China IP News, June 2009.
Since its issuance in 2007, the U.S. Supreme Court's decision in the landmark case of KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007) (hereafter, "KSR") appears generally to have raised the bar for patentability under 35 U.S.C. § 103. That has been, unfortunately, anecdotally true in the USPTO where one Supervisor revealed that his Group's Allowance rate had plummeted to below 20%. The authors have heard strident complaints from bar groups such as those in North Carolina, South Carolina, Virginia, Minnesota, Florida, and California that the USPTO has recreated itself as the USPRO, i.e., the United States Patent Rejection Office. Although a detailed view of the impact of KSR in two short years in both the USPTO and the courts is far beyond the scope of this article, a focus herein will be to see what KSR did to change U.S. law and whether KSR is limited to predictable technologies.
KSR has not changed the fact that in U.S. courts, the determination of obviousness under 35 U.S.C. § 103 is a legal conclusion based on factual evidence.1 Nor did KSR change the focus of the time-honored underlying factual issues defining the obviousness/non-obviousness calculus as set forth in Graham v. John Deere Co. of Kansas City, 383 U.S. 1, 17, 86 S.Ct. 684, 15 L.Ed.2d 545 (1966):
- the scope and content of the prior art;
- differences between the prior art and the claims at issue;
- the level of ordinary skill in the pertinent art; and
- evaluation of any relevant secondary considerations.2
But KSR did shift the focus away from the "teaching-suggestion-motivation" ("TSM") test commonly applied by the Federal Circuit in the years leading up to KSR to determine if an invention was obvious in view of prior art. The TSM test was a judge-made standard by which inventions were only obvious if there was a teaching, suggestion, or motivation to modify or combine the prior art teachings to achieve the claimed invention.
In KSR, the Supreme Court chastised the Federal Circuit for adopting a "rigid approach" in applying the TSM test for obviousness.3 Instead, the Supreme Court stated that "Graham set forth a broad inquiry and invited courts, where appropriate, to look at any secondary considerations that would prove instructive."4 According to the Supreme Court:
But in its zeal to eliminate a rigid TSM rule, the KSR Court may have unwittingly set up another rule that can be equally and wrongly rigidly applied: "obvious to try." Prior to KSR, it was well-established that "obvious to try" was not the standard for evaluating patentability under 35 U.S.C. § 103.6 ("With hindsight, we could perhaps agree that the Houghton article seems like an obvious place to start . . . But, "obvious to try" is not the standard."). Yet, the KSR court, transformed U.S. jurisprudence to the extent it articulated scenarios in which "obvious to try" is enough to defeat patentability under 35 U.S.C. § 103:
What, then, is the scope of the "obvious to try" rule? It is far too early yet to tell. But observers of the case law speculate whether that rule is limited to so-called predictable technologies.
The authors' anecdotal but admittedly limited post-KSR experience has been that the USPTO has enthusiastically jumped on the bandwagon of the "obvious to try" rule. Time and again, using the patent application claim as a mosaic, the USPTO simply finds all the elements of the claim in one or more pieces of prior art art and rigidly declares the mosaic to have been obvious, seemingly losing sight of the Graham findings expressly upheld in KSR. Application of that rigid rationale might explain at least to some extent the very low number of allowances referenced above.
The applicability of the "obvious to try" standard of KSR to unpredictable technology came before the Federal Circuit in Takeda Chemical Industries, Ltd. v. Alphapharm Pty., Ltd., 492 F.3d 1350 (Fed. Cir. 2007), cert. denied, 128 S.Ct. 1739 (U.S., March 31, 2008). Therein, the Federal Circuit seemingly turned its back on "obvious to try" by addressing whether the presumption of obviousness for structurally similar chemical compounds survived the Supreme Court's decision in KSR:
In Takeda, the district court found that one of ordinary skill in the art would not have selected the lead compound relied on by Alphapharm from the "hundreds of millions" of possible compounds.9 Skirting the "obvious to try" issue, the Federal Circuit reasoned:
In Ortho-McNeil Pharmaceutical, Inc. v. Mylan Labs., Inc., 520 F.3d 1358 (Fed. Cir. 2008), Ortho-McNeil's patent claimed the anticonvulsive drug topiramate. Mylan argued that anyone of ordinary skill in the art searching for a diabetes drug would necessarily find topiramate.13 The Federal Circuit found, however, that:
In Eisai Co. Ltd. v. Dr. Reddy's Labs., Ltd., 533 F.3d 1353 (Fed. Cir. 2008), the Federal Circuit articulated the post-KSR application of the "obvious to try" approach as:
In language helpful to "unpredictable technologies," the Court in Eisai went on to say:
Those cases lead some to believe that KSR does not apply to unpredictable technologies, at least certain pharmaceutical inventions like those tested in Takeda, Eisai, Ortho, Sanofi-Synthelabo, and Procter & Gamble. However, in In re Kubin, 561 F.3d 1351 (Fed. Cir. 2009), the Federal Circuit found the claimed gene sequence was obvious over the prior art, and pronounced that KSR is not limited to predictable technologies:
Then, no doubt realizing the confusion it was creating, the Kubin court declared it all a non-issue by pointing out that every patent claim must be evaluated on its own facts:
Clearly, the contours of "obvious to try" in U.S. jurisprudence remain to be worked out in the months and years to come. But with the introduction of "obvious to try," the U.S. law regarding 35 U.S.C. §103 has in fact changed.
And of course, since the Supreme Court made no effort to declare that its decision has no retroactive effect, and KSR was decided just about two years ago, many important pre-KSR patents will see the light of day in litigation and/or licensing brought in the post-KSR world. Patentees may wish to review those patents BEFORE litigation and/or licensing arises and consider their options such as filing a reissue application or, if available, a continuation application, or a request for reexamination. But corrective action might not be easy or desirable for the patentee to do, since reissue requires a statutory error, and reexamination requires the existence of a substantial new question of patentability. Such situations call for careful consultation with expert U.S. counsel.
Endnotes
1 See Princeton Biochemicals, Inc. v. Beckman Coulter, Inc., 411 F.3d 1332, 1336-37 (Fed. Cir. 2005).
2 KSR, 550 U.S. at 406-407.
3 Id. at 415.
4 Id.
5 Id. at 418.
6 See, e.g., Ecolochem, Inc. v. Southern California Edison Co., 227 F.3d 1361, 1374 (Fed. Cir. 2000).
7 KSR, 550 U.S. at 420.
8 Id. at 1356-57.
9 Id. at 1358.
10 KSR, 127 S.Ct. at 1732.
11 Id.
12 Id. at 1359.
13 Id. at 1364.
14 Id.
15 Id. at 1359.
16 Id. See also, Proctor & Gamble Co. v. Teva Pharmaceuticals USA, Inc., -- F.3d ---, *4 (Fed. Cir. May 13, 2009)(citing Eisai with approval and noting, "The district court found that Teva failed to clear that hurdle, establishing insufficient motivation for a person of ordinary skill to synthesize and test risedronate. This finding was not clearly erroneous."); and Sanofi-Synthelabo v. Apotex, Inc., 550 F.3d 1075 (Fed. Cir. 2008)(claimed enantiomer was patentable over a prior art patent that disclosed the racemate because it turned out, surprisingly, that the claimed enantiomer possessed all the activity and none of the side effects.).
17 Id. at 1360.
18 Id.
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