(5)
The biotechnology industry is notable both for its heavy concentration of small businesses and its weighty research and development (R&D) expenses. (7)
Given their small size and heavy expenses, many observers believe that firms in the biotechnology industry rely upon their ability to raise venture capital. (8) The patent law has beenidentified as a facilitator of these R&D financing efforts. (9)
Although many commentators believe that the patent law plays a crucial role in the biotechnology industry, (10) numerous legal,economic and policy issues have arisen concerning thepatenting of biotechnology. A brief reviewof some principal biotechnologies follows. The market capitalization of many biotechnology and other high-technology enterprises has been impacted by patent-relateddevelopments. (113)
Other commentators have expressed concerns over diminishing genetic diversity. (127) In arguing that biotechnology may be put to work todiminish animal suffering, some observers have pointed to the genetically engineered transgenicchicken that resists avian leukemia virus. The Utility Requirement

Section 101 of the Patent Act also mandates that patents issue only to "useful" inventions. Under Justice Story's view, the utility requirement does not provide a significant place for technology assessment. However, other commentators remain deeplyconcerned over the implications of patenting living inventions, genetic materials and otherbiotechnologies, as well as the patenting of biotechnological inventions with unknown or speculativeutilities. The impact of these exceptions is that a signatory may disallow patents from issuing on living entities other than microorganisms. U.S.law arguably includes this exception already, given case law requiring that biotechnologicalinventions be subject to artificial invention in order to be patentable. Congress could examine whether the definition of patentable utility should be legislatively specified.
The biotechnology industry is notable both for its heavy concentration of small businesses and its weighty research and development (R&D) expenditures. Given the small size and heavy expensesof many biotechnology firms, their ability to raise venture capital may be of some consequence. Thepatent law has been identified as a facilitator of these R&D financing efforts.
Although many observers believe that the patent law plays a significant role in the biotechnology industry, two principal issues have arisen regarding biotechnology patenting. First,observers have fundamentally questioned whether patents should be granted for living inventions,genetic materials and other biotechnologies. Ethical issues, concerns that biotechnology patentingpromotes animal suffering and decreases genetic diversity, as well as regard for the traditionalagricultural community animate many of these objections. Supporters of biotechnology patentingcounter that trade secret protection is a less attractive social alternative, observe that patents havelong been granted for biotechnologies, and question whether the patent law is the appropriate vehiclefor technology assessment.
Commentators have also differed over the extent to which an inventor must show a specific, practical use for a biotechnology in order to be awarded a patent. Some observers favor a strict viewof the utility requirement due to concerns over overlapping upstream patents that discourage researchand commercialization. Others believe that the utility requirement should be applied leniently,stating that a strict view of utility will only lead to industry concentration and that biotechnologyresearch tools cannot be meaningfully distinguished from other sorts of inventions.
Congress may choose to exercise oversight on these issues. Such consideration would likely include examination of U.S. commitments in international agreements along with other factors.