Bruce, the FDA does not issue, neither enforce patents, they only approved a medication for use one way or another. The FDA can not stop a company that plan to produce and sell a product if they did approve the product, except for the generic version efficacy and safety (easier to prove cause Zona's work will be out there).
To swallow a pill has never been a patent, so no way they can patent the oral route.
Thay can have a patent on the actual formulation,or how to make the oral form. This makes sense for very complex molecules that need complex manufacturing like the work on insulin by DLVRY, and heparin by EMIS.
But, there are many ways of making oral forms of less complex molecules like phentolamine. Any company able to bypass Zonagen's formulation does not have to abide by their patents.
Phentolamine is very well known for erratic oral route absorption and poor oral bioavailability . If Zonagen found a very neat solution to this problem, and the solution is not obvious, and their way happens to be the only comercially viable alternative, then they do have a good chance of upholding their patent. Short of this scenario is a poor patent. I do not think this is the case. Time will tell.
Most companies that attempt to market generics will try after FDA approval and actual sales by Zona's, this makes their generic approach faster and cheaper.
It will be very nice to have actual information on Zona's scientific base for the patents, but Zonagen has never published anything aside of the pr releases. This is common practice eg Xoma, Amgn, Emis, Allp, Lgnd, and many others do published the basic knowledge on which their patents are based on and in great detail. |
