United States: Delay In Identifying Prior Art Prevents Their Addition To Notice Of Prior Art

In a recent order, Administrative Law Judge Shaw denied in part the Respondents' Motion to Supplement their Notice of Prior Art. In re Certain Strontium-Rubidium Radioisotope Infusion Systems, And Components Thereof Including Generators, Inv. No. 337-TA-1110, Order No. 17 (August 30, 2018). Judge Shaw allowed supplementation in some respects, but denied the addition of several non-patent publications, because the Respondents did not explain why they did not obtain these references earlier or how these references pertained to the asserted patents.

In this investigation, ALJ Shaw set July 18, 2018 as the deadline for filing a Notice of Prior Art. On that day, respondents Jubilant DraxImage, Inc., Jubilant Pharma Limited, and Jubilant Life Sciences Limited (collectively "Jubilant") filed its notice. However, two weeks later, on August 3, 2018, Jubilant filed a "Limited Notice of Prior Art" without leave or a showing of good cause. Complainant Bracco objected, and Jubilant filed a motion for leave to file a supplemental notice of prior art on August 10, 2018.   In its motion, Jubilant requested to supplement its notice in several respects: (1) rename some previously identified references to remove potential ambiguity; (2) add seventeen references produced by a third party on July 26, 2018 in response to a subpoena; (3) add an earlier version of the Complainant's user manual, a later version of which was included in the original notice; and (4) add six non-patent references.

Neither the Complainant nor Staff objected to the first two requests, and Judge Shaw granted the Respondents' request to rename some references and to add references obtained from the third party after the initial deadline for filing the Notice of Prior Art. Bracco objected to the request to add an earlier version of the user manual, but Judge Shaw granted Jubilant's request because the reference was Bracco's own document, describing its own product, and because its relevance was undisputed.

Jubilant's request to add six non-patent references received the most attention in the Order. The references included four technical references identified by the Respondents' expert and provided to Respondents after the deadline for the Notice of Prior Art had passed. Another reference was available to the counsel before the deadline, but was not substantially analyzed until after the deadline. The sixth reference was a technical standard identified by counsel before the deadline, but not obtained until after the deadline.

Bracco argued that Jubilant failed to explain why it had not timely disclosed the four references identified by Jubilant's expert. Bracco also argued that Jubilant had not explained its delay in analyzing and disclosing the reference that was in its possession before the deadline. Finally, Bracco argued that the technical standard was available for purchase online. Staff argued that Jubilant failed to meet its burden to establish good cause to permit supplementation of these references.

Judge Shaw sided with the Staff and the Complainants and denied addition of the six non-patent references. Judge Shaw explained that Jubilant has not shown good cause for adding them; was not diligent in identifying, obtaining, and analyzing the six references; had not shown that the references were difficult to obtain; and had not explained (beyond stating that it seeks to use the references for "invalidity"), how the references pertain to the asserted patents.

Takeaway

This order is a reminder to parties at the ITC to adhere to the ground rules and scheduling order issued by the ALJ. The deadline for submission of Notice of Prior Art typically comes fairly early in the investigation, when fact discovery is still ongoing. To maximize the identification of useful prior art, respondents should identify relevant prior art early.   If it is necessary to supplement, respondents should be prepared to explain why earlier identification was not possible. Complainants should challenge attempts by respondents to supplement notices of prior art after the deadline in situations where earlier disclosure was possible.

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