Category Archives: Antitrust

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California Supreme Court Scrutinizes Reverse Payment ANDA Settlements

In In Re Cipro Cases I & II, the California Supreme Court laid out a four-part rule of reason analysis for evaluating ANDA settlements that involve a reverse payment to the generic challenger (also referred to as “pay for delay” settlements). Although the court’s decision interprets state antitrust laws, it may influence other states applying similarly … Continue reading this entry

Federal Circuit Finds That FDA Citizen Petition Could Give Rise To Antitrust Liability

In Tyco Healthcare Group LP v. Mutual Pharmaceutical Co., Inc., the Federal Circuit remanded-in-part for the district court to determine whether Tyco’s citizen petition to the FDA gave rise to antitrust liability. Judge Newman wrote a dissenting opinion warning against the chilling effect that antitrust liability could have on a citizen’s right to communicate with … Continue reading this entry

District Court Upholds FTC Hart-Scott-Rodino Rules for Pharmaceutical Patent Transfers

A federal court has upheld the validity of the FTC’s recent rules for reporting certain transfers of exclusive patent rights in the pharmaceutical industry under the Hart-Scott-Rodino Antitrust Improvements (“HSR”) Act. We explained these Hart-Scott Rodino rules back in November when the FTC announced them, but note here that these rules require that an HSR filing be made … Continue reading this entry

New FTC Rules For Exclusive Pharmaceutical Patent Licenses

Co-authored by Benjamin R. Dryden. The Federal Trade Commission (FTC) has issued final rules under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (HSR Act) relating to the transfer of exclusive patent rights in the pharmaceutical industry. These new FTC rules go into effect on December 16, 2013. Importantly, these rules clarify when transfers of rights … Continue reading this entry