9/16/2004 USA (The National Law Journal) - The increasing use of geneticsin everything from investigating crimes to improving food is keepingbiotech lawyers busy.

There's only one problem: Scientific discoveries are invading the legalworld so quickly that there aren't enough biotech attorneys to handle theworkload.

Biotech lawyers say the demand for their legal specialty has growntremendously over the last five years-a period during which science hasrecorded several watershed discoveries, including the sequencing of thehuman genetic code, cloning, gene-based therapies and geneticallyengineered crops.

These advances are spawning a wide spectrum of legal battles, lawyersassert.

Drug companies are suing each other over patent rights. Farmers are suingthe makers of bio-engineered corn. Patients are suing doctors over genetictesting. Privacy rights are being raised in child-custody battlesinvolving DNA. And the government is under constant pressure to approvegenetically 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'sWashington office. "As technology races ahead, these wacky areas of lawcome 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'recreating new terrain and you gotta tweak existing law to capture that."

At Arizona State University, producing more biotech lawyers has become atop priority as its College of Law plans to offer the nation's firstMaster of Laws (LL.M.) degree program in biotechnology and genomics nextyear.

Arizona State launched the program in anticipation of the need for legalexpertise as Arizona's biotech industry expands. Other emerging hotbedsfor biotechnology include Minnesota; Florida; Atlanta; Salt Lake City; andAustin, Texas.

"There's a lot of sense that the 21st century is going to be the centuryof the gene," said Gary Marchant, an Arizona State law professor andexecutive director of the Center for Law, Science & Technology, which willoversee the program. "And I think biotechnology is going to be affectingmany 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 wherebusiness goes, law goes."

According to Marchant, the program will address current and emerging legalissues 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 beeninundated with calls from more than 100 serious candidates, includingstudents, 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 tocounsel these companies," said patent attorney Murray Spruill, who has aPh.D in genetics and a law degree from George Washington University. "Tobe very good in my area in patent law, in protecting technologies, youhave to have a very good grasp of the science."

Spruill, who heads Atlanta-based Alston & Bird's biotech practice groupfrom its Raleigh, N.C., office, is helping a drug manufacturer develop amedical diagnostic kit for breast and cervical cancer. His job entailsthree key elements: counseling companies on how to get a patent for aparticular invention, how to protect that patent and how to get it tomarket.

Among his past accomplishments was helping a Swiss company in 1996 get apatent for corn seed used to grow insect-resistant corn. Today, he has abag of that corn seed hanging on the wall of his office to remind himabout how far science has come, and how far it has yet to go.

"It is still an emerging field for lawyers because biotechnology is stillan emerging field itself," Spruill said. "For 20 years we've been tellingpeople how great it's going to be, what biotechnology is going to do andthe impact it's going to have on our lives. And today we're still tellingpeople how great it's going to be."

Attorney Ed Korwek, who for 23 years has helped drug and agriculturalcompanies get governmental approval for their products, remembers the dayin 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, bigthing that will happen. It will take years to unravel,' " recalled Korwekof Hogan & Hartson in Washington. "The human genome project is a massivedevelopment 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 perhapsthe most significant discovery in recent history, spawning a host ofissues in medicine and diagnostics. They say that in recent years,hundreds of companies have flocked to the U.S. Patent and TrademarkOffice, each seeking a patent on various gene discoveries. And scientistsare working continuously to detect and predict genetic variations, whichwill lead to the tailoring of drugs for different people.

"These are cutting-edge technologies. They require attorneys who can ridethis wave of innovation," said Van Dyke, who represents a pharmaceuticalcompany that is researching cancer drugs.

Since the human genome announcement in 2000, dozens of lawsuits have alsohit the biotech industry. Among the most notable was the StarLink corncase, in which farmers in that year filed a class action against themakers of StarLink, a variety of bio-engineered corn that accidentallyentered the food supply and allegedly hurt farmers.

The corn fiasco drew national attention when Kraft Foods Inc. in 2000recalled millions of Taco Bell-brand taco shells from groceries nationwideafter it was discovered that a variety of the gene-spliced corn notapproved for humans had slipped into the Taco Bell shells.

The farmer's suit was filed against StarLink Logistics Inc. and AdvantaUSA. The farmers settled for $112.2 million, with each farmer likely toreceive $1 to $2 per affected acre in the form of a prepaid debit card.Payments are still forthcoming. In re StarLink Corn Products LiabilityLitigation, MDL No. 1403 (N.D. Ill.).

According to a 2003 PricewaterhouseCoopers study, biotechnology firms alsohave been hit with a growing number of investor lawsuits in recent years.The study found that the number of suits against biotechnology companieshas tripled in recent years, from 10 in 2001 to 30 in 2003.

The lawsuits cover a range of allegations, from concealing pivotal Foodand Drug Administration communications to misforecasting the performanceof core company products. Among those sued include an HIV drugmanufacturer, a developer of heart disease remedies and a company thatmarkets immune-system boosters.

And in a recent medical malpractice case, the Minnesota Supreme Courtruled that doctors may have a duty to share a patient's genetic testingresults with others-primarily family members-who might be affected by it.Molloy v. Meier, nos. C9-02-1821 and C9-02-1837). Similar rulings havecome down in several other states, including California, Colorado, Floridaand New Jersey.

California attorney Daniel Lamb, who has spent the last five yearscounseling biotech companies on how to avoid being sued, said it's crucialfor lawyers to have an understanding of science.

For example, he said, knowledge of plants and agriculture was essential tohis winning a $175 million verdict in a 1999 breach-of-contract suitinvolving genetically altered corn and cotton seeds. Lamb, of PillsburyWinthrop's San Diego office, represented a company that sued anothercompany for refusing to license a technology to genetically alter seeds tomake them resistant to insects and weeds. Lamb alleged that this refusalcost 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 jurywhy it was that they should award that amount of damage. They had toappreciate the significance of the technology and why it was protected bya patent. Those are things that I essentially had to learn," said Lamb.

Coe Bloomberg, a partner in Jones Day's Los Angeles office who practicesbiotech and intellectual property law, said biotechnology got a big boostfrom the U.S. Supreme Court in 1980, when it ruled that biotechnology wasprotected by intellectual property laws. In its landmark ruling, the highcourt 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," saidBloomberg, who helps the medical industry in drug research and diagnostictool discoveries.

Michael Ward, a biotechnology patent attorney whose specialty is plants,hails the Supreme Court ruling as being essential to the survival ofscience.

"If it wasn't for the original Supreme Court case, I don't think we wouldhave had a biotech industry," said Ward of Morrison & Foerster in SanFrancisco, "The ability to patent genes led to people willing to takechances...if that decision would have gone the other way, the biotechindustry would be nothing like it is today."

Bloomberg also cites a section of the U.S. Constitution as defendingscientific freedom, saying it allows for individuals who develop new anduseful improvements to receive limited rights of exclusivity to theircreation in return for disclosing their ideas to the public.

"Certainly [the forefathers] didn't foresee biotechnology, but theyunderstood that by definition there would be new and useful contributionsto science that would impact on society, and it was desirable to promotethat type of activity," Bloomberg said.