Judge Robinson Upholds Grant of Limited Discovery of Raw Materials and Intermediate Samples in ANDA Case

December 1, 2015

Publication| Intellectual Property

In Orexo AB v. Actavis Elizabeth LLC, C.A. No. 14-829-SLR/SRF (D. Del. Nov. 20, 2015), Judge Robinson overruled the plaintiffs’ objections to Magistrate Judge Fallon’s ruling regarding a discovery dispute. The plaintiffs had requested samples of the raw materials used to make the defendant’s product and intermediate samples of the product during formulation. Magistrate Judge Fallon had ordered the defendant to produce samples of only two raw materials in its “possession, custody, or control,” and defendant “could not be compelled to produce” intermediate samples due “to defendant’s representations that it has no intermediate samples.” In so holding, the magistrate judge rejected the plaintiffs’ arguments that discovery of raw and intermediate samples was “basic and probative” of infringement of the patents in the case, and that defendant’s documents showed that it was in possession of all the raw materials and had an ongoing duty to preserve them in light of the litigation.

In their objections, the plaintiffs argued that the magistrate judge erred by ignoring the samples’ relevance, citing (apparently for the first time) case law purportedly setting forth an obligation to produce raw materials. Noting the “great discretion” given to a magistrate judge in resolving discovery disputes, Judge Robinson found that the Judge Fallon’s ruling was not clearly erroneous or contrary to law. Judge Robinson declined to consider the newly cited case law, explaining that “a reviewing court may not consider evidence and materials not before the magistrate judge.” Finding no clear error, Judge Robinson affirmed Magistrate Judge Fallon’s order in full.

Analysis: Because of the deferential standard of review, parties dissatisfied with the discovery ruling of a magistrate judge face a difficult path to overturning the decision—and the record regarding the dispute usually is closed upon the magistrate judge’s ruling.

  • sign up for our newsletter

    To keep our clients and friends updated on the latest legal news, Richards Layton distributes practice area e-alerts and newsletters. If you are interested in receiving these publications, please subscribe below.