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investorgold2002

05/15/11 6:22 PM

#120040 RE: DewDiligence #120028

"r should a company develop a regular biologic (via the BLA pathway), and thereby avoid disclosing IP to competitors? "


hmmm...I guess i don't understand this well enough. Wouldn't innovator companies patent both product and processes for making em when they file for new drug ? so they are disclosing IP to competitors, but obviously there is 20 year lock period where no one can infringe on it. But after 20 years, anybody can make the same drug using details in the patent.

In the case of biosimilar , obviously your IP would be around

1. characterization
2. process/quality control

the above discovery is patentable because it is every bit Novel , so should those claims infringe there should be legal recourse.