
On Friday, visiting judge Choe-Groves issued an order addressing a defendant's use of new references in a motivation-to-combine analysis, which it had not disclosed in its invalidity contentions or on the deadline for election of prior art references. It instead disclosed the references for the first time in its expert report on invalidity.
The case involved a scheduling order using Chief Judge Connolly's form, which includes a single round of invalidity contentions and a deadline for election of references, and specifically requires good cause to supplement.
Judge Choe-Groves found that the late disclosure of certain "background" references was acceptable, but rejected the idea that references used in a motivation-to-combine analysis fall into that category:
The Court observes, and Defendant admits, that some of the contested paragraphs of the Dyar Report discuss the disputed references in relation to obviousness arguments regarding motivation to combine. . . .
Defendant’s use of references that were undisclosed previously to advance arguments and opinions addressing motivation to combine transforms the use of the disputed references beyond sources of background material, and into obviousness references. For example, paragraph 175 of the Dyar Report opens with a permissible statement regarding the knowledge of a person of ordinary skill in the art. . . . Dr. Dyar then extrapolates that the prior art would create an expectation of success in combining the teachings of prior art to arrive at the claimed pharmaceutical composition. To the extent that such an argument refers back to the disputed references, it must be stricken as a violation of paragraphs 11 and 7(b) of the Scheduling Order, and Rule 16(b).
The Court will not permit Defendant to use these references to argue obviousness or motivation to combine references.
Aytu Biopharma, Inc. v. Granules Pharma., Inc., C.A. No. 24-1356-JCG, D.I. 76 at 6-7 (D. Del. May 1, 2026).
Of course, this ruling comes up in the context of a scheduling order using Chief Judge Connolly's form. Other judges provide both initial and final contentions, and generally include less language requiring good cause to amend. But it's always safest to think ahead and disclose things wherever possible.
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