Thursday, January 22, 2009

FDA Regulated Health Claims vs. Patent Claims

Someone asked me today if the patent they want to prepare on a health care product can make health claims without getting into trouble with the FDA. Since FDA rules restrict health "claims," it's easy to think there is some relation to patent claims as well. But these are unrelated issues. FDA rules on health claims have no impact on what's in a patent. People can make or discuss all sorts of benefits. The "claims" in a patent, of course, refer only to the list of statements at the end that specifically describe the invention with limitations that should keep each claim away from the prior art. They aren't designed to be claims about the benefits of a product or method. However, the claims of a patent may make or imply health claims, such as "a wipe effective in preventing bacterial growth on the skin of a user, comprising....") - even though you may not be able to say that in advertising or on packaging without going through incredible expense to meet regulatory demands.

What people often do in a patent is mention that the product may contain known actives effective against a list of targeted conditions, with a list of possible actives, and may describe numerous uses such as preventing halitosis, cancer, etc. Sky is the limit about what you can say about your product. You don't want to destroy credibility or be outlandish, and you don't want to imply that the claimed invention necessarily has (i.e., must have) those benefits, because then a similar product that didn't have those benefits might arguably fall outside the scope of the claims. Always be wary of making definitive statements that could let a judge import unintended limitations into a claim.

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