Cardinal Health 2009 Annual Report Download - page 32

Through its Healthcare Supply Chain Services segment, the Company holds patents relating to certain
aspects of its nuclear pharmacy products. Through its Clinical and Medical Products segment, the Company
holds patents relating to certain aspects of its automated pharmaceutical dispensing systems, automated
medication management systems, medical devices, infusion therapy systems, infusion administration sets, drug
delivery systems, infection surveillance and reporting systems, medical and surgical products and devices,
including surgical and exam gloves, drapes, gowns, respiratory equipment and respiratory therapy devices,
patient prep products, including antiseptic solutions and applicator devices, fluid suction and irrigation devices,
devices for interventional procedures and surgical instruments. The Company also holds patents relating to
certain processes and products across all segments.
The Company has a number of pending patent applications in the United States and certain foreign
countries, and intends to pursue additional patents as appropriate. It is possible that in some cases the Company
may be unable to obtain the patents for which it has applied. The Company has enforced and will continue to
enforce its intellectual property rights in the United States and worldwide.
The Company does not consider any particular patent, trademark, license, franchise or concession to be
material to its overall business.
Regulatory Matters
Food and Drug Laws
Certain of the Company’s subsidiaries may be required to register for permits and/or licenses with, and
comply with operating and security standards of, 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. Department of Health and Human Services (“HHS”), and various state boards of pharmacy, state controlled
substance agencies, state health departments and/or comparable state agencies as well as foreign agencies, and
certain accrediting bodies depending upon the type of operations and location of product distribution,
manufacturing and sale. These subsidiaries include those that:
• distribute and/or engage in logistics services for pharmaceuticals (including certain controlled
substances) and/or medical devices;
• manage or own pharmacy operations including retail, hospital, specialty or nuclear pharmacies;
• purchase pharmaceuticals;
• develop, manufacture, package or repackage pharmaceutical products and medical devices;
• market pharmaceutical and medical device products; and
• provide consulting services and solutions that assist healthcare institutions and pharmacies in their
operations as well as pharmaceutical manufacturers with regard to regulatory submissions and filings
made to healthcare agencies such as the FDA.
The DEA, FDA and various state regulatory authorities regulate the distribution of pharmaceutical products
and controlled substances. Wholesale distributors of controlled substances are required to hold valid DEA and
state-level licenses, meet various security and operating standards, and comply with the Controlled Substance
Act and its accompanying regulations governing the sale, marketing, packaging, storage and distribution of
controlled substances. The DEA, FDA and state regulatory authorities have broad enforcement powers, including
the ability to suspend the Company’s distribution centers from distributing pharmaceutical products (including
controlled substances), seize or recall products and impose significant criminal, civil and administrative sanctions
for violations of these laws and regulations.
Between November 28, 2007, and December 7, 2007, the DEA suspended the licenses to distribute
controlled substances held by three of the Company’s distribution centers. The DEA asserted that the Company
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