Patents For Human Therapies: Too Little, Too Late?

Without a patent, a university or small company may struggle to obtain financial support for expensive animal or human studies needed to develop a drug. But the way to a patent may be blocked by a United States Patent and Trademark Office (USPTO) unwilling to accept in vitro data as predictive of human therapeutic usefulness. It is the public who suffers from this dilemma as promising therapies for deadly diseases may never reach the market. During the early 1990s, USPTO sharply limited the is

Daniel Monaco
May 26, 1996

Without a patent, a university or small company may struggle to obtain financial support for expensive animal or human studies needed to develop a drug. But the way to a patent may be blocked by a United States Patent and Trademark Office (USPTO) unwilling to accept in vitro data as predictive of human therapeutic usefulness. It is the public who suffers from this dilemma as promising therapies for deadly diseases may never reach the market.

During the early 1990s, USPTO sharply limited the issuance of patents for claims that were supported by in vitro, not in vivo, data. Now that legal standards for resolving such claims have been clarified, the number of granted patents is rising.

USPTO controls the breadth of issued patents through the legal requirements of utility and enablement. According to the statute that spells out utility requirements for issuing a patent, an invention must work for its...