2007 Minnesota Biosciences

Minnesota is home to at least 425 biotechnology and biosciences organizations, according to a 2006 assessment of the state’s biosciences resources, conducted by the BioBusiness Alliance of Minnesota. That population is sure to swell as biological breakthroughs emerge and ignite commercial activity from the state’s robust research community, shouldered by the University of Minnesota and the Mayo Clinic. And as Minnesota’s biobusiness ranks expand, so too do the life science capabilities and resources of local law firms.

“Law practice basically follows the needs of the client. As life sciences expand in Minnesota, the experience base of lawyers will become greater,” says Minneapolis–based Lindquist & Vennum attorney Robert Thompson.

Patent Protection

The local legal landscape already boasts multiple IP specialists, likely the result of the area’s long history of cutting-edge corporations—from innovation-based 3M to medical-device pioneer Medtronic—in need of patent protection.

Intellectual property attorney Tim Conrad, of the chemistry/biotechnology practice group of the Minneapolis office of Merchant & Gould, represents mostly start-up companies attempting to transform new innovations into clinical and commercial applications, and is typically on board at the beginning of his client’s journey from laboratory discovery to marketplace introduction.

Trouble is, though, that journey is a perilous one for young bioscience firms and their platform technologies. Often times, these start-ups aspire to break in to mature industries, such as medical devices of biofuels, in which older, larger companies have the IP protection—and the financial strength—to box out fledgling firms. Add to that a complex and ever-tightening legal and regulatory environment and it becomes clear that patent protection practice is in a dynamic time.

“It will be very interesting to see how [the changing regulatory environment] plays out in terms of supporting the economic growth of small companies, and in the ability for them to maintain marketplace exclusivity,” says Conrad.

Regulatory Processing

But patents aren’t getting all the attention. Recently, a growing population of regulatory and transactional attorneys has emerged to counsel clients on issues related to U.S. Food and Drug Administration (FDA) regulations, fraud and abuse, clinical trials, and healthcare reimbursement. While such expertise has traditionally been clustered in Washington, D.C., where the laws governing this activity originate, that’s no longer the case. According to Mark DuVal, founder and president of Minneapolis-based DuVal & Associated, P.A., the vast majority of so-called “FDA lawyers” worked for the FDA before joining D.C.-based regulatory firms, which command hefty fees but provide limited service.

DuVal represents about 75 clients locally, primarily in the medical-device and pharmaceutical fields. He says his business background enables him to serve as a business consultant to his client—not simply a legal and regulatory advisor.