the challenges that still remain with the technology. What is the quality of the people who are behind the challenges? What are the strategies that are being put in place to address them? What is the probability of success?
Finally, a very important consideration is, What do you own, what will we have a right to, and will we have the freedom to operate? If we can look at what you have and envision a product possibility and a pathway to get there, will we have the freedom to commercialize the product under the proprietary estate that surrounds it?
From the industry point of view, some of the trends I see in patents are helpful and some are disturbing. We see broad, sweeping patents at the front end of new technology that begin to narrow in scope as later patent applications are filed. The broad earlier filing can be troublesome, and the later filings become more narrow and specific as the technology matures. Broad earlier filing, if granted, will complicate the commercialization of new technology.
I take great pride in the fact that industry has delivered a considerable benefit to the health care community. The early venture capitalists who are taking the high risks with the newest, least-developed technology need to be able to see that risk rewarded if they are to sustain the challenge of developing that technology and putting their capital at risk. During its initial phase, a biotechnology company must develop both its business and its technology. When a company finally offers its technology to a corporate partner, the proprietary estate is a prominent piece of what is being offered to the larger corporate partner, and it has an appropriate and a correct expectation in that regard. If there is uncertainty or lack of predictability and confidence in the partnering system, it will complicate the discussions and make forming partnerships much more difficult. We have enough uncertainty on the science side without introducing uncertainty on the patenting side. For the patent system to work well, predictability and consistency must be a part of it.
Harold Varmus, National Institutes of Health
Decisions that the National Institutes of Health (NIH) makes about intellectual property—be it research tools or anything else—are influenced by at least three goals:
Fostering scientific discovery. This includes providing various kinds of incentives to our investigators but making sure that we maintain the health