<em>Medtronic, Inc. v. Teleflex Life Scis. Ltd.</em>
Nos. 2022-1721, 2022-1722, 2023 U.S. App. LEXIS 30501 (Fed. Cir. Nov. 16, 2023)
The Federal Circuit affirmed the Patent Trials and Appeals Board’s decision on the validity of Teleflex’s patent but refused to address whether an in vivo performance of an in vivo method is required to show actual reduction to practice.
Medtronic requested the inter partes review of several Teleflex patents relating to cardiac catheters. One of their patents, no. ‘116, contains a method for using a guide extension catheter with a normal guide catheter. The patent describes the method as advancing a guide catheter through a main blood vessel to a coronary artery. The guide extension catheter developed by Teleflex using ‘116, the GuideLiner, eventually entered the market in 2009.
Medtronic’s allegedly infringing guide extension catheter was launched in 2019. Medtronic’s petitions to the PTAB asserted that claims 52 and 53 of no. ‘116 were anticipated, while several other claims were obvious based on patents ‘612 (“Ressemann”) and ‘355 (“Itou”). Medtronic claimed Itou was prior art based on diligence. Medtronic also claimed that Teleflex did not show an actual reduction to practice in their application. Teleflex responded that Itou was not prior art because Teleflex’s invention was conceived prior to Itou’s filing date. Teleflex additionally argued their invention was reduced to practice before the critical date.
The Federal Circuit disposed of the obviousness issue in another decision earlier this year, which addressed patent ‘116. The Court chose not to address it in this case further. In their previous decision, the Court upheld the Board’s decision that the asserted combination of references would not make Teleflex’s claims obvious, but the Court did not rule on if Itou counts as prior art or not. More specifically, the Board held that there was a lack of motivation to combine those prior references and a nexus to secondary considerations that weighed in favor of nonobviousness for the claims. The only part of Medtronic’s appeal left for this case is to determine whether Itou was prior art. That is determined by whether or not in vivo testing is required for actual reduction to practice, and if Teleflex exercised reasonable diligence until constructive reduction to practice. Medtronic does not contest that Teleflex’s invention was conceived before Itou’s filing date and did not bring up any challenges to the Board’s diligence finding in their filing.
Following Medtronic’s two petitions for inter partes review of Teleflex’s ‘116 patent, the Patent Trial and Appeal Board (“the Board”) issued its two final written decisions. The Board found that most of Teleflex’s claims were non-obvious, with two exceptions. Moreover, the Board held that claimed invention was actually reduced to practice even though it was not performed in vivo. Medtronic appealed to the Federal Circuit, which ruled on November 16, and upheld the decisions of the Board.
The most significant part of this case was that the Federal Circuit heard, but did not actually consider, the question of whether claims for a method need to be supported by a showing of an actual reduction to practice. “Actual reduction to practice” means the patent claims are shown to be effective for the result it claims to achieve. The Court affirmed the Board’s ruling that Itou did not count as prior art because Teleflex was able to show their reduction to practice. The Board found that such evidence was not necessary and that evidence from an alternative physical model would suffice, and the Court did not disagree or change the Board’s analysis. The Court did note that a showing of either actual or constructive reduction to practice would be enough to affirm the Board’s decision in this case.
The standard the Court used was that a patent owner may antedate an asserted prior art patent by showing the conception of the claimed invention occurred prior to the critical date and either actual reduction to practice or reasonably continuous diligence until its effective filing date. The Court found in Olympus Am. Inc. that diligence is required for the entire critical period, which begins just before the competing reference’s effective date and ends on the date of the invention’s reduction to practice. Medtronic is not contesting that Teleflex’s invention was conceived prior to the filing date, and the Court refused to look at the issue of diligence. Therefore, Itou was not held to be prior art.
The Court chose not to examine the issue of Teleflex’s diligence on appeal since Medtronic attempted to bring that argument in by incorporating the issues discussed by reference. Moreover, Medtronic attempted to incorporate twenty pages, and the panel recognized this as an attempt to circumvent the length limits that they are meant to be following. This failure, and Medtronic’s decision not to contest the conception of the claimed invention, led to Medtronic losing this appeal.
Thus, the Federal Circuit has not yet determined if proving reduction to practice requires one to show that their method worked in vivo on a real person.