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strong patent systems (e.g., China, India, Argentina, Brazil) are not troublesome to the biotech field, although the pharmaceutical industry has expressed concern. However, international trade competition with countries that purport to have a patent system is a very serious issue.

For example, Japan is a strong competitor. In Japan, patent flooding surrounds innovator's patents. The Japanese patent office grants narrow patents instead of broad ones. I think it is pretty obvious to those in this industry that small companies need broad patents. If you are going to try to compete in the marketplace with giants, you had better know that you have some reasonable protection against obvious duplication or partial duplication. The Japanese system has not produced many biotechnology innovations and has not produced biotechnology companies. Our problems with the Japanese system are narrow patents, sometimes taking 10 or more years to issue, and patent flooding, which surrounds the inventor's contribution and forces him to join up with a large, entrenched Japanese company to survive.

To summarize, developing countries have concerned some industries, but they have not been competitive in biotechnology. Europe has awarded strong patents that afford U.S. innovators reasonable protection. Japan has been a very serious issue. Today we see two companies in Japan enjoying the products of Amgen—two products approaching a billion dollars in sales, at prices two to four times that of the products in this country, guaranteeing high profits. It is very easy to see what is going to happen over the long term. Those companies are going to be able to invade other countries in the field of biotechnology and be very active participants in trade.

The question then is, Can the United States dictate or influence international patent practices? Well, somehow it has to. This sounds unfair to some, but it is equally unfair to have misappropriation of intellectual property.

We know the history of what happened: Japan behind, Japan even, Japan ahead. The outlook is very serious. If we think back about that 20year period around the 1960s when U.S. patents were not being upheld, that may have been why it was easy for the Japanese to move in and take over the territory.

Now, for future challenges: The federal government's patenting of the genome was a hypothetical question until a short time ago. Would this be serious? It has now become a very practical question. The U.S. Patent Office is currently examining the NIH's application for patents on certain gene sequences. In the meantime, the Industrial Biotechnology Association has held discussions with Reid Adler of the National Institutes of Health (NIH), biotech executives and administration officials who are examining this issue. What should the NIH do with respect to all of these gene patents? A good start is to provide a forum between industry, NIH and other inter-



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