Friday, August 03, 2012 3:20:51 PM
MNTA's methods won't be so easy to copy if MNTA protects them as trade secrets instead of disclosing everything in patent filings.
Suggest this is largely untrue:
a) I think it is pretty obvious that Amphastar didn't figure out how to manufacture from the Momenta patents. See point #2.
b) Momenta will have difficulty getting approval without disclosing the secrets to the FDA - and the FDA will then build them into their requests to other filers. This is almost certainly how Amphastar ended up in the same place as Momenta - the FDA told them what they wanted, which was what Momenta did. So if there is someone even close to providing an adequate product then Momenta's advantage is largely lost unless they can shut down this communication path.
Separately - about 15 years ago I wrote an detailed paper on patent law. My personal conclusion after looking through many 10's of key decisions was that a very large percentage of patent decisions are idiotic - poorly founded (e.g. driven by agenda, clear in the decision that the judges had zero understanding of the technology, based purely on how it was presented instead of what was presented, ...) and therefore largely random. And that was significantly true even through the appellate level. But, interestingly, the Supreme Court typically makes more rational decisions. (Note: In this particular case I think it is dead obvious that the decision was made by agenda (a large number of judges, throughout US history, have thought 'ideas' shouldn't be 'owned') - e.g. the fact that in this case they never even looked at the legislative history.)
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