A recent change to U.S. patent law has made patents covering surgical procedures unenforceable against physicians and hospitals. Changes like this disturb me -- not only because they are made -- but in the way they are made.

Very few surgical procedure patents have been granted -- largely because (a) most surgeons never appreciated the fact that inventions relating specifically to surgical procedures could and should be patented and (b) commercial enterprises devoted to surgical R&D are few in number (if they exist at all). Patents covering drugs, instruments and equipment used in surgery are commonly obtained and enforced but these inventions are most often made in the laboratories of commercial organizations who sell such tangible goods.

If patents can be justified for the hardware and drugs used by surgeons to promote the progress of those useful arts, logically the same incentives should be available to inventors of purely surgical procedures. By looking at how our government works, you can understand how such logic is overcome. Here's how it was done.

First the amendment to the patent law was attached as a rider to the Omnibus Consolidated Appropriations For Fiscal Year 1997 (H.R. 3610). This tactic assured "...minimal consideration... at a time when Congress is [was] rushing to adjourn for the year..." (Congressman Fred Upton).

To the extent that resistance existed, it was reportedly overcome by the emotional argument that surgeons should not be prevented from using the best available procedures when faced with life and death situations.

That justification was largely trivialized by specifically excluding patents on drugs, machines, manufactures, uses of the foregoing and biotechnology processes -- all used by surgeons under the same circumstances. In other words, patents covering drugs, hardware or biotechnology processes useful to surgeons in life and death surgical procedures can be enforced against physicians and hospitals -- but not patents covering surgical procedures per se.

If you have a great enough economic stake in patents -- and an effective lobbying and financially-contributing presence in Washington -- your interests will be recognized and protected. Since no substantial privately-financed commercial organizations devoted specifically to surgical R&D exist, some do-gooder with no faith in a market economy supported by property rights can get his way. The end result of the absence of patent protection for surgical inventions is that private investment in surgical R&D will continue not to match that devoted to drugs, hardware, and biotechnology.

My own client, an independent surgeon who invented an improvement in the surgical treatment of biliary and pancreatic disease, will not be able to use a patent covering his process to obtain the financial support he needs to develop his invention because he will not be able to enforce the patent which will soon issue following successful prosecution in the patent office.

Let me give you a real life example -- from a patient's perspective -- of what the failure to obtain and/or grant enforceable patents on surgical inventions means.

Anyone who has faced prostate cancer and carefully examined the literature -- or consulted the authorities on the available treatments for the disease -- discovered that there are three possible alternatives -- surgery, radiation or "watchful waiting" (essentially no immediate treatment).

However, the synthesized information shows no significant difference between the three in terms of ten-year outcomes. In other words, no matter what you do, your chances of being alive and free of cancer outside the prostate ten years after diagnosis is about the same. That doesn't mean that there is in fact no difference between the available courses of treatment -- the available data is simply not good enough to be able to detect a difference. Equally disturbing, if the use of surgery and radiation were judged by the same standards as those applied to drugs, neither would be approvable for use.

Wouldn't it pay in the long run to invest in the R&D sufficient to make good decisions? Wouldn't it save money and suffering in the long run if we found out? Patents have financed the R&D necessary to get good information on drugs. Why not on surgery?

Lest some readers believe that the foregoing statements emanating from a medical layman about the state of the medical arts is not supported by competent medical authority, let me quote from a recent editorial commenting on reports made in the Journal of the American Medical Association:

"...the optimal management of clinically localized prostatic cancer may be more a matter of opinion than a matter of fact... The decision analysis by Fleming et al is in agreement with other reviews in suggesting that within the limitations of variously compromised data, the overall results of different treatments at least up to 10 years are remarkably similar. This, however, does not exclude the possibility that different and yet-to-be-defined subsets of patients may be best managed by a specific treatment, a consideration that might not be revealed by the results of randomized trials... The study by Lu-Yao et al indicates a phenomenally increasing but still varied use of radical prostatectomy in a variety of circumstances for which the indications, although logical, lack evidentiary support. The varied use of radical prostatectomy suggests differing perceptions of its efficacy, a possibility supported by continuing investigation of such alternative or supplemental treatment strategies as external-beam irradiation, interstitial irradiation, laser therapy, cryotherapy, hyperthermia, and early endocrine therapy..." (269 JAMA 2677, 1993).

The following statement appears in the Fleming et al review identified above: "If the medical community were to apply the same standards of safety and efficacy required for approval of new drugs to the use of invasive treatments of prostate cancer, it is likely that neither radical prostatectomy nor radiation therapy would be approved for this indication..."

When I first started working in the patent field, patents on new uses of old drugs -- or therapeutic compositions of old drugs -- were not routinely granted, much less enforced. There were emotional arguments on why such patents should not be granted. Once attention was focused on the matter, reason and common sense prevailed until now such patents are routinely granted and enforced.

Until recently the patent office has been granting patents on surgical procedures albeit very few surgical inventors have sought such patent protection. It is not surprising then that some congressman managed to engineer a change in the law so they cannot now be enforced. That's the way Washington works.

The next time you contemplate surgery, how will it feel to know that the evidence to justify its use is inadequate -- most especially for the particular surgical procedure being contemplated by your physician? Only the most naive among us could believe that somehow surgery can be developed and employed effectively in our market economy if investments in surgical R&D are not supported with the same kinds of legal protection and resulting economic incentives as provided for alternative forms of medical treatment.