Federal Courts Improvement

The 94 federal judicial districts are organized into 12 regional circuits, each of which has its own court of appeals. With the Federal Courts Improvement Act ("FCIA") of 1982 (167), the U.S. Congress created the Court of Appeals for the Federal Circuit and vested it with exclusive jurisdiction over patent cases. One of its objectives in doing so was to promote uniformity in the area of patent law and diminish the uncertainty created by inconsistent application of the patent law among the regional circuits (168). The Federal Circuit also hears appeals of patent matters from the PTO, the Court of Federal Claims, and the ITC, as well as appeals of a variety of nonpatent matters. Matters involving issues of patent law make up a substantial portion of the Court s docket, and the Court is considered to have specialized expertise in the patent area. 

In response to these escalating compliance demands, several companies, especially in the blood bank and fractionated plasma product industry, have either gone out of business or signed consent decrees of permanent injunction that eifectively allow FDA to control and oversee the function and improvement of the company. Specific plans, time lines, and personnel issues must be filed with, accepted, and overseen by FDA and supervised by the federal courts. Violations of the negotiated (i. e., dictated by FDA) conditions constitute a contempt of court with increasingly serious penalties. With not only the company but also the chief executive officers being named as defendants in the case, appropriate attention is paid to the plan at all levels of the company. ... 

More complexity is created by judicial decisions. Under OCSLA and other laws, final regulatory decisions such as issuance of a permit or enactment of a rule can be appealed to a federal court by individuals, companies, and other private parties who claim that their interests are impacted by such agency action. 5 The subsequent judicial review may affirm the regulatory action in question or find it invalid on grounds that it is arbitrary, or lacks a sufficient factual basis, violates procedural requirements, exceeds the agency s mandate, or conflicts with a constitutional doctrine. Because agency actions are frequently appealed, fear of judicial review and the delays and costs such cases incur, has the effect of suppressing the timely enactment of improved rules. 

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