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Working
at the Nexus of Law and Science
By Barbara Spector
As
a political science major at Bryn Mawr College,
Ursula Bartels ’79 was inspired by the political
philosophy courses of Stephen G. Salkever, Mary
Katharine Woodworth Professor of Political Science.
Her role model was Bryn Mawr’s former president
Mary Patterson McPherson. The life sciences? They
were far from her mind.
"I
was not a science person at all at Bryn Mawr,"
says Bartels, who took geology to satisfy her
undergraduate science requirement. Her passion
was student government. After graduating with
a degree in political science, Bartels worked
as a paralegal and entered law school at the University
of Virginia a year later. Today, she helps researchers
navigate one of science’s most crucial frontiers
— the nexus between research and the law.
Diversity
of Views
As
vice president and general counsel of Boehringer
Ingelheim Corporation, Bartels, 43, is responsible
for all legal affairs at its five U.S. subsidiaries
and is legal counsel and corporate secretary to
the board of directors. Boehringer Ingelheim,
headquartered in Germany, is the world’s
largest privately held pharmaceutical company.
The company’s products target many disease
areas, but it focuses especially on respiratory
and AIDS medications. In 1999, it reported revenues
of about $4.6 billion. Bartels enjoys investigating
the cutting edge of both law and science. "Part
of the fun of this job is that I’m working
with an underlying substantive topic that is challenging,"
she says.
While
she didn’t do molecular biology or immunology
research in college, Bartels developed skills
that have served her well in her career.
"When
I was at Bryn Mawr, I learned how to think and
ask questions — how to have an open mind
toward a diversity of views," she says. A
stint as a researcher for a former general counsel
to the Food and Drug Administration, Richard Merrill,
sparked her interest in food and drug law. A call
from a headhunter in 1988 brought her to SmithKline
Beecham (now Glaxo SmithKline). She joined Boehringer
Ingelheim nearly two years ago.
Science
Outpaces the Law
From
her office in Ridgefield, Conn., Bartels leads
a team of attorneys who every day face a fundamental
dilemma: "Science is clearly evolving a lot
faster than the law," she says. "The
law has to scramble to catch up."
One
gray area involves patient privacy issues. "We’re
living in the information age, in which anything
you want is available on the Internet," Bartels
notes. Another issue yet to be resolved is whether
pieces of the genetic code can be patented. Although
biomedical research organizations are pressing
forward with patent applications, the courts have
yet to determine whether the patents will hold
up, she says.
"Business
is all about taking intelligent risks," Bartels
asserts. "If you only did things that were
safe, you wouldn’t get anywhere." Her
department educates research staff about the potential
legal pitfalls that inevitably accompany scientific
progress. Lawyers sit in on scientific meetings
and discuss with company researchers the necessity
of patenting the assays or processes used in their
investigations.
One
of her department’s more routine functions
is developing contracts for Boehringer Ingelheim’s
funding of academic research and determining which
institution will own the rights to the products
of experiments Boehringer Ingelheim supports.
"The critical thing is the contact among
the scientists," Bartels stresses. When researchers
collaborate, "kinetic things happen,"
she says. "The idea from a business standpoint
is to be able to harness that."
Global
Business, Multinational Law
The
fact that Boehringer Ingelheim is a global corporation
also poses challenges for the legal department.
Company researchers, seeking to simplify procedures,
would like to have a purchase-order template they
could use to contract for all supplies. Corporate
attorneys, on the other hand, recognize that a
contract that is valid in the United States may
not apply in Belgium. "We have to explain
that you can’t use a single purchase order
all around the world," Bartels says. "The
world is struggling to get to a place where the
law is as globalized as business is."
Bartels
and her staff of 15 attorneys — several of
whom have advanced degrees in science — draw
up contracts with biotechnology company partners
that deal with the details of screening assays
and combinatorial chemistry techniques. Her department
frequently must provide legal input to Boehringer
Ingelheim’s sales and marketing staff on
the language used in product claims to ensure
compliance with FDA regulations. Through meetings
with company researchers, she’s had plenty
of science lessons. "Often they want to start
at Level 1,000, and you have to start at Level
1," she says. "I tell them that I need
to ask a lot of questions, and I hope that they
won’t mind."
Her
nonscientific background has its benefits. When
Boehringer Ingelheim goes to court with a patent-infringement
case, for example, she’s able to see the
scientific evidence the way a juror might see
it — which helps frame arguments and prepare
trial exhibits that lay out the science in an
understandable way.
Bartels’
work takes her to Europe four times a year to
meet with top officials at the company’s
headquarters in Germany’s Rhine Valley. When
she’s not traveling, her days start between
7:15 and 7:30 a.m., a schedule that enables her
to make phone calls to Germany during business
hours in Europe. She tries to leave the office
by 6:30 p.m. to have dinner with her partner,
Laura Zucker, and their three children, ages eight,
six and two. "I’m not sure I could do
this job if I were a single mom," she says.
About the Author
Barbara Spector writes on
science and technology as well as business topics.
She is the executive editor of Family Business
magazine and former editor of The Scientist.
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