Innovation in the Pharmaceutical Industry: The Process of Drug Discovery and Development - Innovation and Marketing in the Pharmaceutical Industry - page 31

Post - market monitoring and Phase 4 trials . Research on a new medicine continues
even after the FDA approval is obtained and the drug has been launched. As a much
larger number of patients start taking the drug, companies must continue to monitor
it carefully for newly found adverse effects. Periodic reports to the FDA are submit-
ted on a quarterly basis for the fi rst 3 years, and annually thereafter.
Sometimes, the FDA requires additional studies on the already approved drug in
what is known as Phase 4 trials. These trials can be set up to evaluate the long-term
safety of the new medicine. The company itself may also choose to conduct such
studies to assess the drug's potential benefi ts in other disease areas or for more spe-
cifi c patient populations (e.g., children, the elderly), leading to extended uses and
indications. 8
The distinct phases of the drug innovation process with their characteristics are
presented in Fig. 2.1 .

2.2.4 Protecting Intellectual Property: Patents

and Market Exclusivity

Pharmaceutical organizations can fi le for a patent on a new drug molecule they
have synthesized. In addition, they can obtain market exclusivity for the drug.
Although both patents and market exclusivity confer protection from competition for
a specifi c molecule, they are conceptually and functionally distinct from one another.
A patent protects the intellectual property of the fi rm from the time of its invention
and is unrelated to the drug's eligibility for commercialization. In contrast, market
exclusivity adds more years past the FDA approval for market launch and is meant
to hold off the entry of generic drugs. Patents and market exclusivity may or may
not run concurrently and may or may not encompass the same claims. While some
drugs have concurrent patent and exclusivity protection, others may have either
type, or none whatsoever.
Patents are typically issued on novel pharmacological compounds quite early in
the drug development process. They cover the active compound in a specifi c formu-
lation and for specifi c indications. Firms can fi le several patents associated with a
single drug, the fi rst of which typically protects the key compound (the core of the
drug as a specifi c new biomolecule or a new chemical entity [NCE]), while the sub-
sequent ones can be related to different indications or new formulations. In the USA,
patents can be granted by the Patent and Trademark Offi ce (PTO) anytime along the
development lifeline of a drug. Regardless of where the fi rm is in its clinical trials or
with the FDA approval process, patents expire 20 years from the date of fi ling.

8 This was the case with Vioxx ® , the anti-infl ammatory drug developed by Merck, which was vol-
untarily taken off the market in 2004 because of fi ndings about elevated risks for a heart attack or
stroke. The unexpected risks were unveiled during a follow-up study designed to test the effi cacy
of its active ingredient for the prevention of colorectal cancer (Cockburn 2007 ).