Following a bench trial, the court concluded that defendants failed to establish inequitable conduct based on plaintiff's alleged failure to disclose the sample size of tests reported in the patent application. "[D]efendants assert that the data presented by table 2 of the [patent-in-suit] is based on a 'vanishingly small' sample size of testing. Defendants theorize that the inventors withheld the sample size so as to prevent the examiner from discovering the statistical insignificance of the presented results. . . . [D]efendants have not identified any requirement of the patent laws regarding statistical significance. Of course, the failure to disclose a small sample size could still fall within the ambit of materiality if, for example, the applicants told the examiner that the disclosed results met the FDA's requirement for statistical significance, or statistical significance was otherwise heralded in the specification of the [patent-in-suit]. Defendants have adduced no such evidence."
Senju Pharmaceutical Co. Ltd. et al v. Apotex Inc. et al., 1-07-cv-00779 (DED June 14, 2010, Memorandum Opinion) (Robinson, J.)