Clearly, there’s a tradeoff here. Patenting a manufacturing process may have value, but no company wants to show its competitors any more that it has to.
Can somebody point me to the IP that protects the Coca Cola manufacturing process?
what do u think of trade-offs of patenting characterization & process control which Momenta does versus not sharing that info ?
can it hold ?
in the case of Lovenox did publicly disclose(via CP response) the criteria and to some extent methods used in characterization. obviously disclosure was not everything MNTA has in it's IP for heparin characterization..
Also ,I don't think the case of biologic would be different as I expect innovators to file CP's over there too...So FDA would disclose "characterization work" at the time it approves a generic just like how they did for generic lovenox
Also, Do you think ANDA package of say MNTA's approval ...eg: process control for lovenox, etc could be shared with any other company? or that is proprietary too ?
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