It was “not persuaded” that a skilled artisan would apply the overlapping pH ranges taught in the prior art of naloxone and naltrexone because none of the “prior art teaches the use of methylnaltrexone in any form.” Appx27-28.
Finally, the district court discounted Mylan’s prior art because none of it expressly linked pH optimization to long-term stability.
The district court also concluded that the stability realized by Claim 8 was not predictable because none of the prior art explicitly linked pH to stability in methylnaltrexone, naltrexone, or naloxone.
It may be correct that, as Plaintiffs contend, none of the prior art cited by Defendants discloses a pharmaceutical solution that is stable for 24 months at about room temperature.
) Defendants then cite to a number of pieces of evidence, none of which supports the assertion.
... buffer, however, appeared to increase somewhat the amount of metbylnaltrex(cid:173) one degradation products, although not to unacceptable lev- 30 els, resulting in Jess than 1.3 9% of degradation products at pH of3.6. Nonetheless, ...
... release, and any combination thereof, etc. The particle may include, in addition to the therapeutic agent(s), any of those materials routinely used in the art of pharmacy and medicine, includiog, but not limited to, erodible, nonerodJole, ...