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The increasing use of genetics in everything from investigating crimes to improving food is keeping biotech lawyers busy. There’s only one problem: Scientific discoveries are invading the legal world so quickly that there aren’t enough biotech attorneys to handle the workload. Biotech lawyers say the demand for their legal specialty has grown tremendously over the last five years — a period during which science has recorded several watershed discoveries, including the sequencing of the human genetic code, cloning, gene-based therapies and genetically engineered crops. These advances are spawning a wide spectrum of legal battles, lawyers assert. 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 the government is 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,” said Raymond Van Dyke, a biotech lawyer and partner in Nixon Peabody’s Washington office. “As technology races ahead, these wacky areas of law come out. This is a relatively new area . … It’s the merger of two worlds: the world of biology and the world of information technology. You’re creating new terrain and you gotta tweak existing law to capture that.” At Arizona State University, producing more biotech lawyers has become a top priority as its College of Law plans to offer the nation’s first Master of Laws (LL.M.) degree program in biotechnology and genomics next year. Arizona State launched the program in anticipation of the need for legal expertise as Arizona’s biotech industry expands. Other emerging hotbeds for biotechnology include Minnesota; Florida; Atlanta; Salt Lake City; and Austin, Texas. “There’s a lot of sense that the 21st century is going to be the century of the gene,” said Gary Marchant, an Arizona State law professor and executive director of the Center for Law, Science & Technology, which will oversee the program. “And I think biotechnology is going to be affecting many different types of businesses and industries.” He added that “[g]overnments and industries are really seeing [biotechnology] as a major economic force of the future, and where business goes, law goes.” According to Marchant, the program will address current and emerging legal issues surrounding biotechnology, which include: � Privacy and confidentiality involving genetic IDs and DNA tests. � Regulation of genetically engineered food, drugs and plants. � Liability in malpractice cases involving genetic testing. � Forensic evidence. � Intellectual property involving patents for various discoveries. Marchant said that since the program was announced last month, he’s been inundated with calls from more than 100 serious candidates, including students, attorneys and judges, who want to sign up. Given this reaction, he may consider increasing the size of the first class to 30 from 10. “Clearly, there’s a need for this,” Marchant said. HELP US OUT “The more the industry grows, the more we’re going to need attorneys to counsel these companies,” said patent attorney Murray Spruill, who has a Ph.D in genetics and a law degree from George Washington University. “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 Raleigh, N.C., office, 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, he has a bag of that corn seed hanging on the wall of his office to remind him about how far 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,” Spruill said. “For 20 years we’ve been telling people how great it’s going to be, what biotechnology is going to do and the impact it’s going to have on our lives. And today we’re still telling people how great it’s going to be.” Attorney Ed Korwek, who for 23 years has helped drug and agricultural companies get governmental approval for their products, 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,’” recalled Korwek of Hogan & Hartson in Washington. “The human genome project is a massive development that will have effects for years in the legal professions.” DISCOVERY TRIGGERS ISSUES Like Korwek, many lawyers believe the mapping of the human gene is perhaps the most significant discovery in recent history, spawning a host of issues in medicine and diagnostics. They say that in recent years, 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 tailoring of drugs for different people. “These are cutting-edge technologies. They require attorneys who can ride this wave of innovation,” said Van Dyke, who represents a pharmaceutical company that is researching cancer drugs. Since the human genome announcement in 2000, dozens of lawsuits have also hit the biotech industry. Among the most notable was the StarLink corn case, in which farmers in that year 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 farmer’s suit was filed against StarLink Logistics Inc. and Advanta USA. The farmers settled for $112.2 million, with each farmer likely to receive $1 to $2 per affected acre in the form of a prepaid debit card. Payments are still forthcoming. In re StarLink Corn Products Liability Litigation, MDL No. 1403 (N.D. Ill.). 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 misforecasting 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. Molloy v. Meier, nos. C9-02-1821 and C9-02-1837). Similar rulings have come down in several other states, including California, Colorado, Florida and New Jersey. California attorney Daniel Lamb, who has spent the last five years counseling biotech companies on how to avoid being sued, said it’s crucial for lawyers to have an understanding of science. For example, he said, knowledge of plants and agriculture was essential to his winning a $175 million verdict in a 1999 breach-of-contract suit involving genetically altered corn and cotton seeds. Lamb, of Pillsbury Winthrop’s San Diego office, represented a company that sued another company for refusing to license a technology to genetically alter seeds to make them resistant to insects and weeds. Lamb alleged that this refusal cost his client potential future profits, and the jury agreed, awarding a $175 million verdict. The verdict was overturned in 2002. Mycogen v. Monsanto, No. 671890 (San Diego Co., Calif., Super. Ct.). “Knowledge of the technology was essential to demonstrating to the jury why it was that they should award that amount of damage. They had to appreciate the significance of the technology and why it was protected by a patent. Those are things that I essentially had to learn,” said Lamb. Coe Bloomberg, a partner in Jones Day’s Los Angeles office who practices biotech and intellectual property law, said biotechnology got a big boost from the U.S. Supreme Court in 1980, when it ruled that biotechnology was protected by intellectual property laws. In its landmark ruling, the high court found that anything man-made — including plants — was patentable. Diamond v. Chakrabarty, 447 U.S. 303 (1980). “That was really the case upon which biotech law was premised,” said Bloomberg, who helps the medical industry in drug research and diagnostic tool discoveries. Michael Ward, a biotechnology patent attorney whose specialty is plants, hails the Supreme Court ruling as being essential to the survival of science. “If it wasn’t for the original Supreme Court case, I don’t think we would have had a biotech industry,” said Ward of Morrison & Foerster in San Francisco, “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.” Bloomberg also cites a section of the U.S. Constitution as defending scientific freedom, saying it allows for individuals who develop new and useful improvements to receive limited rights of exclusivity to their creation in return for disclosing their ideas to the public. “Certainly [the forefathers] didn’t foresee biotechnology, but they understood that by definition there would be new and useful contributions to science that would impact on society, and it was desirable to promote that type of activity,” Bloomberg said.

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