SAN DIEGO

A NEW BILL aimed at simplifying patent law has generated significant support on Capitol Hill. The problem is that it takes the patent model for consumer products and tries to apply it to something quite different: pharmaceuticals.

One of the most difficult provisions in the bill would change how economic damages caused by patent infringement are calculated. Damages would factor in only the specific economic contribution the patented improvement made to a given product. The value of the product as a whole would not be considered.

From a consumer-goods perspective, this new rule may make sense. If a court finds that use of a particular hinge on a car’s flip-down mirror constitutes infringement, the patent-holder shouldn’t be awarded damages based on the value of the entire car. The car with a different mirror hinge is still the same car. Instead, damages for its inappropriate use should focus on the value of the hinge, not the full value of the entire car.

But medicines are completely different. One simply cannot differentiate between any added benefit associated with the particular portion of a patent associated with a drug. A drug or specific parts of the chemical compound can’t be broken down to constituent parts that can be valued as being 1, 5, 50, or 90 percent of the full value of the product. Pharmaceuticals just can’t be treated like they are Blackberrys, cars, or other consumer goods.

Pharmaceuticals are different for other reasons as well. Unlike a new type of camera-phone, for example, a new type of medicine must undergo rigorous, government-mandated testing before it can be marketed. This testing takes researchers over a decade and hundreds of million of dollars, on average. Only one in 5,000 compounds discovered during the expensive initial stages of basic research will ever reach the market. Of these, only one in three will recoup in sales the huge costs of development. The costs associated with this situation are unique to drugs.

In addition, contrary to consumer goods, potential drugs must be patented long before they are known to be able to weather testing to an actual product stage. Indeed, almost half of the term for the average drug patent is used up before the medicine hits the market. Though patents can extend for up to 20 years, the average innovator will have market exclusivity for only 12 years.

In combination with the type of testing, the challenge of limited patent life further makes valuation of medicines, and more precisely, any patent infringement, very difficult to do. Economic progress increasingly depends upon a constant stream of technological innovations. Creating appropriate incentives to ensure that valuation of patents and their violation is consistent with added value rather than the whole product is a laudable step with respect to items such as consumer goods. But applying this paradigm to drugs, which can’t be divvied up in that way and that have unique costs not faced in the rest of the consumer-product world, is wrong.

We need to ensure that patent reform takes the unique needs of pharmaceutical innovation into account before creating a system that stems the tide of lifesaving drugs for this and future generations.

Bryan A. Liang, M.D., is executive director of the Institute of Health Law Studies at California Western School of Law and the co-director of the San Diego Center for Patient Safety at the University of California at San Diego School of Medicine.