I hope you're right, though one wonders why Momenta hasn't sued the FDA for just such a disclosure, in that case. Cuz the FDA sure did spoonfeed another applicant wrt enoxaparin in spite of this:
Clearly, it's arbitrary, and it's the FDA's call, and we know how they made it.
And the reason may be that the FDA nor anyone else has any other method of testing these complex mixtures.
Given that, what's to stop them from making the same call again? They did this once and didn't get sued for the disclosure, after all. Presumably, Momenta didn't sue for fear of poisoning their relations with the FDA. So if m-Copax is approved and others are allowed to copycat, because FDA has only one one way to test, and since they're covered by safe harbor other generic entrants swiftly follow, does Momenta still refrain from suing the FDA for the disclosure? Does Momenta think "Hey, we can't sue cuz they might get sticky on biosimilars if we do?"
Perhaps FDA disclosed no trade secrets, only patented methods.
If process patents can be copied under safe harbor for commercial purposes, then trade secrets are the only way to fly. Then presumably the FDA could say to other applicants "OK send us your stuff, we'll test it, and say yea or nay without saying how we arrived at our conclusion, and you're just going to have to accept it."
The problem for Momenta is that so much of their IP is protected by process patents versus trade secrets. This seems to include Copaxone:
Now that they've seen the way the legal wind is blowing, they can adjust, but those adjustments only apply to stuff deep in the pipeline. Perhaps the biosimilars.
Bottom line, when you're talking about generics that are almost as expensive to develop as innovator drugs, and relatively expensive to manufacture, the legal protections for "generic innovators" must be stronger than they are.
Something the SG clearly does not get.
If I'm Momenta, I am working furiously on trade secrets for Copaxone manufacturing and testing, and amending the ANDA to replace the patented methods with trade secrets. Quite a challenge.
I am in the same camp as you are. I think generic Lovenox approval was precedence setting case, there are many implications all parties have to think through how to deal with similar situation in the future.
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