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The
bio-innovation conference: where biotechnology and intellectual
property meet
Maine Science and Technology Foundation
June 27, 2002
DAY
ONE
Protein
and Gene Discoveries: Revolutionary Drugs, Controversial
Patents
Scott
Brown, Esq., Millennium Pharmaceuticals, Cambridge,
MA
Steven
Lazar, Esq., GPC Biotech Inc., Waltham, MA
Moderator:
Christine Vito, Ph.D., Esq., Testa, Hurwitz & Thibeault,
Boston, MA
What
does it mean to patent a gene? Clear answers have been
a moving target over the last decade as the U.S. Patent
and Trademark Office (PTO) has evolved its requirements
to catch up with innovation in the biotechnology industry.
Under present regulations, genes are eligible for patenting
if the patent applicant establishes the gene's utility
and meets other PTO standards.
Changes
in PTO requirements for gene patents mean that not all
gene patents are equal, but Scott Brown said he believes
that "disallowing gene patenting could result in an
unwanted consequence: decreased flow of gene information."
In the absence of gene patents, said Brown, "competitive
advantage will likely be obtained by keeping genetic
information as a trade secret," which would mean no
access to the information until clinical testing of
a drug.
Brown
said that companies have made a "huge capital investment"
to generate substantial information on genes and that
"recouping investment requires commercial return." Although
Brown said that under current PTO requirements, gene-based
inventions are "held to substantially higher standard
than any other types of inventions," he believes that
scrutiny makes a good political compromise because he
prefers to see some – rather than no – gene properties
under patent protection.
Despite
his corporate perspective on gene patents, Brown said
he's still uncertain of the ramifications of patenting
DNA sequences, including whether or not patents will
slow research. "The commercial fruits of it really aren't
out yet," said Brown, "they're just starting to hit
the market now."
Many
technologies and products on the market, said Lazar,
are discovered in academic research institutions, patented,
and then licensed to biotechnology companies. "What
biotechnology companies specialize in is taking those
inputs… and basically advancing this academic innovation
to a point where it has more of a commercial likelihood
of succeeding," he said. Those outputs, said Lazar,
are frequently licensed to the pharmaceutical industry.
Lazar
discussed exceptions to regulations on patent infringement,
including a statutory research exemption that allows
researchers to use patented products or technologies
if the research is used to develop and submit information
for FDA approval of medical devices, biological products,
and medicines.
Lazar
also emphasized that new requirements for patent applications
require information on the invention's real-world utility,
novelty, non-obviousness, and enablement. Enablement
must include a written description, which, for biotechnology
and chemical invention applications, must include information
on structure.
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