ANDA Statements Fatal to DOE Defense

A recent order from the Federal Circuit serves as a good reminder that a party’s statements in its ANDA may be used against the party in litigation.  Intendis GmbH v. Glenmark Pharms. Inc., 822 F.3d 1355 (Fed. Cir. 2016).  The Court relied on statements in the ANDA about the function of the claimed excipients to conclude that a different excipient satisfied those claim elements under the doctrine of equivalents.

The Federal Circuit affirmed the district court’s determination that Glenmark’s generic version of Finacea® Gel infringed an Intendis’ patent under the doctrine of equivalents.  The central dispute was whether the excipient isopropyl myristate in Glenmark’s generic product met the claim elements of triglyceride and lecithin under the doctrine of equivalents.  The district applied the function-way-result test and concluded it did.  On appeal, Glenmark challenged the district court’s finding with respect to the function portion of the tripartite test.  Several experts had testified that the claimed excipients could act as “penetration enhancers” and nothing in the record indicated that they could not.

On appeal, Glenmark argued that the patentee had failed to prove that the function of the claimed excipients was as penetration enhancers.  Glenmark based its argument of the absence of such evidence in the record, including the lack of any statements in the specification indicating that this was the function of the claimed excipients.  The Federal Circuit found no clear error in the district court’s finding.  The Federal Circuit held that it is not necessary that the specification describe the function of each claim element; instead, the court should determine what a POSA would have considered the function of the claimed element to be.  The Federal Circuit then found that Glenmark’s repeated statements in its ANDA that the claimed excipients function as penetration enhancers tended to show that one skilled in the art would have understood them to function as penetration enhancers.  As the Court explained, “[f]atal to Glenmark’s argument is its own ANDA submission to the FDA repeatedly referring to the claimed excipients (triglyceride and lecithin) as penetration enhancers.”  Glenmark counsel’s arguments during the Federal Circuit hearing that the FDA statements were a “guess” and “wrong” were insufficient to persuade the panel.  Therefore, the Federal Circuit held that the district court did not clearly err in its finding regarding infringement under the doctrine of equivalents.

Takeaway:  Statements in the ANDA may come back to haunt the generic manufacturer during litigation.  The inclusion, whether inadvertent or deliberate, of uncertain or erroneous descriptions may be fatal to later litigation arguments, particularly on the issue of infringement under the doctrine of equivalents.