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April 10, 2011



This might be test case for when "march-in" rights under Bayh-Dole should be exercised. If I were Genzyme, I would be extremely nervous about this petition for rehearing being granted.

"Genzyme has since reported additional manufacturing errors at its Massachusetts plant that will further delay U.S. Fabry patients access to the drug. "

O M F G. Seriously? Someone over there needs to be fired already.

"Additionally, Genzyme announced that due to the loss, it would re-allocate drug away from American patients to overseas markets."

Are they fin joking?

"that Genzyme will de facto never be able to reliably supply Fabrazyme to meet patient needs."

No kidding, they appear to be incompetent.

"The petition also cites a conflict of interest, asking for (among others) NIH director Francis Collins to recuse himself from reviewing their petition because they maintain he has a financial interest in at least nineteen federally-funded inventions, which creates "at least the appearance of a conflict of interest.""

Good for them, they should probably ask that pretty much everyone at the NIH in a position of power recuse themselves and just let the janitor decide. And not even the head janitor. The new guy.

And EG, what possible reason should Genzyme have to be nervous? They're apparently never going to go and make money themselves, let someone who can go and do it.

This is very unfortunate situation. I can understand Fabry Patients are suffering a lot.

Well I am not on the side of Genzyme, but still it is very difficult to comment on situations at Genzyme without knowing the exact problem and what efforts they are making to rectify the problem.

Even though "March-in" rights under Bayh-Dole would be exercised, it is not sure when the shortage of Febrazyme could be restored. Because this is not a simple case of allowing other company to manufacture the drug. Lot many other problems like right sourcing of raw materials, transfer of “technical know-how” to the other company, technology transfer, set-up of customized manufacturing assembly, pilot batches, process validation, sterility validation, site approval by US FDA etc will definitely take a lots of time. Even if Genzyme will try to relocate its manufacturing site (as I heard that Genzyme is shifting some of the operations at Hospira), it will take additional time. One has to bare with it.

The only solution (to my understanding) could be –
Considering this as a primary important problem, everybody expert in the field has to support to Genzyme to get rid of the problem (Not for the financial benefit of Genzyme but for the shake of Fabry patients). Other expert pharma company or government agency should help them to come out and US FDA should review any submission / followup for Febrazyme on urgent basis.

Well, I could be wrong but these are my view. I may be totally overlooking Fabry patients’ conditions. Let me know if anybody has a different view.

This case could have significant future repercussions for patent litigation, in regard to Bayh-Dole, which could put Genzyme under legal obligation to provide a secondary manufacturing source. I hope you will keep us updated on its progress.

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