prices of the drug produced using Alpha’s or Beta’s technology by reducing competition in the relevant market for technology to manufacture the drug.[1]
The Agency would delineate a technology market in which to evaluate likely competitive effects of the proposed joint venture. The Agency would identify other technologies that can be used to make the drug and evaluate the levels of effectiveness and cost per dose relative to that of the technologies owned by Alpha and Beta. In addition, the Agency would consider the extent to which competition from other drugs that are substitutes for the drug produced using Alpha’s or Beta’s technology would limit the ability of a hypothetical monopolist that owned both Alpha’s and Beta’s technology to raise its price for the license.
3.2.3 Research and Development Markets
If a licensing arrangement may adversely affect competition to develop new or improved goods or processes, the Agencies may analyze such an impact as a competitive effect in a separate research and development market. A licensing arrangement may have competitive effects on research and development that cannot be adequately addressed through the analysis of goods or technology markets. For example, the arrangement may affect innovation that is related to research to identify a commercializable product or to the development of particular goods or services.[2] Alternatively, the arrangement may affect the development of new or improved goods or processes in geographic markets where there is no actual or potential competition in the relevant goods.[3]
A research and development market consists of the assets comprising research and development related to the identification of a commercializable product, or directed to particular new or improved goods or processes, and the close substitutes for that research and development. When research and development is directed to particular new or improved goods or processes, the close substitutes may include research and development efforts, technologies,
- ↑ See, e.g., Summit Tech., Inc., 127 F.T.C. 208 (1999).
- ↑ For example, the FTC has identified and referred to research and development markets in the following matters: Complaint, Amgen Inc., 134 F.T.C. 333, 337-39 (2002) (identifying a research and development market for inhibitors of cytokines that promote the inflammation of human tissue); Wright Med. Tech., Inc., Proposed Consent Agreement with Analysis to Aid Public Comment, 60 Fed. Reg. 460, 463 (Jan. 4, 1995) (identifying a research and development market for orthopedic implants for use in human hands); Am. Home Prods. Corp., Proposed Consent Agreement with Analysis to Aid Public Comment, 59 Fed. Reg. 60,807, 60,815 (Nov. 28, 1994) (identifying a research and development market for, among other things, rotavirus vaccines).
- ↑ See Complaint, United States v. Gen. Motors Corp., Civ. No. 93-530 (D. Del. Nov. 16, 1993).
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