In 1988, Michael Long, PhD, a professor in the pediatrics department of the University of Michigan, Ann Arbor, Mich., began research into a process for growing human bone outside the body. Four years later, in 1992, he filed his first patent, titled "a method and composition of matter patent on the isolation of bone precursor cells." It took five years before the patent was approved.

"In biotechnology, the total pendency is 26 to 32 months," says John Doll, director of the US Patent and Trademark Office (USPTO) Technology Center, which oversees the biotechnology patent approval process. "Some of the less complex areas [take less time] and some of the more complex areas such as bioinformatics [take more]."

Michael Long agrees, noting that five years was "an unusually long time and was due to difficulties from our own prior publications that were misconstrued as enabling." The issue of when to disclose information and in what form is a central problem in patent acceptance. "At the core of patent law is the concept of uniqueness or novelty," says Long. "If something is already known and understood by someone 'knowledgeable in the art,' it cannot be patented." This requirement sets up a dichotomy for academic investigators whose first instinct is to publish. That is, the publication necessity is opposed by the need to patent a unique entity. In the case of a paper, it is clear to most investigators that its publication invalidates the ability to patent as it "enables" others to practice the invention. "What is often not understood," says Long, "is that an abstract or a presentation in a public forum also enables an invention. In our case, it was an abstract, published before the application submission, that became an issue."

Although the University of Michigan was the holder of Long's first patent, its success and the potential for commercialization led Long to found a biotechnology company, Velcura Therapeutics Inc., also based in Ann Arbor. "Velcura," says Long, "was spun out of the university, meaning that its technology belonged to the university, although I was the inventor. The university was very helpful in marshaling resources to start the company. But once the company incorporated, it became a separate entity and had to negotiate for the right to the technology, just like any other company."

Long and Velcura Therapeutics now have nine patents "that center around the ability to isolate bone cells, to make human bone in a tissue culture dish, and to use these procedures for diagnosis and drug discovery."

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