“F2O Prosecution”

Have you identified a pending third party patent application which threatens to derail an important new product launch?  Perhaps we can help twice over, negating the legal threat of infringement while also increasing your market share.  We call this “F2O Prosecution” because it fills two goals at once – providing freedom to operate viz the pending third party application, while at the same time protecting your own market share as good quality prosecution should do.  While not easy to execute, the results can be impressive.  Here’s an example:

Donepezil hydrochloride API is unstable.  This limits finished dosage form stability and impacts product distribution.

Responding to this need, USV, Ltd., a leading bulk API manufacturer, developed a more-stable polymorph for this API.  To protect this new product, USV filed WO 2006/011154.  The appurtenant search report, however, revealed troubling news: Dr. Reddy’s Laboratories, another leading bulk API manufacturer, had also found this more-stable polymorph – and filed a patent application 15 months before USV.  News of DRL’s earlier patent application (US 2004 / 00229914) was troubling for two reasons: it implied that USV could not get a patent, and it raised the risk that DRL might get a patent blocking USV’s product from the market entirely. 

USV asked us to help.  In response, we designed and successfully executed a strategy which won USV a patent, and did so quickly, while the earlier-filed DRL application languished in the Patent Office.  Further, we assured that USV’s patent preempted DRL’s planned product.

The upshot: we overcame a 15 month filing date disadvantage to win a patent which both negated a threat of infringement liability and blocked a formidable competitor’s planned product.  This is what we call “F2O Prosecution”: two benefits in one.

To find out how we may help you overcome third-party applications, Contact Us.