In its second obviousness decision issued within a week, the U.S. Court of Appeals for the Federal Circuit, in an opinion apparently written as much to the Supreme Court as to the parties, the lower courts and the Bar, defended its "motivation-suggesting-teaching" (MST) test as preventing "statutory proscribed hindsight" and ensuring that obviousness determinations are "based on evidence rather than mere speculation or conjecture." Alza Corp. v. Mylan Laboratories, Inc., Case No. 06-1019 (Fed. Cir., Sept. 6, 2006) (Gajarsa, J.).
This litigation arose from Mylan’s filing of an Abbreviated New Drug Application (ANDA) for once-daily, controlled-release formulations of oxybutynin, a drug used to treat urinary incontinence. The district court found the asserted claims of Alza’s patent to be invalid as obvious in light of the prior art. Alza appealed.
The Federal Circuit, apparently mindful of the criticism it had received from the petitioner and amicus curiae filings in the recently filed Supreme Court briefs in KSR v. Telflex, opened its discussion with focus on the statute, § 103, as well as the seminal Supreme Court case on obviousness, Graham v. John Deere Co. Quoting from Graham, the Court likened the motivation requirement to the Graham objective evidence on secondary considerations "serv[ing] to guard against slipping into use of hindsight and to resist the temptation to read into the prior art the teachings of the invention in issue." Then, quoting its own recent In re Kahn decision, the Federal Circuit explained that "[a]ccording to the ‘motivation-suggesting-teaching’ test, a court must ask ‘whether a person of ordinary skill in the art, possessed with the understandings and knowledge reflected in the prior art, and motivated by the general problem facing the inventor, would have been led to make the combination recited in the claims."
Apparently stung by criticism that MST requirement, as applied by the Court, has been intractable and inflexible, the Court insisted that "[t]here is flexibility in our obviousness jurisprudence because a motivation may be found implicitly in the prior art. We do not have a rigid test that requires an actual teaching to combine before concluding that one of ordinary skill in the art would know to combine references. This approach, moreover, does not exist merely in theory but in practice, as well." Finally, and in an apparent nod to the chorus of voices criticizing the perceived rigidity of the MST requirement, the Court noted that its "approach has permitted us to continue to address an issue of law not readily amenable to bright-line rules, as we recall and are guided by the wisdom of the Supreme Court in striving for a ‘practical test of patentability.’"
Emphasizing this flexibility, the Court affirmed the district court’s invalidity finding. The Court focused its discussion on "one predicate to a finding of obviousness: that a person of ordinary skill in the art would have had a ‘motivation to combine’ the prior art to achieve the claimed invention and would have had a ‘reasonable expectation of success’ in doing so." Alza argued that a person of ordinary skill in the art in 1995 would have had no reason to expect that an extended-release oxbutynin formulation would have therapeutic value. The Court disagreed, noting that under its "non-rigid ‘motivation-suggesting-teaching’ test, a suggestion to combine need not be found in the prior art." (Emphasis supplied.) In the present case the Court looked to the expert testimony regarding absorption of oxybutynin in the GI tract and concluded that the findings of the district court "were not clearly erroneous."
Practice Note
This case, viewed together with the recently decided Ormco Corp. v. Align Technology, Inc. case discussed above suggests an effort by the Federal Circuit to undercut the petitioner’s arguments in the pending KSR International v. Telflex Supreme Court appeal that the Federal Court motivation-suggesting-teaching requirement is an inflexible, non-statutory and ultimately obviousness-defeating overlay to § 103 and Graham v. John Deere that has led to a plethora of junk patents.
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