AIDS TREATMENT NEWS Issue #208, October 7, 1994
John S. James

Background -- Why It's Important

The AIDS community has largely ignored patent issues until now -- not because it does not matter, but because there has been no activist to investigate this area and explain its importance.

Patent issues are important because it can take four years or more between the time an AIDS, cancer, or other biotechnology patent is applied for, and the time it is granted. During this time, the patent application usually stays secret. Delays, therefore, not only hold up the development of one treatment (since investors are unlikely to finance clinical trials until the patent is granted), but can also delay other research and development by keeping cutting-edge medical information secret.

(One example is compound Q, the well-known experimental AIDS treatment, which seems to have been delayed for about two years while the patent was pending. If this drug had turned out to be the home run that many who were close to it expected, the delay would have caused many thousands of deaths. And if current directions continue, the drug or drugs which finally do lead to major advances in HIV treatment could very well suffer similar delays.)

Biotechnology patents used to take much longer than the average of all patents to be granted, with industry and the PTO essentially blaming each other. In July 1990, the U.S. General Accounting Office reported that it took an average of four years to get a patent in genetic engineering, and three years in other areas of biotechnology, vs. an average of 18 months for all patents. Major improvements have been made since then, but we do not have current figures.

Recently a patent attorney for industry told us that patents for AIDS and cancer treatments take much longer than patents for other diseases, due to the way the PTO interpreted the "utility" requirement -- the requirement that an invention be useful. But another expert told us that there were no figures to prove this -- and that companies often deliberately delayed their own applications, for reasons explained below.

The "Utility" Controversy

The patent law requires that a patentable invention not only be new, and more than a non-obvious advance that would have inevitably been discovered in routine progress of the field, but also that it be useful (have "utility"). This means that somebody trying to patent a new medical treatment may be asked for in vitro (animal or human, not just test tube) data to convince the PTO that it works. The FDA, of course, will ultimately make this determination, when granting marketing approval for the drug (or medical device); but unless the patent is granted at a much earlier stage, the trials leading to FDA approval are unlikely to ever occur. The reason AIDS and cancer patents take longer than patents for other diseases, according to this industry view, is that it is harder to prove that AIDS and cancer drugs work; to solve this problem, the PTO should ease up on the utility requirement.

The second expert quoted above had a different view. He said that with medical patents, it is often in a company's interest to deliberately delay its own application. The reason is that with a non-medical invention, as soon as you get the patent (or even before), you can start selling the product; but with medical treatments, you cannot sell the drug until it is approved by the FDA. Since the patent runs for a fixed term of years, a company may not want to get its patent too long before FDA approval, lest it decrease the value of the patent by reducing the number of years of exclusive sales. (This situation is common enough that patent examiners have a phrase for it: the "submarine patent." For additional background on the submarine patent, and other problems it can cause, see article by Paul Karon in the Los Angeles Times, June 1, 1994, business section, page 9.)

One possible reform would be to not require proof of usefulness for medical treatments. Since the FDA will eventually make this determination anyway, and since without the FDA's finding of efficacy the treatment will be commercially worthless and the patent would not matter much anyway, why should the PTO slow down the process by insisting on making its own separate, lesser determination of whether or not a drug works? This kind of reform might be considered, although it might take an act of Congress; but any big change must be made carefully, since the "utility" requirement -- part of the U.S. patent system for over 200 years -- is there for a reason. Without it, someone could tie up a new area early, without doing the work required to produce a useful invention. Then others who were ready to do the work could be locked out.

Also, the PTO is concerned about the credibility of patent information to investors, who often do not understand the technology involved, and instead rely on the fact that a patent has been issued. There is a fear that if the "utility" requirement were weakened or eliminated in some cases, the public could be misled to invest unwisely.

Issues at the San Diego Hearings

The October 17 hearings in San Diego will address certain specific issues, including:

* The "utility" controversy, partially outlined above. (Other "utility" issues involve patenting human genetic sequences when their function is not known.)

* The "operability" requirement (that the invention must be fully described so that an independent expert in the field can make it work).

* Technical issues around determining "non-obviousness" of biotechnology patents, in a rapidly changing field.

* Implications of patent-reform proposals which have been introduced in Congress. One would provide a patent term of 20 years from the date of filing of the patent application (eliminating the incentive of industry to delay the processing of medical patent applications). Another would automatically publish patent applications 18 months after filing (as the European patent office now does), to prevent important information from being withheld from the public for years in many cases.

* The current rules allowing research use of patented drugs or other materials without the permission of the patent holder. (Loss of this defense to patent-infringement suits would be disastrous to medical research, especially because of the difficulty of getting pharmaceutical companies to cooperate with each other.)

* U.S. plant patents, which currently restrict only the sexual reproduction of plants, or use of the plants so produced. This allows plants to be grown outside the U.S., and the harvested products to be imported to the U.S. without payment to the patent holder. (Changes here could conceivably affect access to improved herbal treatments.)

And a major concern which is not on the program for San Diego is delays caused by the high turnover of patent examiners with experience in both the science and the law of biotechnology. After two or three years experience in the PTO, these people can find more money and a less bureaucratic work environment in industry. (See "The Looming Biotech Vacuum," The Recorder [a legal newspaper in San Francisco], March 28, 1994, page 1.)

For More Information

Anyone planning written or oral comments should obtain "Notice of Public Hearings and Request for Comments on Patent Protection for Biotechnological Inventions," Federal Register, September 1, 1994 (volume 59, number 169), pages 45267-45271. Those wishing to speak must submit a request to do so by October 12; written comments, however, may be sent by mail, fax, or email either before or after the hearings, until November 23.

Comment

It is vitally important that at least a few AIDS activists seriously follow patent issues, and how they affect the development of new treatments for AIDS and other serious illnesses. We hope that this short article will help to introduce this complex but critical area.

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