The innovator always tried to stop generic players from entering into the market. The innovator companies have deviced various novel plans for settlement. The settlement between generic player and innovator results in loss to consumer. Orange book blog has published a following article on antitrust litigation of ciprofloxacin.
The Federal Trade Commission announced last week that it recently filed an amicus brief in In re Ciprofloxacin Hydrochloride Antitrust Litigation , currently pending in the Federal Circuit. In the case, direct purchaser plaintiffs of Ciprofloxacin alleged that settlements of patent litigation between Bayer and several generic drug companies violated federal and state antitrust laws. The case is an appeal of a 2005 decision granting motions for summary judgment filed by Bayer and the generic defendants.
According to the FTC's brief , the case involves agreements between Bayer and generic manufacturers Barr Labs and The Rugby Group (which has since been acquired by Watson Pharmaceuticals). The FTC states that under the agreements (executed in January 1997), Bayer paid the generic companies $398 million to agree not to manufacture any form of Cipro and for Barr's agreement to convert its paragraph IV certification (challenging the validity of the US4670444 ) to a paragraph III certification (permitting Barr to market its generic drug only upon expiration of the '444 patent, in December 2003). The FTC states that the case "illustrates the kind of abuse of the Hatch-Waxman law that prompted congressional intervention in 2003," when it required such agreements to be submitted to the FTC for review.
In short, FTC's brief makes three arguments:
The district court erred in holding that patent settlement agreements containing exclusion payments are immune from antitrust scrutiny;
Paying a potential competitor not to compete is a well established antitrust violation; and
The district court misconstrued the policies and incentives of the Hatch-Waxman Act and misconceived the practical implications of its ruling.
The Federal Trade Commission announced last week that it recently filed an amicus brief in In re Ciprofloxacin Hydrochloride Antitrust Litigation , currently pending in the Federal Circuit. In the case, direct purchaser plaintiffs of Ciprofloxacin alleged that settlements of patent litigation between Bayer and several generic drug companies violated federal and state antitrust laws. The case is an appeal of a 2005 decision granting motions for summary judgment filed by Bayer and the generic defendants.
According to the FTC's brief , the case involves agreements between Bayer and generic manufacturers Barr Labs and The Rugby Group (which has since been acquired by Watson Pharmaceuticals). The FTC states that under the agreements (executed in January 1997), Bayer paid the generic companies $398 million to agree not to manufacture any form of Cipro and for Barr's agreement to convert its paragraph IV certification (challenging the validity of the US4670444 ) to a paragraph III certification (permitting Barr to market its generic drug only upon expiration of the '444 patent, in December 2003). The FTC states that the case "illustrates the kind of abuse of the Hatch-Waxman law that prompted congressional intervention in 2003," when it required such agreements to be submitted to the FTC for review.
In short, FTC's brief makes three arguments:
The district court erred in holding that patent settlement agreements containing exclusion payments are immune from antitrust scrutiny;
Paying a potential competitor not to compete is a well established antitrust violation; and
The district court misconstrued the policies and incentives of the Hatch-Waxman Act and misconceived the practical implications of its ruling.
