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The increasing use of genetics in everything from investigating crimes to improving food is keeping biotechnology lawyers plenty busy these days. But there’s one nagging problem. Scientific discoveries are invading the legal world so quickly that there aren’t enough biotech attorneys to handle the workload. Lawyers who practice in this area say the demand for their legal specialty has grown tremendously over the past five years. During that time, science has recorded several watershed discoveries, including the sequencing of the human genetic code, cloning, gene-based therapies and genetically engineered crops. These and other scientific advances have opened the way for a wide array of legal battles. Drug companies are suing each other over patent rights. Farmers are suing the makers of bio-engineered corn. Patients are suing doctors over genetic testing. Privacy rights are being raised in child-custody battles involving DNA. And federal regulators are under constant pressure to approve genetically altered foods and gene-based drugs. “There is a shortage of truly good people who are able to handle this,” says Raymond Van Dyke, a biotech lawyer and partner in Nixon Peabody’s Washington, D.C., office. “As technology races ahead, these wacky areas of law come out. It’s the merger of two worlds — biology and information technology. You’re creating new terrain and you’ve got to tweak existing law to capture that.” Producing more biotech lawyers has become a top priority at places like Arizona State University, where the law school next year plans to begin offering the nation’s first Master of Laws degree in biotechnology and genomics. The school is launching the program in anticipation of the need for legal expertise as Arizona’s biotech industry expands. “There’s a sense that the 21st century is going to be the century of the gene,” says Gary Marchant, an Arizona State law professor and executive director of the Center for Law, Science & Technology, which will oversee the LL.M. program. “I think biotechnology is going to be affecting many different types of businesses and industries.” And where new business and industries arise, lawyers inevitably follow. “The more the [biotech] industry grows, the more we’re going to need attorneys to counsel these companies,” says Murray Spruill, a patent attorney in Atlanta who holds a Ph.D. in genetics along with his law degree. “To be very good in my area in patent law, in protecting technologies, you have to have a very good grasp of the science.” Spruill, who heads Atlanta-based Alston & Bird’s biotech practice group from its branch in Raleigh, North Carolina, is helping a drug manufacturer develop a medical diagnostic kit for breast and cervical cancer. His job entails three key elements: counseling companies on how to get a patent for a particular invention, how to protect that patent and how to get it to market. Among his past accomplishments was helping a Swiss company in 1996 get a patent for corn seed used to grow insect-resistant corn. Today, a bag of the corn seed hangs on the wall of his office and serves as a reminder of how far the science has come — and how far it has yet to go. “It is still an emerging field for lawyers because biotechnology is still an emerging field itself,” says Spruill. Ed Korwek, a lawyer who has been helping drug and agricultural companies obtain governmental approval for their products for more than two decades, vividly remembers the day in 2000 when scientists first announced they had mapped the human gene. “When it came out, I sent around an e-mail saying, ‘This is a big, big thing that will happen. It will take years to unravel,’” recalls Korwek, a partner at Washington, D.C.’s Hogan & Hartson. “The human genome project is a massive development that will have effects for years in the legal professions.” Korwek is hardly alone among those who believe that the mapping of the human gene may well be the most significant scientific discovery in recent history — and one that will spawn a host of new issues involving medicine and diagnostics. In recent years, for example, hundreds of companies have flocked to the U.S. Patent and Trademark Office, each seeking a patent on various gene discoveries. And scientists are working continuously to detect and predict genetic variations, which will lead to the highly customized tailoring of drugs for individual types of patients. “These are cutting-edge technologies. They require attorneys who can ride this wave of innovation,” says Van Dyke, who represents a pharmaceutical company that is researching cancer drugs. Since the human genome announcement four years ago, dozens of lawsuits have also hit the biotech industry. Among the most notable was the StarLink corn case, in which farmers filed a class action against the makers of StarLink, a variety of bio-engineered corn that accidentally entered the food supply and allegedly hurt farmers. The corn fiasco drew national attention when Kraft Foods Inc. in 2000 recalled millions of Taco Bell-brand taco shells from groceries nationwide after it was discovered that a variety of the gene-spliced corn not approved for humans had slipped into the Taco Bell shells. The plaintiffs later settled for $112 million, with each farmer in the class likely to receive $1 to $2 per affected acre in the form of a prepaid debit card. Payments are still forthcoming. According to a 2003 PricewaterhouseCoopers study, biotechnology firms also have been hit with a growing number of investor lawsuits in recent years. The study found that the number of suits against biotechnology companies has tripled in recent years, from 10 in 2001 to 30 in 2003. The lawsuits cover a range of allegations, from concealing pivotal Food and Drug Administration communications to inaccurately forecasting the performance of core company products. Among those sued include an HIV drug manufacturer, a developer of heart disease remedies and a company that markets immune-system boosters. And in a recent medical malpractice case, the Minnesota Supreme Court ruled that doctors may have a duty to share a patient’s genetic testing results with others — primarily family members — who might be affected by it. Similar rulings have come down in several other states, including California, Colorado, Florida and New Jersey. Daniel Lamb, a partner in the San Diego office of Pillsbury Winthrop who has spent the past five years counseling biotech companies on how to avoid being sued, says it’s crucial for lawyers who practice in this area to possess a thorough understanding of the underlying science. For example, he says that knowledge of plants and agriculture was essential to his winning a $175 million verdict in a 1999 breach-of-contract suit in San Diego involving genetically altered corn and cotton seeds. In the case, Lamb represented a company that sued another one for refusing to license a technology to genetically alter seeds to make them resistant to insects and weeds. Lamb alleged that the refusal cost his client potential future profits. The jury agreed although the verdict was later overturned. “The jury had to appreciate the significance of the technology and why it was protected by a patent,” says Lamb. “Those are things that I essentially had to learn.” Michael Ward, a biotechnology patent attorney at San Francisco’s Morrison & Foerster, traces the origins of the biotechnology industry to a 1980 U.S. Supreme Court ruling that biotechnology was protected by intellectual property laws. In Diamond v. Chakrabarty, 447 U.S. 303, the court held that anything man-made, including plants, was eligible for patent protection. “If it wasn’t for the original Supreme Court case, I don’t think we would have a biotech industry,” says Ward. “The ability to patent genes led to people willing to take chances. If that decision would have gone the other way, the biotech industry would be nothing like it is today.” Tresa Baldas is a staff reporter at The National Law Journal, an ALM publication affiliated with IP magazine.

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