• ALJ Rogers Rules On Motion To Quash And/Or Limit Subpoenas In Certain Gemcitabine (337-TA-766)
  • August 11, 2011 | Authors: Alexander B. Englehart; Eric W. Schweibenz
  • Law Firm: Oblon, Spivak, McClelland, Maier & Neustadt, L.L.P. - Alexandria Office
  • On August 5, 2011, ALJ Robert K. Rogers, Jr. issued the public version of Order No. 9 (dated June 20, 2011) in Certain Gemcitabine and Products Containing Same (Inv. No. 337-TA-766).  In the Order, ALJ Rogers granted-in-part and denied-in-part non-parties Teva Pharmaceuticals USA, Inc. and Teva Parenteral Medicines, Inc.’s (collectively, “Teva”) motion to quash and/or limit the subpoenas duces tecum and ad testificandum issued upon application of Complainant Eli Lilly and Company (“Lilly”).

    According to the Order, Teva explained that in the past, it had received “development quantities” of gemcitabine from Respondent ChemWerth, Inc. (“ChemWerth”).  Teva further stated that ChemWerth served as an agent for Respondent Jiangsu Hansoh Pharmaceutical Co., Ltd. (“Hansoh”), the supplier of gemcitabine.  Teva argued that discovery relating to any analysis, evaluation, or study of Hansoh’s process for manufacturing the gemcitabine sold to Teva was irrelevant to the investigation.  Rather, Teva claimed that only an analysis of the Respondents’ actual imported products, or the process made to use those products, was relevant.  Teva further asserted that Lilly had not explained how information related to a prior developmental batch of gemcitabine manufactured for a non-party was relevant to the investigation.  Teva also argued that the information sought by Lilly was available from ChemWerth and/or Hansoh, and that Lilly had not exhausted its efforts in seeking the discovery from those Respondents.  Lastly, Teva claimed that the subpoenas were overly burdensome because they sought a wide range of documents and sought discovery from Teva and all of its affiliated companies.

    In response, Lilly argued that the information sought from Teva was highly relevant to determining whether or not Hansoh uses the patented process to produce gemcitabine.  Lilly explained that it was seeking two categories of information:  (1) information concerning Hansoh’s process of manufacturing gemcitabine; and (2) Teva’s decision not to source gemcitabine from Hansoh.  Lilly asserted that the first category was relevant because Lilly believed that for the purposes of the asserted patent, the process used to make the gemcitabine for Teva is the same as the process at issue in the investigation.  Lilly asserted that the second category was relevant to the issue of whether Hansoh uses a different process to manufacture gemcitabine than that which is set forth in its documents.  Lilly further argued that much of the information sought was only in Teva’s possession.  For example, Lilly was seeking meeting minutes, emails, and other documents generated by Teva employees concerning Hansoh’s process — and these could not be found outside of Teva’s files.  Finally, Lilly argued that the subpoenas were not an undue burden on Teva.

    After considering the arguments, ALJ Rogers determined to grant-in-part and deny-in-part Teva’s motion.  In particular, the ALJ found that information related to, inter alia, Hansoh’s process of producing gemcitabine for Teva was relevant to Lilly’s claim of infringement in the investigation, or at least reasonably calculated to lead to the discovery of admissible evidence.  However, with respect to a document request and deposition topic directed to Teva’s decision not to source gemcitabine from Hansoh, the ALJ determined that the request and topic should be limited to all documents and things concerning Teva’s understanding, belief, or suspicion that Hansoh uses a different process to manufacture gemcitabine that that which is set forth in Hansoh’s documents.  According to the order, there had been no showing that the remainder of the documents responsive to the request, such as documents evidencing Teva’s strategic or business decisions regarding whether or not to source gemcitabine from Hansoh, were relevant or reasonably calculated to lead to the discovery of admissible evidence.  ALJ Rogers also found that Lilly did have a legitimate need for the allowed discovery and that the subpoenas did not impose undue hardship on Teva.  Accordingly, ALJ Rogers granted-in-part and denied-in-part Teva’s motion to quash and/or limit the subpoenas.