By Eric Schweibenz
On August 5, 2011, ALJ Robert K. Rogers, Jr. issued the public version of Order No. 10 (dated June 22, 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 Complainant Eli Lilly and Company’s (“Lilly”) motion for a presumption of infringement under 35 U.S.C. § 295 and a motion to compel.

According to the Order, Lilly argued that pursuant to 35 U.S.C. § 295, it was entitled to a presumption of infringement with respect to the accused process of Respondent Jiangsu Hansoh Pharmaceutical Co., Ltd. (“Hansoh”) for manufacturing gemcitabine.  Lilly claimed that there was a substantial likelihood that Hansoh uses the patented process to manufacture gemcitabine.  In particular, Lilly claimed that Hansoh’s alleged process was not commercially viable, Hansoh had failed to produce sufficient evidence to corroborate its process, and evidence cast doubt on Hansoh’s claim that the process it uses for Respondent Hospira, Inc. (“Hospira”) differs from the process used for all other Hansoh customers.  Lilly further sought to compel an inspection of Hansoh’s facility and to be allowed to conduct a forensic inspection of Hansoh’s original batch records from the facility.  Lilly sought to inspect the original batch records to determine if the original batch records were themselves authentic and also to determine if the copies produced in the investigation were accurate reproductions.

Respondents Hansoh, Hospira, and ChemWerth, Inc. (collectively, “Respondents”) opposed Lilly’s motion.  Respondents argued that the motion violated Ground Rule 4.1.1 because Lilly had not raised the presumption issue at a Discovery Committee meeting.  Respondents further argued that 35 U.S.C. § 295 does not apply to ITC proceedings.  Respondents additionally argued that Lilly had failed to demonstrate that it is entitled to a presumption of infringement.  Respondents claimed that Lilly had not made reasonable efforts to determine Hansoh’s process.  Respondents also argued that Lilly was not entitled to a plant inspection and noted, inter alia, that any inspection would require the approval of the Chinese government.  Respondents also opposed Lilly’s request for forensic testing of Hansoh’s original batch records. 

The Commission Investigative Staff (“OUII”) also opposed Lilly’s motion.  OUII argued that Lilly had failed to demonstrate that it was entitled to a presumption of infringement.  OUII also opposed Lilly’s request for a plant inspection, claiming that such a request was premature.  OUII also opposed Lilly’s request to inspect the original batch records because such a request was overly burdensome and unjustified at the present time.

After considering the arguments, ALJ Rogers determined to grant-in-part and deny-in-part Lilly’s motion.  ALJ Rogers first found that Lilly’s motion did not violate Ground Rule 4.1.1.  The ALJ next found that while 35 U.S.C. § 295 can apply at the ITC, Lilly was not entitled to the presumption in this instance because Lilly had not followed all avenues of discovery likely to uncover Hansoh’s process.  The ALJ also found that Lilly’s request for a plant inspection was premature in view of Lilly’s failure to explore other less burdensome means of discovery.  ALJ Rogers stated that Lilly could renew its request for a plant inspection at a later date if it is not able to discover the information at issue through less burdensome means.  As to the batch records, ALJ Rogers found that Lilly had a sufficient justification to call into question the authenticity of the batch records produced by Hansoh and that it was therefore proper for Lilly to proceed with testing certain batch records that are relevant and material to the investigation.  Accordingly, ALJ Rogers ordered that Hansoh make its original batch records available for Lilly to test within 10 days from the date of the Order.