Most patent infringement lawsuits are resolved with an agreement for the accused infringer to pay money to the patent right-holder. Generic drug-maker challenges to pharmaceutical patents occasionally follow a different path – with the patent holder paying money to the accused infringer to stay off the market for an extended period of time. This summer, the Obama administration (through the DOJ) indicated that these "pay for delay" settlements are "presumptively unlawful." (WSJ Article). The FTC has opposed these reverse-payment settlements for many years – arguing that they tend to allow a company holding vulnerable patents to maintain monopoly-level drug prices.
Now, the Senate has joined the fray. The Senate Judiciary Committee has approved a ban on reverse-payment settlements. (Prior Art Blog citing Reuters).
S.369 was co-sponsored by Senators Kohl, Grassley, Feingold, Durbin, and Brown. The Bill would amend the Clayton Antitrust Act to make it "unlawful under this Act for any person, in connection with the sale of a drug product, to directly or indirectly be a party to any agreement resolving or settling a patent infringement claim in which– (1) an ANDA filer receives anything of value; and (2) the ANDA filer agrees not to research, develop, manufacture, market, or sell the ANDA product for any period of time." Such an agreement would then result in antitrust liability as well as the ANDA losing its 180-day exclusivity right. (Download S369)