over the availability of affordable health care have focused national attention
upon patents and other intellectual property rights awarded to
pharmaceutical firms. Legislation that was introduced before, but not
enacted by, the 112th Congress proposed amendments to the
Hatch- Waxman Act, legislation dating from 1984 that governs intellectual
property rights in pharmaceuticals and other regulated products. Recent
rulings from the federal judiciary regarding the Hatch-Waxman Act may be
pertinent to future congressional consideration of that statute. Both the
judicial holdings, as well as possible legislative changes to the Hatch-Waxman
Act, potentially affect the availability of both brand-name and generic
drugs in the United States.
The Hatch-Waxman Act includes two core provisions that impact the enforcement
of patent rights by brand-name firms against generic pharmaceutical
companies. 35 U.S.C. §271(e)(1) creates a statutory “safe harbor” that
exempts firms from claims of patent infringement based on clinical trials
and other acts reasonably related to seeking marketing approval from the Food
and Drug Administration (FDA). The explicit wording of that statute does
not preclude activities that occur after the receipt of FDA marketing
approval from the “safe harbor.” Two recent opinions from the U.S. Court
of Appeals for the Federal Circuit are arguably in tension over whether
post-approval acts are exempted from infringement, however.
A second provision, 35 U.S.C. §271(e)(2), allows a brand-name drug company to
enforce its patents against a potential generic competitor at such time
that the generic firm files an application—a so-called Abbreviated New
Drug Application (ANDA)—with the FDA seeking marketing approval. Although
courts have stated that this litigation may only be based upon patents
identified to the FDA and listed in the so-called “Orange Book,” the express
wording of the statute does not appear to impose this requirement. This
issue has yet to be conclusively resolved in the courts.
Should Congress conclude that the current situation with respect to 35 U.S.C.
§271(e) is satisfactory, no action need be taken. If Congress wishes to
intervene, however, then some options present themselves. Congress could
stipulate whether 35 U.S.C. §271(e)(1) applies to acts that occur following
the award of FDA marketing approval or not. Congress could also explicitly state
whether 35 U.S.C. §271(e)(2) establishes a cause of action for infringement of
patents that have not been listed in the Orange Book.
Date of Report: January 17, 2013
Number of Pages: 13 Order Number: R42354 Price: $29.95
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