By Federal Trade Commission, United States Federal Trade Commission

This research tested no matter if the behavior that the FTC challenged, which used to be convinced antitrust activities opposed to brand-name and conventional drug businesses, represented remoted circumstances or is extra ordinary, and even if the 180-day exclusivity and the 30-month remain provisions of the Hatch- Waxman Amendments are at risk of options to hold up or deter buyer entry to favourite choices to model- identify drug items. The research focuses completely at the systems used to facilitate universal drug marketplace access ahead of expiration of the patent(s) that safeguard model- identify drug product.

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Generic Drug Entry Prior To Patent Expiration: An FTC Study

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The recent empirical literature on the outcome of patent litigation provides a point of comparison with these findings, and suggests that this invalidity rate, although it may be understated as noted above, is not out of line with that of patents generally. 15 The brand-name company prevailed against the generic applicant in litigation involving 11 drug products. In one of these 11 cases, the generic applicant abandoned the litigation and admitted infringement before the court issued a decision.

5 Two different generic applicants were the first to file on different strengths of the same drug product. The brand-name company settled the litigation with both applicants (one settlement was a license agreement and the other was a supply agreement). Because the different strengths are covered by only one NDA, the drug product is counted only once as a “supply agreement” to ensure consistency in counting drug products with agreements. 27 Table 3-1 Overview of Final Settlements with the First Generic Applicant Type of Agreement Number of Drug Products Net Sales Number of BrandName Companies Number of Generic Applicants License Agreements 7 Less than $100 million = 3 Between $100 and $250 million = 4; Between $250 and $500 million = 0; Greater than $500 million = 1 6 (two had 2 agreements) 7 (one had 2 agreements) Supply Agreements 2 Between $250 and 500 million = 1; Greater than $500 million = 1 2 2 Agreements with Brand Payments 9 Less than $100 million = 3 Between $100 and $250 million = 2; Between $250 and $500 million = 2; Greater than $500 million = 2 7 (two had 2 agreements) 8 (one had 2 agreements) Other 2 Less than $100 million = 1 Between $100 and $250 million = 1 2 2 Total 20 N/A 11 (3 had 2 agreements each, 2 had 3 agreements each, and 1 had 4 agreements) 14 (3 had 2 agreements each, and 2 had 3 agreements) which was royalty-free) to use the brandname company’s patents for the particular brand-name product prior to the patent expiration.

The resolution of each is classified in Table 2-2 and also is described in Figure 2-1. 7 A court decision resolved the patent infringement claims for 30 drug products. Generic applicants prevailed 73 percent of the time (22 out of 30),8 and brand-name companies prevailed 27 percent of the time (8 out of 30). In 3 miscellaneous instances, either the patents expired before the 30-month stay expired, or the brand-name company withdrew the NDA due to safety reasons. 4 In addition to these 22 cases, there are 2 more pending cases on a dosage strength of a drug product for which the patent litigation on another strength has been resolved.

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