The patent system serves to promote the creation and disclosure of technological information. Some commentators believe that absent a patent system, individuals and institutions would be lesslikely to engage in research and development. Without the availability of patent protection, newinventions could be easily copied by "free riders" who incurred no cost to develop and perfect thetechnology involved. The resulting inability of inventors to capitalize on their inventions wouldlikely lead to an environment where too few inventions are made. By providing individuals withexclusive rights in their inventions for a limited time, the patent system allows inventors to realizefinancial benefits from their inventions. (14) Other observers believe that if the patent system were unavailable, innovators would maintaintheir inventions as trade secrets so that competitors could not exploit them. Trade secrets do notenrich the collective knowledge of society, however, nor do they discourage others from engagingin duplicative research. The patent system avoids these inefficiencies by requiring inventors toconsent to the disclosure of their inventions in issued patent instruments. (15) Legal scholars have offered additional explanations for the patent laws. The patent systemmay stimulate technological advancement by inducing individuals to "invent around" patentedtechnology. Issued patent instruments may point the way for others to develop improvements,exploit new markets or discover new applications for the patented technology. (16) Moreover, the patentsystem may encourage patentees to exploit their proprietary technologies during the term of thepatent. The protection provided by a patent's proprietary rights increases the likelihood a firm willcontinue to refine, produce and market the patented technology. (17) Finally, the patent law hasbeen identified as a facilitator of markets. Absent patent rights, an inventor may have scant tangibleassets to sell or license, and even less ability to police the conduct of a contracting party. Byreducing a licensee's opportunistic possibilities, the patent system lowers transaction costs and makestechnology-based transactions more feasible. (18) The patent system has inspired numerous critics, however. Some detractors have assertedthat the patent system is unnecessary due to market forces that already suffice to create an optimallevel of invention. The desire to gain a lead time advantage over competitors, as well as therecognition that technologically backwards firms lose out to their rivals, may well provide sufficientinducement to invent without the need for further incentives. (19) Others believe that theinventions that fueled the most dynamic sectors of modern industry, such as biotechnologies andcomputer software, arose at a time when patent rights were unavailable or uncertain. (20) While these justifications and criticisms have varying degrees of intuitive appeal, none ofthem has been empirically validated. No authoritative study conclusively demonstrates that societyobtains more rapid technological development with patents than it would without them. As a result,the rationales for, and criticisms of, the patent system remain open to challenge. (21) The Patent Act of 1952 (22) (also known as the Patent Act) obliges innovators to prepare andsubmit applications to the USPTO if they wish to obtain patent protection. (23) USPTO officials knownas examiners then assess whether the application merits the award of a patent. (24) In deciding whether toapprove a patent application, a USPTO examiner considers whether the submitted application fullydiscloses and distinctly claims the invention. (25) The examiner will also determine whether the invention itselffulfills certain substantive standards set by the patent statute. To be patentable, an invention mustbe useful, novel and nonobvious. The requirement of usefulness, or utility, is satisfied if theinvention is operable and provides a tangible benefit. (26) To be judged novel, the invention must not be fully anticipatedby a prior patent, publication or other knowledge within the public domain. (27) A nonobvious inventionmust not have been readily within the ordinary skills of a competent artisan at the time the inventionwas made. (28) If the USPTO allows the patent to issue, the patent proprietor obtains the right to excludeothers from making, using, selling, offering to sell or importing into the United States the patentedinvention. (29) The termof the patent is ordinarily set at twenty years from the date the patent application was filed. (30) Patent title thereforeprovides inventors with limited periods of exclusivity in which they may practice their inventions,or license others to do so. The grant of a patent permits the inventor to receive a return on theexpenditure of resources leading to the discovery, often by charging a higher price than wouldprevail in a competitive market. Once the patent is issued, its proprietor bears responsibility for monitoring its competitorsto determine whether they are using the patented invention or not. Patent owners who wish tocompel others to observe their intellectual property rights must usually commence litigation in thefederal district courts. The U.S. Court of Appeals for the Federal Circuit ("Federal Circuit")possesses exclusive national jurisdiction over all patent appeals from the district courts, (31) while the U.S. SupremeCourt possesses discretionary authority to review cases decided by the Federal Circuit. (32) The U.S. government regulates the marketing of pharmaceuticals and agricultural chemicalsin the interest of public health. (33) Under this regime, the developer of a new drug -- known as its"sponsor" -- must demonstrate that the product is safe and effective before it can be distributed tothe public. This showing requires a sponsor to conduct both preclinical and clinical investigationsof drugs that have not been previously tested. (34) In deciding whether to issue marketing approval or not, the FDAevaluates the test data that the sponsor submits in a so-called New Drug Application (NDA). The FDA maintains the test data incorporated into a NDA in confidence. (35) In addition, because therequired test data is ordinarily quite costly to generate, sponsors of new pharmaceuticals ordinarilydo not disclose them to the public. Otherwise the sponsor's competitors could file their own NDAsusing that test data, and thereby avoid the expenses of developing the information themselves. (36) Prior to the introduction of the Hatch-Waxman Act, federal law contained no separateprovisions addressing generic versions of brand-name drugs that the FDA had previously approvedfor marketing. (37) Theresult was that a would-be generic drug manufacturer had to file its own NDA in order to market itsdrug. (38) Some genericmanufacturers could rely on published scientific literature demonstrating the safety and efficacy ofthe drug. Because these sorts of studies were not available for all drugs, however, not all genericfirms could file these so-called paper NDAs. (39) Further, at times the FDA would request additional studies toaddress safety and efficacy questions that arose from experience with the drug following its initialapproval. (40) The resultwas that some generic manufacturers were forced to prove independently that their pharmaceuticalswere safe and effective, even though their products were chemically identical to those of previouslyapproved drugs. Some commentators believed that the approval of a generic drug was a needlessly costly,redundant, and time-consuming process prior to the Hatch-Waxman Act. (41) These observers noted thatalthough patents on important drugs had expired, manufacturers were not moving to introducegeneric equivalents for these products due to the level of resource expenditure required to obtainFDA marketing approval. (42) As the introduction of generic equivalents often causes pricesto decrease, the interest of consumers was arguably not being served through these observed costsand delays. (43) In response to these concerns, the Hatch-Waxman Act created a new type of application formarket approval of a drug. This application, termed an "Abbreviated New Drug Application"(ANDA), may be filed at the FDA. (44) An ANDA may be filed if the active ingredient of the genericdrug is the bioequivalent of the approved drug. An ANDA allows a generic drug manufacturer torely upon the safety and efficacy data of the original manufacturer. The availability of the ANDAmechanism often allows a generic manufacturer to avoid the costs and delays associated with filinga full-fledged NDA. ANDAs also allow a generic manufacturer, in many cases, to place itsFDA-approved bioequivalent drug on the market as soon as any relevant patents expire. (45) The Hatch-Waxman Act placed certain limits upon the ability of generic competitors toreference the data generated by the manufacturers of brand-name drugs. These limitations -- termedmarketing exclusivities -- consist of a period of time during which a competitor's ability to obtainFDA permission to sell a generic version of a previously approved brand-name drug is restricted. The federal food and drug laws establish several different sorts of marketing exclusivities, relatingto new chemical entities, new clinical studies, orphan drugs, and pediatric studies. (46) This report describes eachof these marketing exclusivities below. The Hatch-Waxman Act established a five-year exclusivity that is available to drugs thatqualify as a new chemical entity (NCE). The purpose of this "NCE exclusivity" is to encourage thedevelopment of innovative drug products that include an entirely new active ingredient (commonlytermed the "active moiety"), in contrast to "me-too" drugs that incorporate chemical variants ofpreviously known compounds. NCE exclusivity prevents a subsequent generic applicant fromrelying upon the data submitted by the innovative drug company during a five-year period. As aresult, generic firms are precluded from relying upon this data for five years from the date of theapproval of the NDA for that active moiety. (47) A drug is judged to be an NCE if the FDA has not previously approved that drug's activeingredient.