Momenta Pharmaceuticals, Inc. (MNTA)

[investorgold2002]

Speculation on Amphastar litigation

Assume judge finds the PI motion is granted based on the likelihood that Momenta would prevail in the trial, what are the odds of settlement before trial gets over.
Let's keep in mind, unlike generic going against innovator when there are couple of unexpired patents which may have another couple of years to go(Eg: Copaxone), here the remaining patent life is >18 years..So there is a lot at stake here. In the case of generic settlement generally is before patent expiry so it is labeled as pro-competitive and passes FTC stamp.(see below quotes from patent docs on settlement)

Assume, during discovery in PI it is found Amphastar infringes on Momenta's testing methods, I am speculating a settlement before trial if any could include many years(say 3-4 years) of delay for Amphastar. I guess even such a settlement between 2 generic companies where the 1st generic company's innovation is testing method to prove equivalence(Shea's words - we were the "path finder/path setter") would still be considered pro-competitive
because it is better than Amphastar waiting for next 18 years for MNTA's patent expiry before launching their generic. Essentially allowing 1 generic to be in extended duopoly with innovator....of course assuming TEVA does not enter

Since there is a lot at stake for both companies if they lose(potentially 18 years of lost revenue I think), I believe a settlement maybe the path forward esp if Amphastar is found to infringe on MNTA and resorts to just "obviousness" defense which IMO is a lottery for both parties. Would Amphastar be willing to fight it out on this defense and see through the trial and risk potential loss in the suit. Same with MNTA esp if the case could go either way. This would most definitely imply(assuming Amphastar loses) Amphastar's lovenox program was a complete waste of time...as in 18 years, lovenox is very likely to be surpassed by other oral ACS...and let's keep in mind Amphastar filed the ANDA in 2003

Also, during discovery, I am speculating, there is likelihood that Amphastar or it's suppliers possibly could be found infringing on other patents like Contamination OSCS QC patent or oxidation patent.

I also believe there is a strong case for expedited discovery based on FDA's published criteria and MNTA's patents. So I expect that motion to go in favor of MNTA.

So I am speculating that Amphastar and MNTA would both be willing to do a settlement like (3 or 4 year delay), esp if it is clear that Amphastar infringes on MNTA's patents during discovery and it's only resort is obviousness defense

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http://www.patentdocs.org/2011/10/generic-pharmaceutical-association-releases-report-on-value-of-pay-for-delay-agreements.html
BEGIN QUOTE
The Report characterizes such settlements as being "pro-consumer" due to the decrease in the time consumers must wait for a generic version of branded drugs involved in patent settlement agreements. "Over the past 10 years, patent settlements have enabled dozens of first-time generics to come to market many month before patents on the counterpart brand drugs expires," the Report asserts in support of this conclusion, citing the 16 of 22 new generic drugs expected to launch in 2011 that were the result of such settlements. The Report also cites a study by RBC Capital Markets, which "found that generic companies are successful, [and] thus able to market the generic product before patent expiration, in just 48 percent of cases, and that when factoring in settlements, generics are successful in bringing the generic product to market before patent expiration in 76 percent of cases." While recognizing (but not acknowledging the identities of "some who contend such generic-brand agreements are non-competitive," the Report declares that "[t]he record is clear: settlements allow generic drugs to come to market long before patents on the counterpart brands expire," and that this results in "billions of dollars in annual savings."
END QUOTE


My speculation read it FWIW:

1. Expedited motion of discovery - in favor of MNTA
2. PI - in favor of MNTA based on likelihood of infringement. Amphastar's arguments basically "obviousness" of those testing methods
3. Trial starts
4. The 2 parties feel considering what is at stake and considering 50-50 chance of winning, agree to a settlement which will delay Amphastar's launch by a few years (maybe 3-4 years?)
5. This could potentially mean another few 100's of millions for MNTA generic lovenox revenue