Authored by Thomas L. Irving and Ningling Wang
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:
[The rigid application of the "TSM" test for obviousness, is] "incompatible with our precedents. The obviousness analysis cannot be confined by a formalistic conception of the words teaching, suggestion, and motivation, or by overemphasis on the importance of published articles and the explicit content of issued patents . . . There is no necessary inconsistency between the idea underlying the TSM test and the Graham analysis. But when a court transforms the general principle into a rigid rule that limits the obviousness inquiry, as the Court of Appeals did here, it errs.5
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:
When there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under § 103.7
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:
That test for prima facie obviousness for chemical compounds is consistent with the legal principles enunciated in KSR . . . Thus, in cases involving new chemical compounds, it remains necessary to identify some reason that would have led a chemist to modify a known compound in a particular manner to establish prima facie obviousness of a new claimed compound.8
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:
The KSR Court recognized that "[w]hen there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp."10 In such circumstances, "the fact that a combination was obvious to try might show that it was obvious under § 103."11 That is not the case here. Rather than identify predictable solutions for antidiabetic treatment, the prior art disclosed a broad selection of compounds any one of which could have been selected as a lead compound for further investigation. Significantly, the closest prior art compound (compound b, the 6-methyl) exhibited negative properties that would have directed one of ordinary skill in the art away from that compound. Thus, this case fails to present the type of situation contemplated by the Court when it stated that an invention may be deemed obvious if it was "obvious to try." The evidence showed that it was not obvious to try.12
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:
[t]he record . . . does not present a finite (and small in the context of the art) number of options easily traversed to show obviousness . . . In this case, the record shows that a person of ordinary skill would not even be likely to start with [the compound selected by the inventor]. Beyond that step, however, the ordinarily skilled artisan would have to have some reason to select (among several unpredictable alternatives) the exact route that produced topiramate as an intermediate. Even beyond that, the ordinary artisan in this field would have had to (at the time of invention without any clue of potential utility of topiramate) stop at that intermediate and test it for properties far afield from the purpose for the development in the first place (epilepsy rather than diabetes). In sum, this clearly is not the easily traversed, small and finite number of alternatives that KSR suggested might support an inference of obviousness.14
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:
determine if there are "reasons for narrowing the prior art universe to a 'finite number of identified, predictable solutions[.]' [citation to KSR and Ortho-McNeil omitted] If so, "this 'easily traversed, small and finite number of alternatives . . . might support an inference of obviousness.'"15
In language helpful to "unpredictable technologies," the Court in Eisai went on to say:
To the extent an art is unpredictable, as the chemical arts often are, KSR's focus on these "identified, predictable solutions" may present a difficult hurdle because potential solutions are less likely to be genuinely predictable.16
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:
This court also declines to cabin KSR to the "predictable arts" (as opposed to the "unpredictable art" of biotechnology). In fact, this record shows that one of skill in this advanced art would find these claimed "results" profoundly "predictable."17
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:
This court cannot, in the face of KSR, cling to formalistic rules for obviousness, customize its legal tests for specific scientific fields in ways that deem entire classes of prior art teachings irrelevant, or discount the significant abilities of artisans of ordinary skill in an advanced area of art.18
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.
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.
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.
12 Id. at 1359.
13 Id. at 1364.
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.
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