Cardinal Health 2010 Annual Report Download - page 33

I
nte
ll
ectua
lP
ro
p
ert
y
We rely on a combination of trade secret, patent, copyright and trademark laws, nondisclosure and other
contractual provisions, and technical measures to protect our products, services and intangible assets. We als
o
o
perate under licenses for certain proprietary technologies, and in certain instances we license our technologies t
o
third parties. All of these proprietary rights are important to our ongoing operations. We enforce our intellectua
l
p
roperty rights when they are infringed by others, and will continue to do so, where appropriate.
We have applied in the United States and other countries for registration of a number of trademarks and
service marks. Some of our marks are registered, but our applications may not always be granted. We also hold
common law rights in various trademarks and service marks
.
We hold patents relating to aspects of our distribution operations, including our nuclear pharmacy products
and service offerings. We also hold patents relating to medical and surgical products and devices, such as flui
d
suction and irrigation devices; surgical waste management systems; surgical and medical examination gloves
;
surgical drapes, gowns and facial protection products; and patient temperature management products.
We have a number of pending patent applications in the United States and other countries, and we intend to
p
ursue additional patents as appropriate. We may not always obtain the patents for which we apply. We do not
consider any particular patent, trademark, license, franchise or concession to be material to our overall business
.
R
egu
l
atory
M
atters
Our business is highly regulated in the United States at both the federal and state level and in foreign
countries. Depending upon their specific business and where they distribute, manufacture and sell their products,
o
ur subsidiaries may be subject to regulation by government entities including:
• the U.S. Drug Enforcement Administration (the “DEA”)
,
• the U.S. Food and Drug Administration (the “FDA”),
• the U.S. Nuclear Regulatory Commission (the “NRC”),
• the U.S. De
p
artment of Health and Human Services (“HHS”),
• state boards of pharmacy
,
• state controlled substance agencies
,
• state health departments, insurance departments or other comparable state agencies, and
• foreign agencies that are comparable to those listed above
.
These regulatory agencies have a variety of civil, administrative and criminal sanctions at their disposal.
T
hey can require us to suspend distribution of products and controlled substances or initiate product recalls; they
can seize products or impose significant criminal, civil and administrative sanctions; and they can seek
injunctions to halt the manufacture and distribution of products.
Distribution. The DEA, FDA and various state authorities regulate the marketing, purchase, storage an
d
distribution of
p
harmaceutical
p
roducts and controlled substances under various state and federal statutes
including the Prescription Drug Marketing Act of 1987. Wholesale distributors of controlled substances mus
t
hold valid DEA registrations and state-level licenses, meet various security and operating standards, and compl
y
with the Controlled Substances Act and its accompanying regulations governing the sale, marketing, packaging,
storage and distribution of controlled substances
.
M
anufacturing and marketing. Our subsidiaries that manufacture medical devices are subject to regulation
by the FDA and comparable foreign agencies including regulations regarding compliance with goo
d
manufacturing practices and quality systems. In addition, our Medical segment’s international manufacturing
o
perations may be subject to local certification requirements.
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