| OBSERVATION'S |
The generic industry decries the maneuvers that lead to multiple automatic stays on FDA action. In many cases, pat-ents being added are based on modifications irrelevant to safety and efficacy--such as in a pill's shape or color. Sometimes, patents that should not be listed in the Orange Book--such as process patents--are listed anyway. Part of the problem is that FDA has no authority to evaluate patents; it simply lists them. And once a patent is listed, it cannot be unlisted, unless it's done voluntarily by the listing company. Nevertheless, flush with the success of GAAP, the generics industry is fired up to push for other changes. A spokesman for Co. points out, for example, that in any other industry, patent infringement cases require the plaintiff to post a bond to compensate the defendant for damages in case the plaintiff loses. The requirement deters frivolous lawsuits. But posting a bond is not required in the pharmaceutical industry, he says
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