	Background

The high cost and availability of health care in the United States have focused attention upon patents and other intellectual property rights available to pharmaceutical firms. Of particular moment to this discussion is the Hatch-Waxman Act, legislation that governs intellectual property rights with respect to pharmaceuticals and other regulated products. The Hatch-Waxman Act includes two core provisions addressing the enforcement of pharmaceutical patents. §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). 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. Two recent judgments from the U.S. Court of Appeals for the Federal Circuit are arguably in tension as to whether the statutory safe harbor is limited to activities performed prior to the award of FDA approval. As well, brand-name firms have attempted to assert patents against generic firms that they have not explicitly identified to the FDA. Next, the report considers judicial developments regarding the patent infringement provision of the Hatch-Waxman Act. The Hatch-Waxman Act exempts a generic firm from infringement suits as it prepares its ANDA. This issue may yet be placed before the courts in the future. Other firms may potentially assert patents that are not listed in the Orange Book under 35 U.S.C. Congressional Issues and Options

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 and therefore were not the subject of a paragraph IV certification.
Concerns 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.