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It’s an exciting but edgy time to be doing IP at a biotechnology company. The business plans of these companies aim for profits, of course, but they are also infused with hope. Biotech companies are in search of cures for cancer, vaccines to eradicate disease, and ways to help relieve the suffering of AIDS patients. As a scientific and business proposition, it doesn’t get much more exciting than that. These companies are edgy, in both a legal and financial sense. They are exploring legal frontiers by patenting gene sequences that critics think should be outside the bounds of patentability. And some of them are on the financial edge, a deal or a payday away from survival or collapse. The biotech sector also has not escaped the wrath that the stock market has unleashed on technology companies of all stripes. Even so, for lawyers who like risk � and they do exist � biotechnology is a great place to be. There is plenty of room for deal lawyers, litigators, and patent prosecutors alike to be fully engaged in their craft. Below, we look at four in-house lawyers whose jobs offer plenty of promise and peril. Their career paths are a window on the genetic structure of the industry. To find these four, we cast our net wide but not high. We deliberately did not look at lawyers with established players like Amgen Inc., Genentech, Inc., and Chiron Corporation. We wanted to find lawyers � and presumably a few companies, too � on their way up, rather than those already throned with success. And we wanted businesses with a compelling story line. We aren’t smart enough to know which of the technologies and companies below are winners (or stupid enough to make a prediction). But we think the IP lawyers that we profile are all winners � even if their companies may turn out not to be. David Earp Geron Corporation Menlo Park, California Patents: 58 Business: Stem cell and cloning research and development To get into his office building on his first day on the job at Geron Corporation in 1999, David Earp had to cross a picket line. The right-to-life group Operation Rescue was protesting Geron’s involvement in stem cell research. Earp was nonplussed. He knew he was courting controversy when he took the position as vice president of intellectual property at Geron. There hasn’t been a protest as close to home since that first day, but Earp says that if stem cells are in the news, his phone will start to ring. And sometimes he will have to field some pretty hostile questions. “You have to answer in a straightforward way and talk about the benefits of the technology,” he says. “There will be people who have firmly held beliefs that are going to put them in a very different camp from yours. You have to recognize that and respect those beliefs.” Many right-to-life groups oppose federal funding for stem cell research because harvesting stem cells requires the destruction of an embryo. These embryos are often donated by couples who are seeking treatment in fertility clinics. In 2001 President George Bush limited federal funding to 11 stem cell lines, including one held by the University of Wisconsin. Geron has certain exclusive rights to the Wisconsin cells. Stem cell technology drew Earp to Geron in 1999. He had been a partner at Klarquist Sparkman, an IP boutique in Portland, Oregon. Before that he received a Ph.D. in molecular biology and chemistry from Cambridge University and completed three years of postdoctoral study in plant genomics at the University of California at Berkeley. “Being a bench scientist employed only a small subset of the skills I have,” Earp says. “I wanted to use more of these skills in a broader context.” Earp attends weekly meetings with the company’s scientists to keep tabs on their progress and to check for any new patentable subject matter. Earp also conducts publication clearance review on all the submissions Geron scientists make to scholarly journals. Geron, unlike many other biotech companies, encourages publication. “When you’re a company like Geron and have no products on the market yet, the way people see what you’re doing is through the scientific literature,” Earp says. Earp is a member of Geron’s operating committee, responsible for company strategy. Part of that strategy is anticipating how Geron’s technologies will mesh with and affect the law. “We are breaking new ground, filing patent applications on cloning methods and on embryonic stem cells,” says Earp. “We really will be making new law to go with the new science.”
Melodie Henderson Genaissance Pharmaceuticals New Haven Patents: 8 Business: Personalized medications Melodie Henderson has spent her entire working life around technology, but she still doesn’t have voicemail. If you want to leave her a message, you must talk to her assistant. The situation seems even odder when you consider that Henderson, 43, is barely ever at her desk. Instead, you’ll find her at one meeting or another, sealing the partnerships and licensing deals that keep her struggling company, Genaissance Pharmaceuticals, Inc., in business. As vice president of intellectual capital and licensing, Henderson has played a role in every IP�related agreement Genaissance has entered since she arrived in May 1999. Already, Genaissance has deals with eight major pharmaceutical companies. And if the company is to survive in its technically dazzling but profit-challenged niche, there will be many more. Henderson didn’t come up through the dealmaking ranks. A biochemist, she was a patent lawyer at Howell & Haferkamp in St. Louis before joining Genaissance. For a scientist, Genaissance’s appeal was obvious: The company’s research may usher in a new generation of genetically tailored drugs � personalized medicine optimized for one’s own genetic makeup. For a lawyer, however, the challenges were just beginning. Not long after its IPO in August 2000, Genaissance’s fortunes began to slide. Its stock dropped from more than $30 in 2000 to $1.20 in April. Designing compounds that are tailored to work for a specific genetic variation isn’t necessarily a pharmaceutical cash cow. “Drug companies are looking for a blockbuster drug, one that will work on the largest possible population,” Henderson says. Genaissance reorganized last summer, laying off employees, bringing in new senior management, and renewing its focus on commercializing its technology. The company is focused on making deals with drugmakers and with diagnostics companies that could create tests using Genaissance’s technology. Since the restructuring, the deals have become more numerous and more varied: a January 2003 collaboration with Bayer HealthCare to develop and market tests to determine reactions to existing and new drugs; a licensing agreement, also in January, with Millennium Pharmaceuticals, Inc., to use Genaissance technology in its drug development programs; a March agreement with Wayne State University to support research into pregnancies with complications. On IP matters, Genaissance has been assisted by New York’s Morgan & Finnegan, Washington, D.C.’s Howrey Simon Arnold & White, and Boston’s Hale and Dorr. Genaissance expects to break even in 2005, when the first product royalties are anticipated. Until then Henderson expects to be working on “an ever-increasing number of transactions.” And she had better be. Science may make personalized medicine possible, but it’s the deals that will make it a reality.
Diana Hamlet-Cox Incyte Corporation Palo Alto Patents: 729 Business: Genetic research and drug discovery Diana Hamlet-Cox always thought she’d be a scientist, not a lawyer. But when she was in graduate school for biological chemistry and molecular biology, Hamlet-Cox decided that research was not for her. So after she received her doctorate at the University of California at Los Angeles in 1984, Hamlet-Cox took a job as a biotechnology consultant at Rand Corporation. On the side, she was a tenants’ rights activist at her apartment building, arguing before the housing court. In 1987 she saw a help-wanted ad for Millen, White, Zelano & Branigan, an Arlington, Virginia, IP firm. The firm was looking for a biochemist with a Ph.D. and an interest in the law. She had the Ph.D. and figured that her housing court experience met the other qualification. “They called and told me what the job was. I said, ‘Patent, what’s a patent?’ ” Within a year, she was a patent agent at Millen, White, attending law school at night at George Mason University. She stayed with the firm for 11 years, leaving in 1999 to join Incyte Corporation. Today, as vice president of intellectual property at Incyte, Hamlet-Cox knows a few things about patents. The genomics company is the largest commercial holder of gene patents in the world. Led by Hamlet-Cox’s efforts, Incyte held 729 U.S. patents at press time � and counting. It also has patent applications pending on 30,000 gene sequences. Most of these will not be prosecuted to completion because of the cost. Besides overseeing a team of 20 lawyers, patent agents, and other staff, Hamlet-Cox manages the company’s IP portfolio, reviews licensing agreements, and advises her team on how to conduct business with the patent office. Far away from the lab, Hamlet-Cox now finds herself in the middle of a highly charged policy arena. Broadly framed, the controversies surround the issue of whether gene patents are ethical and whether they hinder or promote genetic research. “Gene patenting is the biggest controversy Incyte is facing,” says Lila Feisee, who is director of IP at the Biotechnology Industry Organization (also known as BIO). “Diana presents [the issues] in the right way. She’s very creative in handling controversy.” Since its inception in 1991, Incyte has built a business by licensing access to its extensive database � a complete collection of known human genes. The company has licensing agreements and partnerships with such companies as Agilent Technologies, Inc., Genentech, Inc., and Medarex, Inc. As the number of new genes to be patented slows down over the next few years, Incyte plans on switching its focus. The company will increasingly use its gene-based research to discover new medicines. The challenge will be to find commercially useful gene sequences. Hamlet-Cox isn’t just thinking about Incyte’s future. What’s next for this unlikely lawyer? “I guess I would become general counsel somewhere,” she says. “Wherever I end up, this position will be the standard I will apply in evaluating my job satisfaction.”
Philip McGarrigle Affymetrix Santa Clara, California Patents: 230 Business: Genetic tools Since 1989, Affymetrix, Inc.’s IP strategy has been to patent as much as possible as quickly as possible. And Philip McGarrigle, as chief intellectual property counsel, is charged with making sure this happens. “You want to file early, to get your stake in the ground,” says the 48-year-old lawyer. Spun off from Affymax N.V. in 1993, Affymetrix now has more than 230 U.S. patents issued and close to 400 pending. McGarrigle was a patent attorney at Chevron Corporation, Chiron Corporation, and Kaiser Aluminum & Chemical Corporation before coming to Affymetrix in 1998. That was when his crash course in biotechnology began. Although McGarrigle has an undergraduate degree in biology, he had no additional scientific education. Today, McGarrigle is educating others about biotech. He has taken company scientists along with him to make presentations to the Japanese patent office in Tokyo, the European patent office in Munich, and the U.S. Patent and Trademark Office. In addition to those road shows, McGarrigle has handled four patent interference proceedings to defend the company’s patents before the U.S. patent office, and does about half of Affymetrix’s patent prosecutions. A separate department handles licensing. For help with prosecution, Affymetrix turns to Philadelphia’s Morgan, Lewis & Bockius, San Francisco’s Townsend and Townsend and Crew, and Washington, D.C.’s Banner & Witcoff, among others. The biotech company’s “patent all you can” strategy is surprising at first, when you consider that Affymetrix’s general counsel, Barbara Caulfield, has been an outspoken critic of gene patents. But Affymetrix’s patents are different. The company owns the tools that researchers use to analyze the human genome. Its groundbreaking microarray acts as a sort of molecular microscope that stores and displays DNA. Affymetrix’s customers � pharmaceutical companies, universities, and research organizations � use its microarray to learn more about the cells’ genetic properties. If patents lock up the genes that comprise the genome, Affymetrix customers get bogged down in buying licenses. Affymetrix has developed a reputation for aggressively defending its patents. “We want to make sure we protect our freedom to operate,” says McGarrigle, in a tone that reflects the company’s tough approach to IP protection. Last year Affymetrix sued Incyte for patent infringement, after Incyte used a different kind of microarray developed at Stanford University. The suit was settled last December. In previous years, Affymetrix faced off against Oxford Gene Technology, Ltd.; Hyseq, Inc.; Incyte; and Applera Corporation. In litigation, Affymetrix generally calls on San Francisco’s Orrick, Herrington & Sutcliffe, Los Angeles’s Irell & Manella, and London’s Bristows. “People have collaborated against us very carefully,” says McGarrigle, betraying the defensiveness of a lawyer on the receiving end of a suit. “When you’re the leader, people try to get you in every way they can.” Freelancers Alan Cohen, Alexandra Dell, and Daphne Eviatar as well as Victoria Slind-Flor, the West Coast correspondent of IP Law & Business, contributed to this piece.

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