St. Jude Medical, Cardiology Division, Inc. v. Volcano Corp., 749 F.3d 1373

St. Jude petitioned the PTO for inter partes review of Volcano's U.S. Patent No. 7,134,994 in 2013; the Director denied the petition.
The Board, as the Director’s delegee, concluded instituting was barred by §315(b) because a Delaware infringement counterclaim against St. Jude was served more than a year before the petition.
In the Delaware action, the district court dismissed all claims relating to the ’994 patent in 2012.
St. Jude appealed the Director’s non-institution decision; Volcano and the Director moved to dismiss the appeal.
The court held no jurisdiction to review the Director’s non-institution decision; §314(d) provides no-appeal and the appeal is outside the statute’s scope.

Issue	Plaintiff's Argument	Defendant's Argument	Held
Jurisdiction to review non-institution	St. Jude relies on 28 U.S.C. §1295 for appellate review.	Volcano/Director contend no appeal of a non-institution decision exists under §314(d).	No jurisdiction to review the Director's non-institution decision.
Effect of §314(d) No Appeal provision	N/A	§314(d) bars any appeal of the Director's decision to institute or not.	§314(d) bars appeal of the Director's non-institution decision.
Appropriate appeal path in IPR	St. Jude argues for direct Federal Circuit review of the Director's decision.	Court should review only the Board's merits decision if instituted.	Only the Board's final written decision on patentability is appealable; the Director's non-institution decision is not.
Relation of §1295 jurisdiction to Board decision	Section 1295 provides appellate jurisdiction for IPR outcomes.	Jurisdiction limited to Board's decision after institution, not the Director's pre-institution ruling.	Jurisdiction aligns with Board’s merits decision, not the Director’s pre-institution denial.

Belkin Int’l, Inc. v. Kappos, 696 F.3d 1379 (Fed. Cir. 2012) (describes two-step process framework for inter partes review)