In this interesting Order, the Court makes a big swing from allowing five years back of ESI to be collected, to allowing eighteen years. This will definitely result in a large volume of data collected.
Takeda Pharmaceutical Company filed a complaint against Teva Pharmaceuticals for an infringement on U.S. Patent No. 6,034,239. Takeda claimed that Teva violated the plaintiff’s New Drug Application, which covered the drug under patent until 2010, by filing an Abbreviated New Drug Application in July of 2009. In response, Teva stated “that they [did] not infringe the ‘239 patent and that the patent [was] invalid as being obvious and for failure to comply with 35 U.S.C. § 112.” Thus, the defendant requested ESI from 13 years prior, which would “include…research data that [would] reveal how and when the alleged invention was conceived…” Takeda opposed the motion for discovery, asking the Court to “limit its discovery obligations for ESI to 2005 through the present pursuant to Federal Rule of Civil Procedure 26(b)(2)(B).” According to the order, the court considered:
…whether the patent was obvious at the time of the alleged invention, when the inventors first conceived the invention, whether the inventors were aware of an undisclosed best mode during patent prosecution, and what the claims meant to a person of ordinary skill in the art at the time of the invention.
After analyzing these factors, the court concluded that ESI from the time period prior to 2005 was “highly relevant to at least Takeda’s claims of unexpected properties and secondary considerations.” The Court further stated that “Takeda’s supporting declarations [were] rife with gaps relating to its pre-2005 ESI and [did] not satisfy Takeda’s burden.” Also, although the motion for discovery exceeded the usual 5 year time limit, the court ruled that the defendants had “good cause” and granted the motion “to compel production of an additional 13 years of ESI.”