Patent Office Expedites AIDS, Cancer Inventions

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.