Section 337 of the Tariff Act of 1930 (19 U.S.C. §1337) is the primary option available to U.S. companies to protect themselves from imports into the United States of goods made by foreign companies that infringe U.S. intellectual property rights (IPR), such as patents, trademarks, and copyrights. The U.S. International Trade Commission (ITC) administers Section 337 investigations. The ITC is a quasi-judicial federal government agency responsible for investigating and arbitrating complaints of unfair trade practices. The majority of unfair competition acts asserted under Section 337 involve allegations of patent infringement. These cases tend to be complex and require adjudication by the ITC. In the case of most copyrights and trademarks, the Department of Homeland Security's Customs and Border Protection (CBP) agency, is empowered to make on-the-spot determinations of IPR infringement. In general, U.S. companies must fulfill three requirements in order to assert unfair competition under Section 337. First, there must be an importation or a sale for, sale after, or potential future importation of the infringing product into the United States. It is not necessary for the imports to be in commercial, or mass, quantities. Second, an unfair act of competition relating to the imported good must occur, i.e., an infringement of a valid U.S. patent, copyright, or trademark. Third, a domestic company must be engaged in sufficient domestic activity, such as investment in plant and equipment or employment of labor and capital, in the United States related to the imported product in question. U.S. citizenship is not necessary to meet this third requirement. Under statute, Section 337 investigations must completed "at the earliest practicable time" (19 U.S.C. §1337). The ITC issues "target dates" for identifying when the ITC proceedings should be completed. Previously, the ITC has attempted to complete most investigations in less than 15 months. In recent years, the target dates for many investigations have increased, due in part to the growing complexity of the subject matter and number of unfair acts under investigation in cases and the workload of ITC judges. As shown in Table 1 , Section 337 ITC investigations involve multiple steps that take place over the course of many months. Any company seeking relief under Section 337 must prepare a detailed complaint with information supporting the claims with the ITC, including background information on the intellectual property asserted in the claim and evidence of infringement. Upon receiving a complaint, the ITC has thirty days to determine whether or not to initiate a Section 337 investigation. If an investigation is instituted, the ITC assigns the case to an Administrative Law Judge (ALJ), who oversees and conducts the investigation. The ITC also assigns an investigative attorney from its Office of Unfair Import Investigations (OUII), who provides his or her views to the ALJ regarding whether or not a Section 337 violation has taken place. The attorney also represents the public interest during the investigation. A target date for completion of the investigation will be set. The ALJ conducts a formal evidentiary hearing, typically lasting one to two weeks, generally within seven to ten months of the filing. The ALJ then issues a preliminary ruling (an "Initial Determination") determining whether or not a Section 337 violation has occurred and proposing remedies (discussed in next section) if violations are found. The ALJ decision is based on the merits of the case. For instance, in a Section 337 case involving U.S. patents, the ALJ would evaluate the case based on patent infringement issues. The Initial Determination must be issued no later than four months prior to the target date. Within 45 days of the Initial Determination, the ITC Commissioners decide whether or not to review the Initial Determination. The Commissioners may decide to adopt the ruling. Alternately, they may elect to change all or some parts of the Initial Determination, or to completely reject or remand it. Generally, within three months of the Initial Determination, the Commissioners issue a "Final Determination," which takes into account public interest considerations, such as the impact on the public's health and safety or on the ability to satisfy U.S. market demands. Some cases before the ITC are settled before a final decision is made. Complainants (typically the patent holder) and respondents (the alleged infringer) may move to terminate an investigation. For instance, they may agree to cross-licensing or to resolve the dispute through arbitration. The Final Determination is sent to the President for review based on national security considerations. This decision is enforceable within 60 days if no actions are taken by the President. The President rarely has overturned the Final Determination. During the 60 day review period, respondents who continue activities ruled by the ITC to be in violation of Section 337 do so under bond. If the Final Determination is not disapproved by the President, respondents engaging in such activities stand to lose a significant amount of money. In some cases, the bond is 100% of the total value of the imported products. Thus, while remedies are not enforceable until the conclusion of the 60 day review period, the bond frequently serves as a deterrent from engaging in IPR-infringing activities. This is especially the case because the President rarely disapproves of ITC Final Determinations. Within the 60-day Presidential review period, the respondent (or anyone adversely affected by the Final Determination) can file an appeal of the decision to the U.S. Court of Appeals for the Federal Circuit. Depending on the circumstances, the Final Determination may or may not be enforceable while the appeal is being heard. In the original enactment of Section 337, Congress stipulated that the ITC complete investigations within 15 months (from institution of a case to Final Determination). Section 337 was later amended to become compliant with the General Agreement on Tariffs and Trade (GATT), whose national treatment provision requires that member states not treat foreign member states' nationals any less favorably than their own nationals. There was concern that Section 337, as initially enacted, may not have allowed foreign companies to defend themselves adequately because the ITC adjudication process generally takes place at a faster pace than litigation in federal district courts. The ITC is now required by statute to complete investigations "at the earliest practicable time" (19 U.S.C §1337). The ITC grants two primary remedies to U.S. companies: exclusion orders and cease and desist orders. The ITC may not issue monetary damages to U.S. companies. The time that it takes for remedies to become enforceable may vary because of differences in target dates and the possibility of appeals by respondents. Exclusion orders prohibit the importation of the infringing good into the United States. They are effective for as long as the patent is valid. Limited exclusion orders, the most commonly issued type of exclusion order, prohibit the importation of only those infringing goods originating from the parties named in the ITC investigation. In contrast, general exclusion orders prohibit the importation of all goods of the kind determined to be infringing, irrespective of the source of the infringing good. Because general exclusion orders are broad in their scope, they may disrupt international trade significantly. In general, they are issued only when circumvention of a limited exclusion order would be likely or it would be difficult to identify all infringing parties. The U.S. Customs and Border Protection agency enforces exclusion orders. Cease and desist orders require the termination of infringing-related activities, such as selling infringing articles previously imported that are currently in domestic inventories. These orders frequently are issued in conjunction with exclusion orders, particularly in situations where the infringing goods are imported in commercial quantities. Cease and desist orders are enforced by the ITC, which is authorized to impose civil penalties on U.S. importers that violate cease and desist orders. Penalties per day may be as high as $100,000 or double the value of the goods involved. U.S. companies may request that the ITC conduct expedited temporary relief proceedings and issue a temporary exclusion or cease and desist order while the regular investigation takes place. For preliminary relief, U.S. companies must provide significantly more evidence prior to the hearing than for a standard case. The ITC's decision to grant preliminary injunctions is based on: the likelihood of success for the complainant's case and the extent to which the domestic industry, respondents, and the public interest would be adversely affected if a preliminary injunction was not issued. For temporary relief proceedings, a Final Determination (following an Initial Determination by the ALJ) is granted 90 days after institution for standard cases. For more complex cases, a Final Determination is granted 150 days after institution of the case. In cases where the complainant receives a temporary remedy, the complainant is required to put up a bond. Following the preliminary ruling, the full Section 337 standard case will proceed. If the preliminary injunction is not upheld in the regular investigation, the complainant may lose the bond money. In FY2008, the ITC reported a total of 88 active Section 337 investigations and ancillary proceedings, up from 73 in FY2007. Of the 88 active investigations in FY2008, 43 represented new Section 337 investigations and 7 represented new ancillary proceedings stemming from previously concluded Section 337 investigations. The Section 337 investigations frequently involved advanced technology areas such as integrated circuits, computer components, consumer electronic products, and chemical compositions. Over 90% of the new Section 337 investigations that were active in FY2008 involved cases of alleged patent infringement. Since 2002, there has been a general uptick in the number of Section 337 cases. In FY2008, the number of new cases was nearly four times higher than the number of new cases in FY2000. There also were over 50% more active cases in FY2008, compared to FY2007. The overall rise in international IPR infringement has contributed to the increase in Section 337 activity.