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Alza Corporation v. Mylan Laboratories, Inc., et al.

Posted in Opinion Commentary by Jake Ward on September 8, 2006

A Suggestion To Combine Need Not Be Found in the Prior Art Under “Our Non-Rigid ‘Motivation-Suggesting-Teaching’ Test.”

(Fed. Cir. 2006, 06-1019)

On appeal from the district court, Alza contested the judgment of noninfringement by Mylan and invalidity of claims in Alza’s U.S. Patent No. 6,124,355 (the 355 patent).  The CAFC affirmed the judgment in favor of Mylan and found the disputed claims to be obvious in light of three prior art references.

The technology at issue relates to a once-a-day controlled release formulation of the anti-incontinence drug oxybutynin, marketed by Alza as Ditropan XL®.   Important to the analysis in this opinion, oxybutynin has lipophilic characteristics.  Mylan had filed two Abbreviated New Drug Applications (“ANDAs”) for a generic version of the drug, and the litigation arose out of these filings. 

The primary issue confronting the CAFC regarding validity of Alza’s claims was whether one of ordinary skill in the art would have been motivated to combine the cited references, which in combination described all the elements of the disputed claims?  In particular, Alza argued that there was no motivation to design an oral dosage form capable of releasing oxybutynin over more than an approximately 8-12 hour time course, because such drug would be released in the colon, and one of ordinary skill in the art would not have believed that oxybutynin could be absorbed at that point in the GI tract.

In reaching a conclusion of invalidity based on obviousness, the CAFC relied upon the “motivation-suggesting-teaching” (TSM) test.  The TSM test was applied “against the background of the Graham factors” in an attempt “to reach a nonhindsight driven conclusion.”  Interestingly (and maybe with KSR v. Teleflex at the forefront of the court’s collective mind), the CAFC stressed the flexibility of the TSM test in stating that such factors can 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 [flexible] 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.”

The CAFC also highlighted the history of the test, as related to CCPA holdings that have been “developed consistent with the Supreme Court’s obviousness jurisprudence as expressed in Graham.”    

In light of the above standards, the court relied upon witness testimony and journal references which demonstrated the general predictive utility of lipophilicity in estimating the extent of colonic absorption.  Thus, while colonic absorption of oxybutynin was not guaranteed, the evidence was clear and convincing in that a person of ordinary skill in the art would have been motivated to combine the prior art references to make the claimed invention.  Thus, the holding of invalidity based on obviousness was affirmed.

JW Note:  See also the recent opinion of Ormco Corporation, et al. v. Align Technology, Inc. , also discussing obviousness standards

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