11 Biotechnology Law Report 381 (Number 4, July-August 1992)

{BLR 1335} Patents-

Venter-

Bioethics.

IF GENETIC FINDS WIN PATENTS,LET PUBLICS NIH HOLD THEM

Arthur Caplan, M.D.**Scientists at the National Institutes of Health in Washington, D.C., have been very

busy during the past year. They have been rummaging through cells obtained from acollection of human brains. By extracting the DNA from these cells, they can locate theinformation that permits a stew of chemicals to become a bit of brain. The NIH scientistsare breaking the brain's genetic code at a rapid rate: about 180 new sequences a day. Atthis pace, they will have a rough map of all of the 30,000 genes expressed in human braincells in a year.

Activated Brain Cells

The rapid progress being made in mapping these genes has set some other braincells working. These are located in the heads of lawyers, venture capitalists, Wall Streetanalysts, corporate executives and government officials who are wondering who will ownthese gene maps.

Last year, the NIH scientists were going to publish some of their initial discoveriesin the prestigious journal Science. Just before they did, the attorneys responsible forpatents at NIH got wind of their publication plans. The lawyers realized that if the newlydiscovered genetic sequences appeared in print without a patent application having beenfiled, then anyone could use them without having to pay fees or royalties. The lawyersgagged. The NIH attorneys kiboshed publication until they could file patent applicationson the genetic sequences.

Billions and Billions

Many members of the scientific community were and remain outraged at thedecision to seek patents on the information stored in brain cell genes. They feel thatinformation about the genetic code ought to be freely available to anyone who wishes to useit. While morally high minded, it is doubtful whether their view can prevail. The freeexchange of information may prove to be no competition when the stakes are in the tens ofbillions of dollars.

Big money rides on controlling knowledge about the genetic blueprints of human,plant, and animal cells. The pharmaceutical, agricultural, medical, and biotechnologyindustries in this and other countries all plan to make new products based on the emergingunderstanding of the genes that differentiate, at least superficially, Dan Quayle, a turnip,and a toad.

Whoever controls knowledge about the genetic makeup of humans, plants, andanimals will have a huge edge in getting products to market.

This article, reprinted with permission from the St. Paul (Minn.) Pioneer Press, 6/1/92, is an expandedversion of Dr. Caplan's presentation at the AIPLA conference. Copyright 1992 by Dr. Arthur Caplan.

11 Biotechnology Law Report 382 (Number 4, July-August 1992)

The lawyers at the NIH know this. That is why they are seeking patents eventhough their scientists have got only a partial list of the genetic sequences in brain cells.The NIH wizards have no idea what these sequences mean. If the patent application fails,as I suspect it will, it will not be on the grounds that genes cannot or should not bepatented. Rather, it will fail because no one at the NIH can yet say what practical plans ithas for applying this new knowledge. Demonstrating utility is one of the key requirementsfor getting a patent.

But the fact that no one is quite certain what to make of all this new knowledge hasnot stopped others from filing for patents. Early this year, the Medical Research Council inthe United Kingdom filed for patents on some genetic sequences discovered by Britishscientists. Other governments and corporations will surely follow.

Gene Homesteaders?

We are on the verge of a microscopic version of the Oklahoma land rush.Scientists, governments, and companies are about to dash out over the molecular landscapeof the genes to stake their claims.

The patenting of genetic information seems inevitable. If that is so, then even

though the NIH is probably a bit premature, it might be on to something important. Itwould be best if no proprietary ownership were granted over the genetic code. Appliedknowledge, rather than pure knowledge, ought to be the stuff of patents. But if our courtsare willing to let patents be granted on genetic sequences, then maybe it is better if thenation's leading scientific institution owns the code in the name of the taxpayers who footthe bill for the research. If the huge sums of money to be made from licensing the geneticcode are cycled back to the NIH to fund future biomédical research, then maybe assigningpatents to the NIH isn't such a bad idea.

Dr. Caplan is Director of the Center for Biomédical Ethics,University ofMinnesota, Minneapolis

PATENTS

{BLR 1336} NIH-

Human Genome Project-

ABC-

Venter.

ASSOCIATION OF BIOTECHNOLOGY COMPANIESENDORSES VENTER PATENT APPLICATION—Calls It Means to Preserve Government Options inTechnology Transfer

WASHINGTON, DC 5/18/92-The Association of Biotechnology Companies(ABC), representing more than 280 biotechnology firms, research centers, and otherorganizations in 27 countries, has released a statement endorsing the move of the NationalInstitutes of Health (NIH) to seek a patent for the expressed sequence tags (ESTs) forhuman genes being identified at the agency by Dr. Craig Venter and his coworkers. Thepolicy statement is reprinted below in this issue at <BLR 1349>.