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Dodge Retort 

By John Dodge
Executive Editor - IT

John Dodge June 12, 2002 | Henry Huang may come across as the selfless scientist, but the soft-spoken microbiology professor at Washington University in St. Louis is stirring up a hornet's nest regarding the invention of the DNA sequencing technology that sparked the biotech revolution.

Huang says he is the primary inventor of the four-color automated DNA sequencer and that, at the very least, his name should join the five others listed on the relevant patents. The evidence suggests that Huang conceived the idea for the process — using federal grants — during the course of his work in Leroy Hood's group at the California Institute of Technology from 1979 to 1982. Back then, the rights to anything invented using federal monies automatically became the government's property.

Huang says he is not looking for money, but merely recognition and a level playing field in the sequencer market. "I feel my name should be there [on the patents]. The best outcome would be if they opened the licensing, making [the invention] nonexclusive to any company." That is Huang's diplomatic way of saying that, at best, the existing patent holders refined his idea.

One curious twist in the story is that a party other than Huang and the federal government, which stands to gain the most by getting the existing patents annulled, is bringing suit against the patent holders and their affiliates.

MJ Research Inc., a Waltham, Mass.-based biotechnology company, has filed a "whistle-blower" lawsuit, alleging the existing patent holders bilked taxpayers out of "hundreds of millions, if not billions, of dollars." That's because the government has purchased an estimated 6,000 DNA sequencers, at an average cost of between $200,000 and $300,000. The suit contends those prices were inflated by royalties the government should not have had to pay.

Over the years, royalties have been collected by Applied Biosystems Group (ABI), as well as Caltech, which as of 1998, had collected $26 million, according to the suit. Several of the patent holders had considerable financial interest in ABI going back to 1980, the suit says, including cofounder Hood and Michael Hunkapiller, the company's president.


A Mere Five Weeks 
That the existing patents originally denied federal grant money was used in the device's invention has also been in dispute, according to the lawsuit. The first patent, applied for in 1984, said the idea was conceived Oct. 1, 1982 — a mere five weeks after Huang left Caltech for Washington University.

Huang paid little attention to the patents when they were first awarded. "The first patent was awarded eight years after I left [Caltech]," he says. "I figured they must have done a heck of a lot of work on this machine." It was not until 1998 that he realized the date of the seminal invention was barely one month after he had left Caltech. "Did they invent anything new? I looked at the patent and there wasn't anything new. It was all engineering, but no new concept."

Attorney C. Allen Foster with Greenberg Traurig LLP, representing MJ Research, puts it bluntly: "Show me one piece of paper that shows that any of the five contributed to this invention in any way."

Hood, currently president of the Institute for Systems Biology (see "All Systems Go at ISB," page 38), acknowledges Huang made important contributions. "The whole issue should be reconsidered again," Hood admits. "But you don't get a patent just for an idea. What is quite clear is Henry had no role in [its] implementation, and the strategy he proposed was never going to work. Each of the people I assigned to work on the DNA sequencer has their own view of their role in its implementation ... I'm totally in favor of putting him on [the patent]. He was the first to work on it, but there's no way Henry could be the only [inventor]."

Undoubtedly Hood and others have enriched themselves off the royalties through their interests in ABI. Foster calculates the royalties to be worth 40 percent of "monopoly profit" on the $1 billion in sales of DNA sequencers to the government alone. The royalties also generated 80 percent of the ABI profit on $5.6 billion in sales of chemical reagents used in sequencing, the suit alleges.

MJ's civil complaint is known as a qui tam lawsuit, which alleges the government was ripped off. The Latin qui tam is short for qui tam pro domine regis quam pro ipso se, which translated means "as much for our lord the king as for himself," Foster explains. "These cases have been around in England since the 13th century," he says, adding that a similar U.S. law was enacted in 1863 after federal troops at Gettysburg received a box of rifles that contained rocks instead.

Does the case have merit? The Department of Justice began reviewing the facts in 1998, when Huang says he first studied the patents. MJ filed its case in August 2000, frustrated that the DOJ was taking so long to decide. The lawsuit was kept under seal until the government finally declined the case in March.

"We really don't explain the reasoning when we decline," says DOJ spokesman Charles Miller. "That doesn't mean it's not a good case. It just means it was not for us. There have been cases we have declined which have gone on and been successful, but they are very much in the minority."

Foster remains undaunted by the DOJ's ambivalence. "The government tends to take slam dunks most of the time. When the sausage is on the platter, it'll be there with the biggest fork," he says.

At face value, the lawsuit and Huang's version of what happened are compelling. But turning back the clock and recounting events that happened more than 20 years ago will be an uphill battle for the plaintiffs. One advantage is that Huang kept copious notes and drawings of his work.

But if Huang was so instrumental in the invention of automated DNA sequencing, how could his name conceivably be left off the patents? In keeping with his low-key demeanor, his response seems forgiving.

"My assumption is it was an oversight. You know, out of sight, out of mind."

Write me at john_dodge@bio-itworld.com.


Paper Trail: Copies on Huang's original notes on his work contributing to the four-color automated DNA sequencer. 





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