CAFC OKs Expert Testimony on PHOSITA

In proving obviousness in patent litigation, expert testimony may be used to establish the knowledge that a person of ordinary skill in the art would have possessed at a given time, the U.S. Court of Appeals for the Federal Circuit ruled Sept. 6.

The ruling comes as the Supreme Court prepares to review the Federal Circuit's obviousness standard in a case to be heard this term, KSR v. Teleflex. Some commentators see last week's ruling as the Federal Circuit's "brief" to the Supreme Court in support of its standard.

The case, Alza Corporation v. Mylan Laboratories, involved Alza's patent for a once-a-day, extended-release formulation of the anti-incontinence drug oxybutynin. Mylan sought to market a generic version of the drug and successfully challenged the validity of Alza's patent in the district court. The district court invalidated Alza's patent as both anticipated and obvious under the prior art.

On appeal, the Federal Circuit, in a decision written by Circuit Judge Arthur J. Gajarsa, affirmed the district court's decision on obviousness. In so doing, it reviewed its obviousness standard in detail.

In particular, the court focused on the question of whether the person having ordinary skill in the art (sometimes shorthanded as PHOSITA) would have had the motivation to combine the prior art that would have led that person to the combination involved in the claims. This is the "motivation-suggesting-teaching" requirement at issue before the Supreme Court in the KSR case.

Alza argued that, when it obtained its patent in 1995, this motivation would not have existed based on the prior art. But Mylan presented expert testimony contradicting that assertion.

This motivation-to-combine test, the court explained, is intended to avoid the exercise of hindsight and enable obviousness to be determined as of the time of the invention. "At its core, our anti-hindsight jurisprudence is a test that rests on the unremarkable premise that legal determinations of obviousness, as with such determinations generally, should be based on evidence rather than on mere speculation or conjecture," the court said.

The court further said that it does not intend the test to be applied rigidly. "There 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."

In concluding that the district court's findings as to obviousness were not "clearly erroneous," the Federal Circuit said that expert-witness testimony was relevant to the court's findings.

"[I]t is essential to recognize that, as we have explained above, under our non-rigid 'motivation-suggesting-teaching' test, a suggestion to combine need not be found in the prior art," Judge Gajarsa wrote.

"Accordingly, where the testimony of an expert witness is relevant to determining the knowledge that a person of ordinary skill in the art would have possessed at a given time, this is one kind of evidence that is pertinent to our evaluation of a prima facie case of obviousness."

The full text of the opinion is available at www.fedcir.gov/opinions/06-1019.pdf.

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