The amount of legal complexity for little MNTA continues to amaze me. Reading the comments prior to reading the brief about being being premature and an abuse of Hatch-Waxman and desperation by Teva are all likely true but I'd call this a preemptive "hail mary" strike by Teva.
Essentially, this is a suit against all Copaxone ANDA filers (so now we know who they all are) Dr Reddy, Sandoz/Momenta, Mylan, Synthon, Pfizer, Amneal, Biocon, and Apotex.
The suit claims all are infringers on the '874 patent (aka the fifth patent, the other four have been invalidated by the USPTO via IPR and are awaiting a District Court ruling confirming - expected 1Q17).
Teva is asking he court to: 1) judge the '874 patent is valid and enforceable, 2) award all fees and expenses to Teva.
Also, there are specific provisions against each company, which are essentially similar but I will only focus on Sandoz/MNTA.
1) judgement that Sandoz/MNTA's ANDA submission was a violation of the patent and that making, distributing, selling, etc. is an infringement. (This claim alone appears to be in direct violation of HW safe harbor.)
2) judgement that FDA can't approve until after '874 patent expiration.
3) judgement that Sandoz/MNTA can't make, market, sell etc. until after patent expiration.
4) judgement can't even seek approval until after '874 expiration.
5) Award unknown expenses and damages to Teva.
Essentially, Teva is launching a pre-emptive strike against all comers in Copaxone, but it's basically abusing if not outright violating, or rather asking the court to violate the Hatch-Waxman "safe harbor" provision. For that reason alone the court should throw out the lawsuit.
However, given the complexity of HW "safe harbor" and the previous abuse with Lovenox (ironically, in the opposite way) a judge unfamiliar in the technicalities of "safe harbor" may mess it up and cause a huge delay in rectifying. (Just as in Lovenox Amphastar.)
Since CW has already said that '874 has been designed around and the other four patents are awaiting adjudication and possibly may include the fifth patent this may become a non-issue for MNTA. (But if this isn't thrown out this could take a while to prove and potentially expose MNTA IP while delaying launch, but may also create a case for MNTA to counter sue Teva for damages.)
IMO the judge should throw out the case out because Teva is asking the court to violate HW safe harbor provision, is premature in filing, and is abusing the court system.
AI
