Boston Scientific v. Cordis: Obviousness from Two Separate Embodiments

In Boston Scientific v. Cordis, 554 F.3d 982 (Fed. Cir. 2009), the Court of Appeals for the Federal Circuit overturned both the PTO Examiner and the district court trial jury in invalidating Boston Scientific’s patent claims due to invalidity. Specifically, the appellate court determined that prior art disclosed all elements of Boston Scientific’s claims, albeit across two embodiments. In reaching the opinion the court ignored the longstanding Graham v. John Deere obvious analysis and used language more akin to that found in KSR Int’l Co. v. Teleflex Inc., 127 S. Ct. 1740 (2007), perhaps helping to clarify the court’s approach post-KSR.

Background

In 2003, Boston Scientific sued Cordis for infringing its patented drug-eluting, non-thrombogenic, expandable stent (U.S. Patent No. 6,120,536). Boston Scientific’s stent has a metal core that is surrounded by a drug layer, which is in turn surrounded by a non-thrombogenic layer.

At trial before the U.S. District Court for the District of Delaware, Cordis pointed to a prior art patent the “Wolff” stent that, Cordis argued, rendered the Boston Scientific patent claims obvious and therefore invalid. The Wolff patent disclosed two separate, side-by-side embodiments – one with a metallic core and a drug-eluting coating, and another with a drug-eluting core and a non-thombogenic coating. Cordis argued that though these were two separate embodiments, their side-by-side presentation made Boston Scientific’s claims obvious and therefore invalid.

Despite Cordis’ argument, the jury found in favor of Boston Scientific.  The jury concluded that Cordis’ drug-eluting expandable stent did constitute infringement, and that Boston Scientific’s patent was not obvious based on prior art references. Boston Scientific Scimed Inc. v. Cordis Corp., 2007 WL 2775087, No. CIV 03-283-SLR (D.Del. June 3, 2007). The District Court denied Cordis’ motions for new trial and for judgment as a matter of law, and Cordis filed this appeal, found at 554 F.3d 982 (Fed. Cir. 2009).

Two separate embodiments can be combined to find obviousness

All the elements of Boston Scientific’s claims existed in one single prior art reference, though across two separate embodiments. A combination of those two embodiments resulted in the structure described by Boston Scientific’s claims.

The appellate court characterized the situation as a “strong prima facie showing of obviousness,” writing that “[c]ombining two embodiments disclosed adjacent to each other in prior art patent does not require a leap of inventiveness.” 554 F.3d 982, 991.

Surprisingly, in reaching its conclusion of obviousness, the court did not even reference the longstanding analysis for obviousness set forth in Graham v. John Deere, 383 U.S. 1 (1966). Rather, the court drew upon the “predictable variation” language of KSR v. Teleflex, 550 U.S. 393, 127 S.Ct. 1727, 1731 (2007), indicating that “one of ordinary skill in the art would have been motivated to combine the [two embodiments in the reference] to arrive at [the claimed invention].”554 F.3d at 991.

Boston Scientific argued that the prior art reference could not serve as the basis for a finding of obviousness for a couple of reasons, both of which were rejected by the appellate court. Boston Scientific argued that the prior art failed to recognize the benefit of the combination, thus indicating nonobviousness. In rejecting this argument, the court wrote that the “[prior art reference] need not have recognized the additional benefit of one embodiment to have rendered the claim obvious.” 554 F.3d at 991.

Boston Scientific also argued that its claims must not be obvious because if they were, then the inventor of the prior art reference Medtronic would have developed a product that combined the two embodiments in its own patent. The court rejected this argument as “weak” and finally rejected it based on defendant’s evidence that the failure to develop the combination product was not due to an inability to conceive of it, but rather to difficulty in finding a drug suitable for inclusion in the stent product. Id.

Conclusion

KSR left open questions about the continuing role of the teaching-suggestion-motivation test in an obviousness analysis. The court’s failure to apply of the Graham analysis in favor of what appears to be close to a litmus-test treatment of the obviousness issue may hint at clarification of how these tests combine. The court’s opinion suggests that in certain situations – perhaps rare situations like this one where obviousness is found based on combinations of separate embodiments in single prior art reference – a full Graham analysis is simply not necessary.

Moreover, it’s notable that the patent examiner did review the prior art reference at issue in the case, and still issued the patent. Clearly, the examiner did not find obviousness, and the court has repeatedly referenced the need to show deference to the PTO. Nevertheless, in finding obviousness despite both the Examiner and the trial jury’s verdict, the appellate court showed little deference for either.

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