The U.S. Patent and Trademark Office (PTO) will now allow AIDS and cancer patent applications to receive top priority review, PTO Commissioner Bruce Lehman told AIDS TREATMENT NEWS on February 3. The new priority applies only if the patent applicant requests it, and the request is approved by the PTO. The new change is not yet well known, even by pharmaceutical companies applying for patents; we believe this article is the first public report. [See interview with Commissioner Lehman, page 4.] The new system allows the applicant for a patent on a treatment for AIDS or cancer to ask that the application be "made special," under rules outlined in the MANUAL OF PATENT EXAMINING PROCEDURE (section 708.02). This special status has previously been available only for patents related to environmental quality, energy, safety of recombinant DNA research, and superconductivity, and in certain unusual situations. Patent examiners are instructed to give these "special" applications top priority, not only initially, but also in all subsequent actions while the application is pending.

Biotechnology patents now take an average of about 21 months from the time of filing until they are granted or rejected. The new rule will be important in cases where a drug developer or other inventor has a high-priority invention and wants to move it quickly. This will not only speed the development of the drug in question, but can also facilitate discovery of other treatments as well, since companies often keep their research secret until the patent is granted.

But the public should realize that many medical patents are deliberately delayed by the companies that apply for them -- and the new rule will not help in this case. Why would anyone purposely slow their own patent application? The reason is that if the patent is granted years before the FDA approves the drug for marketing, the 17-year patent term will start running, and by the time the FDA approves the drug or medical device, part of the 17 years will have already expired. The company must APPLY for the patent early, to avoid a competitor applying first; but it may not want to RECEIVE the patent until later. As a result, information important for medical research and for patient care can be withheld for long periods.

This problem should be reduced in the future, because of the new implementing legislation for the GATT treaty (the General Agreement on Tariffs and Trade), recently approved by Congress. Under the new law, the U.S. patent term will follow the international standard of 20 years from the date of filing, not 17 years from the date of issuance; this provision will take effect on June 8, 1995. There will be less incentive to deliberately delay pharmaceutical patents filed after that date.

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