LQ Sign Of The Times

March 6, 2006
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With the continued growth of biotechnology and life sciences, more and more law firms are setting up specialized legal practice areas to serve biotech, pharmaceutical, medical device and health care clients.

Dykema Gossett, for instance, has had a biotechnology and life sciences practice in place since early 2002, serving both small start-ups and large public companies.

Attorney Jin-Kyu Koh helped Dykema Gossett form the practice, which is made up of 20 attorneys from all 11 of the firm’s major practice groups. Koh, a corporate lawyer and co-leader of the practice group, said the firm has experienced a significant increase in its biotechnology and life sciences client base since then. The firm is “constantly looking” to expand the practice, he noted.

Koh attended a biomedical expo in Ypsilanti in October 2001, shortly after former Gov. John Engler established the Life Sciences Corridor.

“There was this buzz about biotech and life sciences throughout the entire state,” he recalled. “That motivated me to start a biotech and life sciences practice at Dykema Gossett. It seemed to me that this was an expanding area that we should get heavily involved in right away and, in fact, had the expertise for.”

The Dykema Gossett practice group also maintains close ties with venture capitalists interested in biotech and life sciences investment, and it helped form the Michigan Venture Capital Association, Koh observed.

“We have strong relationships with research universities and research institutions, too, because they like to spin out their technology,” Koh added. 

Koh doesn’t have a biotech background; he’s a corporate lawyer who deals with venture capital, mergers and acquisitions and general contract work. But after hearing about the biotech firms in Michigan, he figured his firm could capture some of that business with the legal expertise and talent it already had in-house.

Just like any other kind of company, a biotech company needs to raise money, they have employee issues, it needs to lease real estate and is in the business of buying and selling companies. Right now, he said, the “biggest, biggest, biggest” issue for Michigan life sciences companies is securing financing and/or grant funding.

However, an intellectual property lawyer working in the life sciences arena really needs the technical — biotech, biology, chemistry — background.

“In the intellectual property arena, we have people with biology degrees and Ph.D.s, FDA experience, and folks who had backgrounds as general counsel at Abbott Labs, for example.”

Warner Norcross & Judd actually started putting together a biotechnology, life sciences and medical device industry group about five years ago when various partners developed client relationships in the industry, said Partner Greg Bondarenko, who oversees the practice group. The group’s six attorneys have a range of specialties that includes intellectual property, regulatory compliance, patent, software and technology transfer, and information technology issues that most life sciences and medical device companies face.

Warner Norcross is presently seeking an attorney who specializes in biotech to deal with specific “high-tech biotech” legal issues, and Bondarenko said he’d like to expand the practice group over the next four to six years.

“Some clients did require more specialized legal services, so we just took it upon ourselves to go learn that niche of law to counsel them on legal issues,” he noted, adding that nearly every lawyer in the practice group has committed to attending seminars and training sessions to improve their ability to counsel clients in that industry group.

He said smaller companies in the industry are seeking the firm’s assistance with anything from FDA compliance and medical device reporting acts to everyday business needs, such as corporate structure and tax planning. Bondarenko anticipates more legal issues will arise as scientists delve deeper into genetic research.

“All across the nation you hear of multiple lawsuits and theoretical papers coming out regarding the implications of genetics and genetic engineering. I think it’s a really developing area, and you can be certain that there will be some pretty significant cases that come from that area.”

Price, Heneveld, Cooper, De Witt and Litton LLP has been doing work for pharmaceutical companies for many years and has several attorneys who work with medical device companies, an area where a lot of commercialization is going on right now in Grand Rapids, said Partner Douglas Siegel. The firm’s clients include private companies, research institutions and academic research departments.

A couple of Price Heneveld attorneys have biochemistry backgrounds. Siegel, who has been an attorney since 1985 and a patent attorney since 1989, earned a master’s degree in cell and molecular biology from MichiganStateUniversity last April. His coursework included molecular biology, cell structure and function, animal biotechnology, microbial genetics and plant biotechnology.

“I saw what I viewed as an opportunity in West Michigan to become more involved with biotechnology to grow as West Michigan grows,” Siegel said. “You have to be able to understand the inventions. Some of them are extremely technical, and if you don’t have the proper training, you really can’t do the work.”

He said there are a lot of joint development issues in the biosciences, such as when a research and development company teams up with a company that commercializes inventions. In those cases, there has to be some sort of joint development, licensing or material transfer agreement that addresses the use of one party’s property or inventive concept, and how the new invention is going to be shared with the other party, he explained.

What makes the biotechnology and life sciences area so interesting to Siegel is that it’s a relatively new field that’s still evolving. One of the issues unique to biotech, he noted, is the volume of data that the U.S. Patent Office requires for a company to properly disclose its invention — particularly when it is related to genetics. To describe a gene, for example, may require the description of thousands or tens of thousands of nuclearic acids in a sequence, Siegel explained.

“You have to disclose the entire sequence to the patent office so that they know exactly what you’re claiming and infringers know exactly what it is they’re not allowed to do. The patent office has never had to handle that kind of a volume of data as part of the disclosure of a patent application.”     LQ

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