Patent Infringement and Experimental Use Under the Hatch-Waxman Act: Current Issues

John R. Thomas
Visiting Scholar

Concerns over the availability of affordable health care has focused national attention upon patents and other intellectual property rights awarded to pharmaceutical firms. Bills before the 112th Congress propose 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 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 brandname 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). Although the explicit wording of that statute does not preclude activities that occur after the receipt of FDA marketing approval from the “safe harbor,” the courts have recently held that this infringement exemption applies only to pre-approval activities.

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: February 9, 2012
Number of Pages: 12
Order Number: R42354
Price: $29.95

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