IP Law Daily No change of heart: artificial valve patent survives challenge by St. Jude
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Thursday, October 15, 2020

No change of heart: artificial valve patent survives challenge by St. Jude

By Sheri A. Wattles-Miller, J.D.

St. Jude Medical failed to show that challenged claims of patent owned by Snyders had been anticipated by other patents, nor did it prove that a particular combination demonstrated obviousness.

Claims of a patent directed to an artificial heart valve manufactured by Snyders Heart Valve LLC and a system for inserting the valve were not proven unpatentable by St. Jude Medical in either of two inter partes review proceedings, the U.S. Court of Appeals for the Federal Circuit found. The Patent Trial and Appeal Board correctly found that St. Jude did not prove that the design and the materials used in the artificial heart valve were anticipated by other patents or that the device was unpatentable due to obviousness. However, the Board erred in finding that four of the challenged claims were unpatentable as anticipated by a prior art patent (St. Jude Medical, LLC v. Snyders Heart Valve LLC, October 15, 2020, Taranto, G.).

Snyders Heart Valve LLC owns U.S. Patent No. 6,540,782 (the ’782 patent), which describes and claims an artificial heart valve and a system for inserting the valve. St. Jude Medical, LLC filed two petitions seeking inter partes reviews of claims 1, 2, 4–8, 10–13, 17–19, 21, 22, and 25–30 of the ’782 patent (the challenged claims). The Board instituted both reviews.

In regard to the first petition, IPR2018-00105 (IPR-105), the Board ruled that St. Jude had failed to establish unpatentability of any of the challenged claims. Specifically, the Board rejected St. Jude’s contention that all the challenged claims were anticipated by U.S. Patent No. 5,855,601 (Bessler) or U.S. Patent No. 5,957,949 (Leonhardt) and would have been obvious over other patents. In the other petition, IPR2018-00106 (IPR-106), the Board found four claims (claims 1, 2, 6, and 8) anticipated by Bessler, but it rejected St. Jude’s contentions as to all other claims. Specifically, it ruled that St. Jude had not proven, in regard to all but the four claims, anticipation or obviousness. In addition to St. Jude's appeal of the Board's rejection of its challenge to most of the claims at issue for anticipation and obviousness, Snyders cross-appealed the Board's finding that the four claims in IPR-106 were anticipated.

St. Jude’s challenge to IPR-105. The issue on appeal for IPR 105 was whether the Board erred in rejecting St. Jude’s argument that Leonhardt anticipated claims 1, 2, 4–8, and 28. St. Jude contended that the Leonhardt disclosed a "band," while the Board found that it was a full-length sleeve-like covering. According to the Board, Leonhardt’s graft material—the component in Leonhardt that St. Jude argued was the required "band"—did not meet the band limitation. The fact that the width of the band was not specified meant that the sleeve was not necessarily the same thing as a "band." The court went on to say that St. Jude did not address the terms, "strip" or "ring," and that it offered nothing to indicate that those items could not have any width. The full-length sleeve-like covering was not within a skilled artisan's understanding of "band," "strip," or "ring," the court found. Thus, the use of these words did not show that the other patent claim was anticipated.

Snyder’s challenge to IPR-106. Snyders challenged the Board’s finding that Bessler anticipated claims 1, 2, 6, and 8. The court determined that the Board erred in finding patent claims were anticipated. The Board did not carefully consider the "sized and shaped" limitation when it evaluated the four claims. At issue was whether the claims required removing the native heart valve in order to repair a damaged heart valve. The Bessler patent specified that removal of the native heart valve was necessary, and that "sized and shaped" was meant to refer only to placement of the artificial heart valve. The Snyders patent specifications made clear that "sized and shaped" referred to both the intact native heart valve, and also the new artificial heart valve. The specifications stressed this was an improvement on prior patent designs. This conclusion precluded anticipation by the Bessler patent in regard to IPR-106.

St. Jude’s challenge to IPR-106. St. Jude also appealed the Board's conclusion that it failed to prove that other challenged claims would have been obvious. The court reviewed the Board's evaluation of whether a skilled artisan would be motivated to make the proposed combination to arrive at the claimed invention. The Bessler patent had a "cuff" that was integral to its design. Another artificial heart valve also involved a cuff, but then combined a leaflet portion to the design. The Board found, and the court agreed, that there was no meaningful explanation for why a relevant artisan would keep the "integral" cuff portion while replacing the leaflet portion to which it is attached. Thus, St. Jude did not adequately or persuasively establish it the motivation to make the particular combination it proposed in arguing obviousness.

This case is No. 19-2108.

Attorneys: John C. O'Quinn (Kirkland & Ellis LLP) for St. Jude Medical, LLC. Matthew James Antonelli (Antonelli, Harrington & Thompson, LLP) for Snyders Heart Valve LLC.

Companies: St. Jude Medical, LLC; Snyders Heart Valve LLC

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