In that regard then, is it correct to say that under the language of the amendment, when a company includes information in its ANDA which pertains to the capital investments it has made in bringing a product to the market, such as the building of plants, buildings, or equipment or investments in developing manufacturing processes or personnel, that that information can be fully used in court proceedings to prove its claim of substantial investment.
Discussing the implications of an amendment related to capital investments in court proceedings.
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