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Ever since he was 8, when he began attending astronomy and mineralogy classes at the local community college, Robert Millman has had a passion for science. The obsession set him on a meandering path, but he eventually earned a master’s in genetics and cell biology. He then bounced through a series of jobs — including one stint as a fire-juggling waiter in Hawaii — before winding up as a technical specialist at Washington D.C.’s Sterne, Kessler, Goldstein & Fox. The high-tech boutique liked him so well that the partners paid his way through law school. Today, at age 39, Millman can be found at Celera Genomics Group, in Rockville, Maryland. “I never, ever guessed I’d be working as an attorney, sitting on my butt and typing half the day,” he says. “I always thought I would be a Nobel Prize-winning scientist working for the betterment of mankind.” He’s actually not too far off. In January 1999 Millman landed his current post at Celera, where scientists expect to soon complete the world’s first map of the human genome — a detailed diagram of the long and winding chemical code that carries the blueprint for human life. Although the pony-tailed dreamer sits in a corner office filled with toys, his tasks are anything but childlike. His duties range from surveying competitors’ gene patent portfolios to developing strategies for staking claims on Celera’s own development of DNA-assembling algorithms. His mission: to help get the company the intellectual property protections it needs to make its business boom. With the wide-eyed delight of a boy wonder imparting the secret to a favorite video game, he ushers his visitor through a series of unmarked doors, into room after room filled with impressive-looking machinery. He explains how Celera cultivates, clones, breaks apart, purifies, and finally sequences human DNA faster than any other organization on the planet. “What we are doing will lead to significant scientific breakthroughs that I can actually see,” he concludes, comparing Celera’s work to the first walk on the moon. As he enters the office of a colleague, however, Millman’s enthusiasm dampens quickly. “Did you hear about the lawsuit?” he asks, his smile fading. He is incredulous at the prospect of yet another line of attack on his employer’s integrity. As Celera’s top lawyer, Millman has become expert at deflecting blows against it. For one reason or another, Celera is the genomics company that everyone — from government scientists to commercial competitors to the popular press — loves to hate. Celera has been named in three shareholder class action suits — so far. New York plaintiffs law powerhouse Milberg Weiss Bershad Hynes & Lerach filed the first suit on April 18, alleging that Celera misrepresented the viability of its business plan, which, according to the complaint, “is dependent upon its ability to protect its database [of genomic] information through patent protection.” The other complaints allege much the same, and it seems likely there are more to come. The shareholder claims center on a one-two punch that recently knocked Celera’s stock price down to less than a third of its all-time high. The first hit came in early March, when attempts to collaborate with the Human Genome Project (HGP), the government-funded effort to map the human genome, erupted into a public spat — leaving two already bitter rivals at odds over the extent to which Celera could protect its genomic research as intellectual property. The second swipe came just a week later, when Bill Clinton and British prime minister Tony Blair issued a joint statement applauding “the decision by scientists working on the Human Genome Project to release raw fundamental information about the human DNA sequence … into the public domain.” The statement, issued to support the HGP’s policy of making its data immediately accessible to the public, was interpreted as a direct threat to Celera, the HGP’s only private sector competitor. Adding insult to the injury of a $5 billion plunge in its market cap, the company had to endure a denigrating mischaracterization of its mission, says Millman. Craig Venter, Celera’s president and chief scientific officer, had always said that Celera, like the government-funded project, would place its version of the human genome sequence in the public domain; he just wanted to wait until the effort was finished. Venter had trumpeted the fact that while Celera would patent a relatively small number of what he hoped were the most medically important genes for licensing purposes, Celera’s core business was not dependent on patenting the human genome, or even on patenting individual genes. Instead, Celera would turn a profit by selling subscriptions to a database of information about genes — much the way Lexis-Nexis sells information about law. But the shareholders hadn’t heard that message, it seemed. The collapse of Celera’s negotiations with the HGP, rails Milberg’s complaint, “created a very volatile situation in which the U.S. and the U.K. governments would take whatever steps they could to prevent Celera from reaching its goal of patentability.” Fifteen years ago, a legal showdown over the economics of human gene patenting was hardly conceivable. Then, genetic research had progressed far enough only to suggest the possibility of understanding the chemical makeup of DNA. In 1985, when the first ideas about mapping the genome were being dreamed up, the undertaking was so enormous, so far-reaching, that only the government was considered capable of mobilizing the necessary resources. In 1990 the Human Genome Project was launched, backed in large part by the Department of Energy and the National Institutes of Health (NIH), and partnered with major university research labs from Boston to California. Its lofty goal: to read, or “map,” a complete human DNA molecule, or genome — to put in exact sequence a chain of 3 billion pairs of alternating chemicals and to identify the genes scattered along that chain. Soon, governments all over the world had joined in. But American entrepreneurs got plucky in the nineties. Just a year after the HGP began its work, Incyte Genomics, Inc., was founded and began sequencing — and patenting — human DNA in assembly-line fashion. A year later, NIH scientist Craig Venter, armed with a controversial new technique for mining genes, and disgruntled after NIH head Harold Varmus withdrew patent applications on Venter’s early genetic discoveries, left his government post to start up his own proving ground. Funded by Human Genome Sciences, Inc. (HGSI), a new company centered on the discovery and understanding of the medical utility of genes, Venter founded a research lab called The Institute for Genomic Research (TIGR). A third company called Millennium Pharmaceuticals, Inc., began its own sequencing work in 1993. But these companies, less interested in mapping the full human genome than mining it for the 100,000-plus genes it contains, did not seem to pose a direct threat to the federally funded Human Genome Project. And then came Celera. Bad blood between Venter and William Haseltine, the head of HGSI, drove Venter to abandon TIGR in 1998 in search of a new platform for his genomic research. In May 1998 Venter partnered with PE Corporation, a manufacturer of lightning-fast DNA sequencing machines. The venture was named Celera (derived from the Latin word for “swiftness”), and its founders adopted a simple motto: “Speed matters.” Setting itself apart from its private-sector competition, Celera would devote the bulk of its resources, in particular its 300 high-power sequencing machines, to beating the HGP to the entire human genome. In fact, Venter declared, Celera aimed to have the first complete DNA map by the end of 2000 — less than two years after turning to the task, and for less than $300 million. When Millman arrived at Celera in January of 1999, he was quickly caught up in the firestorm Celera had already created. “I’m not sure he knew exactly what he was doing there,” says Jeffrey Kushan, an intellectual property lawyer at D.C.’s Powell, Goldstein, Frazer & Murphy who once worked with Millman. Celera’s sudden arrival on the genomics landscape launched a fierce rivalry between the public and private efforts. At that point, the government project had already spent nearly ten years and $3 billion in taxpayer money on mapping the human genome. And yet the project hadn’t come close to achieving its goal. Immediately, government-funded scientists working for the HGP condemned Celera and the renegade Venter. They scoffed at Celera’s claim that the human genome could be properly mapped so quickly and cheaply. Venter was employing a novel “whole genome shotgun” approach to sequencing — breaking DNA into tiny fragments, decoding them in random order, and then fitting them together again to get the fully sequenced genome. To HGP scientists — who painstakingly sequence the DNA bits in something much closer to the order in which they appear within the molecule — this was an untested shortcut. “They will end up with something that falls far short of [the HGP's] complete contiguous map,” said Francis Collins, the director of the National Human Genome Research Institute at the NIH. Celera’s more cursory map, went this logic, meant misguided research and a slower path to lifesaving drugs. Some in the genomics industry say that Venter’s taste for rattling cages and bragging about his scientific exploits in the media only fueled an already developing antagonism between Celera and the HGP. “The leaders of the HGP view him as an egomaniac essentially trying to take all the glory and credit for himself,” says an executive at one of Celera’s for-profit competitors. That Celera — the only private or public enterprise brazen enough to take on the HGP — openly supplemented its own research with GenBank, the free, public genomic information database created by the HGP, was especially galling to the government players. Even though Celera has never planned to patent the entire human genome — “legally it’s not possible,” snaps Millman — the company’s bold entry onto the genomics scene resurrected passionate debates about gene patenting. Genes, bits of DNA sequence that influence everything from what color hair we have to what diseases we get, can be cloned in laboratories and picked out from a strand of DNA by high-powered computers. Genes that are produced and identified in this way are considered inventions, and can be patented. Once an inventor earns rights to the chemical makeup of a particular gene, others wishing to make use of that gene for further research usually must pay its inventor for the privilege. Because it is widely expected that important medical advances — miracles ranging from the cure for cancer to a vaccination against AIDS — will stem from genetic research, gene patents are at least potentially worth their (paper) weight in gold. These days, success in the gene patenting business has a lot to do with John Doll, who has served as chief of the biotech section of the U.S. Patent and Trademark Office since 1995. Doll has been an instrumental adviser to Celera and other genomics companies, helping them to navigate the gene patenting process. Under Doll’s watch, say lawyers at several genomics companies, the patent process has become more user-friendly. The backlog on patent examination has dwindled dramatically, meaning less lag time between making discoveries and making a profit. Recently, Doll helped oversee revisions to the guidelines that patent examiners use to review patent applications. By virtue of the changes, which were subject to public review and comment, inventors will now have to attribute a substantial, real-world utility to their gene patent applications. “You can’t patent a transgenic mouse by saying it makes great snake food,” explains Doll. But even the newly revised standard is not demanding enough for the HGP. In 1996 the many constituents of the HGP signed the so-called Bermuda Statement — a pledge to dump all of its human genome data into free public databases such as GenBank every 24 hours. In keeping with its manifesto that the human genome be freely accessible, the HGP explicitly prohibits its own scientists from applying for patents in the course of their mapping efforts. Time is limited, and the HGP’s commitment to data-dumping comes first. (Government-funded labs working in conjunction with the HGP are free to pursue, and capitalize on, research building on the raw sequencing data — on their own time.) Policymakers at the HGP consider Celera’s decision to delay sharing its raw data a public disservice, a violation of the spirit of the Bermuda Statement. Yet the federally funded project faces a more explicit policy challenge from the legislative arena. Coexisting uncomfortably with the Bermuda Statement is the Bayh-Dole Act, a federal law mandating that federally funded scientists be allowed to pursue patents on their inventions. HGP head Collins, a champion of public access to the human genome, has avoided a direct conflict with Bayh-Dole by publicly and consistently taking issue with one very specific type of gene patent — those granted too early in the discovery process. Comparing such premature filings to tollbooths, Collins argues that too many — placed too near the beginning of the patent turnpike — would create the equivalent of traffic jams in genetic technology development. Incyte, HGSI, and Millennium Pharmaceuticals have all staked out impressive gene patent claims — the sort of patent portfolios that seem to foil the best intentions of the HGP. Millennium, the youngest company of the three, has earned 100-plus patents and has filed applications for 1,000-plus more. HGSI, whose business is the pharmaceutical development of genes, held 111 gene-related patents at the end of last year and has applications outstanding for 7,500 more. Incyte Genomics, whose database-centered business makes it Celera’s closest competitor, held 490 gene-related patents as of the end of last year, and currently has applications filed for more than 7,000. “We are the single biggest customer of the biotechnology section of the [U.S. Patent and Trademark Office],” says Lee Bendekgey, Incyte’s general counsel. “Patents are like currency — the more, the better.” Bendekgey explains that Incyte patents the genes in its database to safeguard their customers from infringement suits down the line. (Bendekgey calls it a “protective umbrella” — they worry about patenting their genes so their database subscribers don’t have to.) Notwithstanding all the other patent holders — Incyte, for one, has actually won a partnership with the NIH “to create a public domain set of full-length expressed human and mouse genes” — the HGP has reserved its ammunition for Celera, its only competitor in the race to map the entire human genome. In October 1999 Venter announced that Celera had filed its first set of provisional patent applications — essentially time-stamping its 6,500 genetic inventions without yet triggering patent review. Celera would have to file full, “national stage” patent applications within a year on whichever of those it wished to pursue; each of Celera’s competitors had filed thousands of provisionals in order to compile their respective patent portfolios. But Celera’s news met with singular reproach from HGP scientists. “I think it’s going to inhibit work on these genes,” said Robert Waterston, director of an HGP-affiliated gene-sequencing center at Washington University School of Medicine. “I worry that both companies and people will not invest their time and effort into something if they think things are tied up.” But a look at a day in the life of Celera’s free-spirited patent director — not to mention the company’s still-empty patent portfolio — seems to betray Celera’s image as the evil empire seeking to swindle the human race out of its genetic secrets. On the way into his sunny, low-budget office, Millman points out the neat piles of yellow provisional patent applications that cover a no-frills folding table nearby. Millman’s day is spent, with the help of a small staff including just one other lawyer, implementing Celera’s intellectual property agenda. He attends research meetings to discuss which genetic inventions might be worth patenting, and which are better protected as trade secrets. He works with the company’s software developers on Celera’s proprietary genomics database. And much of Millman’s time is spent doing reconnaissance — reading the weekly updates on other people’s patents. As a latecomer to the industry, Celera does not hold a single gene patent to date. Millman will not disclose how many of its thousands of provisional applications it is pursuing, but Venter has maintained since Celera’s founding that he does not plan to patent more than 300 genes. Unlike Incyte, which seeks to patent all of the genes in its database as a service to subscribers, Celera hopes to patent just a few, and license them as a sideshow to its database business. And yet Celera’s rivals continue to accuse it of trying to patent the human genome itself — of seizing science’s holy grail for its own, exclusive commercial benefit. “Well, it’s about monopoly, isn’t it?” said John Sulston, the director of London’s Sanger Center, in a recent interview addressing Celera’s business motives. “Because there’s only one human genome, by tying it up you inevitably establish a monopolistic position, and that will be to the detriment of biology.” Observers interpreted the Clinton-Blair joint statement in March as an endorsement of the HGP’s antipatent policy; combined with news of Celera’s failed attempt to collaborate with the HGP, it was considered the death knell for Celera. Though little more than a reiteration of the Bermuda Statement, it caused the company’s stock to tumble from $189 to $155 in a single day. A subsequent statement by Clinton that companies conducting genetic research should have the right to patent their inventions had the desired effect of sending Celera’s stock — and other Nasdaq darlings that had slid — back into the stratosphere. But the rebound didn’t allay the frustration of Celera’s stockholders, who had lost millions by the time the stock settled down. Months later, with Celera’s stock again knocked below the $100 mark by the recent Nasdaq slide, the litigation is just starting to gain steam. And it did little to persuade those who are less than convinced that Celera is the innocent it claims to be. “If they had more genes to patent, they would patent them,” says Donald Pochopien, a lawyer at Chicago’s McAndrews, Held & Malloy, who does not represent Celera or any of its competitors. Of Venter’s insistence that Celera will not patent more than 300 genes, he is skeptical. “That’s probably something they put out there for public consumption,” he adds, “to look like the good guys wearing white hats.” Happily, Millman will have little to do with litigating the class action Celera now faces. (“A costly nuisance,” he says dismissively.) That job will be left to Simpson Thacher & Bartlett, PE Corp.’s hired guns in New York. But courtroom clashes aside, his job as Celera’s top advocate is about to get harder. “DNA sequencing is only the most trivial first step,” warns Rebecca Eisenberg, a member of NIH’s board of advisers who has written extensively on the topic. The newly relaunched genomics database company DoubleTwist Inc., having recently completed the first full computer sequencing of GenBank and identified 105,000 genes lurking there, is hot on Celera’s heels. Cases will be filed, patents squabbled over, and the major battles lost and won. In the meantime, Millman, for one, has been instructed to curtail his direct dealings with the press. He knows that Celera’s struggle is just beginning — and he knows that he’s sitting in the eye of the storm. Sometimes he takes it personally. “I wish everyone would just leave us alone,” he says plaintively, “so I can do my job.”

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