By Kevin E. Noonan ---
To even the most casual observer of the Federal Circuit, the Supreme Court's interest in the Court's jurisprudence is startling. After fifteen years of giving scant attention to the Federal Circuit's development of patent law, the Supreme Court has spent the last decade overturning what was thought to be settled law. Warner-Jenkinson Co. v. Hilton Davis Chem. Co., Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., Dickinson v. Zurko, eBay Inc. v. MercExchange, LLC, Merck KGAA v. Integra Lifesciences I, Ltd., Medimmune, Inc. v. Genentech, Inc. - the list includes several major, and different, areas of patent law, the Federal Circuit's supposed area of special expertise. By consistently reversing the Federal Circuit, the Supreme Court has reasserted its preeminence in patent law as it has in all other areas.
The case having the most significant impact on patent law generally, and that threatens to significantly diminish the Federal Circuit's institutional integrity, is KSR Int'l Co. v. Teleflex, Inc., where the Supreme Court will rule on one of the crown jewels of the Federal Circuit's explication of patent law, the teaching-suggestion-motivation (TSM) test of In re Vaeck. This test has provided the analytical framework for determining non-obviousness, both before the Patent and Trademark Office and in district court litigation. Its main advantage is to bridge the gap in applying the rubrics enunciated by the Supreme Court in Graham v. John Deere Co. on obviousness, something that the Supreme Court had occasion to do only fitfully in the time between Graham and the institution of the Federal Circuit.
With the shadow of the KSR case looking over its shoulders, the Federal Circuit has spent the past year or so addressing not only the litigants, the Patent Office, and the patent bar, but, at every opportunity, the Supreme Court itself regarding the TSM test for non-obviousness. The fundamental rationale for the test, according to the Federal Circuit, has been to avoid the "insidious" effects of hindsight, and the inability of the general Graham test to avoid these effects, as the Court noted in In re Kahn (Fed. Cir. 2006) (affirming a Patent Office obviousness determination). Notably, the Kahn Court spent a significant portion of its opinion explaining how the TSM test "informs" (and, accordingly, is subservient to) the Graham rubrics.
The Court has addressed most consistently the motivation prong of the TSM test, notably in Ormco Corp. v. Align Tech., Inc. (Fed. Cir. 2006) and Alza Corp. v. Mylan Labs., Inc. (Fed. Cir. 2006). In Alza, the Court noted the provenance of the test in CCPA jurisprudence. The Court was careful to address sub silentio the criticism that it applied the TSM test rigidly, pointing out that its application of the test encompassed implicit as well as explicit motivation to combine prior art references. The Court explicitly stated that its application of the TSM test was not rigid in DyStar Textilfarben GmbH v. C.H. Patrick Co. (Fed. Cir. 2006), and suggested that the criticisms of their earlier decisions were "taken out of context." And in Cross Med. Prod., Inc. v. Medtronic Sofamor Danek, Inc. (Fed. Cir. 2007), the Court asserted that the motivation to combine was not only to be found (or looked for) in the prior art, but in the knowledge of those with skill in the art and their recognition of the problem to be solved (adduced, one supposes, by expert testimony). The Court also increased its reliance on secondary considerations when possible, for example, in Eli Lilly and Co. v. Zenith Goldline Pharm., Inc. (Fed. Cir. 2006).
Most recently, the Court held the patents-in-suit obvious in Pfizer, Inc. v. Apotex, Inc., reversing the district court's non-obviousness determination. Here, the Court easily found the motivation to combine, and reversed the district court on the grounds that there was a reasonable expectation of success not trumped by secondary considerations of surprising and unexpected results. The Court recited In re O'Farrell in support of the proposition that unpredictability per se was insufficient to avoid obviousness; a reasonable expectation, not certainty, is the standard. The Court reasserted that what was required was:
more than merely to vary all parameters or try each of numerous possible choices until one possibly arrived at a successful result, where the prior art gave either no indication of which parameters were critical or no direction as to which of many possible choices is likely to be successful.
In Pfizer, testimony including assertions made by Pfizer before the FDA and in related proceedings (Pfizer Inc. v. Dr. Reddy's Labs., Ltd.) was sufficient to suggest that there were neither numerous possible choices nor a plethora of parameters to vary - the number of addition salt candidates were few and their identities known in art-established pharmacopeias. The Court also distinguished between the:
type of experiments used by Pfizer's scientists to verify the physicochemical characteristics of each salt [that] are not equivalent to the trial and error procedures often employed to discover a new compound where the prior art gave no motivation or suggestion to make the new compound nor a reasonable expectation of success.
Finally, the Federal Circuit may have been directing a quotation from the DyStar case towards the Supreme Court as it considered the obviousness issue in KSR:
Obviousness is a complicated subject requiring sophisticated analysis, and no single case lays out all facets of the legal test. [There is] danger inherent in focusing on isolated dicta rather than gleaning the law of a particular area from careful reading of the full text of a group of related precedents for all they say that is dispositive and for what they hold. When parties . . . do not engage in such careful, candid, and complete legal analysis, much confusion about the law arises and, through time, can be compounded.
Some commentators have noted that the KSR challenge to the Federal Circuit's TSM test for obviousness was surprising and unexpected, and may have caught the Court off-guard over a matter of supposedly-settled law. Under this scenario, the Court in its more recent holdings is attempting, belatedly, to forestall the Supreme Court from overturning almost twenty years of accumulated precedent, by demonstrating that the petitioner's and amici's complaints about the Court's obviousness jurisprudence are overstated.
This reaction is in stark contrast to another area of great controversy in the Court, the decision in Cybor Corp. v. FAS Tech., Inc. that claim construction is a matter for the Court's de novo review, with no deference given to any findings by the trial court (see "Amgen Asks Supreme Court to Reverse Cybor"). Despite a vocal minority of the Federal Circuit expressing doubts about the practical utility of the Cybor rule, and the widespread appreciation of the negative consequences that have developed in implementing the rule, the Court has refused to reconsider Cybor en banc. Just last week, Amgen petitioned the Supreme Court to review the Federal Circuit's claim construction in Amgen Inc. v. Hoechst Marion Roussel, Inc., and its petition directly challenged the Cybor rule. It remains to be seen whether the Federal Circuit will take the opportunity to get its own house in order on this issue before the Supreme Court decides whether to grant certiorari and take the matter out of the Federal Circuit's hands.
For additional information, please see:
- "Eli Lilly and Co. v. Zenith Goldline Pharm., Inc. (Fed. Cir. 2006)" - December 28, 2006
- "Medimmune, Inc. v. Genentech, Inc. (2007)" - January 9, 2007
- "Pfizer, Inc. v. Apotex, Inc. (Fed. Cir. 2007)" - March 25, 2007