Just don’t read any further unless you’re deep in to pharmaceuticals.
 
For those who are still reading, every now and then there’s a case or two that we just can’t help but comment on.  The latest is the Navinta case decided a wee little while ago by the New Jersey District Court.  To summarize, unless this is overturned on appeal, polymorphs are now an even stronger weapon in the innovator patent armory, and generic companies the world over are or should be reviewing their non-infringement strategies very carefully indeed.
 
One of the interesting aspects of the case was the finding that you can’t assume complete dissociation of a compound in a solution – there’s every chance that the claimed polymorph/hydrate  may be still found in the solution which would therefore still infringe. In this case the court determined that the monohydrate always existed in solution and crystallization merely separates the monohydrate rather than contributing in its preparation.
 
The Court also made determinations on infringement of claims to pure enantiomers and the age-old issue of carve outs to avoid Method of Use claims.  To wit, it was held that the S enantiomer as claimed is one with more than 99 % purity.  Interestingly, the Court seems to have ignored a limitation of claim 1 (monohydrate) in the dependent claims.
 
According to this Court, carving out a patented lower strength from a PI leaflet is not alone sufficient to avoid infringement.  In this case, the generic label was not able to support the carve out and it was held that doctors would be likely to dilute and use the generic version of Naropin® in an infringing manner.
 
The Appellate decision in the Navinta case looks set to decide the fate of several current and future disputes.   Recently Schering Corp. (Merck and Co. Inc) sued Apotex for infringing three patents related to Nasonex nasal spray by submitting an ANDA for permission to market and distribute a generic version of Nasonex® .  One of these patents cover the monohydrate of mometasone furoate…

To round out the picture, in a slightly more expected vein (read completely expected) was the Eli Lilly V Actavis (Strattera case).  Here the court opined that there is an induced infringement by defendants as their label, albeit only to comply with an FDA requirement, prescribed the patented use (ADHD) which is the only on-label use.   The Court said that the label induces an infringing use.  (Which makes sense, right?)   The court detrmined that the test should be objective and even proven intentions take a back seat to the decision to move ahead with an infringing label.
 
Check out the court’s opinion and the comments from Patent Docs on the Navinta case and let us know what you think.

[Photo credit: jsrcyclist]