In a recent order, Administrative Law Judge Lord denied Respondents CSL Behring LLC, CSL Behring GMBH, and CSL Behring Recombinant Facility AG ("CSL Behring") motion to compel discovery from Complainants Bioverativ Inc., Bioverativ Therapeutics Inc., and Bioverativ U.S. LLC ("Bioverativ") related to CSL Behring’s affirmative defense of inequitable conduct. Certain Recombinant Factor IX Products, Inv. No. 337-TA-1066, Order No. 11.
On September 5, 2017, CSL Behring responded to Bioverativ’s Section 337 complaint and included a litany of affirmative defenses. Although CSL Behring did not specifically plead inequitable conduct as an affirmative defense, its Fifth Affirmative Defense purported to reserve “the right to amend its Response to include other additional defenses that CSL Behring may learn of during the course of this Investigation, including, but not limited to unenforceability.”
During discovery, CSL Behring served the following Interrogatories (and corresponding request for production) on Bioverativ:
Interrogatory No. 14 states:
For each of the Bioverativ Patents-in-Suit, identify each and every piece of prior art relevant to each patent of which any of the Named Inventors, or any other Person involved in the prosecution of the Bioverativ Patents-In-Suit; was aware at any time prior to the date of issuance of the respective Bioverativ Patents-in-Suit; and, if that prior art was not disclosed to the PTO before issuance of the respective Bioverative Patents-in-Suit, explain why.
Interrogatory No. 15 states:
For each of the Bioverativ Patents-In-Suit, identify each and every piece of prior art relevant to each patent of which Biogen or Bioverativ, including, without limitation, their officers, agents, employees, consultant, attorneys, the Named Inventors, and any other Person involved in the prosecution of the Bioverativ Patents-In-Suit, became aware at any time after the issuance of the respective Bioverativ Patents-In-Suit.
While Bioverativ agreed to produce all responsive prior art publications, it opposed the remaining portions of these discovery requests. As ALJ Lord indicated, these interrogatories are directed to an affirmative defense of inequitable conduct, which must be pled with particularity. Exergen Corp. v. Wal-Mart Stores, 575 F.3d 1312, 1327 (Fed. Cir. 2009). According to ALJ Lord, CSL Behring had not pled a single fact in satisfaction of the particularity requirement and its catchall defense was merely an effort to keep open the possibility of alleging additional facts as they become known after conducting discovery – a procedure ALJ Lord indicated was improper under Exergen. She further noted that courts “favor dismissal of general allegations of inequitable conduct to prevent parties from engaging in a fishing expedition.”
Accordingly, ALJ Lord denied CSL Behring’s motion to compel and ordered CSL Behring to show cause why its Fifth Affirmative Defense should not be dismissed. But she also pointed out that Bioverativ appropriately may be required in discovery to identify relevant prior art of which it is aware and if CSL Behring learns of prior art that was not submitted to the PTO, it may seek further discovery concerning that prior art. If the facts discovered would support the affirmative defense of inequitable conduct, CSL Behring may seek leave to amend its response to the complaint.
As ITC litigants are no doubt aware, under Exergen a respondent must plead the affirmative defense of inequitable conduct with particularity or it may be dismissed. Complainants and respondents should also be aware of the limitations such a requirement imposes on certain discovery requests. For example, even though an ALJ may view discovery requests of this nature as a fishing expedition, there may be ways to request the desired information in an incremental manner. But this may be difficult to do given the expedited nature of Section 337 investigations. For their part, complainants should review such discovery requests and challenge them if they appear to overreach.