination and even bits of
trash found in some products. The gaffes prompted outrage from some
large investors, a proxy fight by Carl Icahn and helped set the stage
for the takeover bid by Sanofi-Aventis (background here, here, here and
here).

For patients, however, the manufacturing ills have been a disaster as
Genzyme rationed supplies of Fabrazyme to the point where patients are
receiving about one-third of their usual dosing, some are experiencing
increased pain and no newly diagnosed patients can receive Fabrazyme.
Meanwhile, Shire Pharmaceuticals is trying to obtain FDA approval of its
own drug, Replagal, which is available in Europe and in the US on an
experimental basis, but there are shortages of this med, too. Although
Genzyme has stated supplies should pick up later this year, there is no
certainty. And so, Joseph Carik of Nevada, and Anita Hochendoner and
Anita Bova, both of Pennsylvania, want HHS approval on an expedited
basis using a so-called ‘march-in right’ (read the petition). Their hope
is that securing rights will attract a partner interested in grabbing a
chunk of a $400 million market and provide a backstop in the event
Genzyme continues to fall down on the job.

They contend HHS can override the patents because the National
Institutes of Health paid for research at the Mount Sinai School of
Medicine, which exclusively licensed Fabrazyme to Genzyme. Three
previous ‘march-in’ attempts, however, have failed, suggesting the odds
may be slim the HHS will intervene in this case. Their lawyer, though,
says the circumstances were different. In two cases, manufacturers
raised prices, making their drugs unaffordable for many patients. In
another case, a dispute centered on commercializing stem cell
technology.

"Our case is different for two reasons. The intended beneficiaries of
the government funds (Fabry victims) are ‘marching in’ because they have
been physically harmed," their lawyer, Allen Black, who is working with
the Knowledge Ecology International advocacy group, tells us. "Also, the
march-in is in response to a massive drug shortage which has never
occurred before. The obvious practical solution is to let others step in
to make up the deficit. To my knowledge no manufacturer of a public
invention has actually had to ration access to drugs. Consequently, this
is the exact situation that the Bayh-Dole act contemplates where ‘a
licensee cannot reasonably meet the public health and safety needs of
the public.’ Moreover, Genzyme is under an FDA consent decree for $175
million. It is possible that they may be tempted to make up the lost
profits by raising the drug price due to the sort supply. In other words
the patent could be used to undermine the FDA sanctions. If there was a
second source, this behavior would be deterred." Is this a worthy idea?
Or an untenable goal? What do you think?
-- 
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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