Apotex v. Merck (Fed. Cir. 2007)
Enalapril (VASOTEC) is a Merck drug used to treat high blood pressure. In 2001, the CAFC affirmed that two Apotex patents allegedly covering the drug’s manufacturing process were invalid under 35 USC 102(g) (because the process had been invented and used by Merck prior to Apotex’s invention).
A year after losing, Apotex re-filed its case — charging Merck with alleged fraudulent discovery responses uncovered in a later trial.
Under FRCP Rule 60(b), a final judgment may be set aside based on the fraud or misrepresentation of an adverse party. Ordinarily, a Rule 60(b) motion must be brought within one year of judgment. One exception is the more serious ‘fraud on the court,’ which has no statute of limitations. Here, Apotex filed the 60(b) motion more than one year after the final judgment — and thus needed to show fraud on the court.
On appeal, the CAFC affirmed the lower court’s dismissal of Apotex’s claims of fraud on the court. False statements made by witnesses being examined do not typically constitute fraud on the court — rather, that charge is reserved to activities that harm “the judicial machinery itself and is not fraud between the parties or fraudulent documents, false statements or perjury.” Thus, in this case the alleged false statements made on the witness stand and in attorney argument “do[] not establish corruptoin of the judicial process.”



