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'Add-on Patents': Innovation or Sham?

By Teresa J. Welch, Ph.D.

Some recent estimates suggest that by 2007 brand name pharmaceutical companies will lose more than $80 billion in drug sales because of patent term expirations. Patent term expirations, of course, usher the entry of generic drugs into the marketplace. On average, the market share for branded products decreases by 15% to 30% when a first generic version reaches the market, and as much as 75% to 90% when subsequent generics launch. Such significant losses provide incentive to extend patent life and maximize the period of market exclusivity for a patented drug.

One approach for brand name pharmaceutical companies is to develop so-called “add-on” patents to those for existing drugs. Add-on patents typically address different aspects or new uses of an existing drug. These add-ons are also referred to as “second-generation patents,” “secondary patents” or “late-filed patents.” Some critics refer to add-on patents as sham patents, claiming that they often address insignificant elements of a drug, having less to do with any improved patient benefits and more to do with maintaining profits.

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