IT'S BEEN A BUSY YEAR AND I HOPE NO ONE THINKS we've been remiss by not mentioning a milestone anniversary until now. On the other hand, I personally can't recall reading about this anniversary elsewhere in the lab industry press during 2005. So maybe I am among the few to call attention to the fact that, on March 28, 2005, a number of foundational PCR (polymerase chain reaction) patents expired in the United States. These patents have been held by Roche, which was bold in its original decision to acquire these patents.

PCR was developed in 1985 by biochemist and surfer Kary Mullis, Ph.D. while he worked for Cetus Corporation of Emeryville, California. Cetus paid Mullis a $10,000 bonus for this invention. It was in 1998 that Cetus, in collaboration with Perkin-Elmer Corporation, introduced the"DNA Thermal Cycler" to automate the PCR process.

By early 1989, Cetus had agreed to collaborate with Hoffman- LaRoche to develop and commercialize IVD diagnostic products that incorporated PCR technology. In 1991, Hoffman-LaRoche paid $300 million to Cetus and acquired the rights to PCR. Mullis was honored by a Nobel Prize in Chemistry (for PCR) in 1993, just eight years after publication of his work.

Today, with full hindsight, that bold decision to pay $300 million to license PCR technology is widely viewed as a savvy business decision. Roche has enjoyed substantial revenue from licensing fees and royalties paid by companies and laboratories using this technology. Over 100 companies and 600 laboratories worldwide have such arrangements with Roche.

Moreover, the expiration of the first PCR patents on March 28, 2005 may be characterized as"The King is Dead! Long Live the King!" That's because Roche states that"continuing patents and patent applications number approximately 300 in the U.S. and approximately 900 outside the U.S." It has built this patent estate with an eye toward maintaining PCR licensing and royalty fees for some time into the future.

Because of the contribution that PCR has made in accelerating the genetic revolution—including the mapping of the human genome—I certainly think it is appropriate to remind all laboratorians that PCR is officially 20 years old in 2005!

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