Recently, in a case involving Sandoz Inc. vs Acerta Pharma B.V. (IPR2023-00478), the Patent Trial and Appeal Board (“PTAB”) found itself denying IPR institution where the asserted prior art was labelled as cumulative of that considered during prosecution. This ruling is drawing attention from legal professionals and corporations alike, in light of its precedent-setting nature. For those who wish to delve into the details of the case.
The PTAB panel dismissed the inclusion of prior art that had not been cited during prosecution, yet was found to expose the same limitations that the Examiner had identified within different references priorly. It was yet another instance spotlighting the careful eye with which such evidentiary matters are being treated, warranting further discussion and the need for cogently formulated litigation models.
This has significant implications for cases in the future, underscoring the crucial nature of novel elements in patent claims. An examination of the arguments made by both Sandoz Inc. and Acerta Pharma B.V. will offer necessary insights for the development of future strategies in patent litigation.
An analysis of this most recent patent dispute does provide an insight into the PTAB’s current approach and highlighting the importance of providing unique references when asserting a claim of prior art.
A growing shift is being noticed towards prioritization of novelty and strategy over plain volume of multiple combined prior art references. This approach, if consistently upheld in subsequent rulings, may have profound reverberations on the development of patent strategy in contested litigation proceedings.
Considering the rapidly evolving legal landscape, every patent practitioner, corporate counsel, and firm involved in patent-related cases must be cognisant of these aspects and should be ready to adapt their strategy in defending or challenging patent claims.