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Editor’s note — In the fall, IP Law & Business magazine, which, like IP magazine, is published by American Lawyer Media, profiled 10 lawyers that it had selected for its “Patent Hall of Fame.” In the interest of shining a particular spotlight on West Coast attorneys who are performing notable work in intellectual property, we are pleased to reprise here four of those profiles. BUILDING PATENTS — AND RELATIONSHIPS As a microbiologist, Lisa Haile could keep up with science. But science, it seemed, couldn’t keep up with her. “For me, getting a positive result every six months, that’s not enough,” says Haile, who co-chairs the life sciences group at Gray Cary Ware & Freidenrich’s San Diego office. Little wonder, then, that Haile is one of the most prolific biotech prosecutors around, averaging some 50 issued patents a year. Haile’s biotech credentials not only let her talk shop and strategy with inventors, but also help make her case with patent examiners at the U.S. Patent and Trademark Office, who can get a bit gun-shy around biotech applications. “All of these patents are hard to get through the PTO,” says Haile. “You have to know where to push. I’m on the phone with them every single day.” Her efforts have paid off in the form of a portfolio of novel and important patents. Haile’s work for Johns Hopkins University School of Medicine (a client she brought with her in 1999, when she left her previous firm, Fish & Richardson), has produced a family of patents for the Serial Analysis of Gene Expression (SAGE) technology, a widely used technique — licensed exclusively to Genzyme Corp. — that enables researchers to identify normal and cancerous cells. “SAGE is like a bar code,” explains Haile. “In a normal cell you’ll see a certain pattern. In a cancerous cell you’ll see a different pattern. SAGE lets you do comparisons very quickly.” The technology is used to determine how different drugs affect cancer cells, enabling researchers not only to screen new pharmaceuticals but also to pick the best drug for a specific patient by seeing how that patient’s cells respond to each treatment. Haile also prosecuted — again on behalf of Johns Hopkins — the patents for myostatin, a protein found to be important in regulating muscle growth. Researchers hope that by manipulating myostatin levels, they will eventually be able to treat various muscular diseases, notably muscular dystrophy. Myostatin may also be used to identify drugs to treat conditions such as diabetes and obesity. An avid “relationship builder,” as she puts it, Haile is a regular on the IP conference and committee circuit, which seems to be time well spent. In the past two years, Haile has carved out a niche — now accounting for about 15 percent of her practice — doing IP due diligence work for investors, including the venture capital firm Frazier Healthcare Ventures. While associates at the firm now handle much of the day-to-day interaction with clients, Haile is still the point person, she says, who is very much involved on the front end, talking to the inventors, then strategizing with her associates. The pace is frenetic; 12- to 15-hour days are the norm. But she says that was all part of the plan when she left the lab more than a decade ago. “A scientist is supposed to be asking questions, but you’re asking one question,” she says. “Now I work with so many great scientists, there’s almost no way I can be bored.” – Alan Cohen THE OBSESSIVE-COMPULSIVE LAWYER Al Halluin isn’t the type of guy who rests on his laurels. As an in-house lawyer for biotech pioneer Cetus Corp., Halluin wrote the patent for Interleuken II, one of the breakthrough anticancer drugs of the early 1980s. But Interleuken paled next to his next big thing. In 1984 Halluin learned about a new method a Cetus scientist developed for replicating DNA called polymerase chain reaction, or PCR. It is almost an understatement to call the technology — which acts like a photocopier for DNA — revolutionary. PCR has led to genetic testing in the courtroom. It has revolutionized drug research and medical diagnostics by enabling researchers to find faulty genes and identify viruses. It has also allowed scientists to map the human genome and has ushered in the technology behind cloning. Halluin pushed to get a patent for the technology. Today PCR is used in hundreds of labs around the world. The technology brought Cetus hundreds of millions of dollars in revenue and earned PCR inventor (and ex-Cetus scientist) Kary Mullis a Nobel Prize. As for Halluin, he received credit in a 1990 edition of Scientific American for being the first to spot PCR’s patent potential. “There were very few people — you could probably count them on one hand — who thought it was important at the time,” recalls Halluin. But Halluin adds that if a novel invention catches his fancy, he immediately starts thinking patent strategy. “I tend to be a little on the obsessive-compulsive side,” he says. “It’s part of my personality.” Halluin hasn’t managed to shake that trait in private practice. Since leaving Cetus for Washington, D.C.’s Howrey Simon Arnold & White in 1990 (he’s a partner in the firm’s office in Menlo Park, California), he’s written dozens of patent applications for a career total of more than 500 issued patents. Among them is a method for identifying a key gene related to breast cancer and a medicine to treat dry eye that is currently awaiting approval by the Federal Drug Administration. In 2002 he helped longtime client BioMarin Pharmaceutical Inc., secure a patent for an enzyme replacement therapy, recently approved by the FDA, for treating MPS-1, a rare genetic disease in children. In taking on a new patent application, says Halluin, he first makes sure he has a clear understanding of the science behind it. Next he tries to imagine what challenges it might face at the U.S. Patent and Trademark Office so that the application addresses potential objections. “I try to make sure they’ll see it the same way I do,” he says. Halluin spent four years as a patent examiner while attending night classes at the University of Baltimore Law School. That has given him the ability to explain complicated patent claims in a way examiners can relate to. “He’s taught me the human side of patent law — that you need to put yourself in the patent examiner’s shoes,” says Ben Yerxa of Inspire Pharmaceuticals Inc., one of Halluin’s clients. “Anyone can write an application. That doesn’t get you anywhere. You need to have a rapport [with the PTO] to get it through.” Halluin’s communications savvy hasn’t only helped clients. Over the years, he has managed to patent nine of his own inventions, including a batch of patents related to a new enzyme-based anti-clotting treatment for stroke and heart attack victims that he developed with help from scientists at Cetus. Eight years ago he even founded his own company, Halzyme Technologies Inc., to develop and eventually market the new drugs. But trying to juggle a biotech startup and a full-time patent practice isn’t easy. Says Halluin: “I just wish I had more time.” – Susan Hansen THE IMPORTANCE OF BEING MODEST Scott Harris may be a top-notch patent prosecutor, but he’d make one lousy press agent. Ask him about the business he brings into his firm, Fish & Richardson, and Harris will tell you that he’s “not much of a networker.” Press him further and you’ll learn — eventually — that Harris landed the firm’s two biggest clients, Intel Corp. and AOL Time Warner Inc., which together account for more than a third of Fish’s annual revenue. And if you ask about the patents Harris has worked on, he’ll rave about a technique to simulate sandblasted designs on jeans, casually throwing in that he’s worked, too, on revolutionary fuel cells and impossibly small devices that may, one day, literally cut cancer out of the human body. Harris, who works out of the firm’s San Diego office, is equally modest about his own goals. Right now, he’s “really shooting for a 10-hour day.” Wish him luck. While Harris still drafts between 60 and 80 new patent applications a year, he’s spending an increasing amount of time on strategy, passing some 300 to 500 other applications to lawyers in his group. “To me, strategy is the fun part of the job,” Harris says. “Trying to figure out how you’re going to screw your competitors.” Harris has also built a burgeoning practice — accounting for 30 percent to 40 percent of his workload — advising the firm’s clients on what he calls “new and screwy” technologies that are potentially worthy of their investment. While lucrative, the work can be thankless, as “90 percent of the stuff is just garbage,” Harris says. Indeed, he has been fired by a disappointed investor on more than one occasion only to be rehired when the next new technology came along. “It’s like Vegas for these guys,” he says. It’s little surprise that investors have taken to Harris. An electrical engineer by training (he attended night classes at George Washington University Law School while working at Comsat Corp. in Washington, D.C.), Harris has prosecuted a steady stream of potentially change-the-world patents. Foremost among these is a fuel cell patent, issued in 1997 to the California Institute of Technology, a client Harris brought with him to Fish in 1994 from Cushman, Darby & Cushman, where he’d been for 10 years. The Caltech patent covers a cell that runs without sulfuric acid and that uses methanol as its hydrogen source. The result is a cell small enough to fit into a laptop computer (and safe enough to take on an airplane). For laptop users, the cells might provide enough power to last a full day as opposed to the few hours provided by current batteries. For Caltech, it may bring vast riches. When an IP valuation firm examined the patent a year ago, it estimated its potential worth in double-digit billions. “So far, it’s taken in a few million,” says Harris, “but every Japanese laptop manufacturer has announced they will be using this.” Harris also prosecuted the patent for Caltech’s cell lysis device, which uses extremely small knives to split open human cells, a boon for medical researchers. The device — known as a micromachine — is built with the same processing techniques used to make an electronics chip. Down the road, one might see similar devices that latch onto cancerous cells and cut the disease out of an organ, one cell at a time. The patent didn’t come easy, though. Harris had to go before a U.S. Patent and Trademark Office examiner three times over the course of a year to make his case. A regular visitor to the PTO — he makes two or three weeklong trips each year on behalf of his toughest cases — Harris still spends some 30 percent of his time “writing up arguments to convince examiners.” Harris originated $6 million in client revenue in 2002. He landed one client in a pool-supply store after walking in for a pool filter and walking out with business from Chris Grace and his computer graphics company, Johnson Grace Corp. “The guy behind the counter didn’t speak English, so I helped Chris figure out what part he needed,” Harris recalls. Patent assignments followed, and when Grace sold his company, the buyer kept Harris on. That buyer was AOL. If Harris is really set on that 10-hour day, he may want to have his kids do the shopping from now on. – Alan Cohen THE LATE BLOOMER Gladys Monroy, the co-chair of Morrison & Foerster’s intellectual property group, waited a while before going to law school. But once she finished, as she was nearing 50, she wasted no time making her mark in patent law. As a second-year associate, in 1987, one of Monroy’s assignments was to write the patent application for the technology that led to groundbreaking blood-screening test for the hepatitis C virus, a key cause of liver disease. That in turn led to other related assignments. In the end, Monroy, who holds a Ph.D. in biochemistry, wrote five successful hepatitis C-related patent applications for biotech pioneer Chiron Corp. The patent portfolio is now worth an estimated $1 billion, says Monroy, and has led to major advances in the fight to control the spread of hepatitis C. “It’s had a tremendous impact on world health,” says Monroy, who spent over a dozen years as a biochemistry professor and researcher before enrolling at the University of San Francisco School of Law in the early 1980s. Monroy has worked to get Chiron’s blood-screening test patented in India, Japan, Australia and other countries. She also helped the company fend off major court challenges to the hepatitis C patents in the United States and the United Kingdom — both of which ultimately failed. Monroy started her law career at Ciotti & Murashige, a now-defunct patent boutique that operated in Menlo Park, California, and joined MoFo in 1991. After nearly 17 years as a biotech patent lawyer, Monroy estimates that she has written (or supervised associate work on) at least 300 patents covering biotech breakthroughs in everything from cell-based immunology to cancer-gene therapeutics. With every patent application, Monroy says it’s key to have a thorough understanding of the invention. But just as important, she believes, is the ability to project how the technology and the market might develop. “It’s important that it not be [written] in a vacuum,” says Monroy. Marc Malandro, vice president of Sagres Discovery Corp., one of Monroy’s clients, values her approach. He says Monroy has played a large role in the company’s efforts to win protection for its work in identifying and developing targeted therapies for cancer-causing genes. “She’s helped us craft a difficult patent strategy,” says Malandro. Monroy put together the template patent application that Sagres used to win patent protection for some 1,500 individual genes. Longtime client Kim Clary of Targeted Genetics Corp. also looks to Monroy for IP strategy. “She knows the science as well as our in-house scientists,” says Clary. Monroy also knows how to write an application that homes in on the distinguishing features of a given invention, while still winning broad protection. Says Clary: “She can write an application that will blow you out of the water.” – Susan Hansen Alan Cohen is a freelance writer in New York City who contributes to various American Lawyer Media publications. Susan Hansenis a freelance writer in New York City who contributes to various American Lawyer Media publications.

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