On March 30th,
the Federal Trade Commission filed a lawsuit against drug manufacturer Endo
Pharmaceuticals, alleging that Endo is paying generic drug manufacturers in order to
delay the release of lower cost generic versions of their drugs, Opana ER and
Lidoderm.
Generic drugs
come to market when the patents on name brand drugs expire. This results in branded
drug companies losing their monopoly on the market for these drugs, forcing
them to compete for the first time with their lower-cost counterparts. Branded
drug manufacturers have figured out that it will cost them less money to pay a
settlement to generic manufacturers to delay the release of these drugs rather
than to have directly compete with lower-cost versions of their drugs. At the
same time, generic manufacturers make money without manufacturing a product. It
is a win-win for drug manufacturers, but not necessarily for consumers.
This is not
the first time this type of tactic has been used by branded drug manufacturers.
In fact, it has been used so often that is has acquired a nickname,
“pay-for-delay”, and stopping this practice has become a top priority for the FTC.
This practice
has evolved as a result of Hatch-Waxman litigation, known colloquially as Orange
Book litigation. Oftentimes, generic manufacturers have to file lawsuits to
compel branded drug companies to release expired patents on name brand drugs so
they can bring generics to market. This type of litigation has become big
business, with billions of dollars at stake. “Pay-for-delay” essentially
bypasses this process, saving both branded and generic manufacturers time and
money.
To get the
latest updates on this case and other Orange Book litigation, attorneys can
sign up for Docket Alarm— the only legal research platform that offers
attorneys a suite of tools to stay abreast of Orange Book litigation. Users can
track updates to the Orange Book, search Orange Book correspondence, and view
Patent Trial and Appeal Board analytics for Orange Book litigation. Download
Docket Alarm’s free report on Orange Book litigation today at docketalarm.com/welcome/Big-Pharma-Patent-Litigation-Infographic.
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Tara Klamrowski is the director of
IP content at One400. She writes about current IP issues, IP trends, and how
Docket Alarm can help attorneys and their clients achieve success.
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Docket Alarm is an advanced search and litigation tracking service for the Patent Trial and Appeals Board (PTAB), the International Trade Commission (ITC), Bankruptcy Courts, and Federal Courts across the United States. Docket Alarm searches and tracks millions of dockets and documents for thousands of users.
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