"Get court OK for patent settlement deals," US FTC tells generics meeting

No industry is receiving as much attention from the US Federal TradeCommission as the drug sector, David Balto, a former FTC policy director and now of White & Case, told a recent Center for Business Intelligence meeting (see also pages 24-25). Current areas of concern include patent settlements and extensions because of the huge amount of commerce involved here, he said.

The upcoming FTC report is trying to determine how typical settlement agreements are and what is their economic impact and business rationale; the study will also serve as a means of advice for Waxman-Hatch on 180-day exclusivity and 30-month stays, he said.

From the branded firms, the FTC study is looking at all patent settlements with generic companies since 1995, licensing agreements, frequency of settlements, patent extension strategies for Orange Book listings, Paragraph IV suits, sales of drugs with Paragraph IV listings and Citizen Petitions. From the generic side, it is viewing all patent settlements, licensing agreements, lawsuits with brand-name firms, complaints about Orange Book listings and sales of drugs with Paragraph IV listings.