Replies to post #120042 on Biotech Values

[investorgold2002]

"Maufacturing processes for drugs are generally protected by trade secrets rather than patents."


i take your word for it. i guess in the CP's innovator always claim that if the product is manufactured using a different process, it may yield a different product (at least for complex drugs like lovenox)

"Note that the FDA’s Orange Book explicitly prohibits inclusion of process patents."

Is there a reason why FDA does this ? Are there drugs out there, where product patent has expired and no other generic company has been able to come forward to manufacture the drug because nobody knows the process to make em ?
I thought it would make sense to give protection and exclusivity if they disclose everything

[investorgold2002]

Dew - Why do u think this does not provide sufficient protection ???

for a biosimilar maker .

Read this in the context of Lovenox(i understand lovenox is approved using new drug pathway which is different from biologic)

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"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"
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Are you saying somebody can read this IP and get clues and come up with a different , non-infringing way of making biosimilar ?