Five Tips for IPR Practice Following the Federal Circuit’s Decisions in Medtronic v. Teleflex

“Ultimately, the PTAB found that [the secondary] considerations made the difference between upholding patentability or finding otherwise. And the Federal Circuit remarked that the PTAB’s factual findings on this score were entitled to deference, making them harder to overturn on appeal.”

continuationThis week, the U.S. Court of Appeals for the Federal Circuit (CAFC) issued two precedential decisions that provide additional guidance for those participating in inter partes review (IPR) proceedings. These decisions are Medtronic, Inc. v. Teleflex Innovations S.a.r.l., cases 21-2357 and 21-2359. In total, they address six IPR proceedings challenging five patents related to various advances in guide catheter technology. The 21-2357 case affirms the PTAB’s final written decisions across IPR2020-00127, IPR2020-00130, and IPR2020-00136, while the 21-2359 case affirms the PTAB’s final written decisions for IPR2020-00129, IPR2020-00134, and IPR2020-00138.

The decisions raise a number of issues that suggest some tips for practice going forward.

IPR Practice Pointers

First, arguments of a combination’s inoperability are alive and well, and IPR practitioners should employ these arguments where appropriate. In the 21-2359 case, one dispute focused on whether the primary reference (Ressemann) had multiple purposes and whether the art’s critical purpose was destroyed by Medtronic’s proposed combination of Ressemann with Takahashi. The Federal Circuit noted that the proposed modifications to Ressemann were extensive, that the parties’ experts provided conflicting testimony regarding the critical nature of Ressemann’s embolic protection goal, and that this particular goal was one shared by both Ressemann and the challenged claims. The decision also focused on the Patent Trial and Appeal Board’s (PTAB’s) finding that Ressemann’s entire purpose was destroyed by the combination. Thus, when offering or combatting an inoperability argument, parties to an IPR should carefully consider how extensive the modifications are to the primary reference; whether the primary reference includes multiple goals, some of which support the modification; whether any goals or purposes of the primary reference are shared by the challenged claims; and whether that goal/purpose is destroyed by the combination.

Second, the petition must address all of the modifications necessary to achieve the asserted obviousness combination. The 21-2357 decision observes that Medtronic’s new, extensive modifications raised in reply suggested the use of hindsight bias rather than a known need in the art that would support obviousness. To steer clear of this same issue in the future, when a petitioner proposes a combination that substantially modifies the primary reference—much like replacing a proximal funnel with distal side openings as in this case—the petitioner and its expert should go to great lengths to explain the modifications and how they operate to form the device suggested by the combination.

Third, parties to an IPR should not give short shrift to secondary considerations. Ultimately, the PTAB found that these considerations made the difference between upholding patentability or finding otherwise. And the Federal Circuit remarked that the PTAB’s factual findings on this score were entitled to deference, making them harder to overturn on appeal.

Fourth, parties challenging a final written decision must provide a detailed description of all matters that the PTAB allegedly overlooked or misapprehended. This should include not only the PTAB’s merits rulings, but the factual determinations and the underlying facts and testimony as well. Although the Federal Circuit had no need to decide Teleflex’s waiver argument in these cases, it made a point to note that its decision to consider waived arguments was discretionary. Parties do not want to be in the position of relying on a court’s discretion to consider what it believes to be strong arguments to overturn a final written decision.

Finally, these cases are notable because they relate to IPRs where patent owners filed contingent motions to amend. Only 9% of IPR trials have included motions to amend, so there are few cases providing any discussion of the subject. When faced with this scenario, IPR practitioners should mine the underlying Medtronic and Teleflex IPR papers, final written decisions, and Federal Circuit decisions here to find analogous facts to support their arguments.

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2 comments so far.

  • [Avatar for Frank Coppa]
    Frank Coppa
    June 9, 2023 09:23 am

    Nice analysis; good hints!

  • [Avatar for Pro Say]
    Pro Say
    June 7, 2023 08:06 pm

    Important, eminently worthwhile tips all. Thanks.