But, Hatch-Waxman discriminates industries in favor of pharmaceuticals---that opens the door to industry-specific lobbying.

According to § 156(a) of the Patent Act, "the term of a patent which claims a product, a method of using a product, or a method of manufacturing a product shall be extended" if the other requirements of the section are met. The term 'product' is defined in that section to comprise "drug product(s)" and "any medical device, food additive, or color additive subject to regulation under the Federal Food, Drug, and Cosmetic Act (FFDCA)." Drug products include new drugs, antibiotic drugs, and human biological products, as those terms are used in the FFDCA and the Public Health Service Act, and new animal drugs and veterinary biological products, as those terms are used in the FFDCA and the Virus-Serum-Toxin Act.49

Consequently, the statutory framework limits the availability of a patent term extension to a narrow field of products. By its narrow definition of the term 'product', the statute forecloses other products subject to pre-market approval from being eligible for extension of the patent term under § 156 of the Patent Act. A patent term extension for inventions in the pesticide industry can therefore not be issued under that section.

The examination of the USPTO's Manual of Patent Examining Procedure, which devotes chapters 2750-2764 to the extension of the patent term, buttresses the fact that pesticides are not considered to fall within the scope of § 156 of the Patent Act.5 0 Paragraph II of chapter 2751 of the manual outlines the meaning of the word "product" as defined in 156(f) of the Patent Act. The remarks are silent with respect to pesticides or products approved by the EPA. A thorough search of secondary sources and case law did not reveal any means for extending patents on pesticides subject to EPA approval. Therefore, at this point, it appears that patents in the pesticide industry are not eligible for patent term extension in the United States. 51

Medical devices, drugs, and pesticides are all subject to premarket approval by regulatory agencies. The approval process can effectively shorten the time the patentee will have to recoup his or her investments. For the pharmaceutical and the medical device industries, Congress has addressed this problem in §156 of the Patent Act. The pesticide industry does not enjoy a comparable restoration of the time lost during the approval process by the EPA.

This finding raises the question of whether denying a patent term extension for pesticide patents is reconcilable with the TRIPs Agreement. It seems worth highlighting that at the time the patent term extension provision was enacted, the prohibition against discrimination as to the field of technology stipulated in the TRIPs Agreement had not yet been adopted. The Agreement came only into force more than a decade later, in 1995. During the Uruguay Round negotiations the issue of patent term extensions for products requiring pre-marketing approval was discussed, yet not incorporated into the Agreement. 52 , Despite the long-standing tradition of industry and technology neutrality of patent law, at the time Congress passed the Hatch-Waxman Act it was not coerced to craft non-discriminatory rules, but, if anything, bound by tradition. 53 However, the laws of the game have changed: if a country now decides to provide restoration for some technologies subject to premarket approval but not for others, this raises the issue of compliance with the prohibition of discrimination with regard to the field of technology in the TRIPs Agreement. 54

Discrimination can generally be found where there is an unjustified imposition of differentially disadvantageous treatment.5 5 However, differential treatment does not always result in a finding of discrimination. For instance, it may aim to offset recognized differences. 5 6 Instead, Article 27 allows "bona fide exceptions to deal with problems that may exist only in certain product areas." 57

Unlike pharmaceuticals and medical devices, patented products in the pesticide industry do not enjoy the possibility of a patent term extension. Therefore, pesticide patents are treated less favorably. The similarities between the industries are readily discernible. Products in all three industries are subject to lengthy approval processes that reduce the time for recoupment of investments. The former congressional Office of Technology Assessment published a report on the patent term extension in 1981.58 The report focuses on patent term extension for patents in the pharmaceutical industry, but also discusses in its appendix potential extensions in the medical device, pesticide, and chemical industries. It concluded that the pesticide and pharmaceutical industries are "subject to similar regulations."5 9

Looking for potential justifications for unequal treatment, the legislative history of the Hatch-Waxman Act remains mostly unrevealing. In 1980, Representative Robert W. Kastenmeier and Senator Birch E. Bayh proposed bills to introduce a patent term extension that would cover human drugs; animal drugs; food additives; human or veterinary biological products; pesticides; chemical substances or mixtures; and medical devices. 60 However, upon referral to Senate Judiciary Committee and the House Committee on the Judiciary, the possibility of patent term extension for pesticides was not pursued.61 In the following years, further bills for patent term extensions were introduced that also covered pesticides and chemical substances. 62 The congressional materials and hearings that led to the enactment of the Hatch-Waxman Act are not instructive as to why pesticides were not included in the final bill.63 However, the 1981 report by the former Office of Technology assesses three aspects potentially prompting the lawmakers' decision not to expand the patent term extension to pesticides: 1) a high innovation rate despite the increasing costs and time associated with the approval process; 2) the increasing amounts flowing into R&D; and 3) the risk of double rewards for patentees. 64

In 1972, the FIFRA was amended and now requires that companies submit a demonstration of human safety, which has resulted in an increasingly resource-intensive approval process for pesticides. Nevertheless, the report found a continuing increase in innovations from 1967-79, and concluded: "The measures of innovation available in the pesticide industry indicate innovation has, thus far, been virtually unaffected by the increased costs and times required for regulatory approval."65 This suggests that the Office thought there might be no need for a patent term extension. The assertion of uncertainties as to whether research and development (R&D) expenditures would be positively affected if there was a patent term extension for pesticides, points in the same direction. 66 Finally, the federal government is recognized to play an important role in the R&D of pesticides. According to the report, the involvement of the government could lead to a double reward of patentees, where public research funds result in privately-owned patents. 67

Comparing the evaluation of the Office of Technology Assessment, regarding the pesticide industry to the pharmaceutical industry, indicates disparate needs between the two industries. In particular, their innovation trends deserve closer consideration. Unlike in the pesticide industry, the innovation rate in the pharmaceutical industry had shown a less positive trend in the decades prior to the enactment of the Hatch Waxman Act. The report concluded: "[I]nterpretations of trends of innovation depend on the measures used at the time period being measured, but, by most measures, innovation does not appear to be increasing." 68 Due to the tenuous information available on why pesticides were not included in the bill that led to the Hatch-Waxman Act, it will be assumed that the unequal innovation trends were at least one critical factor.69 Allowing different treatment based on innovation data is perilous. All too easily, the gates would be opened for disparate treatment of patents from different fields of technology. The process of innovation is complex and predicting innovation rates is often not more than a shot in the dark. Innovation data is influenced by a myriad of factors-many of them stemming from outside the specific industry sector, like the global economy and user demand. Further, the process of innovation is diverse. 70 Innovation in different industries varies in terms of the pace of innovation, actors involved and degree of change. If differences in innovation pace were sufficient to overcome the prohibition of discrimination against certain field of technology the prohibition itself would become an empty phrase. The disadvantageous treatment of pesticide patents raises serious doubts about the United States' compliance with respect to the discrimination prohibition articulated in Article 27(1) of the TRIPs Agreement.

The implications of this finding are not limited to the pesticide industry. There are other industries subject to regulatory approval. One example is the aviation industry. The Code of Federal Regulations prescribes airworthiness approval by the Federal Aviation Agency (FAA) for certain products related to aircrafts. 71 In order to determine a violation of Article 27(1) TRIPs Agreement, the specifics of each of the approval processes have to be examined. For example, an argument might be made that if the approval process is more akin to a non-time-consuming registration process, there is a stronger case for not granting a patent term extension.72

This Article concluded above that the patent term extension for pharmaceuticals and medical devices is not a bounty for some industries and, in fact, a promising example of industry-specific patent law. This finding still stands, albeit only with some reservations. Denying the patent term extension to the pesticide industry is a manifestation of the perils of industry-specific law: similar industries are treated differently for weak reasons. Cynics might say it is not surprising that the pharmaceutical industry pushed their claim for a patent extension through, given it is represented by the strongest special-interest group in the country. 73 One can have his or her own opinion about the demonization of lobbying groups, but the fact remains that the Patent Act in its current form treats the pesticide industry discriminatorily compared to the pharmaceutical and medical device industries.